Japan PHARMACEUTICAL AFFAIRS LAW[1](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 assurethe health of humans or animals.
3. The term "cosmetic" in this Law refers to items (other than quasi-drugs) with mild action on the human body and which are intended to be applied to the human body by means of rubbing, sprinkling and the like for the purpose of cleaning, beautifying, adding to the attractiveness, altering the appearance, or keeping the skin or hair in good condition, excluding those intended at the same time for the uses specified in Paragraph 1, Item (2) or (3).
4. The term "medical device" in this Law refers to equipment or instruments intended for use in the diagnosis, cure or prevention of disease in humans or animals, or intended to affect the structure or functions of the body of humans or animals, and which are designated by cabinet order.
5. The term "pharmacy" in this Law refers to the place where a pharmacist engages in dispensing drugs for the purpose of sale or giving (including the place necessary for selling drugs in cases where the proprietor concurrently sells drugs), excluding dispensaries in hospitals or clinics, or in veterinary clinics [clinics as specified in the provisions of Article 2, Paragraph 2 of the Veterinary Service Law (Law No. 46. 1992), including residences of persons who provide medical care for domestic animals by veterinarians only on an outside visit basis; the same hereinafter]
6. The term "orphan drug" in this Law refers to drugs which have been designated pursuant to the provisions of Article 77-2, Paragraph 1, and "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.