1. PHARMACEUTICAL AFFAIRS LAW (Law No.145 of August 10, 1960) Revisions (１) Law No. 161, 1962 (10) Law No. 33, 1990 (２) Law No. 135, 1963 (11) Law No. 46, 1992 (３) Law No. 51, 1969 (12) Law No. 27, 1993 (４) Law No. 37, 1975 (13) Law No. 89, 1993 (５) Law No. 27, 1978 (14) Law No. 50, 1994 (６) Law No. 87, 1978 (15) Law No. 84, 1994 (７) Law No. 56, 1979 (16) Law No. 104, 1996 (８) Law No. 57, 1983 (17) Law No. 105, 1997 (９) Law No. 78, 1983 CONTENTS Chapter I General Provisions (Articles 1, 2) 5 Chapter II Pharmaceutical Affairs Council (Articles 3, 4) 7 Chapter III Pharmacies (Articles 5－11) 7 Chapter IV Manufacturers and Importers of Drugs, etc. 11 Section 1. Manufacturers (Articles 12－21) Section 2. Importers (Articles 22, 23) Chapter IV-2 Designated Review Organizations (Articles 23-2－23-15) 29 Chapter V Selling Drugs and Selling and Leasing Medical Devices (Articles 24－40) 37 Chapter VI Standards and Tests for Drugs, etc. (Articles 41－43) 43 Chapter VII Handling of Drugs, etc. 45 Section 1. Handling of Poisonous and Powerful Drugs (Articles 44－48) Section 2. Handling of Drugs (Articles 49－58) Section 3. Handling of Quasi-Drugs (Articles 59, 60) Section 4. Handling of Cosmetics (Articles 61, 62) Section 5. Handling of Medical Devices (Articles 63－65) Chapter VIII Advertising of Drugs, etc. (Articles 66－68) 57 Chapter IX Surveillance (Articles 69－77) 59 Chapter IX-2 Designation, etc. of Orphan Drugs and Orphan Medical Devices (Article 77-2－Article 77-2-6) 69 Chapter X Miscellaneous Provisions (Articles 77-3－83-2) 73 Chapter XI Penal Provisions (Articles 84－89) 85 Additional Provisions 90 Chapter I General Provisions (Purpose) Article 1 The purpose of this Law is to control and regulate matters required toassure the quality, efficacy and safety of drugs, quasi-drugs, cosmetics and medical devices and to improve public health and hygiene by taking the measures required to promote research and development of drugs and medical devices which are especially important for medical practice. (Definition) Article 2 The term "drug" in this Law refers to the following items: (1) Items recognized in the Japanese Pharmacopoeia (2) Items (other than quasi-drugs) which are intended for use in the diagnosis, cure or prevention of disease in humans or animals, and which are not equipment or instruments (including dental materials, medical supplies and sanitary materials; the same hereinafter) (3) Items (other than quasi-drugs and cosmetics) which are intended to affect the structure or functions of the body of humans or animals, and which are not equipment or instruments. 2. The term "quasi-drug" in this Law refers to the following items. These shall be items (other than equipment or instruments) which have mild action on the human body and similar items designated by the Minister of Health and Welfare (hereinafter referred to as "the Minister"). These items shall exclude those intended at the same time for the uses in (2) or (3) of the preceding paragraph. (1) Items to prevent nausea or other discomfort, or those to prevent bad breath or body odor; (2) Items to prevent heat rash, festering and the like (3) Items to prevent the loss of hair, or those to grow or remove hair (4) Extermination or prevention of rats, flies, mosquitoes, fleas, etc. to assurethe health of humans or animals. 3. The term "cosmetic" in this Law refers to items (other than quasi-drugs) with mild action on the human body and which are intended to be applied to the human body by means of rubbing, sprinkling and the like for the purpose of cleaning, beautifying, adding to the attractiveness, altering the appearance, or keeping the skin or hair in good condition, excluding those intended at the same time for the uses specified in Paragraph 1, Item (2) or (3). 4. The term "medical device" in this Law refers to equipment or instruments intended for use in the diagnosis, cure or prevention of disease in humans or animals, or intended to affect the structure or functions of the body of humans or animals, and which are designated by cabinet order. 5. The term "pharmacy" in this Law refers to the place where a pharmacist engages in dispensing drugs for the purpose of sale or giving (including the place necessary for selling drugs in cases where the proprietor concurrently sells drugs), excluding dispensaries in hospitals or clinics, or in veterinary clinics [clinics as specified in the provisions of Article 2, Paragraph 2 of the Veterinary Service Law (Law No. 46. 1992), including residences of persons who provide medical care for domestic animals by veterinarians only on an outside visit basis; the same hereinafter] 6. The term "orphan drug" in this Law refers to drugs which have been designated pursuant to the provisions of Article 77-2, Paragraph 1, and "oprhan medical device" refers to medical devices which have been designated pursuant to the provisions of the same article. 7. The term "clinical trial" in this Law refers to clinical trials performed for the purpose of collection of data related to the results of the clinical trial for inclusion among the data submitted pursuant to the provisions of Article 14, Paragraph 3 (applied mutatis mutandis to Article 14, Paragraph 6; Article 19-2, Paragraph 4 and Article 23). Chapter II Pharmaceutical Affairs Council (Central Pharmaceutical Affairs Council) Article 3 The Central Pharmaceutical Affairs Council shall be established in the Ministry of Health and Welfare (hereinafter referred to as the "MHW") to perform reviews and deliberations, in response to inquiries from the Minister, concerning important matters related pharmaceutical affairs (including those concerning medical devices; the same hereinafter). 2. The organization and management of the Central Pharmaceutical Affairs Council and other necessary matters concerning the Central Pharmaceutical Affairs Council shall be determined by cabinet order. (Local Pharmaceutical Affairs Council) Article 4 A Local Pharmaceutical Affairs Council may be established in each prefecture (including To, Do, Fu or Ken; the same hereinafter) in order to perform reviews and deliberations in response to inquiries from the prefectural governor, concerning important matters related to pharmaceutical affairs originally pertaining to the prefecture concerned and the affairs designated by cabinet order from among those affairs which fall under the authority of the governor of the prefecture concerned under the provisions of this Law. 2. The organization and management of the Local Pharmaceutical Affairs Council and other necessary matters concerning the Local Pharmaceutical Affairs Council shall be established by the prefectural bylaw concerned. Chapter III Pharmacies (License for Establishment) Article 5 No one shall establish a pharmacy without a license from the governor of the prefecture where the pharmacy is located. 2. The license mentioned in the preceding paragraph shall become invalid unless it is renewed every 6 years. (License Standards) Article 6 In either of the following cases,the license under Paragraph 1 of the preceding article might not be granted: (1) When the structure or facilities of the pharmacy are not in conformity with the standards laid down by MHW ordinance (1)-2 When the number of pharmacists engaged in actual work related to pharmaceutical affairs in the pharmacy does not conform to that laid down by MHW ordinance (2) When the applicant (including the working directors in the case of a corporation; the same in Article 13, Paragraph 2, Item (3) and Article 19-2, Paragraph 2) comes under any one of the following headings: (a) A person whose license was canceled less than 3 years before pursuant to the provisions of Article 75, Paragraph 1 (b) A person who was given a court sentence of imprisonment or a more severe sentence and who, less than 3 years before, completed serving, or was exempted from the execution of the sentence (c) Except for those who fall under (a) or (b), a person who, less than 2 years before, violated any of the laws and ordinances related to pharmaceutical affairs, such as this Law, the Narcotics and Psychotropic Drug Control Law (Law No. 14, 1953) and the Poisonous and Powerful Substances Control Law (Law No. 303, 1950), or any of the measures taken in accordance with these laws and ordinances: (d) A person adjudged incompetent, a mental patient, or a person addicted to narcotics, cannabis, opium or a stimulant drug (e) A person who, in view of his proclivities and conduct, is considered certain to impede greatly the pharmacist supervising the pharmacy in the performance of his duties as specified in Article 9. (Restriction in Using the Designation of Pharmacy) Article 7 Any place in which drugs are handled and which is not an establishment licensed as a pharmacy under Article 5, Paragraph 1 (hereinafter referred to simply as "pharmacy"), shall refrain from using the designation of pharmacy, except in cases specified by MHW ordinance. (Supervision of Pharmacies) Article 8 A person who is licensed in accordance with the provisions of Article 5, Paragraph 1 (hereinafter referred to as "proprietor of a pharmacy") shall, if he is a pharmacist, supervise technically the pharmacy by himself in actual practice. This regulation shall not apply when the proprietor of a pharmacy designates a pharmacist, from among other pharmacists engaged in actual business related to pharmaceutical affairs in the pharmacy, as supervisor for the practical administration thereof. 2. A proprietor of a pharmacy, if he is not a pharmacist, shall designate a pharmacist, from among the pharmacists engaged in actual business related to pharmaceutical affairs in the pharmacy, as technical supervisor for the practical supervision thereof. 3. A supervisor of a pharmacy (including a proprietor supervising the pharmacy in actual practice pursuant to the provisions of Paragraph 1; the same in Article 9, Paragraph 1) shall not concurrently engage in the supervision of any other pharmacy or in any other pharmaceutical business at any place other than the pharmacy he or she supervises. Exemptions to this rule may be granted under permission from the governor of the prefecture where the pharmacy is located. (Duty of Supervisor) Article 9 In order not to jeopardize public health and hygiene, a supervisor of a pharmacy shall take good care of the business of the pharmacy, such as supervising pharmacists or other employees working in the pharmacy, and taking charge of the drugs and other articles therein and of the structure and facilities of the pharmacy. 2. A supervisor of a pharmacy shall state his or her opinions required in relation to performing his or her duties in the pharmacy to the proprietor of the pharmacy in order not to jeopardize public health and hygiene. (Items to Be Observed by Proprietors of Pharmacies) Article 9-2 The Minister shall be able to specify by means of MHW ordinances items which the proprietor of a pharmacy shall observe with respect to the operation of the pharmacy including methods of performing tests and inspections of drugs in the pharmacy and other items for which care is necessary when the supervisor of the pharmacy performs his or her duties. 2. When the proprietor of a pharmacy designates a supervisor of the pharmacy pursuant to the provisions of the proviso of Paragraph 1 and Paragraph 2 of Article 8, the proprietor shall respect the opinions of the supervisor of the pharmacy pursuant to the provisions of Article 9, Paragraph 2. (Notification of Abolishment, Suspension, etc.) Article 10 When the proprietor of a pharmacy has closed down his pharmacy, suspended business, or resumed business which had been suspended, or when he has appointed a different supervisor for this pharmacy or has altered other matters laid down by MHW ordinance, he shall give notice within 30 days to the governor of the prefecture where his pharmacy is located. (Mandate to Cabinet Order) Articele 11 Regulations which are supplementary to the provisions of this Chapter and which are necessary for the licensing and the establishment of pharmacies, for the renewal of licences, and for the administration, as well as other necessary matters concerning pharmacies, shall be laid down by cabinet order as required. Chapter IV Manufacturers and Importers of Drugs, etc. Section 1. Manufacturers (License for Manufacture) Article 12 Any person who has not obtained a license for manufacturing drugs, quasi-drugs, cosmetics or medical devices shall not professionally manufacture (including repackaging; the same hereinafter) drugs, quasi-drugs, cosmetics or medical devices. 2. The license specified in the preceding paragraph shall be granted by the Minister for each manufacturing factory. 3. The license in Paragraph 1 shall become invalid unless it is renewed after a period of not less than 3 years specified by cabinet order . (License Criteria) Article 13 If the product which the applicant for the license mentioned in Paragraph 1 of the preceding article intends to manufacture is a drug, quasi-drug, cosmetic or medical device specified in Article 14, Paragraph 1, and is a product for which the applicant has not obtained approval of the Minister as provided for in the same article (including application mutatis mutandis in Article 23), the license specified in Paragraph 1 of the preceding article shall not be granted with respect to such a product. 2. In any of the following cases, the license specified in Paragraph 1 of the preceding article might not be granted. (1) When the structure or facilities of the factory are not in conformity with the standards laid down by MHW ordinance; (2) When the product manufactured by the applicant is a drug, quasi-drug, cosmetic or medical device specified by cabinet order, and the methods of manufacturing control or quality control used in the factory concerned do not comply with the standards laid down by MHW ordinance. (3) When the applicant corresponds to any of (a) to (e) in Article 6, Item (2) of the Law. (Special Licenses Prior to Approval) Article 13-2 If the product which the applicant for the license mentioned in Article 12, Paragraph 1 intends to manufacture is a drug corresponding to any one of the following items as specified by cabinet order, the applicant shall, notwithstanding the provisions of Paragraph 1 of the preceding article, be able to obtain the license mentioned in Article 12, Paragraph 1 for such a product without the approval of the Minister pursuant to the provisions of the following article (including application mutatis mutandis in Article 23; the same in the following paragraph). However, this does not apply when the applicant does not file the approval application concerned. (1) Drugs required for use in emergencies to prevent the spread of diseases which might have major effects on the life and health of the public and for which no appropriate methods other than such drugs exist. (2) With respect to use, drugs which are sold, given or stored or exhibited for the purpose of sale or giving in a foreign country (limited countries which have a system of approval of drugs for manufacture or import which assures that the drug has quality, efficacy and safety equivalent to those obtained in Japan, or an equivalent system, as specified by cabinet order). 2. The Minister shall, when it is found necessary in order not to jeopardize public health and hygiene, be able to have the person who has received a license as specified in Article 12, Paragraph 1 pursuant to the provisions of the preceding paragraph submit reports to the Minister or take other measures as specified by cabinet order when diseases, injuries or death suspected to be caused by use of the product occur with respect to products related to the license concerned (excluding products approved by the Minister pursuant to the provisions of the following article). (Approval to Manufacture Drugs) Article 14 When an application has been made in regard to a drug (excluding those drugs designated by the Minister with specified standards), a quasi-drug, a cosmetic containing ingredients designated by the Minister, or a medical device (excluding those designated by the Minister with specified standards), by a person intending to manufacture it, the Minister shall, for every item, give his approval for its manufacture. 2. The approvals mentioned in the previous paragraph shall be based on a review of the name, ingredients and quantities, structure, directions and dosage, method of use, indications and effects, performance, adverse reactions, etc. of the drug, quasi-drug, cosmetic or medical device concerned. Approvals shall not be granted when any of the following conditions are met: (1) The drug, quasi-drug or medical device is not shown to possess the indications, effects or properties indicated in the application. (2) The drug, quasi-drug or medical device in the application is found to haveno value as a drug, quasi-drug or medical device because it has harmful action which outweighs its indications, effects and properties. (3) In addition to the cases indicated in the preceding two items, the drug, quasi-drug, cosmetic or medical device is designated by MHW ordinance as not being appropriate as a drug, quasi-drug, cosmetic or medical device. 3. Persons who wish to obtain approvals pursuant to the provisions of Paragraph 1 shall attach data concerning the results of clinical trials and other pertinent data to their applications. When the drug concerned in such applications is specified by MHW ordinance, the data concerned must be collected and compiled in accordance with standards specified by the Minister. 4. In the reviews pursuant to the provisions of Paragraph 2, the quality, efficacy and safety of the drug concerned shall be examined (including examinations of the equivalence of ingredients and quantities, structure, directions and dosages, method of use, indications, performance, etc. to those of products which have already been approved for manufacture or import) based on the contents of the application for the drug concerned and the data specified in the first part of the preceding paragraph. When the drug is one specified by MHW ordinance pursuant to the provisions of the last part of the preceding paragraph, an examination in writing or an on-site examination shall be performed beforehand to determine if the data for the drug concerned complies with that specified in the last part of the preceding paragraph. 5. When the Minister confirms that drugs or medical devices in applications for approval as specified in Paragraph 1 are orphan drugs, orphan medical devices or other drugs or medical devices which are particularly important in medical practice, reviews of these drugs or medical devices pursuant to the provisions of Paragraph 2 may be given priority over those of other drugs or medical devices. 6. When persons who have received an approval as specified in Paragraph 1 wish to make a partial change of approved items, it shall be possible to obtain approvals for such changes. In such cases, the provisions of the preceding paragraphs shall apply mutatis mutandis. (Reviews Performed by the Organization for Drug ADR Relief, R&D Promotion and Product Review) Article 14-2 The Minister of Health and Welfare may have all or part of the review work specified by cabinet order among the reviews based on the provisions of the first part of Paragraph 4 of the previous article (including application mutatis mutandis in Paragraph 6 of the same article) of drugs (excluding those intended for exclusive use with animals; the same hereinafter in this article), quasi-drugs (excluding those intended for exclusive use with animals; the same hereinafter in this article) quqsi-drugs (excluding those intended for exclusive use with animals; the same hereinafter in this article) and cosmetics and the reviews based on the provisions of the last part of Paragraph 4 of the previous article (including application mutatis mutandis in Paragraph 6 of the same article) of drugs performed by the Organization for Drug ADR Relief, R&D Promotion and Product Review (hereinafter referred to as the "Drug Organization"). 2. When the Minister has all or part of the review work performed by the Drug Organization as specified in the preceding paragraph, the Minister shall not perform all or part of the review concerned. In such cases, the Minister must perform the review in accordance with the provisions in Paragraph 2 of the preceding article (including cases where it applies mutatis mutandis under Paragraph 6 of the same article) in consideration of the results of the review notified by the Drug Organization in accordance with the provisions of Paragraph 4 . 3. When the Minister has all or part of the work performed by the Drug Organization pursuant to the provisions of Paragraph 1, the person who wishes to obtain approval as specified in Paragraph 1 or Paragraph 6 of the preceding article for the drug, quasi-drug or cosmetic shall submit the application to the Drug Organization as specified by MHW ordinance for the review performed by the Drug Organization notwithstanding the provisions of Paragraphs 1 and 6 of the same article. 4. When the Drug Organization performs a review based on applications as specified in the preceding paragraph, it shall notify the Minister without delay of the results of the review concerned as specified by MHW ordinance. 5. The Minister may be requested to undertake a review with respect to the disposition related to the review (excluding the review results) performed by the Drug Organization or its omission in accordance with the Administrative Appeal Law (Law No.160, 1962). (Reviews by Designated Review Organizations) Article 14-3 The Minister may have all or part of the reviews specified by cabinetorder among the reviews pursuant to the provisions of Article 14, Paragraph 4 (including cases where it is applied mutatis mutandis under Article 14, Paragraph 6) for medical devices (excluding those used exclusively for animals ; hereinafter the same in this article) performed by designated persons (hereinafter referred to as "designated review organizations"). 2. When the Minister has all or part of the review performed by a designated review organization pursuant to the provisions of the preceding paragraph, the Minister shall not perform all or part of the review concerned himself. In such cases, the Minister shall perform the review in accordance with the provisions of Article 14, Paragraph 2 (including cases where it is applied mutatis mutandis under Article 14, Paragraph 6) in consideration of the results of the review notified by the designated review organization as specified in Paragraph 4. 3. When the Minister has all or part of the review performed by a designated review organization pursuant to the provisions of Paragraph 1, persons receiving approval for medical devices in Article 14, Paragraph 1 or Paragraph 6, must submit an application to the designated review organization as specified by MHW ordinance for the review performed by the designated review organization notwithstanding the specifications in Paragraphs 1 and 6 of the same article. 4. When a designated review organization performs a review based on applications as specified in the preceding paragraph, it shall notify the Minister without delay of the results of the review concerned as specified by MHW ordinance. 5. The provisions in Paragraph 5 of the preceding article shall apply mutatis mutandis to designated review organizations. (Reexamination of New Drugs and New Medical Devices) Article 14-4 Persons who have received manufacturing approvals pursuant to the provisions of Article 14 for the drugs or medical devices indicated in the following items shall apply within the period specified in each item for the drug or medical device concerned for a reexamination by the Minister. (1) Drugs or medical devices which are designated by the Minister at the time of granting approval as drugs for which the active ingredients and quantities, directions and dosage, indications and effects, etc. or as medical devices for which the structure, method of use, indications and effects or performance are clearly different from those of drugs or medical devices which have already been approved for manufacture or import (hereinafter referred to as "new drugs" or "new medical devices")：Within 3 months (referred to the "application period" in the following items) from the date on which the period specified in the following items (hereinafter referred to as the "reexamination period") has passed. (a) A period designated by the Minister of at least 6 years but not exceeding 10 years from the date of the manufacturing approval for orphan drugs or other drugs specified by MHW ordinance which the Minister designates after hearing the opinion of the Central Pharmaceutical Affairs Council. (A period designated by the Minister of at least 4 years but not exceeding 7 years for orphan medical devices or other medical devices which the Minister designates) (b) A period designated by the Minister not exceeding 6 years (4 years for medical devices) from the date of manufacturing approval for drugs or medical devices for which only the indications and effects clearly differ from those of drugs or medical devices which have already been approved for manufacture or import [excluding drugs or medical devices in (a) above] or other drugs specified by MHW ordinance which the Minister designates after hearing the opinion of the Central Pharmaceutical Affairs Council. (c) Six years from the date of manufacturing approval for drugs or medical devices other than those specified in (a) or (b) above. (2) Drugs or medical devices which are designated by the Minister at the time of granting manufacturing approval as drugs for which the active ingredients and quantities, directions and dosage, indications and effects, etc. or medical devices for which the structure, method of use, indications and effects or performance are the same as those of new drugs or new medical devices [excluding those for which the reexamination period has passed from the date of manufacturing or import approval (the extended period when the reexamination period is extended pursuant to the provisions of the following article)]：A period designated by the Minister which corresponds to the application period (the application period specified on the basis of the period after the extension when the reexamination period is extended pursuant to the provisions of the following paragraph) 2. When the Minister confirms that it is especially necessary to perform proper reexaminations of new drugs, the Minister shall be able to extend the reexamination period to a period not exceeding 10 years from the date of manufacturing approval after hearing the opinion of the Central Pharmaceutical Affairs Council. 3. These reexaminations of the Minister shall be performed by confirming that the drugs or medical devices specified in the items of Paragraph 1 do not conform to any of the items in Paragraph 2 of Article 14 on the basis of findings obtained in the reexamination. 4. The applications specified in Paragraph 1 shall be made by means of an application form with data concerning the results of use of the drug or medical device and other data specified by MHW ordinance attached. When the drug concerned in such applications is specified by MHW ordinance, the data concerned must be collected and compiled in accordance with standards specified by the Minister. 5. The confirmation pursuant to the provisions of Paragraph 3 shall be performed by means of an examination of the quality, efficacy and safety of the drug or medical device concerned based on the contents of the application for the drug or medical device in each item of Paragraph 1 and the data specified in the first part of the preceding paragraph. When the drug in each item of Paragraph 1 is one specified by MHW ordinance pursuant to the provisions of the last part of the preceding paragraph, an examination in writing or an on-site examination (the "examination on compliance of reexamination data" in the following article) shall be performed beforehand to determine if the data for the drug concerned complies with that specified in the last part of the preceding paragraph. 6. Persons who have received approval to manufacture drugs or medical devices specified in the items in Paragraph 1 as indicated in Article 14 shall investigate the results of use, etc. for the drug or medical device concerned as specified by MHW ordinance and shall report these results to the Minister. 7. Persons who should receive reexaminations for drugs specified in MHW ordinance pursuant to the provisions of the last part of Paragraph 4, persons entrusted with the collection or compilation of data pursuant to the provisions of the last part of the same paragraph or their executives or employees shall not reveal secrets concerning the collection or compilation of data or the secrets of persons they have become acquainted with in connection with their work unless they have a valid reason for doing so. This shall also apply to persons whom such persons meet. (Application Mutatis Mutandis) Article 14-4-2 The provisions of Article 14-2 shall apply mutatis mutandis to the examination of compliance of reexamination data for drugs (excluding those intended for exclusive use with animals). (Reevaluations of Drugs and Medical Devices) Article 14-5 When the Minister designates ranges of drugs or medical devices to be reevaluated on hearing the opinion of the Central Pharmaceutical Affairs Council and this is made public, persons who have received approval to manufacture drugs or medical devices pursuant to the provision of Article 14 shall receive reevaluations of the designated drugs or medical devices by the Minister. 2. The reevaluations of the Minister shall be performed by confirming that the drugs or medical devices specified in the previous paragraph do not conform to any of the items in Article 14 Paragraph 2, on the basis of findings obtained in the reevaluation. 3. The publication specified in Paragraph 1 shall be accompanied by notification of the data to be submitted by the person who is to be subjected to the reevaluation, and the deadline for the submission of such data. 4. When the drugs specified in Paragraph 1 are those specified by MHW ordinance, the data submitted by the person receiving the reevaluation must be collected and compiled in accordance with standards specified by the Minister. 5. The confirmation pursuant to the provisions of Paragraph 2 shall be performed by means of an examination of the quality, efficacy and safety of the drug or medical device specified in Paragraph 1 based on the data submitted by the person receiving the reevaluation. When the drug in each item of Paragraph 1 is one specified by MHW ordinance pursuant to the provisions of the last part of the preceding paragraph, an examination in writing or an on-site examination (the "examination on compliance of reevaluation data" in the following article) shall be performed beforehand to determine if the data for the drug concerned complies with that specified in the last part of the preceding paragraph. 6. Persons who should receive reevaluations for drugs specified in MHW ordinance pursuant to the provisions of Paragraph 4, persons entrusted with the collection or compilation of data pursuant to the provisions of the last part of the same paragraph or their executives or employees shall not reveal secrets concerning the collection or compilation of data or the secrets of persons they have become acquainted with in connection with their work unless they have a valid reason for doing so. This shall also apply to persons whom such persons meet. (Application Mutatis Mutandis) Article 14-5-2 The provisions of Article 14-2 shall apply mutatis mutandis to the examination of compliance of reexamination data for drugs (excluding those intended for exclusive use with animals). (Supervision of the Manufacture of Drugs) Article 15 A drug manufacturer, unless he is a pharmacist and supervises the manufacture by himself and in actual practice, shall keep a pharmacist in every factory to supervise the manufacture in actual practice; however, when manufacturing drugs for which it is not necessary to have a pharmacist, he may, as specified by MHW ordinance, substitute a technician other than a pharmacist. 2. Notwithstanding the provisions of the preceding paragraph, a manufacturer of biological products or other drugs designated by the Minister, except when supervising his own factory by himself and in actual practice with the approval of the Minister, shall employ a physician, a person with a knowledge of bacteriology, or other technician, for each factory with the approval of the Minister, in order to supervise the manufacture in actual practice. 3. The provisions of Article 8, Paragraph 3 and Article 9, Paragraph 1 shall be applied mutatis mutandis to a person who supervises the manufacture of drugs under the provisions of the preceding two paragraphs (hereinafter referred to as "supervisor of drug manufacture"). In this case, in Article 8, Paragraph 3, "the governor of the prefecture where the pharmacy is located" shall read "the Minister". (Items to Be Observed by Manufacturers of Drugs and Medical Devices) Article 16 The Minister shall be able to specify by means of MHW ordinances items which manufacturers of drugs or medical devices shall observe with respect to their work including methods of performing tests and inspections of drugs or medical devices in the factory and other items for which care is necessary when the supervisor of drug manufacture of the responsible technician performs his or her duties. (Responsible Technician for Manufacturing Quasi-Drugs, Cosmetics or Medical Devices) Article 17 A manufacturer of quasi-drugs, cosmetics or medical devices shall, as specified by MHW ordinance, employ a responsible technician for each factory for the practical supervision of the manufacture of quasi-drugs, cosmetics or medical devices. 2. The provisions of Article 9, Paragraph 1 shall apply mutatis mutandis to the responsible technician in the preceding paragraph. (License for Changes, etc. in Manufactured Items) Article 18 When a manufacturer of drugs, quasi-drugs, cosmetics or medical devices wants to change or add to the items to be manufactured in his factory, he shall obtain a license from the Minister. 2. The provisions of Article 13 and Article 13-2 shall be applied mutatis mutandis to the license in the preceding paragraph. (Notification of Abolishment, Suspension,etc.) Article 19 When a manufacturer has closed down his factory, suspended operation of his factory, or resumed operation he had previously suspended, or when he has appointed a different supervisor of drug manufacture or responsible technician in his factory for quasi-drugs, cosmetics or medical devices or changed other matters as specified by MHW ordinance, he shall give notice to the Minister within 30 days. (Approvals to Manufacture Drugs, etc. Manufactured in Foreign Countries) Article 19-2 When applications are received for manufacture in foreign countries of drugs, quasi-drugs, cosmetics or medical devices as specified in Article 14, Paragraph 1, in order to export to Japan, the Minister shall be able to grant approvals for the manufacture of such drugs, etc. 2. In cases where an applicant has had canceled all or part of approval pursuant to the provisions of Article 75-2, Paragraph 1 and a period of 3 years has not passed from the date of the cancellation, the Minister may refuse to grant the approval specified in the preceding paragraph. 3. In order to take the necessary measures to prevent hazards to public health and hygiene by drugs, quasi-drugs, cosmetics or medical devices approved, persons who seek approval as specified in Paragraph 1 must appoint at the time of approval application a person corresponding to the standards specified in MHW ordinance from among persons domiciled in Japan (including a representative of the office concerned in the case of foreign corporations with offices in Japan). 4. To the approvals specified in Paragraph 1, the provisions of Article 14, Paragraphs 2 to 6 inclusive and Article 14-2 shall apply mutatis mutandis. 5. The provisions of Article 14-2 and Article 14-3 shall apply mutatis mutandis for approvals in Article 14, Paragraph 6 which apply mutatis mutandis in the preceding paragraph. (Notification of Changes Concerning In-Country Caretakers) Article 19-3 When persons who have received manufacturing approval pursuant to the provisions of the preceding article have changed the person designated pursuant to the provisions of Paragraph 3 of the same article (hereinafter referred to as the "in-country caretaker") or when the name, address or other items concerning the in-country caretaker designated by MHW Ordinance are changed, such changes shall be reported to the Minister within 30 days. (Application Mutatis Mutandis) Article 19-4 The provisions of Articles 14-4 to 14-5-2 and Article 16 shall apply mutatis mutandis to persons who have received manufacturing approvals pursuant to the provisions of Article 19-2. (Items to Be Observed by In-Country Caretakers) Article 19-5 The Minister shall be able to specify by means of MHW ordinances items which in-country caretakers shall observe with respect to their work including methods for the collection of information required for the proper use of drugs. (Application or Notification via a Prefectural Governor) Article 20 The application for a license, for the renewal of a license, or for approval (excluding approval under the provisions of Article 14 and Article 19-2) and also the notifications (excluding notifications in accordance with Article 19-3), which are specified in this section, shall be made via the governor of the prefecture where the factory is located. 2. The application for approval provided for in Article 14, for reexamination provided for in Article 14-4 and for reevalution provided for in Article 14-5 shall be made via the governor of the prefecture in which the applicant's residence (signifying the head office, in the case of a corporation; the same hereinafter) is located. However, the application may also be made via the governor of the prefecture where the drug concerned is to be manufactured or the factory is located. 3. Applications for approvals pursuant to the provisions of Article 19-2, notifications pursuant to the provisions of Article 19-3, and applications for reexamination pursuant to the provisions of Article 14-4 which apply mutatis mutandis to the preceding article or for reevaluations pursuant to the provisions of Article 14-5 shall be made through the governor of the prefecture where the in-country caretaker is domiciled (where the office is located in cases of a representative of a foreign corporation which has an office in Japan). (Exceptions for Manufacturing etc in Two or More Factories) Article 20-2 When the manufacturing process of one drug, quasi-drug, cosmetic or medical device is conducted in two or more factories, or when the manufacture of medical devices refers to repair of existing medical devices, the application of part of the provisions in this section may be exempted and other exceptions may be specified as required by cabinet order. (Mandate to MHW Ordinance) Article 21 Matters not covered by the provisions of this section, insofar as they relate to licensing for manufacture, renewal of licenses, approval of items for manufacture, reexamination or reevaluations of such items, and supervision of factories, as well as other necessary matters concerning the manufacturing of drugs, quasi-drugs, cosmetics or medical devices (including manufacturing conducted by persons who have received approval in accordance with the provisions in Article 19-2), shall be regulated by MHW ordinance. Section 2. Importers (License for Import) Article 22 No person who has not obtained the license for importing drugs, quasi-drugs, cosmetics or medical devices shall professionally import drugs, quasi-drugs, cosmetics or medical devices. 2. The license specified in the preceding paragraph shall be granted by the Minister to each business office. 3. The license in Paragraph 1 shall become invalid unless it is renewed after a period specified by cabinet order of not less than 3 years. (Application Mutatis Mutandis) Article 23 To importers of drugs, quasi-drugs, cosmetics and medical devices, the provisions of Articles 13 to 19 inclusive, Article 20, Paragraphs 1 and 2, and Article 21 shall apply Mutatis Mutandis. In such cases, "the applicant has not obtained approval of the Minister" in Article 13, Paragraph 1 shall read "the applicant has not obtained approval of the Minister (excluding cases where persons who manufacturer the product in foreign countries have received approval for that product from the Minister pursuant to the provisions of Article 19-2"; "might not be granted" in Article 13, Paragraph 2 shall read "might not be granted. The same shall apply when persons who manufacture the product to be imported in a foreign country (including the executives involved in such business when these persons are corporations) conform to the provisions of Article 19-2, Paragraph 2."; "the applicant shall ....without the approval of the Minister pursuant to the provisions of the following article (including application mutatis mutandis in Article 23; the same in the following paragraph." in Article 13-2, paragraph 1 shall read "the applicant and the person manufacturing the product in a foreign country shall ...without the approval of the Minister pursuant to the provisions of the following article (including application mutatis mutandis in Article 23) and Article 19-2."; "the applicant" in the proviso of Article 13, Paragraph 1 shall read "the applicant and the person manufacturing the product in a foreign contry"; and "the following article" in Article 13-2, Paragraph 2 shall read "the following paragraph (including application mutatis mutandis in Article 23) and Article 19-2". Chapter IV-2 Designated Review Organizations (Designations) Article 23-2 Designations pursuant to the provisions of Article 14-3, Paragraph 1 shall be made on the basis of applications by persons who perform reviews in accordance with the provisions of Article 14, Paragraph 4 (including cases where it is applied mutatis mutandis under Article 14, Paragraph 6) (hereinafter referred to as "reviews" in this chapter) as specified by MHW ordinance. (Designation Criteria) Article 23-3 The Minister shall not perform the designation in Article 14-3, Paragraph 1 unless the application in the preceding article complies with the following criteria. (1) Persons with knowledge and experience in compliance with conditions specified by MHW ordinance shall perform the reviews and the number shall equal or exceed the number specified by MHW ordinance. (2) Protocols concerning the performance of the review work and including such matters as the facilities for the reviews and the methods for performing the review work shall be appropriate for performing suitable and reliable reviews. (3) An accounting basis adequate for implementing the protocol concerning performance of the review work in the preceding item suitably and reliably shall be provided. (4) When work other than the review work is performed, there shall be no possibility of the review work being improperly performed because of the other work. 2. When the Minister finds that the person submitting the application in the preceding article conforms to any of the following items, the designation in Article 14-3, Paragraph 1 shall not be made. (1) Persons other than corporations established pursuant to the provisions of the Civil Code (Law No.89, 1896) (2) Persons who were convicted of violations of this Law, other pharmaceutically- related laws or regulations or orders or dispositions based on such laws, and for whom a period of 2 years has not passed since the date of completion of the sentence or the date on which the sentence becomes ineffective (3) Persons for whom a designation was canceled pursuant to the provisions of Article 23-13, Paragraph 1 or Paragraph 2, and for whom a period of 2 years has not passed from the date of the cancelation. (4) Among the executives of the corporation, those who conform to either of the following items. (a) Persons conforming to item (2) (b) Persons dismissed pursuant to the provisions of Article 23-6, Paragraph 3 and for whom a period of 2 years has not passed since the date of the dismissal (Publicizing of the Designation) Article 23-4 When the Minister makes a designation pursuant to the provisions of Article 14-3, Paragraph 1, the name of the designated review organization, the address of its head office, the range of review work undertaken by the designated review organization and the date of the designation concerned shall be publicized. 2. When the name or the address of the head office of the designated review organization is changed, this fact must be notified to the Minister up to 2 weeks before the date of the change. 3. When the Minister receives a notification pursuant to the provisions in the preceding paragraph, this fact must be publicized. (Obligation to Perform Reviews) Article 23-5 When designated review organizations are requested to perform reviews, they shall perform the review without delay except when there is a valid reason not to do so. 2. When designated review organizations undertake reviews, the reviews must beperformed by persons pursuant to the provisions of Article 23-3, Item (1) (hereinafter referred to "review staff") based on the methods specified by MHW ordinance. (Appointment and Dismissal of Executives) Article 23-6 The appointment and dismissal of executives of designated review organizations employed in review work shall not be valid unless approval is obtained from the Minister. 2. When designated review organizations appoint or dismiss review staff, this fact must be notified to the Minister without delay. 3. When the executives or review staff of designated review organizations violate this Law or any other pharmaceutically-related laws or regulations or orders or dispositions based on them, or the review work regulations pursuant to the provisions of Article 23-8, the Minister may order the designated review organization to dismiss the executive or review staff concerned. (Positions of Executives and Employees) Article 23-7 The executives and employees of designated review organizations engaged in review work shall be considered legally as employees engaged in government service with respect to the Penal Code (Law No.45, 1907) or application of other penal regulations. (Review Work Regulations) Article 23-8 Designated review organizations shall specify work regulations (hereinafter referred to as "review work regulations") for items concerning the performance of review work as specified by MHW ordinance, and these regulations must be approved by the Minister. The same shall apply when these regulations are changed. 2. When the Minister confirms that the review work regulations approved pursuant to the provisions of the preceding paragraph are unsuitable with respect to performing the review work appropriately and reliably, the Minister may order the designated review organization to change the regulations. (Approval of Work Plans) Article 23-9 Designated review organizations shall prepare a work plan and balance sheets for each fiscal year, and they must be approved by the Minister before the start of the fiscal year concerned (when the business year includes the date of designation in Article 14-3, Paragraph 1, without delay after the designation). The same shall apply in cases of changes. 2. Designated review organizations shall prepare a work report and a statement of accounts for each fiscal year and shall submit them to the Minister within 3 months after completion of the business year. (Keeping of Account Books) Article 23-10 Designated review organizations shall keep account books as specified by MHW ordinance, enter items related to the review work as specified by MHW ordinance and preserve such books. (Supervision Orders) Article 23-11 When the Minister finds that it is necessary with respect to compliance with this Law, orders required for supervision of the review work may be given to the designated review organization. (Suspension or Discontinuation of Work) Article 23-12 If the designated review organization is not approved by the Minister, the designated review organization shall suspend or discontinue all or part of the review work. 2. When the Minister grants approval based on the preceding paragraph, this fact shall be publicized. (Cancelation of Designations) Article 23-13 When designated review organizations correspond to any of the items in Article 23-3, Paragraph 2 [excluding Item (3)], the Minister shall cancel the designation. 2. When the designated review organization corresponds to any of the following items, the Minister may cancel the designation or order suspension of all or part of the review work for a specified period. (1) When there is a violation of the provisions of this chapter (2) When it is confirmed that there is non-compliance with any of the items in Article 23-3, Paragraph 1 (3) When there is a violation of an order pursuant to the provisions of Article 23-6, Paragraph 3; Article 23-8, Paragraph 2; or Article 23-11 (4) When review work is not performed in accordance with the review work regulations approved as in Article 23-8, Paragraph 1 (5) When the designation has been received by improper means 3. When the Minister has canceled the designation pursuant to the provisions of Paragraph 2 or ordered suspension of all or part of the review work pursuant to the provisions of the preceding paragraph, this fact shall be publicized. (Conditions for Designations) Article 23-14 The designations, and approvals pursuant to the provisions of Article 14-3, Paragraph 1; Article 23-6, Paragraph 1; Article 23-8, Paragraph 1; Article 23-9, Paragraph 1 or Article 23-12, Paragraph 1 may have conditions attached. 2. The conditions in the preceding paragraph shall be limited to the minimum degree necessary to perform reliably items related to the designation or approval, and shall not impose any inappropriate obligation on the person receiving the designation or approval. (Reviews Performed by the Minister) Article 23-15 The Minister shall perform all or part of the review work concerned when the designated review organization stops performing all or part of the review work after receiving approval pursuant to the provisions of Article 23-12, Paragraph 1; when the designated review organization is ordered to suspend all or part of the review work pursuant to the provisions of Article 23-13, Paragraph 2; or when it is confirmed to be necessary when the designated review organization finds it difficult to perform all or part of the review work because of a natural disaster or some other valid reason. 2. When the Minister himself performs all or part of the review work pursuant tothe provisions of the preceding paragraph or when all or part of this review work is not performed, this fact shall be publicized. 3. All items required for the Minister to perform the review work pursuant to the provisions of the preceding paragraph and to continue the review work when the review work has been suspended pursuant to the provisions of Article 23-12, Paragraph 1, or when the designation of the designated review organization has been canceled pursuant to the provisions of Article 23-13, Paragraph 1 or Paragraph 2 shall be specified by MHW ordinance. Chapter V. Selling Drugs and Selling and Leasing of Medical Devices (Licenses for Selling Drugs) Article 24 No person, unless he is either a proprietor of a pharmacy or has obtained a license for selling drugs, shall professionally sell or give drugs, or store or exhibit (including household distribution; the same hereinafter) drugs for the purpose of sale or giving. This provision shall not apply to a manufacturer or importer of drugs who intends to sell or give drugs, which the manufacturer or importer himself has manufactured or imported, to a proprietor of a pharmacy or another drug manufacturer or importer, or intends to store or exhibit such drugs for the purpose of sale or giving to such persons. 2. The license under the preceding paragraph shall become invalid unless it is renewed every 6 years. (Kinds of Licenses for Selling Drugs) Artivle 25 The licenses for selling drugs shall be divided into the following four kinds: (1) The first-class license for selling drugs (2) The second-class license for selling drugs (3) The license for selling drugs by household distribution (4) The third-class license for selling drugs. (First-Class License for Selling Drugs) Article 26 The first-class license for selling drugs shall be granted to each store by the governor of the prefecture where the store is located [for first-class retailers other than those which sell or give drugs as a business exclusively to proprietors of pharmacies, manufacturers or sellers of drugs, or the proprietors of hospitals, clinics or veterinary clinics (hereinafter referred to as "first-class wholesalers"), the mayor or the municipality or ward when the store is located in a municipality specified by government ordinance in Article 5, Paragraph 1 of the Regional Health Care Law (Law No.101, 1947) (hereinafter referred to as "municipality with a health center") or in a region in a special ward]. 2. To the license in the preceding paragraph, the provisions of Article 6 shall apply mutatis mutandis with the proviso that the provisions of Paragraph 1, Item (1)-2 of the same Article shall not apply to the first-class license for a first-class wholesaler. 3. No person who has obtained a first-class license for selling drugs shall, with respect to the store concerned, sell or give drugs to those other than proprietors of a pharmacy, manufacturers, importers or sellers of drugs, or proprietors of a hospital, clinic or veterinary clinic with the proviso that this shall not apply if the license has been received from the prefectural governor. 4. To the license under the proviso of the preceding article, the provisions of Article 6, Paragraph 1, Item (1)-2 shall apply mutatis mutandis. (Application Mutatis Mutandis) Article 27 To first-class drug sellers, the provisions of Articles 8 to 9-2 shall apply mutatis mutandis. In such cases, "prefectural governor" in Article 8, Paragraph 3 shall read "prefectural governor (for first-class sellers other than first-class wholesalers pursuant to the provisions in Article 26, Paragraph 1, the mayor of the municipality or ward when the store is located in a municipality with a health center or in a region in a special ward pursuant to the provisions in the same paragraph)". (Second-Class License for Selling Drugs) Article 28 The second-class license for selling drugs shall be granted to each store by the governor of the prefecture where the store is located. 2. The above-mentioned license shall not be given unless the applicant (including working directors and those specified by cabinet order in the case of a corporation; the same in the next paragraph and Article 30, Paragraph 2) has passed the examinations establishing that he has the necessary knowledge and experience for carrying on the business of his profession, or unless the applicant meets the standards laid down by cabinet order for those who have the necessary knowledge and experience to deal with drugs other than those designated in the next article. 3. In either of the following two cases, the license specified in Paragraph 1 might not be granted: (1) When the structure or facilities of the store are not in conformity with thestandards specified by MHW ordinance (2) When the applicant comes under any one of the headings of Article 6, Item (2) from (a) to (d). (Prohibition of Selling Designated Drugs) Article 29 No person who has obtained a second-class license for selling drugs (hereinafter referred to as "second-class seller") shall sell or give, or store or exhibit for the purpose of sale or giving, certain drugs as designated by the Minister. (License of Selling Drugs by Household Distribution) Article 30 The license for selling drugs by household distribution shall be granted, for each prefecture containing the whole or a part of the business area, by the governor of the prefecture concerned. In this case the governor shall specify the drug items according to the standards specified by the Minister. 2. In either of the following two cases, the license specified in the preceding paragraph might not be granted: (1) When the applicant comes under any one of the headings of Article 6, Item (2) from (a) to (d). (2) When the applicant lacks the necessary knowledge and experience for carrying on the business of such a profession. 3. The necessary matters in regard to determining whether or not the applicantcomes under Item (2) of the preceding paragraph, shall be established by cabinet order. (Restriction of Drugs for Household Distribution) Article 31 No person who has a license for selling drugs by household distribution (hereinafter referred to as "household distributor") shall sell or give, or store or exhibit for the purpose of sale or giving, drugs other than those designated by the prefectural governor under the provisions of Paragraph 1 of the preceding article. (Notification of Engaging in Distribution) Article 32 When any household distributor or any of his employees intends to engage in selling drugs by means of household distribution, he shall give prior notice of his name, his business area, and other matters laid down by MHW ordinance, to the governor of the prefecture containing the business area. (Identification Certificate for Persons Engaging in Household Distribution) Article 33 No household distributor nor any of his employees shall engage in selling drugs by means of household distribution unless he carries with him an identification certificate issued by the governor of the prefecture where his residence is located. 2. The necessary matters concerning the identification certificate of the preceding paragraph shall be laid down by MHW ordinance. (Direction and Superintendence of Employees) Article 34 A household distributor shall, in order not to jeopardize public health and hygiene, direct and superintend, with respect to the business of selling drugs by household distribution, his employees engaging in such distribution. (Third-Class License for Selling Drugs) Article 35 The third-class license for selling drugs shall be granted to each store by the governor of the prefecture where the store is located (the mayor of the municipality or ward when the store is located in a municipality with a health center or in a region in a special ward; the same in the next article.), but only in cases of special need; special need arises, for example, when insufficient facilities for selling drugs are available in the vicinity of the store. In this case, the governor shall specify the drugs to be sold. (Restriction on Drugs Sold by Third-class Sellers) Article 36 No person who has obtained the third-class license for selling drugs (hereinafter referred to a "special seller") shall sell or give, or store or exhibit for the purpose of sale or giving, drugs, other than those specified by the prefectural governor pursuant to the provisions of the preceding article. (Restriction of Means of Selling, etc.) Article 37 No proprietor of a pharmacy and no person who has obtained the first- class license for selling drugs (hereinafter referred to as "first-class seller") and no second-class seller and no special seller, by means other than sale or giving through a store, and no household distributor, by means other than distribution, shall sell or give drugs, or store or exhibit drugs for the purpose of sale or giving. 2. No household distributor and no special seller shall open the immediate container or wrapper (not including the inner package; the same hereinafter except in Article 54 and Article 57, Paragraph 1) of a drug and sell it in lots. (Application Mutatis Mutandis) Article 38 To the profession of selling drugs, the provisions of Article 10 and 11 shall apply mutatis mutandis. In such cases, "prefectural governor" in Article 10 shall read "prefectural governor (for first-class sellers other than first-class wholesalers pursuant to the provisions in Article 26, Paragraph 1, the mayor of the municipality or ward when the store is located in a municipality with a health center or in a region in a special ward pursuant to the provisions in the same paragraph)". (Selling and Leasing Medical Devices) Article 39 Any person who intends to sell or lease the medical devices designated by the Minister shall beforehand and for each business office report the matters laid down by MHW ordinance to the governor of the prefecture where the business office is located. In cases where a manufacturer or importer of medical devices intends to sell the medical devices, which he himself has manufactured or imported, to another manufacturer, seller or leaser of medical devices, this shall not apply. 2. The Minister may specify standards for the structure or equipment of the business office by MHW ordinance. (Items to Be Observed by Sellers and Leasers of Medical Devices) Article 39-2 The Minister shall be able to specify by means of MHW ordinances items which the sellers or leasers of medical devices in Paragraph 1 of the preceding article shall observe with respect to their work including methods to assure the quality of the medical devices in the business office of the seller or leaser of medical devices. (Application Mutatis Mutandis) Article 40 The provisions pursuant to Article 10 shall apply mutatis mutandis to the business of selling and leasing medical devices specified in Article 39, Paragraph 1. Chapter VI Standards and Tests for Drugs, etc. (Japanese Pharmacopoeia) Article 41 For the purpose of regulating the properties and quality of drugs, theMinister shall establish and publish the Japanese Pharmacopoeia, after hearing the opinion of the Central Pharmaceutical Affairs Council. 2. The Japanese Pharmacopoeia shall consist of Part I and Part II. Part I shall mainly contain widely used bulk drugs and basic preparations, and Part II, mixed preparations and their bulk drugs. 3. In order that the Central Pharmaceutical Affairs Council may investigate the whole of the Japanese Pharmacopoeia at least every 10 years, the Minister shall consult the Central Pharmaceutical Affairs Council on the revision of the Japanese Pharmacopoeia. (Standards of Drugs, etc.) Article 42 The Minister may lay down the necessary standards, after hearing the opinion of the Central Pharmaceutical Affairs Council, related to the manufacturing process, properties, quality, storage method, etc. of those drugs to which require special attention concerning public health and hygiene, such as biological or antibiotic preparations. 2. The Minister may, when it is indispensable for safeguarding public health and hygiene, lay down the necessary standards related to the properties, quality, performance, etc. of quasi-drugs, cosmetics and medical devices, after hearing the opinion of the Central Pharmaceutical Affairs Council. (Tests) Article 43 The drugs designated by the Minister shall not be sold or given, or stored or exhibited for the purpose of sale or giving, unless they have passed the tests performed by the person whom the Minister has designated with the proviso that reasonable variations shall be permitted by regulations laid down by MHW ordinance. 2. Medical devices designated by the Minister shall not be sold, leased or given, or stored or exhibited for the purpose of sale, leasing or giving, unless they have passed tests performed by a person designated by the Minister. However, this shall not apply when specified otherwise by MHW ordinance. 3. Necessary matters concerning the tests under the preceding two paragraphs shall be specified by cabinet order. 4. With respect to the results of the tests specified in Paragraphs 1 and 2, no appeal can be made under the Administrative Appeal Law. Chapter VII Handling of Drugs, etc. Section 1. Handling of Poisonous and Powerful Drugs (Display) Article 44 On the immediate container or wrapper of any drug designated as poisonous by the Minister (hereinafter referred to as "poisonous drug"), its name and the word "Poison" shall be exhibited in white on a black ground framed in white. 2. On the immediate container or wrapper of any drug designated as powerful by the Minister (hereinafter referred to as "powerful drug"), its name and the word "Powerful" shall be exhibited in red on a white ground framed in red. 3. No poisonous or powerful drugs not meeting the provisions of the preceding two paragraphs shall be sold or given, or stored or exhibited for the purpose of sale or giving. (Restriction of Sale, etc. of Unsealed Products) Article 45 No sellers of drugs other than first-class sellers shall sell or give, or store or exhibit for the purpose or sale or giving, poisonous or powerful drugs when the seal applied under the provisions of Article 58 has been removed. (Transfer Procedure) Article 46 No proprietor of a pharmacy, and no manufacturer, importer or seller of drugs shall sell or give a poisonous or powerful drug to a person unless he receives from the transferee a document with the signature or seal of the transferee in which are entered the name of the poisonous or powerful drug, the amount, the purpose of use, the date of transfer, and the name, address, and occupation of the transferee. 2. When a poisonous or powerful drug is sold or given to a pharmacist, a proprietor of a pharmacy, a manufacturer or seller of drugs, a physician, dentist or veterinarian, or a proprietor of a hospital, clinic or veterinary clinic, the provisions of the preceding paragraph shall not apply, provided that the transferee presents an identification certificate issued by an official agency, or has long-standing business relations with the transferer. 3. The transferer shall keep the document in Paragraph 1 for two years from the date of the transfer. (Restriction of Delivery) Article 47 Poisonous or powerful drugs shall not be delivered to a person who is under 14 years of age or who is considered likely to handle such a drug without due care. (Storage and Exhibition) Article 48 A person who handles poisonous or powerful drugs in the conduct of his business shall store or exhibit them separately from other goods. 2. In the case described in the preceding paragraph, the warehouse or showcase for poisonous drugs shall be locked. Section 2. Handling of Drugs (Sale of Drugs Requiring Directions or Prescriptions) Article 49 No proprietor of a pharmacy and no seller of drugs shall sell or give drugs so designated by the Minister to persons other than those who have received a prescription or directions from a physician, dentist or veterinarian. This shall not apply when such drugs are sold or given to a pharmacist, a proprietor of a pharmacy, a manufacturer or seller of drugs, a physician, dentist or veterinarian or a proprietor of a hospital, clinic or veterinary clinic. 2. A proprietor of a pharmacy or a seller of drugs shall keep a book in his pharmacy or store, and when he has sold or given the drugs prescribed in the preceding paragraph to those who have received a prescription or directions from a physician, dentist or veterinarian, he shall, as specified by MHW ordinance, enter in the book the matters concerning the sale or giving of such drugs. 3. A proprietor of a pharmacy or a seller of drugs shall keep the abovementioned book for 2 years from the date of the last entry. (Matters to be Indicated on the Immediate Container, etc.) Article 50 On the immediate container or wrapper of a drug, the matters prescribed in the following items shall be indicated with the proviso that reasonable variations may be permitted by regulations laid down by MHW ordinance: (1) The name and address of the manufacturer or importer (2) The name (for a drug in the Japanese Pharmacopoeia, the name given therein; for other drugs, the generic name, if applicable) (3) The manufacturing number or code (4) The quantity of the contents in terms of weight, volume, number, etc. (5) For a drug in the Japanese Pharmacopoeia, the words "Japanese Pharmacopoeia" and the matters specified by the Japanese Pharmacopoeia to be indicated on the immediate container or wrapper (6) For a drug for which the standards have been laid down under the provisions of Article 42, Paragraph 1, method of storage, expiry date or any other matters specified by the standards to be indicated on the immediate container or wrapper (7) For a drug not in the Japanese Pharmacopoeia, the name (generic name, if applicable) and quantity of each ingredient (for a drug with unknown active ingredients, its nature and an outline of its manufacturing process) (8) For a drug designated as habit-forming by the Minister, the words "Caution - Habit-forming" (9) For a drug designated by the Minister under the provisions of Paragraph 1 of the preceding article, the words "Caution - Use only pursuant to the prescription or directions of a physician, etc." (10) For a drug designated by the Minister, the expiry date (11) Any matters laid down by MHW ordinance supplementary to those specified in the preceding items. Article 51 If the immediate containers or wrappers of a drug are packaged for retail, and if the matters indicated thereon which are prescribed in Article 44, Paragraph 1 or 2, or in the items of the preceding article, are not easily legible through the outer container or wrapper, the same matters shall also be indicated on the outer container or wrapper. (Matters to be Indicated on Package Inserts, etc.) Article 52 On the insert enclosed with a drug, or on the container or wrapper of a drug, the matters prescribed in the following items shall be indicated, with the proviso that exemptions may be established as specified by MHW ordinance: (1) Directions, dosage, or other necessary precautions for use and handling (2) For a drug in the Japanese Pharmacopoeia, the matters specified by the Japanese Pharmacopoeia to be indicated on the insert, container, or wrapper (3) For a drug for which the standards have been laid down under Article 42, Paragraph 1, the matters required by the standards to be indicated on the insert, container, or wrapper (4) In addition to matters specified in the preceding items, any matters laid down by MHW ordinance. Article 53 The matters specified in Article 44, Paragraph 1 or 2, or in the preceding three articles shall be exhibited more prominently than other texts, descriptions, diagrams, or designs, and these matters shall be accurately indicated, pursuant to the provisions specified by MHW Ordinance, in such terms as to render them easily read and understood by the ordinary purchaser or user of the drug concerned. (Inadmissible Claims) Article 54 The entries in the following items shall not be made in the package inserts or on the drug itself, its container or wrapper (including the inner wrapper). (1) Entries which are false or which might lead to misundertanding concerning the drug (2) Indications or effects for which approval has not be obtained as specified in the provisions of Article 14 (including cases which apply mutatis mutandis under Article 23; the same hereinafter) or Article 19-2 (excluding indications or effects specified in the standards for drugs designated by the Minister based on specified standards pursuant to the provisions of Article 14, Paragraph 1) (3) Directions, doses or periods of use which might jeopardize public health and hygiene. (Prohibition of Sale, Giving, etc.) Article 55 Drugs which fail to comply with the provisions of the preceding five articles shall not be sold or given, or exhibited for the purpose of sale or giving. 2. No drug which is an imitation of another drug, or is manufactured or imported contrary to the provisions of Article 12, Paragraph 1; Article 18, Paragraph 1 (including cases where it applies mutatis mutandis under Article 23); or Article 22, Paragraph 1, shall be sold or given, or stored or exhibited for the purpose of sale or giving. (Prohibition of Sale, Manufacture, etc.) Article 56 No drug which comes under any of the following items shall be sold orgiven, or manufactured, imported, stored, or exhibited for the purpose of sale or giving: (1) A drug which is in the Japanese Pharmacopoeia and for which the quality or properties are not in conformity with the standards established by the Japanese Pharmacopoeia (2) A drug which is approved according to the provisions of Article 14 or Article 19-2 and for which the ingredients or quantities (for a drug with unknown ingredients, its nature or an outline of its manufacturing process) or its properties or quality are not as approved (2)-2 A drug designated by the Minister based on specified standards pursuant to the provisions of Article 14, Paragraph 1 for which the ingredients or quantities (for a drug with unknown ingredients, its nature or an outline of its manufacturing process), properties or quality do not comply with the standards (3) A drug for which the standards are laid down under the provisions of Article 42, Paragraph 1 and which is not in conformity with the standards [excluding the standards specified in Article 50, Item (6) and Article 52, Item (3)] (4) A drug, the whole or a part of which consists of any impure, putrid or decomposed substance (5) A drug in or on which any foreign matter is found (6) A drug which is contaminated, or is likely to be contaminated, by pathogenic microorganisms (7) A drug which bears or contains, for the purpose of coloring only, any coal-tar pigment other than those laid down by MHW ordinance. Article 57 No drug shall be packaged with any article, or in any container or wrapper (including the inner package), which is composed, wholly or partly, of any poisonous or harmful substance which may render the contents injurious to health; and the container or wrapper of a drug shall not be of such a nature that it leads to the possibility of misuse of the drug. 2. No drug which fails to comply with the provisions of the preceding paragraph shall be sold or given, or manufactured, imported, stored, or exhibited for the purpose of sale or giving. (Sealing of Drugs) Article 58 When a manufacturer or an importer of drugs sells or gives a drug that he himself has manufactured or imported, he shall, according to the regulations specified by MHW ordinance, seal the container or wrapper of the drug with the proviso that the same shall not apply in the case of a drug sold or given to a manufacturer of drugs. Section 3. Handling of Quasi-Drugs (Matters to be Indicated on the Immediate Container, etc.) Article 59 On the immediate container or wrapper of a quasi-drug, the matters prescribed in the following items shall be indicated with the proviso that reasonable variations may be permitted by regulations laid down by MHW ordinance: (1) The name and address of the manufacturer or importer (2) The designation "quasi-drug" (3) The name (generic name, if applicable) (4) The manufacturing number or code (5) The quantity of the contents in terms of weight, volume, number etc. (6) For a quasi-drug containing ingredients designated by the Minister, the name of the ingredient(s) (7) For a quasi-drug designated by the Minister, the expiry date (8) Any matters laid down by MHW ordinance supplementary to those specified in the preceding items. (Application Mutatis Mutandis) Article 60 To quasi-drugs, the provisions of Articles 51 to 57 inclusive shall applymutatis mutandis. In this case, "in Article 44, Paragraph 1 or 2, or in the items of the preceding article" in Article 51 shall read "in the items of Article 59"; "in Article 42, Paragraph 1" in Article 52, Item (3) shall read "in Article 42, Paragraph 2"; "in Article 44, Paragraph 1 or 2, or in the preceding three articles" in Article 53 shall read "in Article 59, in Article 51, or in Article 52 which is applicable mutatis mutandis under Article 60"; "the preceding five articles" in Article 55, Paragraph 1 shall read "Article 59, or from Article 51 to 54 which is applicable mutatis mutandis under Article 60"; and "Article 42, Paragraph 1" in Article 56, Item (3) shall read "Article 42, Paragraph 2". Section 4. Handling of Cosmetics (Matters to Be Indicated on the Immediate Container, etc.) Article 61 On the immediate container or wrapper of a cosmetic, the matters prescribed in the following items shall be indicated with the proviso that reasonable variations may be permitted by regulations laid down by MHW ordinance: (1) The name and address of the manufacturer of importer (2) The name of the product (3) The manufacturing number or code (4) For a cosmetic containing ingredients designated by the Minister, the nameand quantity of such ingredient(s) (5) For cosmetics designated by the Minister, the expiry date (6) Any matters laid down by MHW ordinance supplementary to those specified in the preceding items. (Application Mutatis Mutandis) Article 62 To cosmetics, the provisions of Article 51 to 57 inclusive shall apply mutatis mutandis. In this case, "in Article 44, Paragraph 1 or 2, or in the items of the preceding article" in Article 51 shall read "in the items of Article 61"; "in Article 42, Paragraph 1" in Article 52, Item (3) shall read "in Article 42, Paragraph 2"; "in Article 44, Paragraph 1 or 2, or in the preceding three articles" in Article 53 shall read "in Article 61, in Article 51 or in Article 52 which is applicable mutatis mutandis under Article 62"; "the preceding five articles" in Article 55, Paragraph 1 shall read "Aricle 61, or from Article 51 to 54 which is applicable mutatis mutandis under Article 62"; and "Article 42, Paragraph 1" in the Article 56, Item (3) shall read "Article 42, Paragraph 2". Section 5. Handling of Medical Devices (Matters to Be Indicated on the Immediate Container, etc.) Article 63 On the immediate container or wrapper of a medical device, or on the medical device itself, the matters prescribed in the following items shall be indicated with the proviso that reasonable variations may be permitted by regulations laid down by MHW ordinance (1) The name and address of the manufacturer or importer (2) For a medical device designated by the Minister, the manufacturing number or code (3) For a medical device designated by the Minister, the quantity of the contents in terms of weight, volume, number, etc. (4) For a medical device designated by the Minister, the expiry date (5) Any matters laid down by MHW ordinance supplementary to those specified in the preceding items. (Matters to Be Entered in Package Inserts, etc.) Article 63-2 The matters specified in the following items shall be entered in the package insert or on the container or wrapper of medical devices. However, this shall not apply when specifed otherwise by MHW ordinance. (1) The method of use and any precautions required for use or handling (2) Matters concerning maintenance and inspections for medical devices designated by the Minister (3) For medical devices for which standards have been specified pursuant to the provisions of Article 42, Paragraph 2, the matters specified in these standards to be entered in the package insert or on the container or wrapper. (4) Matters specified by MHW ordinance other than the matters in the preceding 3 items. (Application Mutatis Mutandis) Article 64 To medical devices, the provisions of Articles 52 to 55 inclusive shall apply mutatis mutandis, In this case, "in Article 42, Paragraph 1" in Article 52, Item (3) shall read "in Article 42, Paragraph 2"; "in Article 44, Paragraph 1 or 2, in the preceding three articles" in Article 53 shall read "in Article 63 or Article 52 which is applicable mutatis mutandis under Article 64", and "the preceding five articles" in Article 55, Paragraph 1 shall read "Articles 63, Article 63-2 or Article 53 or 54 which are applicable mutatis mutandis under Article 64" and "sold or given, or... sale" shall read "sold, leased or given or... sale, leasing or giving". (Prohibition of Sale, Manufacture, etc.) Article 65 No medical device which comes under any of the following items shall be sold, leased or given, or manufactured, imported, stored, or exhibited for the purpose of sale, leasing or giving: (1) A medical device which is approved pursuant to the provisions of Article 14 or Article 19-2 and for which the properties, quality or performance is not as approved (2) A medical device for which the standards are established under the provisions of Article 42, Paragraph 2 and which is not in conformity with the standards (3) A medical device, the whole or a part of which consists of any impure, putrid or decomposed substance (4) A medical device in or on which any foreign matter is found (5) A medical device which is contaminated, or is likely to be contaminated, by pathogenic microorganisms (6) A medical device, the use of which might jeopardize public health and hygiene. Chapter VIII Advertising of Drugs, etc. (Exaggerated Advertisement) Article 66 No person shall, explicitly or implicitly, advertise, describe or circulate false or exaggerated statements regarding the name, manufacturing process, indications and effects or properties of drugs, quasi-drugs, cosmetics or medical devices. 2. It shall be construed as falling under the preceding paragraph to advertise, describe or circulate such statements as lead to the false impression that a physician or other person has certified the indications, effects or properties of drugs, quasi-drugs, cosmetics or medical devices. 3. Statements or diagrams suggesting criminal abortion, or any obscene statements or diagrams shall not be used in connection with drugs, quasi-drugs, cosmetics or medical devices. (Restriction on Advertising of Drugs for Designated Diseases) Article 67 With regard to the advertisement of drugs specified by cabinet order which are intended for use in the cure of cancer or other designated diseases laid down by cabinet order and for which use not under the direction of physicians or dentists is likely to be highly dangerous, necessary measures for maintaining the appropriate use of such drugs such as restriction of the means of advertising to ordinary people other than persons concerned with medical and pharmaceutical affairs, may be provided for by cabinet order. 2. The Minister shall, in advance, hear the opinion of the Central Pharmaceutical Affairs Council, when he intends to ask for a cabinet meeting related to the establishment, alteration or abolition of regulations in cabinet orders laying down the designated diseases under the preceding paragraph. (Prohibition of Advertisement of Drugs, etc. Before Their Approval) Article 68 No person shall advertise the name, manufacturing process, indicationsand effects or properties of either drugs or medical devices specified in Article 14, Paragraph 1, which have not yet been approved pursuant to the provisions of the same paragraph (including cases where it applies mutatis mutandis under Article 23) or Article 19-2, Paragraph 1. Chapter IX Surveillance (Spot Inspection, etc.) Article 69 The Minister, the prefectural governor, the mayor of a municipality where a health center is located or the mayor of a special ward may, when he deems it essential, request necessary reports from a proprietor of a pharmacy; proprietor of a hospital, clinic or veterinary clinic; a manufacturer, importer or seller of drugs, quasi-drugs, cosmetics or medical devices; a leaser of medical devices; an in-country caretaker; or other persons who handle drugs, quasi-drugs, cosmetics or medical devices in the course of business as laid down by MHW ordinance, or persons entrusted pursuant to the provisions of Article 77-5, Paragraph 4, or have a qualified official enter a pharmacy, hospital, clinic, veterinary clinic, factory, store, office or other sites where drugs, quasi-drugs, cosmetics or medical devices are handled in the course of business and inspect its structure or equipment, or books or other articles, question the employees or other persons concerned, or collect samples which are suspected for falling under the matters in Article 70, Paragraph 1, only in the minimum quality necessary for examination. 2. When found to be necessary, the Minister may request a designated review organization to report on the review work or accounting conditions, many have a spot inspection of the office of the designated review organization performed or the accounting documents or other articles examined by a qualified official, or may ask questions to those concerned. 3. The qualified official shall carry a certificate showing his status and present it on demand to the persons concerned in cases when he enters the sites and inspects, questions or collects samples pursuant to the provisions of the preceding two paragraphs. 4. The powers in the preceding Paragraphs 1 and 2 shall not be construed as having been authorized for the detection of crimes. (Emergency Orders) Article 69-2 When the Minister finds that is it necessary to prevent the occurrence or spread of hazards to public health and hygiene caused by a drug, quasi-drug, cosmetic or medical device, he shall be able to suspend temporarily the selling or giving of the drug, quasi-drug, cosmetic or medical device or leasing of the medical device by the manufacturer, importer, seller, leaser of medical devices, in-county caretaker, persons entrusted pursuant to provisions of Article 77-5, Paragraph 4 or pharmacy proprietor concerned and shall be able to order any emergency measures to be taken to prevent the occurrence or spread of hazards to public health and hygiene. (Disposing of Drugs, etc.) Article 70 With regard to drugs which are stored or exhibited contrary to the provisions of Article 43, Paragraph 1; to drugs which have been sold or given contrary to the provisions of the same paragraph; to medical devices which are stored or exhibited contrary to the provisions of Article 43, Paragraph 2; to medical devices which are sold, leased or given contrary to the provisions in the same paragraph; to the drugs, quasi-drugs, cosmetics or medical devices which are stipulated in Article 44, Paragraph 3, Article 55 (including cases where it applies mutatis mutandis under Articles 60, 62 and 64), Article 56 (including cases where it applies mutatis mutandis under Articles 60 and 62), Article 57, Paragraph 2 (including cases where it applies mutatis mutandis under Articles 60 and 62) or Article 65; to drugs, quasi-drugs, cosmetics and medical devices for which approval to manufacture or import has been canceled as specified in Article 74-2, Paragraph 1 (including cases where it applies mutatis mutandis under Article 75-2, Paragraph 2); or to adulterated bulk and processed materials, the Minister or the prefectural governor (for first-class sellers or third-class sellers other than first-class wholesalers, the mayor of the municipality or mayor of the ward when the store is located in a municipality with a health center or in a region in a special ward; the same in Article 72, Article 72-2, Article 73, Article 75, Paragraph 1 and Article 76) may order the persons who handle drugs, quasi-drugs, cosmetics or medical devices in the course of business to take steps to prevent hazards to public health and hygiene, such as destroying or withdrawing such materials. 2. The Minister, the prefectural governor, the mayor of the municipality where a health center is located or the mayor of the special ward may, when a person who has received an order pursuant to the provisions in the preceding paragraph has not obeyed it or in cases of urgent necessity, have a competent official dispose of or withdraw the material specified in the same paragraph or take other necessary action. 3. In cases when the competent official takes the action pursuant to the preceding paragraph, the provisions of Article 69, Paragraph 2 shall be applied mutatis mutandis. (Test Order) Article 71 The Minister or the prefectural governor may, when he deems it necessary, issue to a manufacturer or importer of drugs, quasi-drugs, cosmetics or medical devices, an order that the drugs, quasi-drugs, cosmetics or medical devices, which the manufacture or importer himself has manufactured or imported, be tested by the person designated by the Minister or the prefectural governor. (Order for Improvement,etc.) Article 72 If the building or facilities of a pharmacy, factory, business office or store is not in conformity with the standards laid down by MHW ordinance pursuant to the provisions of Article 6, Item (1) (including cases where it applies mutatis mutandis under Article 26, Paragraph 2); Article 13, Paragraph 2, Item (1) (including cases where it applies mutatis mutandis under Article 23); Article 28, Paragraph 3, Item (1) or Article 39, Paragraph 2; or if it is likely to cause drugs, quasi-drugs, cosmetics or medical devices to fall under the drugs, etc., prescribed under Article 56 (including cases where it applies mutatis mutandis under Articles 60 and 62) or Article 65, the Minister or the prefectural governor may order the proprietor of the pharmacy; the manufacturer or importer of drugs, quasi-drugs, cosmetics or medical devices; or the seller of drugs or the seller or leaser of the medical devices specified pursuant to the provisions of Article 39, Paragraph 1, to improve the structure or facilities, or may prohibit him from using a part or the whole of the facilities concerned until completion of the improvement. Article 72-2 The prefectural governor may, when the number of pharmacists engaged in practical work related to pharmaceutical affairs in a pharmacy or a first-class seller's store is less than that laid down by MHW ordinance under the provisions of Article 6, Item (1)-2 (including cases where it applies mutatis mutandis under Article 26, Paragraph 2), order the proprietor or the first-class seller to increase the pharmacists to the required number. Article 72-3 The Minister may order drug manufacturers or importers and marketers of drugs, quasi-drugs, cosmetics or medical devices to make improvements in the methods of manufacturing control or quality control or to suspend business until such improvements are made when the methods used for manufacturing control or quality control do not comply with the standards specified by MHW ordinance pursuant to the provisions of Article 13, Paragraph 2, Item 2 (including cases where it applies mutatis mutandis under Article 23) or when the methods of manufacturing control or quality control used might cause the drug, quasi-drug, cosmetic or medical device concerned to correspond to any of those specified in the provisions of Article 56 (including cases where it applies mutatis mutandis under Article 60 or Article 62) or Article 65. (Order of Replacement of the Supervisor, etc.) Article 73 The Minister, with respect to the supervisors or responsible technicians in the manufacture or import of drugs, quasi-drugs, cosmetics or medical devices, and the prefectural governor, with respect to the supervisors of pharmacies or first-class sellers' stores, may order the manufacturers, importers, proprietors or sellers to replace them, when they have violated this Law or any of the other laws and ordinances related to pharmaceutical affairs, or any of the measures taken in accordance with these laws and ordinances, or when they are considered unfit for their post. (Supervision of the Business of Selling Drugs by Household Distribution) Article 74 When an employee of a household distributor has, in connection with the business of distribution, violated this Law, any of the ordinances under this Law or any of the measures taken in accordance with them, the prefectural governor may order the household distributor to prohibit the employee from the engaging in household distribution for a specified period. In this case, the governor may, if necessary, also order the employee to suspend his business for a specified period. (Cancelation of Approvals, etc.) Article 74-2 When the Minister finds that a drug, quasi-drug, cosmetic or medicaldevice approved pursuant to provisions of Article 14 corresponds to any of the items in Paragraph 2 of the same article, the approval shall be canceled. 2. The Minister shall be able to order changes to be made in part of the items approved pursuant to the provisions of Article 14 for a drug, quasi-drug, cosmetic or medical device when this is found to be necessary with respect to public health and hygiene. 3. In addition to cases specified in the previous two paragraphs, the Minister shall be able to cancel approvals or order partial changes in approved items in cases where persons who have received approval pursuant to the provisions of Article 14 for a drug, a quasi-drug, cosmetic or medical device conform to one or both of the following items. (1) Cases where the person must undergo a reexamination or reevaluation pursuant to the provisions of Article 14-4, Paragraph 1 or Article 14-5, Paragraph 1 (including application mutatis mutandis in Article 23) does not submit all of part of the required date by a specified deadline, submits data containing falsehoods or submits data which do not comply with the provisions of the second part of Article 14-4, Paragraph 4 or Article 14-5, Paragraph 4 (including application mutatis mutandis in Article 23). (2) Cases where the drug, quasi-drug, cosmetic or medical device approved pursuant to the provisions of Article 14 has not been manufactured or imported for 3 consecutive years without a valid reason. 4. When the approval to manufacture or import of a person manufacturing or importing a drug, quasi-drug, cosmetic or medical device is canceled as specified in Paragraph 1 or 3, the approval pursuant to the provisions of Article 14 of the item concerned shall also be regarded as canceled. (Cancelation of License, etc.) Article 75 The Minister, with respect to manufacturers or importers of drugs, quasi-drugs, cosmetics or medical devices, and the prefectural governor, with respect to proprietors of a pharmacy, sellers of drugs or sellers or leasers of medical devices under Article 39, Paragraph 1, may cancel their license or order suspension of the whole or a part of their business for a specified period when they have violated this Law, any of the other laws and ordinances related to pharmaceutical affairs or any of the measures taken in accordance with these laws and ordinances, or when they (including the directors, when they are corporations, and also including persons who shall be specified by cabinet order pursuant to the provisions of Article 28, Paragraph 2, when the corporations are second-class sellers of drugs or household distributors) fall under the provisions of Article 6, Item (2) (including cases where it applies mutatis mutandis under Article 26, Paragraph 2), Article 13, Paragraph 2, Item (3) (including cases where it applies mutatis mutandis under Article 23), Article 28, Paragraph 3, Item (2) or Article 30, Paragraph 2, Item (1). 2. When the prefectural governor has recognized the necessity of applying the legislation provided for in the preceding paragraph with respect to a manufacturer or importer of drugs, quasi-drugs, cosmetics or medical devices, he shall report this to the Minister. (Cancelation of Approvals to Manufacture Drugs, etc. Manufactured in Foreign Countries) Article 75-2 When a person who has received manufacturing approval as specified in Article 19-2 (hereinafter referred to as the foreign acquirer of manufacturing approval) falls under any of the following items, the Minister shall be able to cancel all or part of the said approval. (1) Cases where a new in-country caretaker is not designated when the in- country caretaker is lacking. (2) Cases where the Minister requests that the in-country caretaker be changed because he does not conform to the standards laid down by MHW ordinance in Article 19-2, Paragraph 3, and this request is not complied with. (3) Cases where the Minister requests the foreign acquirer of manufacturing approval to submit the required reports laid down by MHW ordinance, and these reports are not submitted or false reports are submitted. (4) Cases where the Minister confirms that it is necessary to investigate by his personnel the structure and facilities, books and ledgers or some other item in the factory, office or other locations of the foreign acquirer of manufacturing approval where drugs, quasi-drugs, cosmetics or medical devices are handled, and to question by his personnel the employees and other related persons, and the investigation is refused, obstructed or evaded, or no replies for no valid reason or false replies are given to the questions. (5) Cases where requests as specified in Article 74-2, Paragraph 2 or 3 whichapply mutatis mutandis to the next paragraph are not complied with. (6) Cases where requests to the foreign acquirer of manufacturing approval or his in-country caretaker as specified in Article 77-4, Paragraph 2 are not complied with or the instructions specified in the same paragraph are not obeyed. (7) Cases where the foreign acquirer of manufacturing approval or his in- country caretaker commits an act in violation of this Law, any of the other laws and ordinances related to pharmaceutical affairs or any of the measures taken in accordance with such laws and ordinances. 2. The provisions of Article 74-2, Paragraphs 1 to 3 shall apply mutatis mutandis to approvals obtained pursuant to the provisions of Article 19-2. In such cases, "order" in Paragraph 2 of Article 74-2 shall read "request"; and "the previous two Paragraphs" in Paragraph 3 shall read "Article 74-2, Paragraphs 1 and 2 which apply mutatis mutandis in Article 75-2, Paragraph 2", "order" shall read "request" and "Article 14-4, Paragraph 1 or Article 14-5, Paragraph 1" (including application mutatis mutandis in Article 23) shall read Article 14-4, Paragraph 1 or Article 14-5, Paragraph 1 which apply mutatis mutandis to Article 19-4", and "the second part of Article 14-4, Paragraph 4 or Article 14-5, Paragraph 4 (including application mutatis mutandis in Article 23)" shall read "the second part of Article 14-4, Paragraph 4 or Article 14-5, Paragraph 4 which apply mutatis mutandis in Article 19-4". 3. When approvals of foreign acquirers of manufacturing approvals are canceled as specified in Article 75-2, Paragraph 1 or Article 74-2, Paragraph 1 or 3 which apply mutatis mutandis to the preceding paragraph, the import licenses of importers of the items for which the approval has been canceled shall also be regarded as canceled. (Cancellation of Special Licenses Before Approval) Article 75-3 The Minister may cancel the licenses concerned when it is found that the product (excluding products approved pursuant to the provisions of Article 14 or Article 19-2) in the license in Article 12, Paragraph 1, Article 18, Paragraph 1 (including application mutatis mutandis in Article 23 ; the same in the next Paragraph) or Article 22, Paragraph 1 granted pursuant to the provisions of Article 13-2, Paragraph 1 (including application mutatis mutandisin Article 18, Paragraph 2 and Article 23 ; the same in remainder of this article) does not comply with any one of the items in Article 13-2, Paragraph 1 or when it is confirmed necessary to prevent the occurrence or spread of damage to public health or hygiene. 2. When approvals pursuant to the provisions of Article 14 or Article 19-2 for products related to licenses in Article 12, Paragraph 1, Article 18, Paragraph 1 or Article 22, Paragraph 1 granted pursuant to the provisions of Article 13-2, Paragraph 1 were not granted, the license concerned shall be considered as canceled. (Procedures in Cases of Refusal of License Renewals) Article 76 When the Minister or the prefectural governor refuses to renew a license pursuant to the provisions of Article 5, Paragraph 2; Article 12, Paragraph 3; Article 22, Paragraph 3 or Article 24, Paragraph 2, he shall notify the person concerned of the reasons for this refusal, and the person concerned shall be given the opportunity to submit an explanation on his behalf or evidence in his favor. (Special Cases Concerning Methods of Hearings) Article 76-2 In cases where the provisions of Chapter 3, Section 2 of the Admini- strative Procedures Law (Law No.88, 1993) are applied when measures pursuant to the provisions of Article 75-2, Paragraph 1 are undertaken for the reasons corresponding to Article 75-2, Paragraph 1, Item (2), Item (6) or Item (7) (limited to the parts related to the in-country caretaker), the in-country caretaker of the person in whose name the measures are taken shall be notified under the provisions of Article 15, Paragraph 1 of the Administrative Procedures Law. (Pharmaceutical Affairs Inspectors) Article 77 There shall be pharmaceutical affairs inspectors in the central government, prefectures, municipalities in which health centers are located and special wards charged with the functions of the competent officials provided for in Article 69, Paragraph 1 and Article 70, Paragraph 2. 2. Pharmceutical affairs inspectors shall be appointed from among government or prefectural officials, officials of municipalities where a health center is located or those of special wards by the Minister, the prefectural governor, the mayor of the municipality where a health center is located or the mayor of the special ward. 3. Regulations which are supplementary to the provisions of the preceding two paragraphs and which are necessary for pharmaceutical affairs inspectors shall be laid down by cabinet order. Chapter IX-2 Designation, etc. of Orphan Drugs and Orphan Medical Devices (Designation) Article 77-2 When the Minister receives an application from a person intending to manufacture or import (including manufacture in a foreign country in cases of export to Japan) a drug or a medical device corresponding to either of the following items, the Minister may designate the drug or medical device concerned as an orphan drug or orphan medical device. (1) The number of prospective patients for whom such a drug or medical device is used does not exceed the number specified by MHW ordinance. (2) A drug or medical device which, if approved for manufacture or import, will prove especially valuable when applied in medical practice. 2. When the Minister makes a designation in accordance with the provisions of the preceding paragraph, this fact shall be publicized. (Guarantee of Funds) Article 77-2-2 The government shall make efforts to guarantee the funds required to promote research and development of drugs and medical devices corresponding to the items in the preceding article. (Tax Relief Measures) Article 77-2-3 The government shall take measures required to promote research and development of orphan drugs or orphan medical devices in accordance with the Tax Exemption Law (Law No.26, 1957). (Notification of Suspension of Drug Development) Article 77-2-4 When persons receiving the designation pursuant to the provisions of Article 77-2, Paragraph 1 wish to suspend research and development, manufacture or import of the designated orphan drug or orphan medical device concerned, notification of this fact must be submitted to the Minister beforehand. (Cancelation of Designations) Article 77-2-5 When the Minister receives a notification as specified in the preceding article, the designation granted pursuant to the provisions of Article 77- 2, Paragraph 1 (hereinafter referred to as "the designation") shall be canceled. 2. The Minister may cancel the designation in cases corresponding to any one of the following items: (1) When the orphan drug or orphan medical device no longer corresponds to either of the items in Article 77-2, Paragraph 1 (2) When an irregularity arises concerning the designation (3) When the orphan drug or orphan medical device is not developed, manufactured or imported for no valid reason (4) When the person receiving the designation commits an act in violation of this Law or any other pharmaceutically-related law or regulation in connection with the designation 3. When a designation is canceled pursuant to the provisions of the preceding Paragraph 2, the Minister shall publicize this fact. 4. When measures are taken pursuant to the provisions of Paragraph 2, the Minister must notify the other party of the reason for such measures beforehand and give the other party the opportunity to present a defense and submit supporting evidence. (Mandate to MHW Ordinance) Article 77-2-6 In addition to the provisions included in this Chapter, the required items concerning orphan drugs and orphan medical devices shall be specified by MHW ordinance. Chapter X Miscellaneous Provisions (Supply of Information, etc) Article 77-3 Manufacturers or importers and marketers of drugs or medical devices, persons who have received first class wholesaler licenses, person who sell of lease medical devices (limited to persons who sell or give medical devices as a business to proprietors of pharmacies, persons who manufacturer, sell or lease medical devices, or proprietors of hospitals, clinics or veterinary clinics, or persons who lease medical devices as a business to persons who market or give medical devices to proprietors or pharmacies or proprietors of hospitals, clinics or veterinary clinics; referred to in subsequent Paragraphs as "wholesalers or sellers of medical devices, etc.") and persons who have acquired foreign manufacturing approval or their in-country caretakers shall make efforts to collect and study information related to the efficacy and safety of drugs or medical devices and other information required for the proper use of drugs or medical devices (including information concerning maintenance and inspection of medical devices pursuant to the provisions of Article 63-2, Item 2; the same hereinafter) and supply it to proprietors of pharmacies, proprietors of hospitals, clinics or veterinary clinics, marketers of drugs, persons who sell or lease medical devices, and health professionals such as physicians, dentists, pharmacists and veterinarians. 2. The proprietors of pharmacies, hospitals, clinics or veterinary clinics, sellers of drugs, persons selling or leasing medical devices, or health professionals such as physicians, dentists, pharmacists or veterinarians shall make efforts to cooperate in the collection of information required for the proper use of drugs or medical devices with manufacturers or importers and marketers of drugs or medical devices, persons who have received first class wholesaler licenses, wholesalers or sellers of medical devices, etc., and persons who have acquired foreign manufacturing approval or their in-country caretakers. 3. Proprietors of pharmacies, proprietors of hospitals or clinics, or health professionals such as physicians, dentists or pharmacists shall make efforts to apply information supplied pursuant to the provisions of Paragraph 1 (including undertaking appropriate maintenance and inspections of medical devices designated pursuant to the provisions of Article 63-2, Item 2) and to collect, study and utilize other required information by maintaining close connections with each other in order to assure the proper use of drugs and medical devices. 4. Proprietors of pharmacies and sellers of druqs shall make efforts to supply information required for the proper use of drugs to those who usually purchase or use drugs. Article 77-4 The foreign acquirer of manufacturing approval or his in-country caretaker shall provide the importer who imports the approved drug, quasi- drug, cosmetic or medical device with the items approved for the drug, etc. concerned or any other data required for the correct handling of the drug, etc. as laid down by MHW ordinance. 2. When the foreign acquirer of manufacturing approval or his in-country caretaker does not submit the data as specified in the preceding paragraph, the Minister shall be able to request or instruct the foreign acquirer of manufacturing approval or his in-country caretaker to submit the data specified in the same paragraph when it considered necessary to prevent the occurrence or spread of hazards to public health and hygiene. (Reports of Adverse Reactions, etc.) Article 77-4-2 Manufacturers or importers and marketers of drugs, quasi-drugs, cosmetics or medical devices, persons who have acquired foreign manufacturing approval or their in-country caretakers must report to the Minister as specified by MHW ordinance when they learn of disease, disability or death suspected to be caused by an adverse reaction, an infectious disease suspected to be caused by use or any other matter specified by MHW ordinance related to the efficacy and safety of drugs, quasi-drugs, cosmetics or medical devices which they manufacture or import and market or have received approval to manufacture or import and market. (Reports of Recalls) Article 77-4-3 Manufacturers or importers and marketers of drugs, quasi-drugs, cosmetics or medical devices, persons who have acquired foreign manufacturing approval or their in-country caretakers must report to the Minister as specified by MHW ordinance when they undertake recalls of drugs, quasi-drugs, cosmetics or medical devices which they manufacture or import and market or have received approval to manufacture or import and market (excluding recalls undertaken by orders pursuant to the provisions of Article 70, Paragraph 1). (Preparation and preservation of records on designated medical devices) Article 77-5 In the case of medical devices designated by the Minister as those for which their location must be known in order to prevent the occurrence or spread of hazards to public health and hygiene such as medical devices which are used by implantation in the human body or other medical devices which might be used outside facilities providing medical treatment (hereinafter referred to as "designated medical devices"), companies which have received approval pursuant to the provisions of Article 14, in-country caretakers or importers and marketers who have received approval pursuant to the provisions of Article 14 applied mutatis mutandis under Article 23 (hereinafter referred as "persons with manufacturing approval") shall keep and appropriately preserve records including the names and addresses of persons with implanted designated medical devices or other person using medical devices (referred to as "users of designated medical devices" in the subsequent paragraphs), and other items specified by MHW ordinance. 2. Physicians or other health professionals handling designated medical devices shall supply information on items specified by MHW ordinance pursuant to the provisions of the preceding paragraph related to users of designated medical devices under their charge to persons with manufacturing approvals either directly or via a person selling, leasing or importing and marketing designated medical devices. However, this shall not apply when it is against the wishes of the user of the designated medical device. 3. Persons selling, leasing or importing and marketing designated medical devices shall make explanations to physicians and other health professionals handling designated medical devices and cooperate in other ways to facilitate the work involved in the preparation and preservation of records performed by persons with manufacturing approvals (hereinafter referred to as "record preparation work"). 4. Persons with manufacturing approvals may entrust all or part of the record preparation work to sellers handling exclusively a designated medical device for which the person has received approval or other persons in compliance with criteria specified by MHW ordinance. In such cases, the person with the manufacturing approval shall notify the Minister of items specified by MHW ordinance beforehand. 5. Persons with manufacturing approval, persons selling, leasing or importing and marketing designated medical devices or persons entrusted pursuant to the provisions of the preceding paragraph, or their executives or employees shall not divulge secrets related to record preparation work of persons they have become acquainted with at work without a valid reason. The same also applies to persons formerly in such positions. 6. In addition to the items specified in the preceding paragraphs, items required in relation to record preparation work shall be specified by MHW ordinance. (Guidance and Advice) Article 77-6 The Minister or the prefectural governor may give guidance or advice required for record preparation work to persons with manufacturing approvals, persons entrusted pursuant to the provisions of preceding Paragraph 4, persons selling, leasing or importing and marketing designated medical devices, or physicians or other health professionals handling designated medical devices. (Fees) Article 78 The persons specified in the following items shall pay the fees in the amounts specified by cabinet order in consideration of the expenses required for review of the applications specified in each item. (1) Persons applying for licenses as specified in Article 12, Paragraph 1 or Article 22, Paragraph 1. (2) Persons applying for renewal of licenses as specified in Article 12, Paragraph 3 or Article 22, Paragraph 3. (3) Persons applying for approvals as specified in Article 14 or Article 19-2. (4) Persons applying for reexamination pursuant to the provisions of Article 14-4 (including cases where it is applied mutatis mutandis under Article 19-4 or Article 23). (5) Persons applying for business licenses pursuant to the provisions of Article 18 (including cases where it is applied mutatis mutandis under Article 23) 2. Person applying for reviews performed by the Drug Organization pursuant to the provisions of Article 14-2, Paragraph 1 [including application mutatis mutandis to Article 14-4-2 (including application mutatis mutandis in Article 19-4 and Article 23), Article 19-2, Paragraphs 4 and 5 and Article 23] shall pay the fees in the amounts specified by cabinet order in consideration of the actual expenses required for the review concerned. 3. The fees paid pursuant to the provisions of the preceding paragraph shall be income of the Drug Organization. 4. Persons submitting applications for review work performed by designated review organizations pursuant to the provisions of Article 14-3, Paragraph 1 (including cases where it is applied mutatis mutandis under Article 19-2, Paragraph 4 and Paragraph 5 and Article 23) shall pay a fee to the designated review organization in an amount specified by cabinet order in consideration of the actual expenses incurred by the review work. 5. The fee paid to the designated review organization pursuant to the provisions of the preceding paragraph shall be income of the designated review organization. (License Conditions) Article 79 Conditons may be appended to the license or approval (excluding that specified in Article 23-12, Paragraph 1) prescribed in this Law. 2. The abovementioned conditions shall be confined to the minimum necessary for the prevention of hazards to public health and hygiene and shall never be those imposing undue obligations on the person who receives the license. (Application Exemptions, etc.) Article 80 Concerning drugs, quasi-drugs, cosmetics or medical devices for the purpose of export, necessary exceptions such as exemption from application of part of this Law may be laid down by cabinet order. 2. For drugs manufactured or marketed by obtaining a license in Article 12, Paragraph 1, Article 18, Paragraph 1 (including application mutatis mutandis in Article 23), or Article 22, Paragraph 1 pursuant to the provisions of Article 13-2, Paragraph 1 (including application mutatis mutandis in Article 18, Paragraph 2 and Article 23) (excluding those approved pursuant to the provisions of Article 14 or Article 19-2), application of part of the provisions or Article 43, Article 44, Articles 50 to 52, Article 54, Article 55, Paragraph 1 and Article 56 may be exempted or other required exemptions may be specified by cabinet order. (Handling of Clinical Trials) Article 80-2 Sponsors of clinical trials (limited to those performed on drugs ; the same in the remainder of this article) must do so in accordance with standards specified by MHW ordinance. 2. Sponsors of clinical trials must submit the clinical trial protocol to the Minister beforehand as specified by MHW ordinance. However, this shall not apply when specified otherwise by MHW ordinance. 3. Persons submitting protocols pursuant to the provisions of the preceding paragraph (limited to those submitting protocols as specified in the previous paragraph for the first time for the drug in the clinical trial related to the submission) shall not sponsor the clinical trial until after a period of 30 days has passed from the date of the submission concerned. In such cases, the Minister shall undertake a review of the clinical trial protocol in the submission concerned required in order not to jeopardize public health and hygiene. 4. Persons requested to perform clinical trials shall do so in accordance with the standards specified by MHW ordinance. 5. Persons requested to perform clinical trials shall manage the clinical trials in accordance with the standards specified by MHW ordinance. 6. Persons requested to perform clinical trials must report to the Minister as specified by MHW ordinance when they learn of disease, disability or death suspected to be caused by an adverse reaction, an infectious disease suspected to be caused by use of the drug or any other matter specified by MHW ordinance related to the efficacy and safety of the drug subject to the clinical trial concerned. 7. When it is confirmed necessary to determine if the clinical trial meets the standards in Paragraphs 4 and 5, the Minister shall be able to have the person sponsoring the clinical trial, the person reguested to perform the clinical trial or the person professionally handling the drug subject to the clinical trial submit the necessary reports, to have his employees visit the hospital, clinic, veterinary clinic, factory, office or other site where the drug subject to the clinical trial is professionally handled, to have them inspect the facilities and equipment, ledgers or other documentation or other materials, and to have them question employees or other related persons. 8. The Provisions of Article 69, Paragraph 3 apply mutatis mutandis tospot-inspections and questions specified in the preceding paragraph, and the provisions of Article 69, Paragraph 4 apply mutatis mutandis to the authority specified in the preceding paragraph. 9. When it is confirmed necessary to prevent the occurrence or spread of damage to public health and hygiene by use of the drug subject to the clinical trial, the Minister shall be able to order the sponsor of the clinical trial or the person requested to perform the clinical trial to cancel sponsoring or change the clinical trial, to stop performing or to change the clinical trial or to take other necessary measures. 10. The sponsor or the clinical trial, executives or his employees shall not leak any secrets concerning the clinical trial of persons they have become acquainted with in connection with their work. This shall also apply to persons whom such persons have met. Article 80-3 Sponsors of clinical trials (limited to those performed on medical devices; the same in the remainder of this article) must do so in accordance with standards specified by MHW ordinance. 2. Sponsors of clinical trials must submit the clinical trial protocol to the Minister beforehand as specified by MHW ordinance. However, this shall not apply when specified otherwise by MHW ordinance. 3. When it is confirmed necessary to prevent the occurrence or spread of damage to public health and hygiene by use of the medical device subject to the clinical trial, the Minister shall be able to order the sponsor of the clinical trial to cancel sponsoring, change the clinical trial, or to take other necessary measures. (Reviews of Clinical Trial Protocols Undertaken by the Organization for Drug ADR Relief, R&D Promotion and Product Review) Article 80-4 The Minister shall be able to have all or part of the work specified by cabinet order among the review work pursuant to the provisions of the last part of Article 80-2, Paragraph 3 for drugs subject to clinical trials (excluding drugs intended exclusively for use with animals) performed by the Drug Organization. 2. When the Minister has all or part of the work specified in the preceding paragraph performed by the Drug Organization, he shall not perform all or part of the work concerned. 3. When the Drug Organization is requested to perform all or part of the review work by the Minister as specified in Paragraph 1 and it has completed the review concerned, it shall report the results to the Minister ass specified by MHW ordinance without delay. (Delegation of Authority) Article 81 Part of the authority of the Minister prescribed in this Law may be delegated to the prefectural governors as specified by cabinet order. (Interim Measures) Article 82 When a cabinet order or MHW ordinance is enacted, altered or abolished pursuant to the provisions of this Law, the required interim provisions (including interim measures related to penal provisions) may, within reasonable limits, be established respectively by cabinet order or MHW ordinance. This shall also apply when the Minister specifies or changes the scope of poisonous or powerful drugs and other matters. (Drugs, etc. for Animals) Article 83 Regarding drugs, quasi-drugs, cosmetics or medical devices (including investigational drugs and devices or equipment) which are intended for exclusive use with animals, "the Minister of Health and Welfare" in this law (excluding paragraph 3 of the subsequent article) shall read "the Minister of Agriculture, Forestry and Fisheries"; "Ministry of Health and Welfare ordinance (MHW) ordinance" shall read "Ministry of Agriculture, Forestry and Fisheries Ordinance"; "the life and health of the public" in Article 13-2, Paragraph 1, Item 1 shall read "maintenance of the production and health of animals"; "medical practice" in Article 14, Paragraph 4 shall read "veterinary practice"; in Article 26, Paragraph 1, "the governor of the prefecture where the store is located [for first-class sellers other than those which sell or give drugs as a business exclusively to proprietors of pharmacies, manufacturers or marketers of drugs, or the proprietors of hospitals, clinics or veterinary clinics (hereinafter referred to as "first-class wholesalers"), the mayor of the municipality or ward when the store is located in a municipality specified by government ordinance in Article 5, Paragraph 1 of the Regional Health care Law (Law No. 101, 1947) (hereinafter referred to as "municipality with a health center") or in a region in a special ward] shall read "the governor of the prefecture where the store is located"; in Article 26, Paragraph 2, "first-class wholesaler" shall read "first class sellers which sell or give drugs as a business exclusively to proprietors of pharmacies, manufacturers or marketers of drugs, or the proprietors of hospitals, clinics or veterinary clinics"; in Article 26, Paragraph 3, "first-class wholesaler" shall read "first-class seller pursuant to the provisions in the proviso of the preceding paragraph (hereinafter "first-class wholesaler")"; and in Article 27, "mutatis mutandis." In such cases, "prefectural governor" in Article 8, Paragraph 3 shall read "prefectural governor (for first-class wholesalers pursuant to the provisions of Article 26, Paragraph 1, the mayor of the municipality or ward when the store is located in a municipality with a health center or in a region in a special ward pursuant to the provisions in the same paragraph)" shall read "mutatis mutandis." In Article 35, "the governor of the prefecture where the store is located (the mayor of the municipality or ward when the store is located in a municipality with a health center or in a region in a special ward. The same in the following article.)" shall read "the governor of the prefecture where the store is located." In Article 38, "mutatis mutandis." In such cases, "prefectural governor" in Article 10 shall read "prefectural governor (for first-class wholesalers pursuant to the provisions of Article 26, Paragraph 1, the mayor of the municipality or ward when the store is located in a municipality with a health center or in a region in a special ward pursuant to the provisions in the same paragraph)" shall read "mutatis mutandis." In Article 69, Paragraph 1; Article 70, Paragraph 2; and Article 77, Paragraph 2, "the prefectural governor, the mayor of the municipality where a health canter is located or the mayor of a special ward." shall read "or the prefectural governor". In Article 70, Paragraph 1, "or the prefectural governor (for first-class sellers or third-class sellers other than first class wholesalers, the mayor of the municipality or mayor of the ward when the store is located in a municipality with a health center or in a region in a special ward; the same in Article 72, Article 72-2, Article 73, Article 75, Paragraph 1 and Article 76)" shall read "or the prefectural governor". In Article 77, Paragraph 1, "prefectures, municipalities in which health centers are located and special wards" shall read "and prefectures", and in Article 77, Paragraph 2, "prefectures, municipalities in which health centers are located and special wards" shall read "and prefectures". (Restrictions on the Use of Drugs for Animals) Article 83-2 When there is a possibility that meat, milk or other products used for food from animals such as cattle and pigs designated by Ministry of Agriculture, Forestry and Fisheries ordinance (hereinafter referred to as "subject animals") may damage the health of humans if drugs used exclusively for animals are not used properly, the Minister of Agriculture, Forestry and Fisheries shall be able, on hearing the opinion of the Central Pharmaceutical Affairs Council, to specify the subject animals for which such drugs can be used, the periods during which the drug can be administered to the subject animals and other standards to be observed by the users of such drugs. 2. The users of drugs for which standards have been specified pursuant to the provisions of the previous paragraph shall use such drugs in accordance with these standards. However, this shall not apply when a drug in used in accordance with specifications in Ministry of Agriculture, Forestry and Fisheries ordinance in cases where a veterinarian judges that the use of the drug is unavoidable to treat or prevent disease in a subject animal under his care. 3. When it is considered neccessary from the standpoint of public health and hygiene, the Minister or Health and Welfare shall be able to give his opinion to the Minister of Agriculture, Forestry and Fisheries concerning the establishment, revision or cancelation of Ministry of Agriculture, Forestry and Fisheries ordinances indicated in the previous two paragraphs. Chapter XI Penal Provisions Article 84 Any person who comes under any of the following definitions shall be liable to penal servitude not exceeding 3 years or a fine not exceeding 2,000,000 yen, or both: (1) A person who has violated the provisions of Article 5, Paragraph 1 (2) A person who has violated the provisions of Article 12, Paragraph 1 (3) A person who has violated the provisions of Article 18, Paragraph 1 (including cases where it applies mutatis mutandis under Article 23) (4) A person who has violated the provisions of Article 23, Paragraph 1 (5) A person who has violated the provisions of Article 24, Paragraph 1 (6) A person who has violated the provisions of Article 29 (7) A person who has violated the provisions of Article 31 (8) A person who has violated the provisions of Article 36 (9) A person who has violated the provisions of Article 43, Paragraph 1 and Paragraph 2 (10) A person who has violated the provisions of Article 44, Paragraph 3 (11) A person who has violated the provisions of Article 49, Paragraph 1 (12) A person who has violated the provisions of Article 55, Paragraph 2 (including cases where it applies mutatis mutandis under Articles 60, 62 and 64) (13) A person who has violated the provisions of Article 56 (including cases where it applies mutatis mutandis under Article 60 and 62) (14) A person who has violated the provisions of Article 57, Paragraph 2 (including cases where it applies mutatis mutandis under Articles 60 and 62) (15) A person who has violated the provisions of Article 65. Article 85 Any person who comes under any of the following definitions shall be liable to penal servitude not exceeding 2 years or a fine not exceeding 300,000 yen, or both: (1) A person who has violated the provisions of Article 37, Paragraph 1 (2) A person who has violated the provisions of Article 47 (3) A person who has violated the provisions of Article 55, Paragraph 1 (including cases where it applies mutatis mutandis under Articles 60, 62 and 64) (4) A person who has violated the provisions of Article 66, Paragraph 1 or 3 (5) A person who has violated the provisions of Article 68 (6) A person who has violated the order to suspend business issued pursuant to the provisions of Article 75, Paragraph 1. Article 86 Any person who comes under any of the following definitions shall be liable to penal servitude not exceeding one year or a fine not exceeding 200,000 yen, or both: (1) A person who has violated the provisions of Article 8, Paragraph 1 or 2 (including cases where it applies mutatis mutandis under Article 27) (2) A person who has violated the provisions of Article 15, Paragraph 1 or 2 (including cases where it applies mutatis mutandis under Article 23) (3) A person who has violated the provisions of Article 17, Paragraph 1 (including cases where it applies mutatis mutandis under Article 23) (4) A person who has violated the provisions of Article 45 (5) A person who has violated the provisions of Article 46, Paragraph 1 or 3 (6) A person who has violated the provisions of Article 48, Paragraph 1 or 2 (7) A person who, contrary to the provisions of Article 49, Paragraph 2, has not entered the matters specified in the same paragraph or has entered them falsely, or who has violated the provisions of Paragraph 3 of the same article (8) A person who has violated the provisions of Article 58 in regard to poisonous or powerful drugs (9) A person who has violated the restrictions or other actions fixed by cabinet order enacted under the provisions of Article 67 (10) A person who has violated the stipulations under the provisions of Article 72 to prohibit him from using his facilities (11) Persons violating an order to suspend operations pursuant to the provisions of Article 72-3 (12) A person who has violated an order under the provisions of Article 73 (13) A person who has violated an order under the provisions of Article 74 (14) A person who has violated an order under the provisions of Article 83-2 Paragraph 2. 2. Any person who has used to his own advantage, or revealed without reason to persons other than the competent officials, confidential business matters acquired under authority of this Law, shall be liable to penal servitude not exceeding one year or a fine not exceeding 500,000 yen. Article 86-2 When violation of an order to suspend review work pursuant to the provisions of Article 23-13, Paragraph 2 occurs, the executives or employees of the designated review organization committing this violation shall be liable to penal servitude not exceeding one year or a fine not exceeding 500,000 yen. Article 87 Any person who comes under any of the following definitions shall be liable to a fine not exceeding 300,000 yen: (1) A person who has violated the provisions of Article 10 (including cases where it applies mutatis mutandis under Articles 38 and 40) (2) A person who has violated the provisions of Article 14-4, Paragraph 7 (including cases where it applies mutatis mutandis under Article 19-4 and Article 23) (3) A person who has violated the provisions of Article 14-5, Paragraph 6 (including cases where it applies mutatis mutandis under Article 19-4 and Article 23) (4) A person who has violated the provisions of Article 19 (including cases where it applies mutatis mutandis under Article 23) (5) A person who has violated the provisions of Article 33, Paragraph 1 the first part of paragraph 3 or paragraph 1 (6) A person who has violated the provisions of Article 39, Paragraph 1 (7) A person who has neglected to report or made false reports contrary toArticle 69, Paragraph 1, or who has refused, hindered or evaded the inspection or the acqusition of samples provided for in the same paragraph, or who has neglected to report without reason or made false reports on the questions specified in the same paragraph (8) A person who has violated an order issued pursuant to the provisions of Article 69-2 (9) A person who has violated the order issued pursuant to the provisions of Article 70, Paragraph 1, or who has refused, hindered or evaded the stipulations on disposal, etc. under the provisions of Paragraph 2 of the same article (10) A person who has violated the order under the provisions of Article 71 (11) A person who has violated the provisions of Article 77-5, Paragraph 5 (12) A person who has violated the order under the provisions of Article 80-2, Paragraph 1 or 2, the first part of Paragraph 3 or Paragraph 5 (13) A person who has violated the provisions of Article 80-2, Paragraph 10 (14) A person who has violated the provisions of Article 80-3, Paragraph 1 or Paragraph 2 2. The crime in Items 2, 3, 11 and 13 of the preceding paragraph shall be dealt with after an accusation has been made. Article 88 Any person who comes under any of the following definitions shall be liable to a fine not exceeding 200,000 yen: (1) A person who has violated the provisions of Article 7 (2) A person who has violated the provisions of Article 32. Article 88-2 Executives or employees of a designated review organization who have committed a violation corresponding to any one of the following items shall be liable to a fine not exceeding 200,000 yen. (1) When account books are not provided, entries are not made or false entries are made in the account books or the account books are not preserved pursuant to the provisions of Article 23 (2) When all of the review work is suspended without having received approval pursuant to the provisions of Article 23 (3) When no reports or false reports are made pursuant to the provisions of Article 69, Paragraph 2; when spot inspections in accordance with the provisions of the same paragraph are refused, hindered or evaded; or when the person does not reply for no valid reason or gives a false reply to questions asked pursuant to the provisions of the same paragraph. Article 89 If any representative of a corporation, or any agent, employee or other worker of a corporation or an individual has perpetrated, in connection with the business of the corporation or the individual, a violation under Article 84, Article 85, Article 86, Paragraph 1 or the preceding Articles 87 or 88, not only the perpetrator shall be punished, but also the corporation or the individual shall be subject to a fine under the respective article. Additional Provisions Article 1 (Date of Enforcement) This Law shall come into effect from April 1, 1997. However, in Article 1, the revised provisions pursuant to Article 13, Paragraph 1 of the Law; the revised provisions in the Article following Article 13; the revised provisions pursuant to Article 18, Paragraph 2 and Article 23 of the Law; the revised provisions in the Article following Article 75-2 of the Law; the revised provisions pursuant to Article 80 and the revised provisions pursuant to Article 83 (excluding the part in the which "investigational product" was changed to "investigational drugs and devices or equipment") and the provisions in the following Article and Article 3 of the Additional Provisions shall come into effect from the data of promulgation. Article 2 (Investigation) The government shall undertake a general investigation promptly concerning measures to prevent impairment of health by drug products, etc. in connection with the AIDS problem caused by administration of blood products, and based on the results of this investigation, shall enact laws and regulations and take other necessary measures. Article 3 (Interim Measures Associated with Partial Revision of the Law) The provisions the last part of Article 14, Paragraph 3 (including cases where it applies mutatis mutandis in Article 14, Paragraph 6, and Article 19-2, Paragraph 4 and Article 23 of the new Law) in the Pharmaceutical Affairs Law after revision (hereinafter referred to in this Article as "the new Law) pursuant to the provisions of Article 1 do not apply to data in applications for approval submitted pursuant to the provisions of Article 14, Paragraph 3 (including cases where it applied mutatis mutandis in Article 14, Paragraph 6, and Article 19-2, Paragraph 4 and Article 23 of the old Law) in the Pharmaceutical Affairs Law before revision (hereinafter referred to in this Article as "the old Law), pursuant to the provisions of Article 1 before enforcement of the Law. 2. Among the data in applications for reexaminations submitted pursuant to the provisions of Article 14-4, Paragraph 1 (including cases where it applies mutatis mutandis in Article 19-4 and Article 23 of the old Law) in the old Law before enactment of this Law and the data in applications for reexaminations submitted pursuant to the provisions of Article 14-4, Paragraph 1 (including cases where it applies mutatis mutandis in Article 19-4 and Article 23 of the new Law) in the new Law after enforcement of this Law, the provisions the last part of Article 14-4, Paragraph 4 of the new Law (including cases where it applies mutatis mutandis in Article 19-4 and Article 23 of the new Law) do not apply to the data collected or prepared before enforcement of the Law and that collected or prepared at the time of enforcement of the Law. 3. The provisions the last part of Article 14-5, Paragraph 4 of the new Law (including cases where it applies mutatis mutandis in Article 19-4 and Article 23 of the new Law) do not apply to the data submitted by persons who have received reevaluations pursuant to the provisions of Article 14-5, Paragraph 1 (including cases where it applies mutatis mutandis in Article 19-4 and Article 23; the same in the remainder of this paragraph) of the old Law before enforcement of this Law and data which persons who should receive reevaluations of drugs published pursuant to the provisions of Article 14-5, Paragraph 1 of the old Law before enactment of this Law submitted after enforcement of this Law. 4. The provisions of Article 80-2, Paragraph 3 of the new Law do not apply to requests for clinical trials (limited to those on drug products; the same in the following paragraph) in Article 80-2, Paragraph 1 according to a protocol notified pursuant to the provisions of Article 80-2, Paragraph 2 before enactment of this Law. 5. The provisions of Article 80-2, Paragraph 4 of the new Law do not apply to persons who have received requests to perform clinical trials in Article 80-2, Paragraph 1 of the old Law before enactment of this Law, and the provisions of Article 80-2, Paragraph 5 do not apply to persons requesting the clinical trials concerned.