Enforcement Ordinance of the Pharmaceutical Affairs Law Article 1. (Range of Medical Devices) The medical devices specified in Article 2, Paragraph 4 of the Pharmaceutical Affairs Law (hereinafter referred to as"the Law") shall be as specified in Attached Table 1. Article 1-2. [Range of Drugs and Medical Devices to Which Good Manufacturing Practice (GMP) Applies] Drugs specified in the provisions of Article 13, Paragraph 2, Item 2 of the Law (with application mutatis mutandis of Article 16, Paragraph 2 of the Law; the same hereinafter) shall be drugs other than the following. (1) Drugs intended exclusively for the extermination or prevention of rodents, flies, mosquitoes, fleas, etc. which do not come into direct contact with the bodies of humans or animals. (2) Drugs used exclusively for sterilization or disinfection which do not come into direct contact with the bodies of humans or animals. (3) Bulk drugs used exclusively for the manufacture of drugs specified in the previous two items (limited to drugs used with humans). (4) Drugs used exclusively for the diagnosis of disease which do not come into direct contact with the bodies of humans or animals (in vitro diagnostics). (5) Drugs manufactured in factories where the only processes performed are the pulverization or shredding of natural drugs. (6) Drugs manufactured by the proprietors of pharmacies using equipment and utensils in their own pharmacies (7) Gases designated by the Minister of Health and Welfare among the gases used in medical treatment of humans or animals. (8) Drugs in the Japanese Pharmacopoeia designated by the Minister as those with mild action on the human body among drugs other than those specified in the previous items. (9) Bulk drugs supplied for use in the manufacture of drugs used exclusively in animals (10) Calcium preparations manufactured by the physical selective pulverization of limestone, shell, etc. and used exclusively for animals 2. Medical devices pursuant to the provisions of Article 13, Paragraph 2, Item (2) of the Law shall be those not included in Attached Table 2 Article 1-2-2. (Measures Which Can Be Imposed as Obligations on Recipients of Special Licenses Prior to Approval) The measures specified by cabinet order in Article 13-2, Paragraph 2 of the Law (with application mutatis mutandis in Article 18, Paragraph 2 and Article 23) shall be as follows. (1) Performance of a survey of the results of use of the product concerned, and reporting of the results to the Minister (2) Prompt reporting to the Minister when the recipient learns of a disease, disability or death suspected of being caused by use of the product concerned. (3) Measures required to explain or inform the ordinary purchaser or user of the drug concerned that a license in Article 12, Paragraph 1; Article 18, Paragraph 1 (with application mutatis mutandis in Article 23) and Article 22, Paragraph 1 pursuant to the provisions of Article 13-2, Paragraph 1 (with application mutatis mutandis in Article 18, Paragraph 2 and Article 23) (hereinafter referred to as a "special license prior to approval") has been obtained for the product concerned. (4) In addition to the measures in the preceding item, reporting to the Minister of the persons sold or given the product concerned and the amounts sold or given to each of these persons, as well as any other measures specified by the Minister to prevent the onset or spread of risks to the public health or hygiene. Article 1-3. (Special Cases of Manufacture in Two or More Factories) When a person granted a license pursuant to the provisions of Article 12, Paragraph 1 of the Law for a drug, quasi-drug or cosmetic (excluding those designated by MHW ordinance) or medical device (limited to the product for which the license was granted; hereinafter referred to as "product manufacturing business license") performs part of the manufacturing process of the product concerned (excluding repair of existing medical devices from the content of the manufacturing concerned when medical devices are manufactured; the same hereinafter) in a factory other than that for which the product manufacturing business license was granted (excluding factories where the final inspection in the manufacture of the product concerned is performed; hereinafter referred to as "partial processing factory"), the Minister of Health and Welfare shall be able to grant a license pursuant to the provisions of Article 12, Paragraph 1 of the Law in accordance with the categories specified by MHW ordinance based on Good Manufacturing Practice (GMP) (hereinafter referred to as "category"). 2. When the provisions specified in Article 18 of the Law apply concerning changes in or additions to the category in the partial processing factory concerned in cases where a person granted product manufacturing business licenses receives a license to perform part of the processing of the product concerned in the product manufacturing business license in a partial processing factory pursuant to the provisions of Article 12, Paragraph 1 of the Law (excluding cases related to the category to which the product concerned belongs), "product" shall read "category specified in Article 1-3, Paragraph 1 of the Enforcement Ordinance of the Law " in Paragraph 1 of Article 18, and "Article 13 in Paragraph 2 of Article 18 shall read "Article 13, Paragraph 2". Article 1-3-2. (Special Cases of Repair of Medical Devices) The Minister shall be able grant licenses specified in Article 12, Paragraph 1 of the Law in accordance with categories designated by MHW ordinance related to repaired products and repair methods (referred to simply as "categories" in the following Paragraph) to manufacturers of medical devices (limited to cases where the contents of the manufacturing concerned are repair of medical devices). The provisions of Article 13, Paragraph 2, Item (1) of the Law shall not apply in such cases. 2. When the provisions of Article 18 of the Law are applied to changes in or additions to categories for manufacturers of medical devices, "drugs, quasi-drugs, cosmetics or medical devices" in Paragraph 1 of the same article shall read "medical devices" and "products" shall read "categories specified in Article 1-3-2 of the Enforcement Ordinance of the Law". "Article 13" in Paragraph 2 of the same article shall read "Article 13, Paragraph 2 [excluding Item (2)]". Article 1-4. (Period of Validity of Manufacturing Business Licenses) The period specified by cabinet order pursuant to the provisions of Article 12, Paragraph 3 of the Law shall be the period specified in each of the following items in accordance with the category of the license in each item. (1) Licenses to manufacture drugs (excluding those in the following items): 5 years (2) Licenses to manufacture drugs by proprietors of pharmacies using equipment and utensils in their own pharmacies: 6 years (3) Licenses to manufacture quasi-drugs: 5 years (4) Licenses to manufacture cosmetics: 5 years (5) Licenses to manufacture medical devices: 3 years Article 1-5. (Range of Reviews Performed by the Organization for Drug ADR Relief, R&D Promotion and Product Review) The reviews which the Minister may request the Organization for Drug ADR Relief, R&D Promotion and Product Review (hereinafter referred to as "Drug Organization") to perform pursuant to the provisions of Article 14-2, Paragraph 1 of the Law (with application mutatis mutandis in Article 19-2, Paragraphs 4 and 5 and Article 23) shall be as follows. (1) Among the reviews pursuant to the provisions of the first part of Article 14, Paragraph 4 of the Law [with application mutatis mutandis in Article 6 (with application mutatis mutandis Article 19-2, Paragraph 4 and Article 23), Article 19-2, Paragraph 4 and Article 23], reviews concerning the equivalence of ingredients and quantities, dosage and administration, indications, etc. of a drug (excluding those specified in the following items), quasi-drug [excluding those for which the Minister has transferred the authority pursuant to the provisions of Article 14, Paragraph 1 and Article 6 (with application of these provisions mutatis mutandis in Article 23) of the Law to the prefectural governors pursuant to the provisions of Article 81 of the Law] or cosmetic to those of a product which has already been approved for manufacture or import. (a) Drugs designated as orphan drugs pursuant to the provisions of Article 77-2, Paragraph 1. (b) In addition to the drugs in the preceding item, drugs with active ingredients, formulations or routes of administration which are different from those of drugs entered in the Japanese Pharmacopoeia (JP) or drugs which have already been approved for manufacture or import [excluding new drugs pursuant to the provisions of Article 14-4, Paragraph 1, Item (1) of the Law for which the reexamination period specified in the same item (period after the extension when the period is extended pursuant to the provisions of Article 14-4, Paragraph 2) from the date of manufacturing or import approval has not elapsed, or drugs designated by the Minister pursuant to the provisions of Article 14-4, Paragraph 1, Item (2) for which the period specified by the Minister as specified in the same item has not elapsed] [in the case of drugs with different active ingredients or formulations only, this is limited to drugs specified as prescription drugs by the Minister (hereinafter referred to as "prescription drugs")]. However, among those drugs used exclusively for the diagnosis of disease, those which are not used in direct contact with humans or animals, or which adhere to the skin of humans or animals are excluded.) (2) All reviews pursuant to the provisions of the last part of Article 14, Paragraph 4 [with application mutatis mutandis in Article 6 (with application mutatis mutandis Article 19-2, Paragraph 4 and Article 23), Article 19-2, Paragraph 4 and Article 23] 2. Reviews which the Minister may have the Drug Organization perform pursuant to the provisions of Article 14-2, Paragraph 1 with application mutatis mutandis in Article 14-4-2 (with application mutatis mutandis in Article 19-4 and Article 23) shall include all reviews of reexamination data compliance pursuant to the provisions of the last part of Article 14-4, Paragraph 5 (with application mutatis mutandis in Article 19-4 and Article 23). 3. Reviews which the Minister may have the Drug Organization perform pursuant to the provisions of Article 14-2, Paragraph 1 with application mutatis mutandis in Article 14-5-2 (with application mutatis mutandis in Article 19-4 and Article 23) shall include all reviews of reevaluation data compliance pursuant to the provisions of the last part of Article 14-5, Paragraph 5 (with application mutatis mutandis in Article 19-4 and Article 23). Article 1-5-2. (Range of Reviews by Designated Review Organizations) Reviews which may be performed by review organizations designated by the Minister (hereinafter referred to as "designated review organizations") pursuant to the provisions of Article 14-3, Paragraph 1 of the Law (including application mutatis mutandis of Article 19-2, Paragraph 4 and Article 23) shall be reviews of the equivalence of the structure, methods of use, indications, effects, performance, etc. of the medical device concerned [excluding the following medical devices and those for which the authority of the Minister pursuant to the provisions of Article 14, Paragraph 1 of the Law (including application mutatis mutandis of Article 23 of the Law) had been transferred to the prefectural governors pursuant to the provisions of Article 81 of the Law] to those of medical devices which have already been approved for manufacture or import. (1) Medical devices designated as orphan medical devices pursuant to the provisions of Article 77-2, Paragraph 1 of the Law (2) Medical devices designated as designated medical devices pursuant to the provisions of Article 77-5 of the Law other than those specified in the previous item. (3) Medical devices which have already been approved for manufacture or import other than those specified in the previous two items [excluding new medical devices pursuant to the provisions of Article 14-4, Paragraph 1, Item (1) for which the reexamination period from the day after manufacturing or import approval specified in the same item (the extended period when the reexamination period has been extended pursuant to the provisions of Paragraph 2 of the same article) has not elapsed or medical devices designated by the Minister pursuant to the provisions of Paragraph 1, Item (2) of the same article for which the period specified by the Minister pursuant to the provisions of the same item has not elapsed] and medical devices with structures different from those designated by the Minister pursuant to the provisions of Article 14, Paragraph 1. Article 1-6. (Period of Validity of Import and Marketing Business Licenses) The period specified by cabinet order pursuant to the provisions of Article 22, Paragraph 3 shall be 5 years. Article 2. (Issuance of Licenses, etc.) When the prefectural governors [the mayor of the municipality or ward in the cases of first class sellers other than first class wholesalers or third class sellers with stores or places of businesses located in municipalities or special wards specified by cabinet order pursuant to the provisions of Article 5, Paragraph 1 of the Regional Insurance Law (Law No.101, 1947); the same in Articles 3 and 4] grant licenses for operating pharmacies or drug retailing businesses, the required items as specified by MHW ordinance must be entered in the license register and the license form must be issued to the license applicant. The same shall apply in cases where licenses for operating pharmacies or drug retailing businesses are renewed. 2. When the prefectural governors grant licenses pursuant to the provisions ofthe proviso in Article 26, Paragraph 3 of the Law, the required items as specified by MHW ordinance must be entered in the license register and the license form must be issued to the license applicant. Article 3. (Revision and Issuance of Licenses) When the prefectural governors receive applications for revision and issuance of license forms from proprietors of pharmacies or sellers of drugs because of changes in the items entered in the license form, the license form must be revised and issued. Article 4. (Reissuance of License Forms) When the prefectural governors receive applications for reissuance of licenseforms from proprietors of pharmacies or sellers of drugs because of destroyed or lost licenses, the license forms must be issued. Article 5. (Persons Who Are Working Executives of Corporations) Persons who are working executives of corporations pursuant to the provisions of Article 28, Paragraph 2 of the Law shall be employees of nonprofit corporations who are in a position of overall supervision of the store concerned or the houseshold distribution marketing area with respect to the operation of the drug marketing business performed by the corporation concerned. Article 6. (Criteria for Persons with the Knowledge and Experience Required for a Second-class License for Selling Drugs) Persons who may receive second-class licenses for selling drugs from the prefectural governors without taking an examination pursuant to the provisions of in Article 28, Paragraph 2 of the Law shall be those who have completed courses majoring in pharmaceutical science in universities based on the former Universities Ordinance (Imperial Ordinance No.388, 1932) (hereinafter referred to as"former universities"), colleges based on the former Colleges Ordinance (Imperial Ordinance No.61, 1903) (hereinafter referred to as"former colleges"), or universities based on the School Education Act (Law No.26, 1947) (excluding junior colleges) (hereinafter referred to as"universities"); persons who have passed examinations as specified in the same paragraph; or persons who have had at least 8 years experience working for drug sellers with a second class license, and are found to be suitable by the prefectural governors. Article 7. (Criteria for Persons with the Knowledge and Experience Required as Household Distributors of Drugs) Persons with knowledge and experience required for working as household distributors of drugs pursuant to the provisions of Article 30, Paragraph 2, Item (2) of the Law shall be those corresponding to any one of the following items. (1) Persons who have completed a course majoring in pharmaceutical science at a former university, former college or a university. (2) Persons who heve been employed for at least 3 years by a household distributor of drugs after completion of a course majoring in pharmaceutical science at a former middle school based on the former Middle School Ordinance (Imperial Ordinance No.36, 1933) or a high school or equivalent school based on the School Education Act. (3) Persons who have been employed for at least 5 years by a household distributor of drugs and are found to be appropriate by the prefectural governor. Article 8. (Applications for Tests) Persons who have tests (hereinafter referred to as"applicants") performed by institutions (hereinafter referred to as"testing institutions") designated by the Minister pursuant to the provisions in Article 43, Paragraph 1 of the Law for drugs designated by the Minister pursuant to the provisions in Paragraph 1 or Paragraph 2 of the same article of the Law or medical devices designated by the Minister pursuant to the provisions in Paragraph 2 of the same article of the Law must submit applications to the testing institutions via the prefectural governors with the fee indicated by the Minister as specified by MHW ordinance. Article 9. (Test Items) When the prefectural governors receive an application as specified in thepreceding article, the items to be tested shall be collected by a pharmaceutical inspector and sent to the testing institution together with the application form as specified by MHW ordinance. Article 10. (Test Certificates) When testing institutions perform tests by means of the criteria specified by the Minister on items sent pursuant to the provisions of the preceding article, the results are notified to the prefectural governor and when the drug or medical device concerned has passed the test, the required number of test certificates must be sent. Article 11. (Sealing with the Test Certificate) When the prefectural governors are notified of the results of tests in accordance with the specifications in the preceding article, the applicant shall be notified of the results and when the test certificate is sent, the container or wrapper holding the drug or medical device which has passed the test must be sealed with the test certificate by a pharmaceutical inspector. Article 12. (Restrictions on Advertising of Drugs for Designated Diseases) Diseases designated in accordance with the specifications in Article 67, Paragraph 1 of the Law are cancer, sarcoma and leukemia, and the drugs designated in accordance with the specifications in the same article and same paragraph are as shown in Attached Table 3. 2. Advertising of drugs specified in the preceding paragraph to treat the designated diseases in the same paragraph shall be limited to that in newspapers or journals containing medically or pharmaceutically related articles aimed at persons in the medical or pharmaceutical fields or other media aimed mainly at persons in the medical or pharmaceutical fields. Article 13. (Qualifications of Pharmaceutical Inspectors) Persons may only serve as pharmaceutical inspectors if they correspond to any one of the following. (1) Pharmacists, physicians, dentists or veterinarians (2) Persons who have completed a course majoring in pharmaceutical science, medicine, dentistry, veterinary science, science or engineering at a former university, former college or university or a special high school based on the School Education Act, and who have sufficient knowledge and experience to serve as a pharmaceutical inspector. (3) Persons who have been working in the government service related to pharmaceuticals for at least one year and who have sufficient knowledge and experience to serve as a pharmaceutical inspector. Article 14. (Fees Specified by Cabinet Order Pursuant to the Provisions of Article 78. Paragraph 1 of the Law) The amounts of the fees specified by cabinet order pursuant to the provisions of Article 78, Paragraph 1 of the Law shall be as specified in the following items for the type of person specified in each of these items. (1) The amounts specified in (a) to (h) corresponding to the license specified in (a) to (h) for persons applying for licenses pursuant to the provisions of Article 12, Paragraph 1 or Article 22, Paragraph 1 of the Law. (a) Licenses for the manufacture or import of drugs [excluding those specified in (b), (c) and (h)]: ￥114,000 (b) Licenses for the manufacture or import only of drugs subject to special reviews [drugs in Article 1-2, Paragraph 1, items (1) to (8); the same hereinafter in this article] [excluding those in items (c) and (h)]: ￥69,400 (c) Licenses for the manufacture of drugs by pharmacy proprietors usingequipment and utensils in their own pharmacies (hereinafter referred to as "pharmacy manufacturing licenses"): ￥11,000 (d) Licenses for the manufacture or import of quasi-drugs or cosmetics[excluding those specified in (h)]: ￥34,800 (e) Licenses for the manufacture or import of medical devices [excluding those specified in (f), (g) and (h)]: ￥114,000 (f) Licenses for the manufacture or import only of medical devices subject to special reviews (medical devices in Attached Table 2; the same hereinafter in this article) [excluding those in items (g) and (h)]: ￥69,400 (g) Licenses for the manufacture or medical devices (limited to cases where the manufacture refers to repair of existing medical devices) [excluding those in item (h)]: ￥69,400 (h) Licenses for the manufacture or import of drugs, quasi-drugs or medicaldevices for exclusive use with animals: ￥24,500 (2) The amounts specified in a to h corresponding to the type of license renewal specified in (a) to (h) for persons applying for renewal of licenses pursuant to the provisions of Article 12, Paragraph 3 or Article 22, Paragraph 3 of the Law.(a) Renewal of licenses for the manufacture or import of drugs [excluding those specified in (b), (c) and (h)]: ￥83,100 (b) Renewal of licenses for the manufacture or import only of drugs subject to special reviews [excluding those in items (c) and (h)]: ￥47,600 (c) Renewal of pharmacy manufacturing license: ￥5,600 (d) Renewal of licenses for the manufacture or import of quasi-drugs or cosmetics [excluding those specified in (h)]: ￥22,200 (e) Renewal of licenses for the manufacture or import of medical devices [excluding those specified in (f), (g) and (h)]: ￥83,100 (f) Renewal of licenses for the manufacture or import only of medical devices subject to special reviews [excluding those in items (g) and (h)]: ￥47,600 (g) Renewal of licenses for the manufacture or medical devices (limited to cases where the manufacture refers to repair of existing medical devices) [excluding those in item (h)]: ￥47,600 (h) Renewal of licenses for the manufacture or import of drugs, quasi-drugs or medical devices for exclusive use with animals: ￥12,800 (3) The amounts specified in (a) or (b) corresponding to the type of person specified in (a) or (b) for persons applying for approvals pursuant to the provisions of Article 14 (with application mutatis mutandis of Article 23) or Article 19-2 of the Law. (A) The amounts specified, from (1) to (4) corresponding to the type of persons specified from (1) to (4) for persons applying for approvals pursuant to the provisions of Article 14, Paragraph 1 (application mutatis mutandis of Article 23) and Article 19-2, Paragraph 1 of the Law. (1) The amounts specified in (a) to (l) corresponding to the type of drug specified in (a) to (l) in the case of drug approvals. However, ￥111,900 shall be added to these amounts for drugs specified by MHW ordinance as special expenses required for approval reviews. (a) Drugs with active ingredients, rates of combination or routes of administration which differ from those of drugs in the Japanese Pharmacopoeia or drugs which have already been approved for manufacture or import [excluding new drugs pursuant to the provisions of Article 14-3, Paragraph 1, Item (1) of the Law for which the period specified in the some item (the period after the extension when an extension is made pursuant to the provisions of Article 14-3, Paragraph 2) has not passed since the date of approval for manufacture or import and drugs specified by the Minister pursuant to the provisions of Item (2) of the same paragraph for which the period specified by the Minister pursuant to the provisions of the same item has not passed; hereinafter "approved drugs" in this Article] [drugs for which only the combination rates of the active ingredients differ are limited to ethical drugs]. However, drugs which are used exclusively for the diagnosis of diseases and are not used in direct contact with the bodies of humans or animals, adhere to the skin of humans or animals or are used exclusively for animals are excluded: ￥1,625,500 (b) Drugs with different indications or dosage and administration from those of approved drugs which as subject to reviews specified in Article 1-5, Paragraph 1, Item (1) (hereinafter "equivalence reviews"): ￥1,046,100 (c) Drugs with different indications or dosage and administration from those of approved drugs [excluding those in (b)]: ￥1,142,500 (d) Prescription drugs subject to equivalence reviews [excluding those in (b), (f) and (h)]: ￥76,700 (e) Prescription drugs [excluding those in (a) to (d) and (f) to (h)]: ￥195,200 (f) Drugs in the Japanese Pharmacopoeia (JP) subject to equivalence reviews [excluding those in (b) and (h)]: ￥17,500 (g) Drugs in the JP for which the Minister has transferred the authority pursuant to the provisions of Article 14, Paragraphs 1 and 6 (with application mutatis mutandis in Article 23) of the Law to the prefectural governors pursuant to the provisions of Article 81 of the Law (hereinafter "drugs approved by prefectural governors" in this Article) {excluding those in (h)]: ￥34,500 (h) Drugs specified in Item 1-(c): ￥90 (i) Drugs other than those specified in (b), (d), (f) and (h) which are subject to review by the Drug Organization: ￥26,600 (j) Drugs other than those spcified in (a) to (i) and (k) and (l): ￥69,300 (k) Drugs used exclusively for animals which are in the Japanese Pharmaco-poeia (JP) or which have different active ingredients or routes of administration from drugs already approved for manufacture or import [excluding new drugs pursuant to the provisions of Article 14-3, Paragraph 1, Item 1 for which the reexamination period as specifed in the same item from the date of manufacturing or import approval (the period after the extension when an extension has been made pursuant to the provisions of Article 14-3, Paragraph 2) has not passed, and drugs designated by the Minister of Agriculture, Forestry and Fisheries pursuant the provisions of Article 14-3, Paragraph 1, Item (2) with the reading changed as stipulated in Article 83 of the Law for which the period designated by the Minister of Agriculture, Forestry and Fisheries pursuant to the provisions of Article 14-3, Paragraph 1, Item (2) with the reading changed as stipulated in Article 83 of the Law has not passed]. However, drugs used exclusively for the diagnosis of disease which do not come into direct contact with animals or which adhere to the skin of animals shall be excluded: ￥595,200 (l) Drugs used exclusively for animals [excluding those specified in (k)]: ￥50,400 (2) Approval of quasi-drugs: Amounts as specified in (a) to (c) for the types of quasi-drugs specified in (a) to (c) (a) Quasi-drugs [excluding those specified in (b) and (c)]: ￥34,000 (b) Quasi-drugs subject to equivalence reviews: ￥17,200 (c) Quasi-drugs for exclusive use with animals: ￥28,700 (3) Approval of cosmetics: ￥17,200 (4) Approval for medical devices: Amounts specified in (a) to (d) for the types of medical devices specified in (a) to (d), respectively. (a) Medical devices [excluding those specified in (b) to (d)]: ￥101,300 (b) Medical devices which the Minister has reviewed by designated review organizations pursuant to the provisions of Article 14-3, Paragraph 1 of the Law (with application mutatis mutandis in Article 19-2, Paragraph 4 and Article 23 of the Law) (hereinafter, "medical devices subject to review by designated organizations"): ￥34,000 (c) Medical devices with structures which are different from those of medical devices which have already been approved for manufacture or import [excluding new medical devices pursuant to the provisions of Article 14-4, Paragraph 1, Item (1) of the Law for which the reexamination period specified in the same item (period after the extension when the period is extended pursuant to the provisions of Article 14-4, Paragraph 2) from the date of manufacturing or import approval has not elapsed, or medical devices designated by the Minister pursuant to the provisions of Article 14-4, Paragraph 1, Item (2) for which the period specified by the Minister as specified in the same item has not elapsed] and medical devices specified by the Minister pursuant to the provisions of Article 14, Paragraph 1 [excluding those specified in (d)]: ￥667,400 (d) Medical devices for exclusive use with animals: ￥50,400 (B) The amounts specified in (1) to (4) for the respective types of approval in (1) to (4) for persons applying for approvals pursuant to the provisions of Article 14, Paragraph 6 (with application mutatis mutandis of Article 19-2, Paragraph 4 and Article 23) of the Law. (1) Approvals for drugs The amounts specified in (a) to (j) for the respective types of drugs in (a) to (j). (a) Drugs with different indications and dosage and administration from those of existing drugs, which are subject to equivalence reviews: ￥917,800 (b) Drugs with different indications and dosage and administration from those of existing drugs [excluding those specified in (a)]: ￥964,600 (c) Prescription drugs subject to equivalence reviews [excluding those specified in (a), (e) and (g)]: ￥42,400 (d) Prescriptions drugs [excluding those specified in (a) to (c) and (e) to (g)]: ￥93,600 (e) Drugs in the Japanese Pharmacopoeia subject to equivalence review [excluding those specified in (a) and (g)]: ￥10,400 (f) Drugs in the JP approved by the prefectural rovernors [excluding those specified in (g)]: ￥20,300 (g) Drugs specified in 1-c: ￥90 (h) Drugs subject to equivalence review excluding those specified in (c), (e) and (g): ￥15,800 (i) Drugs excluding those specified in (a) to (h) and (j): ￥30,100 (j) Drugs for exclusive use with animals: ￥25,400 (2) Approvals of quasi-drugs: Amounts as specified from (a) to (c) for the types of quasi-drugs specified in (a) to (c) (a) Quasi-drugs [excluding those specified in (b) and (c)]: ￥20,300 (b) Quasi-drugs subject to equivalence review : ￥10,400 (c) Quasi-drugs for exclusive use with animals: ￥15,900 (3) Approvals of cosmetics: ￥10,400 (4) Approvals of medical devices: Amounts specified in (a) to (c) for the types of medical devices specified in (a) to (c), respectively (a) Medical devices [excluding those specified in (b) and (c)]: ￥60,300 (b) Medical devices subject to reviews by designated organizations: ￥24,700 (c) Medical devices for exclusive use with animals: ￥25,400 (4) Persons applying for reexaminations pursuant to the provisions of Article 14-4 (with application mutatis mutandis of Article 19-4 and Article 23): Amounts as specified in (a) and (b) for the type of reexamination specified in (a) or (b) (a) Reexaminations of drugs: Amounts specified in (1) and (2) for the categories of drugs specified in (1) and (2), respectively (1) Drugs excluding those specified in (2): ￥243,600 (2) Drugs for exclusive use with animals: ￥233,300 (b) Reexaminations for medical devices: Amounts specified in (1) to (3) for the categories of medical devices specified in (1) to (3), respectively (1) Medical devices specified in Item (4)(c) of the previous item: ￥258,500 (2) Medical devices excluding those specified in (1) and (3): ￥39,200 (3) Medical devices for exclusive use with animals: ￥29,600 (5) Persons applying for licenses pursuant to the provisions of Article 18 (with application mutatis mutandis of Article 23): Amounts as specified in (a) to (c) for the types of licenses specified in (a) to (c) (a) Pharmacy manufacturing license: ￥90 (b) Licenses for manufacture or import of drugs excluding those specified in Item(1)(c), quasi-drugs (excluding those used exclusively for animals), cosmetics or medical devices (excluding those used exclusively for animals): Amounts as specified in (1) or (2) according to the cases specified in (1) to (3) (1) Cases where a license to manufacture or import drugs is obtained: Amounts specified in (a) to (d) corresponding to the respective categories in (a) to (d) (a) Changes in or additions of products [excluding those specified in (b)]: ￥33,400 (b) Changes in or additions of products (limited to cases where the newly added product based on the change in or addition of the product concerned is a drug not subject to a special review): ￥16,300 (c) Changes in or additions of the categories specified in Article 1-3, Paragraph 1 [excluding those in (d)]: ￥83,100 (d) Changes in or additions of the categories specified in Article 1-3, Paragraph 1 (limited to cases where the newly added category based on the change in or addition of the category concerned is related to a drug not subject to a special review): ￥47,600 (2) Case where a license to manufacture or import a quasi-drug or cosmetic isapplied for: Amounts as specified in (a) or (b) according to the quasi-drug or cosmetic product for the corresponding license or the category as specified in Article 1-3, Paragraph 1 (a) Products in licenses for manufacturing or import and marketing businesses: ￥15,900 (b) Category licenses for manufacturing businesses: ￥30,100 (3) Cases where a license to manufacture or import medical devices is obtained: Amounts specified in (a) to (d) corresponding to the respective categories in (a) to (d) (a) Changes in or additions of products [excluding those specified in (b)]: ￥33,400 (b) Changes in or additions of products (limited to cases where the newly added product based on the change in or addition of the product concerned is a medical device not subject to a special review): ￥16,300 (c) Changes in or additions of the categories specified in Article 1-3, Paragraph 1 [excluding those in (d)]: ￥83,100 (d) Changes in or additions of the categories in Article 1-3, Paragraph 1 (limited to cases where the newly added category based on the change in or addition of the category concerned is related to a medical device not subject to a special review): ￥47,600 (e) Changed in or additions of categories specified in Article 1-3-2, Paragraph 1: ￥17,500 (C) Licenses of manufacture or import of drugs, quasi-drugs or medical devices used exclusively for animals: ￥3,550 2. The amounts of the fees as specified by cabinet order in Article 78, Paragraph 1 of the Law for persons specified in Items (3) or (4) of the preceding paragraph may have the following amounts added to the amounts specified in Items (3) or (4), notwithstanding the specifications in Items (3) or (4) of the preceding paragraph, in cases where it is confirmed necessary by the Minister for employees of the Ministry to make trips to local facilities to perform investigations related to tests concerning the results of use, etc. for reviews pursuant to the provisions of Article 14, Paragraph 2 (with application mutatis mutandis of Article 14, Paragraph 4, Article 19-2, Paragraph 4 and Article 23) of the Law or for reexaminations pursuant to the provisions of Article 14-4, Paragraph 4 (with application mutatis mutandis of Article 19-4 and Article 23) of the Law with respect to data concerning the results of tests related to safety and other tests on drugs, quasi-drugs, cosmetics or medical devices which the persons specified in Item (3) of the preceding paragraph attach to the applications concerned pursuant to the provisions of Article 14, Paragraph 3 (including cases applied mutatis mutandis in Article 14, Paragraph 6, Article 19-2, Paragraph 4 or Article 23) of the Law or data concerning the results of use, etc. of the drug which the persons specified in Item (4) of the preceding paragraph attach to the application concerned in accordance with the specifications in Article 14-3, Paragraph 3 (with application mutatis mutandis of Article 19-4 or Article 23) of the Law. (1) The amount corresponding to the travel expenses which should be paid pursuant to the provisions of the Law concerning Travel Expenses of Civil Servants (Law No.114, 1950) in cases where two employees make the trip concerned (hereinafter referred to as"travel expenses"). (2) The amount obtained by multiplying ￥52,200 by the number of days of travel which forms the basis of calculation of the amount of travel expenses for the trip concerned. 3. In cases in the preceding paragraph, the employees concerned shall be official grade 6 in Government Official Salary Table (1) in Attached Table 1 a of the Law concerning the Salaries, etc. of Regular Government Employees (Law No.95, 1950) and their travel expenses shall be calculated accordingly. The details concerning the number of travel days and other items required for calculating travel expenses shall be specified by MHW ordinance. Article 14-2. (Fees Paid to the Drug Organization) The amounts paid by applicants for equivalence reviews to the drug organization shall be the amounts specified as follows corresponding to the respective categories of applicants. (1) Applicants for approvals pursuant to the provisions of Article 14, Paragraph 1 of the law (with application mutatis mutandis in Article 23 of the Law) and Article 19-2, Paragraph 1: the amounts in (a) or (b) corresponding to the respective category of approval in (a) or (b). (a) Approvals for drugs: Amounts specified in (1) to (3) corresponding to the respective categories of drugs in (1) to (3) (1) Prescription drugs [excluding those in (2)]: ￥254,800 (2) Drugs included in the JP: ￥48,700 (3) Drugs other than those specified in (1) and (2): ￥75,300 (b) Approvals for quasi-drugs and cosmetics: ￥48,400 (2) Applicants for approvals pursuant to the provisions of Article 14, Paragraph 6 of the law (with application mutatis mutandis in Article 19-2, Paragraph 4 and Article 23 of the Law): the amounts in (a) or (b) corresponding to the respective category of approval in (a) or (b). (a) Approvals for drugs: Amounts specified in (1) to (3) corresponding to the respective categories of drugs in (1) to (3) (1) Prescription drugs [excluding those in (2)]: ￥126,600 (2) Drugs included in the JP: ￥32,400 (3) Drugs other than those specified in (1) and (2): ￥44,100 (b) Approvals for quasi-drugs and cosmetics: ￥32,200 2. Among the reviews pursuant to the provisions of Article 1-5, Paragraph 1, Item 2, the amounts of fees paid to the Drug Organization by applicants who apply for reviews in writing shall be the amounts specified as follows corresponding to the respective categories of applicant. (1) Applicants for approvals pursuant to the provisions of Article 14, Paragraph 1 of the Law (with application mutatis mutandis in Article 23 of the Law) and Article 19-2, Paragraph 1: the amounts in (a) to (e) corresponding to the respective category of approval in (a) to (e). (a) Drugs specified in Article 14, Paragraph 1, Item 3, A(1)(a) (excluding those in (b)): ￥3,554,900 (b) Drugs in Article 14, Paragraph 1, Item 3, A(1)(a) designated as orphan drugs pursuant to the provisions of Article 77-2, Paragraph 1: ￥1,924,900 (c) Drugs specified in Article 14, Paragraph 1, Item 3, A(1)(b): ￥1,784,900 (d) Drugs specified in Article 14, Paragraph 1, Item 3, A(1)(c): ￥1,000,200 (e) Drugs specified in Article 14, Paragraph 1, Item 3, A(1)(d) and (e): ￥203,400 (2) Applicants for approvals pursuant to the provisions of Article 14, Paragraph 6 of the Law (with application mutatis mutandis in Article 19-2, Paragraph 4 and Article 23 of the Law): the amounts in (a) to (d) corresponding to the respective category of approval in (a) to (d). (a) Drugs specified in Article 14, Paragraph 1, Item 3, B(1)(a): ￥1,783,000 (b) Drugs specified in Article 14, Paragraph 1, Item 3, B(1)(b): ￥997,500 (c) Drugs specified in Article 14, Paragraph 1, Item 3, B(1)(c) and (e): ￥112,800 (d) Drugs specified in Article 14, Paragraph 1, Item 3, B(1)(d): ￥155,600 3. Among the reviews pursuant to the provisions of Article 1-5, Paragraph 1, Item 2, the amounts of fees paid to the Drug Organization by applicants who apply for reviews in writing shall be the amounts specified as follows corresponding to the respective categories of applicant. (1) Reviews related to criteria for performance of non-clinical studies concerning the safety of drugs: ￥1,447,800 (2) Reviews related to criteria for performance of clinical studies of drugs: the amounts in (a) and (b) corresponding to the respective category of approval in (a) and (b). (a) Drugs specified in Article 14, Paragraph 1, Item 3, A(1)(a) to (c): ￥1,082,500 (b) Drugs specified in Article 14, Paragraph 1, Item 3, A(1)(d) and (f): ￥541,600 4. The amounts of fees paid to the Drug Organization by applicants who apply for reviews pursuant to the provisions of Article 1-5, Paragraph 2 shall be the amounts specified as follows corresponding to the respective categories of applicant. (1) Reviews in writing: ￥1,028,200 (2) Implemented reviews: the amounts in (a) and (b) corresponding to the respective category of approval in (a) and (b). (a) Reviews related to criteria for performance of non-clinical studies concerning the safety of drugs: ￥1,447,800 (b) Reviews other than those in (a): ￥948.000 Article 14-3. (Fees Paid to Designated Review Organizations) The fees specified by cabinet order in Article 78, Paragraph 4 of the Law shall be the amounts specified as follows corresponding to the respective categories of applicant. (1) Applicants for approvals pursuant to the provisions of Article 14, Paragraph 1 (with application mutatis mutandis in Article 23) and Article 19-2, Paragraph 1 of the Law: ￥71,800 (2) Applicants for approvals pursuant to the provisions of Article 14, Paragraph 6 (with application mutatis mutandis in Article 19-2, Paragraph 4 and Article 23) of the Law: ￥39,700 Article 15. (Exceptional Licenses Concerning Drugs for Export) When drugs, quasi-drugs, cosmetics or medical devices (hereinafter referred to as "drugs, etc.") are manufactured or imported for export, the manufacturer or importer shall notify the Minister beforehand of items such as the drugs, etc. concerned as specified by MHW ordinance via the governor of the prefecture where each factory or business office is located, and the provisions of Article 13, Paragraph 1 and Article 18 (with application mutatis mutandis of Article 23) of the Law shall not apply as long as the manufacturing or import is performed in accordance with the contents of this notification. 2. The provisions of Article 43 and Chapter 7 [excluding the specifications in Article 47, Article 48, Article 55, Paragraph 2, (with application mutatis mutandis of Article 60, Article 62 and Article 64), Article 56, Items (4) to (6) (with application mutatis mutandis of Articles 60 and 62), Article 57 and Article 65, Items (3) to (6)] of the Law shall not be applied to the manufacture, import, marketing, giving, storage or display of drugs, etc. for export. However, this shall apply only in cases where the drugs, etc. are manufactured or imported in accordance with the contents of the notification pursuant to the provisions of the preceding paragraph or where drugs, etc. manufactured or imported in accordance with the contents of the notification pursuant to the provisions of the preceding paragraph are marketed, given, stored or displayed with respect to the manufacture or import of drugs, etc. undertaken as a business for export or the marketing, giving, storage or display for export of drugs, etc. manufactured or imported as a business. Article 15-2. (Exemptions for Drugs Granted Special Licenses Before Approval) The provisions pursuant to Article 43 of the Law shall not apply to drugs specified in Article 80, Paragraph 2 of the Law (limited to drugs designated by the Minister for which it is confirmed that there is not sufficient time to undergo the testing pursuant to the provisions of Article 43, Paragraph 1 because the drug concerned is required for emergency use). 2. In cases of application of the provisions pursuant to Article 44 of the Law to poisons specified in Article 44, Paragraph 1 and powerful drugs specified in Article 44, Paragraph 2 of the Law among the drugs specified in Article 80, Paragraph 2 of the Law (limited to drugs designated by the Minister for which it is confirmed that there is not sufficient time to label the immediate container or wrapper of the drugs pursuant to the provisions of Article 43, Paragraphs 1 and 2 because the drug concerned is required for emergency use), "immediate container or wrapper" shall read "package insert or container or wrapper". 3. In cases of application of the provisions pursuant to Article 50 of the Law to drugs specified in Article 80, Paragraph 2 of the Law (limited to drugs designated by the Minister for which it is confirmed that there is not sufficient time to label the immediate container or wrapper of the drugs pursuant to the provisions of Article 50 because the drug concerned is required for emergency use), "immediate container or wrapper" shall read "package insert or container or wrapper". 4. The provisions pursuant to Article 51 of the Law shall not apply to drugs designated by the Minister pursuant to the provisions of Paragraph 2 of this article. 5. In cases of application of the provisions pursuant to Article 52 of the Law to drugs specified in Article 80, Paragraph 2 of the Law, "shall be indicated" shall read "shall be indicated and the fact that the license in Article 12, Paragraph 1, Article 18, Paragraph 1 (with application mutatis mutandis in Article 23) and Article 22, Paragraph 1 has been obtained pursuant to the provisions of Article 13-2, Paragraph 1 (with application mutatis mutandis in Article 18, Paragraph 2 and Article 23) shall be indicated on the package insert or container or wrapper as specified by MHW ordinance". 6. In cases of application of the provisions pursuant to Article 54 of the Law to drugs specified in Article 80, Paragraph 2 of the Law, "(including the inner wrapper)" shall read "including the inner wrapper; the same in the following articles)" and "the entries in the following items shall not be made" shall read "the entries in Items 1 and 3, and applications other than those of the drug concerned related to the license in Article 12, Paragraph 1, Article 18, Paragraph 1 (with application mutatis mutandis in Article 23) and Article 22, Paragraph 1 pursuant to the provisions of Article 13-2, Paragraph 1 (with application mutatis mutandis in Article 18, Paragraph 2 and Article 23) shall not be entered. However, this shall not apply to entries in a foreign language made on the drug or its container or wrapper (excluding outer container or wrapper in cases when an immediate container or wrapper is used) as designated by the Minister pursuant to the provisions of Article 15-2, Paragraph 2 or Paragraph 3 of the Enforcement Regulations of the Law." 7. In cases of application of the provisions pursuant to Article 55, Paragraph 1 of the Law for drugs designated by the Minister pursuant to the provisions of Paragraphs 2 and 3, "the preceding five articles" shall read "Article 50 or the preceding three articles". 8. In cases of application of the provisions pursuant Article 56 of the Law for drugs pursuant to the provisions of Article 80-2 of the Law, "any of the following items" shall read "item 4 to 6". Article 15-3. (Range of Reviews of Clinical Trial Protocols by the Drug Organiza- tion) Reviews which the Minister can have the Drug Organization perform pursuant to the provisions of Article 80-4, Paragraph 1 of the Law shall be all of the reviews pursuant to the provisions of the last part of Article 80-2, Paragraph 3 of the Law. Article 15-4. (Transfer of Authority) The following authorities of the Minister as specified in the Law have been transferred to the prefectural governors. (1) The authority pursuant to the provisions of Article 12, Paragraph 2 and Article 18, Paragraph 1 of the Law concerning the manufacture of drugs in pharmacies by the proprietors of the pharmacies using equipment and utensils in the pharmacies concerned. (2) The authority pursuant to the provisions of Article 14, Paragraphs 1 and 6 of the Law concerning the manufacture of drugs in the preceding item which do not have active ingredients other than those designated by the Minister. (3) The authority pursuant to the provisions of Article 19, Article 73, Article 75, Paragraph 1 and Article 77-4-3 concerning manufacturers of the drugs specified in Item (1) 2. In addition to the authorities specified in the preceding paragraph, the authorities of the Minister in the following cases shall be transferred to the governor of the prefecture where the person who manufactures or imports drugs, quasi-drugs or medical devices specified in Item (1) is domiciled (the head office is located in the case of a corporation) or where the factory or business office is located in the case of the authority in items (2) to (4) However, this shall not hinder the authority specified in Item (3) exercised by the Minister (limited to cases pursuant to the provisions in Article 72-3, Article 73 and Article 75, Paragraph 1 of the Law). (1) Among the authorities pursuant to the provisions of Article 14, Paragraphs 1 and 6 (with application mutatis mutandis of Article 23) of the Law, those concerning the following drugs (excluding injections), and quasi-drugs and medical devices designated by the Minister. (a) Cold remedies, gastrointestinal agents, anthelmintics and other types ofdrugs designated by the Minister for which the types of active ingredients, the rates of combination and quantities, and indications and effects are within the ranges specified by the Minister. (b) Bulk drugs designated by the Minister for exclusive use in the manufacture of other drugs. (2) Among the authorities pursuant to the provisions of Article 12, Paragraph 2 and Article 22, Paragraph 2, those concerning factories or business offices for the manufacture or import only of drugs (excluding the drugs specified in the following items) quasi-drugs or medical devices (excluding medical devices designated by the Minister pursuant to the provisions of Article 43, Paragraph 2 of the Law and those designated by the Minister as requiring special precautions in manufacturing control and quality control) for exclusive use with humans, drugs, quasi-drugs or medical devices for exclusive use with animals (limited to those corresponding to the drugs. quasi-drugs or medical devices specified in the preceding item) or cosmetics. (a) Biological products [excluding drugs in Article 1-2, Paragraph 1, Item (4)] (b) Radiopharmaceuticals [Drugs which emit radiation pursuant to the provisions of Article 3, Item (5) of the Basic Nuclear Power Law (Law No. 186, 1955) designated by the Minister] (c) Drugs manufactured or imported under special license before approval which have not been granted approval pursuant to the provisions of Article 14 (with application mutatis mutandis in Article 23) and Article 19-2 [excluding drugs specified in (a) and (b)] (d) Drugs designated by the Minister pursuant to the provisions in Article 43, Paragraph 1 of the Law [excluding drugs specified in items (a) to (c)] (e) In addition to the drugs specified in items (a) to (d), drugs which are manufactured utilizing recombinant DNA technology or other drugs requiring special precautions for manufacturing control or quality control designated by the Minister. (3) The authority pursuant to the provisions of Article 8, Paragraph 3 with application mutatis mutandis of Article 15, Paragraph 3 (with application mutatis mutandis of Article 23), Article 15, Paragraph 2, and Article 19 (with application mutatis mutandis of Article 23), Article 72-3 Article 73, Article 75, Paragraph 1 and Article 77-4-3 of the Law concerning manufacturers or importers as specified in the preceding item (4) Among the authorities pursuant to the provisions of Article 18, Paragraph 1 (with application mutatis mutandis of Article 23) of the Law concerning factories or business offices as specified in Item (2), those concerning only drugs, quasi-drugs, cosmetics or medical devices specified in the same item which the manufacturer or importer changes or adds for the factory or business office concerned (when the category specified in Article 1-3, Paragraph I or that specified in Article 1-3-2, Paragraph 1 is added or changed for the factory concerned, the products corresponding to each category). 3. In cases specified in the preceding Paragraph 2, the provisions of Article 20, Paragraphs 1 and 2 and Article 75, Paragraph 2 of the Law shall not apply. Article 16. (Transfer to MHW Ordinance) In addition to the specifications in this cabinet order, the required items concerning pharmacies, drug retailers, tests on drugs and medical devices and pharmaceutical inspectors shall be specified by MHW ordinance. Article 17. (Drugs, etc. for Veterinary Use) With respect to drugs, quasi-drugs and medical devices exclusively for veterinary use, "Minister" in this ordinance shall read "Minister of Agriculture, Forestry and Fisheries","MHW ordinance" shall read "Ordinance of the Ministry of Agriculture, Forestry and Fisheries", and in Article 2, Paragraph 1, "prefectural governors [the mayor of the municipality or ward in the cases of first class sellers other than first class wholesalers or third class sellers with stores or places of businesses located in municipalities or special wards specified by cabinet order pursuant to the provisions of Article 5, Paragraph 1 of the Regional Insurance Law (Law No.101, 1947); the same in Articles 3 and 4]" shall read "prefectural governors". Additional Provisions (Cabinet Order No. 58, 1997) Article 1. (Date of Enforcement) This Cabinet Order shall come into effect from April 1, 1997. Article 2. (Partial Revision of the MHW Organization Ordinance) The MHW Organization Ordinance (Cabinet Order No., 388, 1952) shall be revised as follows. In Article 54 , Item 4, "and Item 12" shall be revised to "from -- to Item 13", and "(excluding guidance and advice concerning the implementation of surveillance of results of use, etc. of drugs by the general public among the tasks in the same Item) and" shall be revised to "and". The following proviso shall be added to Item 4: "However, those items falling under the supervision of the Safety Division shall be excluded." In Article 56, Item 2, "Article 27, Paragraph 2, Item 12 and Item 13" shall be revised to "Article 27, Paragraph 2, Item 11, Item 13 and Item 14", and "Item 12" shall be revised to "Article 27, Paragraph 2, Item 13 of the Law of the Organization for Drug ADR Relief, R & D Promotion and Product Review, limited to surveillance pursuant to the provisions of Article 14-2, Paragraph 1 of the Pharmaceutical Affairs Law as applied mutatis mutandis in Article 14-4-2 and Article 14-5-2 (including cases where these provitions apply mutatis mutandis in Article 19-4 and Article 23 of the Law) of the Law among the tasks in Item 11 of the same Paragraph".