Japan pharmaceutical affairs law



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Japan PHARMACEUTICAL AFFAIRS LAW1 (Law No.145 of August 10, 1960) Revisions (1) Law No. 161, 1962 (2) Law No. 135, 1963 (11) Law No. 46, 1992 (3) Law No. 51, 1969 (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 (8) Law No. 57, 1983 (9) Law No. 78, 1983 (10) Law No. 33, 1990 (12) Law No. 27, 1993 (16) Law No. 104, 1996 (17) Law No. 105, 1997 (18) Law No. 69 of 2006 (19) Law No. 103 of December 13, 2013 (Effective after one year from the promulgation date)

CONTENTS

Chapter I General Provisions (Articles 1, 2)

Chapter II Pharmaceutical Affairs Council (Articles 3, 4)

Chapter III Pharmacies (Articles 5

11)


Chapter IV Manufacturers and Importers of Drugs, etc.

Section 1. Manufacturers (Articles 12

21)

Section 2. Importers (Articles 22, 23)



Chapter IV-2 Designated Review Organizations (Articles 23-2

23-15)


Chapter V Selling Drugs and Selling and Leasing Medical Devices (Articles 24

40)


Chapter VI Standards and Tests for Drugs, etc. (Articles 41

43)


Chapter VII Handling of Drugs, etc.

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)

Chapter IX Surveillance (Articles 69

77)

Chapter IX-2 Designation, etc. of Orphan Drugs and Orphan Medical Devices (Article 77-2



Article 77-2-6)

Chapter X Miscellaneous Provisions (Articles 77-3

83-2)

Chapter XI Penal Provisions (Articles 84



89)

Chapter I General Provisions

(Purpose)

Article 1

The purpose of this Law is to control and regulate matters required to assure 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

1. 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 assure the 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 "orphan 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

1. 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

1. 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

1. 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

1. 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)

Article 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 licenses, 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.
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