Article 1Medical devices prescribed in Article 2, paragraph (4) of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (hereinafter referred to as the "Act") are as in appended table 1.

Article 1-2Regenerative medicine products prescribed in Article 2, paragraph (9) of the Act are as in appended table 2.

Article 1-3The laws and regulations specified by Cabinet Order prescribed in Article 5, item (iii), (d) of the Act are as follows:

Article 1-4The prefectural governor (or the mayor of the city where the pharmacy is located (specified by Cabinet Order prescribed in Article 5, paragraph (1) of the Community Health Act (Act No. 101 of 1947)) (hereinafter referred to as a "city with established health centers") or the head of the special ward (hereinafter the same applies in this Chapter)) must, when granting the license for establishing a pharmacy, issue a license certificate to the applicant for the license, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare. The same applies when renewing a license for establishing a pharmacy.

Article 1-5(1)When any pharmacy proprietor (referring to pharmacy proprietors provided in Article 1-4 of the Act; hereinafter the same applies) encounters any change in matters stated in the license certificate for establishing a pharmacy, the pharmacy proprietor may apply for an updated issuance of the license certificate reflecting the change.

(2)The application under the preceding paragraph must be made by submitting a written application with a license certificate to the governor of the prefecture where the pharmacy is located, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

Article 1-6(1)Proprietors of pharmacies may, in the event of tearing, dirtying or loss of a license certificate for establishing pharmacies, apply for the reissuance of the license certificate.

(2)The application under the preceding paragraph must be submitted to the governor of the prefecture where such pharmacy is located, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.In this case, any pharmacy proprietor who tore or dirtied a license certificate must attach the license certificate to the written application.

(3)Pharmacy proprietors must, when finding the lost license certificate for establishing pharmacies after having the license certificate reissued, promptly return such license certificate to the governor of the prefecture where the pharmacy is located.

Article 1-7Pharmacy proprietors must, when they are subject to a disposition to rescind the license for establishing pharmacies under Article 75, paragraph (1) of the Act, or when they discontinue their operations, promptly return the license certificate for establishing pharmacies to the governor of the prefecture where such pharmacy is located.

Article 1-8The prefectural governors are to keep a registry of license prescribed in Article 4, paragraph (1) of the Act, stating necessary matters in such registry, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

Article 2Pharmacy proprietors must, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare, notify the governor of the prefecture where such pharmacy is located of the total number prescriptions dispensed during the previous year (referring to the total number of prescriptions for othinolaryngology, ophthalmology and dentistry dispensed during the previous year, multiplied by two thirds, respectively, plus the number of prescriptions for the other departments; hereinafter the same applies in this Article) by March 31 of every year; provided, however, that this does not apply to cases where the total number of prescriptions dispensed is significantly small, as well as any other case specified by Order of the Ministry of Health, Labour and Welfare as equivalent to the preceding case.

Article 2-2Beyond what is specified in this Chapter, any necessary matters pertaining to pharmacies are specified by Order of the Ministry of Health, Labour and Welfare.

Article 3The valid term specified by Cabinet Order prescribed in Article 12, paragraph (2) of the Act is five years; provided, however, with regard to a license pertaining to marketing of pharmacy-made pharmaceuticals (referring to pharmaceuticals manufactured by a pharmacy proprietor using equipment and instruments in the pharmacy, and directly sold or provided to customers at the pharmacy (excluding in-vitro diagnostics; hereinafter the same applies in this Chapter) which do not contain any active components but active components designated by the Minister of Health, Labour and Welfare; hereinafter the same applies), the term specified by Cabinet Order prescribed in the same paragraph is valid for six years.

Article 4(1)The Minister of Health, Labour and Welfare must, when granting a license for marketing pharmaceuticals, quasi-pharmaceutical products, or cosmetics, issue a license certificate to the applicant for such license, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare. The same applies when renewing a license for marketing pharmaceuticals, quasi-pharmaceutical products, or cosmetics.

(2)In the application in the provisions of the preceding paragraph, when the prefectural governor (or the mayor of the city or special ward when a pharmacy marketing pharmacy-made pharmaceuticals is located in a city with established heath centers or a special ward; hereinafter the same applies in paragraph (4) of the following Article, Article 6, paragraph (5), Article 7, paragraph (2), Article 8, paragraph (2) and Article 19, paragraph (2)) is to grant a license for marketing pharmacy-made pharmaceuticals, pursuant to the provisions of Article 80, paragraph (1) (limited to the part pertaining to item (i)), "the Minister of Health, Labour and Welfare" in the same paragraph is to be replaced with "the prefectural governor (or the mayor of the city or special ward when a pharmacy marketing pharmacy-made pharmaceuticals is located in a city with established heath centers or a special ward)".

(3)In the application in the provisions of paragraph (1), when the prefectural governor is to grant a license for marketing pharmaceuticals, quasi-pharmaceutical products, or cosmetics provided in Article 80, paragraph (2), item (i), pursuant to the provisions of Article 80, paragraph (2) (limited to the part pertaining to item (i)), "the Minister of Health, Labour and Welfare" in the same paragraph is to be replaced with "the prefectural governor".

Article 5(1)If a change occurs in the matters described on the license certificate for marketing pharmaceuticals, quasi-pharmaceutical products, or cosmetics, holders of marketing authorization for pharmaceuticals, quasi-pharmaceutical products, or cosmetics may apply for an updated issuance of the license certificate to reflect the change.

(2)In the application under the preceding paragraph, a written application must be submitted to the Minister of Health, Labour and Welfare with a license certificate via the governor of the prefecture where the applicant resides (in the case of a corporation, where the principal office is located; hereinafter the same applies in the following Article and Article 7), pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

(3)When an application under paragraph (1) is made, a fee specified by Cabinet Order after taking into consideration the actual costs must be paid.

(4)In the application in the preceding two paragraphs, in the case where the prefectural governor is to grant a license for marketing pharmacy-made pharmaceuticals, pursuant to the provisions of Article 80, paragraph (1) (limited to the part pertaining to item (i)), "to the Minister of Health, Labour and Welfare via the governor of the prefecture where the applicant resides (in the case of a corporation, where the principal office is located; hereinafter the same applies in the following Article and Article 7)" in paragraph (2) is to be replaced with "the governor of the prefecture where the office for business engaged in by a marketing director of pharmaceuticals, quasi-pharmaceutical products or cosmetics provided in Article 17, paragraph (2) of the Act is located (or when the place is located in a city with established health centers or a special ward, the mayor of the city or the special ward)", and "a fee specified by Cabinet Order after taking into consideration the actual costs" in the preceding paragraph is to be replaced with "pursuant to the provisions of Prefectural Ordinance or Municipal Ordinance, pursuant to the provisions of Article 227 of the Local Autonomy Act (Act No. 67 of 1947)".

(5)In the application in the provisions of paragraph (2) and paragraph (3), in the case where the prefectural governor is to grant a license for marketing pharmaceuticals, quasi-pharmaceutical products, or cosmetics provided in Article 80, paragraph (2), item (i), pursuant to the provisions of Article 80, paragraph (2) (limited to the part of item (i)), "the Minister of Health, Labour and Welfare via the governor of the prefecture where the applicant resides (in the case of a corporation, where the principal office is located; hereinafter the same applies in the following Article and Article 7)" in paragraph (2) is to be replaced with "the governor of the prefecture where the office for business engaged in by a marketing director of pharmaceuticals, quasi-pharmaceutical products or cosmetics provided in Article 17, paragraph (2) of the Act is located", and "a fee specified by Cabinet Order after taking into consideration the actual costs" in paragraph (3) is to be replaced with "pursuant to the provisions of Prefectural Ordinance or Municipal Ordinance, pursuant to the provisions of Article 227 of the Local Autonomy Act (Act No. 67 of 1947)".

Article 6(1)If tearing, dirtying or losing a license certificate for marketing pharmaceuticals, quasi-pharmaceutical products, or cosmetics, holders of marketing authorization for pharmaceuticals, quasi-pharmaceutical products, or cosmetics may apply for reissuance of the license certificate.

(2)The application under the preceding paragraph must be submitted to the Minister of Health, Labour and Welfare via the governor of the prefecture where the applicant resides, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.In this case, any holder of marketing authorization for pharmaceuticals, quasi-pharmaceutical products, or cosmetics who tore or dirtied a license certificate must attach such license certificate to the written application.

(3)A person making an application under paragraph (1) must pay a fee specified by Cabinet Order after taking into consideration the actual costs.

(4)Holders of marketing authorization for pharmaceuticals, quasi-pharmaceutical products, or cosmetics must, when finding the lost license certificate for marketing pharmaceuticals, quasi-pharmaceutical products, or cosmetics after having the license certificate reissued, promptly return such license certificate to the Minister of Health, Labour and Welfare via the governor of the prefecture where the person resides.

(5)In the application in the preceding three paragraphs, in the case where the prefectural governor license is to grant a license for marketing pharmacy-made pharmaceuticals, pursuant to the provisions of Article 80, paragraph (1) (limited to the part pertaining to item (i)), "to the Minister of Health, Labour and Welfare via the governor of the prefecture where the person resides" in paragraph (2) and the preceding paragraph is to be replaced with "the governor of the prefecture where the office for business engaged in by a marketing director of pharmaceuticals, quasi-pharmaceutical products or cosmetics provided in Article 17, paragraph (2) of the Act is located (or when the pharmacy is located in a city with established health centers or a special ward, the mayor of the city or the special ward)", and "a fee specified by Cabinet Order after taking into consideration the actual costs" in paragraph (3) is to be replaced with "pursuant to the provisions of Prefectural Ordinance or Municipal Ordinance, based on the provisions of Article 227 of the Local Autonomy Act (Act No. 67 of 1947)".

(6)In the application in the provisions of paragraph (2) to paragraph (4), in the case where the prefectural governor is to grant a license for marketing pharmaceuticals, quasi-pharmaceutical products, or cosmetics provided in Article 80, paragraph (2), item (i), pursuant to the provisions of Article 80, paragraph (2) (limited to the part of item (i)), "the Minister of Health, Labour and Welfare via the governor of the prefecture where the person resides" in paragraph (2) and paragraph (4) is to be replaced with "the governor of the prefecture where the office for business engaged in by a marketing director of pharmaceuticals, quasi-pharmaceutical products or cosmetics provided in Article 17, paragraph (2) of the Act is located", and "a fee specified by Cabinet Order after taking into consideration the actual costs" in paragraph (3) is to be replaced with "pursuant to the provisions of Prefectural Ordinance or Municipal Ordinance, based on the provisions of Article 227 of the Local Autonomy Act (Act No. 67 of 1947)".

Article 7(1)Holders of marketing authorization for pharmaceuticals, quasi-pharmaceutical products, or cosmetics must, when they are subject to a disposition to rescind the license for marketing pharmaceuticals, quasi-pharmaceutical products or cosmetics under Article 75, paragraph (1) of the Act, or when they discontinue their operations, promptly return the license certificate for marketing pharmaceuticals, quasi-pharmaceutical products, or cosmetics to the Minister of Health, Labour and Welfare via the governor of the prefecture where the person resides.

(2)In the application in the provisions of the preceding paragraph, in the case where the prefectural governor is to grant a license for marketing pharmacy-made pharmaceuticals, pursuant to the provisions of Article 80, paragraph (1) (limited to the part pertaining to item (i)), "the Minister of Health, Labour and Welfare via the governor of the prefecture where the person resides" is to be replaced with "the prefectural governor receiving the license (or when the pharmacy marketing pharmacy-made pharmaceuticals is located in a city with established health centers or a special ward, the mayor of the city or the special ward)".

(3)In the application in the provisions of paragraph (1), in the case where the prefectural governor is to grant a license for marketing pharmaceuticals, quasi-pharmaceutical products, or cosmetics provided in Article 80, paragraph (2), item (i), pursuant to the provisions of Article 80, paragraph (2) (limited to the part pertaining to item (i)), "the Minister of Health, Labour and Welfare via the governor of the prefecture where the person resides" is to be replaced with "the prefectural governor receiving the license".

Article 8(1)The Minister of Health, Labour and Welfare is to keep a registry of license prescribed in Article 12, paragraph (1) of the Act, and enter necessary matters in it, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

(2)In the application in the provisions of the preceding paragraph, in the case where the prefectural governor is to grant a license for marketing pharmacy-made pharmaceuticals, pursuant to the provisions of paragraph (1) of Article 80 (limited to the part pertaining to the item (i)), "the Minister of Health, Labour and Welfare" in the same paragraph is to be replaced with "the prefectural governor (or in the case of where the pharmacy marketing pharmacy-made pharmaceuticals is located in a city with established health centers or a special ward, the mayor of the city or the special ward)".

(3)In the application in the provisions of paragraph (1), in the case where the prefectural governor is to grant a license for marketing pharmaceuticals, quasi-pharmaceutical products, or cosmetics provided in Article 80, paragraph (2), item (i), pursuant to the provisions of Article 80, paragraph (2) (limited to the part pertaining to item (i)), "the Minister of Health, Labour and Welfare" in the same paragraph is to be replaced with "the prefectural governor".

Article 9In the case where the prefectural governor is to grant a license for marketing pharmaceuticals, quasi-pharmaceutical products, or cosmetics provided in Article 80, paragraph (2), item (i), pursuant to the provisions of Article 80, paragraph (2) (limited to the part pertaining to item (i)), in the case where a person has already obtained another license of the same type license from any other prefectural governor, the previous license that person obtained becomes invalid.

Article 10The term specified by Cabinet Order prescribed in Article 13, paragraph (3) of the Act (including as applied mutatis mutandis pursuant to paragraph (7) of the same Article; hereinafter the same applies in this Article) is five years; provided, however, that the term of license for marketing pharmacy-made pharmaceuticals specified by Cabinet Order prescribed in Article 13, paragraph (3) of the Act is six years.

Article 11(1)The Minister of Health, Labour and Welfare must, when license granting a license for manufacturing pharmaceuticals, quasi-pharmaceutical products, or cosmetics, issue a license certificate to the applicant for the license, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare. The same applies when renewing a license for manufacturing of pharmaceuticals, quasi-pharmaceutical products, or cosmetics.

(2)In the application in the provisions of the preceding paragraph, in the case where the prefectural governor (or the mayor of the city or special ward in the case where a pharmacy manufacturing pharmacy-made pharmaceuticals is located in a city with established heath centers or a special ward; hereinafter the same applies in paragraph (4) of the following Article, Article 13, paragraph (5), Article 14, paragraph (2) and Article 15, paragraph (2)) is to grant a license for manufacturing pharmacy-made pharmaceuticals, pursuant to the provisions of Article 80, paragraph (1) (limited to the part pertaining to item (ii)), "the Minister of Health, Labour and Welfare" in the same paragraph is to be replaced with "the prefectural governor (or the mayor of the city or special ward in the case where a pharmacy marketing pharmacy-made pharmaceuticals is located in a city with established heath centers or a special ward)".

(3)In the application in the provisions of paragraph (1), in the case where the prefectural governor is to grant a license for manufacturing pharmaceuticals, quasi-pharmaceutical products, or cosmetics provided in Article 80, paragraph (2), item (iii), pursuant to the provisions of Article 80, paragraph (2) (limited to the part pertaining to item (iii)), "the Minister of Health, Labour and Welfare" in the same paragraph is to be replaced with "the prefectural governor".

Article 12(1)When any manufacturer of pharmaceuticals, quasi-pharmaceutical products, or cosmetics encounters any change in matters stated on the license certificate for manufacturing pharmaceuticals, quasi-pharmaceutical products, or cosmetics, the manufacturer may apply for an updated issuance of such license certificate reflecting the same.

(2)The application under the preceding paragraph must be made by submitting a written application with a license certificate to the Minister of Health, Labour and Welfare via the governor of the prefecture where the manufacturing facility is located, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

(3)A person making an application under paragraph (1) must pay a fee specified by Cabinet Order after taking into consideration the actual costs.

(4)In the application of the preceding two paragraphs, in the case where the prefectural governor is to grant a license for manufacturing pharmacy-made pharmaceuticals, pursuant to the provisions of Article 80, paragraph (1) (limited to the part pertaining to item (ii)), "to the Minister of Health, Labour and Welfare via the governor of the prefecture where the manufacturing facility is located" in paragraph (2) is to be replaced with "the governor of the prefecture where the pharmacy for manufacturing pharmacy-made pharmaceuticals is located (or where the place is located in a city with established health centers or a special ward, the mayor of the city or the special ward)", and "a fee specified by Cabinet Order after taking into consideration the actual costs" in the preceding paragraph is to be replaced with "pursuant to the provisions of Prefectural Ordinance or Municipal Ordinance, based on the provisions of Article 227 of the Local Autonomy Act (Act No. 67 of 1947)".

(5)In the application in the provisions of paragraph (2) and paragraph (3), in the case where the prefectural governor is to grant a license for manufacturing pharmaceuticals, quasi-pharmaceutical products, or cosmetics provided in Article 80, paragraph (2), item (iii), pursuant to the provisions of Article 80, paragraph (2) (limited to the part of item (iii)), "the Minister of Health, Labour and Welfare via the governor of the prefecture where the person resides" in paragraph (2) is to be replaced with "the prefectural governor", and "a fee specified by Cabinet Order after taking into consideration the actual costs" in paragraph (3) is to be replaced with "pursuant to the provisions of Prefectural Ordinance or Municipal Ordinance, based on the provisions of Article 227 of the Local Autonomy Act (Act No. 67 of 1947)".

Article 13(1)Holders of a license for manufacturing pharmaceuticals, quasi-pharmaceutical products, or cosmetics may, when tearing, dirtying or losing a license certificate for manufacturing pharmaceuticals, quasi-pharmaceutical products, or cosmetics, apply for reissuance of such license certificate.

(2)The application under the preceding paragraph must be submitted to the Minister of Health, Labour and Welfare via the governor of the prefecture where such manufacturing facility is located, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.In this case, any manufacturers of pharmaceuticals, quasi-pharmaceutical products, or cosmetics who tore or dirtied a license certificate must attach such license certificate to the written application.

(3)A person making an application under paragraph (1) must pay a fee specified by Cabinet Order after taking into consideration the actual costs.

(4)Holders of a license for manufacturing pharmaceuticals, quasi-pharmaceutical products, or cosmetics must, when finding the lost license certificate for manufacturing pharmaceuticals, quasi-pharmaceutical products, or cosmetics after having the license certificate reissued, promptly return such license certificate to the Minister of Health, Labour and Welfare via the governor of the prefecture where such manufacturing facility is located.

(5)In the application of the preceding three paragraphs, in the case where the prefectural governor is to grant a license for manufacturing pharmacy-made pharmaceuticals, pursuant to the provisions of Article 80, paragraph (1) (limited to the part pertaining to item (ii)), "to the Minister of Health, Labour and Welfare via the governor of the prefecture where such manufacturing facility is located" in paragraph (2) and the preceding paragraph is to be replaced with "the governor of the prefecture where the pharmacy for manufacturing pharmacy-made pharmaceuticals is located (or where the place is located in a city with established health centers or a special ward, the mayor of the city or the special ward)", and "a fee specified by Cabinet Order after taking into consideration the actual costs" in paragraph (3) is to be replaced with "pursuant to the provisions of Prefectural Ordinance or Municipal Ordinance, based on the provisions of Article 227 of the Local Autonomy Act (Act No. 67 of 1947)".

(6)In the application in the provisions of paragraph (2) to paragraph (4), in the case where the prefectural governor is to grant a license for manufacturing pharmaceuticals, quasi-pharmaceutical products, or cosmetics provided in Article 80, paragraph (2), item (iii), pursuant to the provisions of Article 80, paragraph (2) (limited to the part of item (i)), "the Minister of Health, Labour and Welfare via the governor of the prefecture" in paragraph (2) and paragraph (4) is to be replaced with "the prefectural governor", and "a fee specified by Cabinet Order after taking into consideration the actual costs" in paragraph (3) is to be replaced with "pursuant to the provisions of Prefectural Ordinance or Municipal Ordinance, based on the provisions of Article 227 of the Local Autonomy Act (Act No. 67 of 1947)".

Article 14(1)Holders of a license for manufacturing pharmaceuticals, quasi-pharmaceutical products, or cosmetics must, when they are subject to a disposition to rescind the license for manufacturing pharmaceuticals, quasi-pharmaceutical products or cosmetics under Article 75, paragraph (1) of the Act, or when they discontinue their operations, promptly return the license certificate for manufacturing pharmaceuticals, quasi-pharmaceutical products, or cosmetics to the Minister of Health, Labour and Welfare via the governor of the prefecture where the person's manufacturing facility is located.

(2)In the application in the provisions of the preceding paragraph, in the case where the prefectural governor is to grant a license for manufacturing pharmacy-made pharmaceuticals, pursuant to the provisions of Article 80, paragraph (1) (limited to the part pertaining to item (ii)), "the Minister of Health, Labour and Welfare via the governor of the prefecture where the manufacturing facility is located" is to be replaced with "the prefectural governor receiving the license (or in the case where the pharmacy manufacturing pharmacy-made pharmaceuticals is located in a city with established health centers or a special ward, the mayor of the city or the special ward)".

(3)In the application in the provisions of paragraph (1), in the case where the prefectural governor is to grant a license for manufacturing pharmaceuticals, quasi-pharmaceutical products, or cosmetics provided in Article 80, paragraph (2), item (iii), pursuant to the provisions of Article 80, paragraph (2) (limited to the part pertaining to item (iii)), "the Minister of Health, Labour and Welfare via the governor of the prefecture where the manufacturing facility is located" is to be replaced with "the prefectural governor receiving such license".

Article 15(1)The governor of the prefecture is to keep a registry of license prescribed in Article 13, paragraph (1) and paragraph (6) of the Act, stating necessary matters in such registry, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

(2)In the application in the provisions of the preceding paragraph, in the case where the prefectural governor is to grant a license for manufacturing pharmaceuticals, specified in the same item, pursuant to the provisions of Article 80, paragraph (1) (limited to the part pertaining to item (ii)), "the Minister of Health, Labour and Welfare" is to be replaced with "the prefectural governor (or where the pharmacy manufacturing pharmacy-made pharmaceuticals is located in a city with established health centers or a special ward, the mayor of the city or the special ward)".

(3)In the application in the provisions of paragraph (1), in the case where the prefectural governor is to grant a license for manufacturing pharmaceuticals, quasi-pharmaceutical products, or cosmetics provided in Article 80, paragraph (2), item (iii), pursuant to the provisions of Article 80, paragraph (2) (limited to the part pertaining to item (iii)), "the Minister of Health, Labour and Welfare" is to be replaced with "the prefectural governor"

Article 16Pharmaceuticals (excluding those intended exclusively for use on animals), quasi-pharmaceutical products (excluding those intended exclusively for use on animals), or cosmetics specified by Cabinet Order prescribed in Article 13-2, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 13-3, paragraph (3) of the Act) are those other than the following pharmaceuticals, quasi-pharmaceutical products, or cosmetics, from among pharmaceuticals (excluding those intended exclusively for use on animals), quasi-pharmaceutical products (excluding those intended exclusively for use on animals) or cosmetics:

Article 17The term specified by Cabinet Order prescribed in Article 13, paragraph (3) of the Act, applied mutatis mutandis pursuant to Article 13-3, paragraph (3) of the Act (including as applied mutatis mutandis pursuant to paragraph (7) of the same Article; hereinafter the same in this Article) is five years.

Article 18The Minister of Health, Labour and Welfare must, when granting an accreditation prescribed in Article 13-3, paragraph (1) of the Act, issue an accreditation certificate the person applying for the accreditation. The same applies when renewing an accreditation prescribed in the same paragraph.

Article 18-2(1)When any person accredited pursuant to the provisions of Article 13-3, paragraph (1) of the Act (hereinafter referred to as an "accredited foreign manufacturer of pharmaceuticals, quasi-pharmaceutical products or cosmetics" in the following Article and Article 18-4) encounters any change in matters stated in the accreditation certificate, the person may apply for an updated issuance of the accreditation certificate reflecting the change.

(2)The application under the preceding paragraph must be made by submitting a written application with an accreditation certificate to the Minister of Health, Labour and Welfare, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

(3)A person making an application under paragraph (1) must pay a fee specified by Cabinet Order after taking into consideration the actual costs.

Article 18-3(1)Accredited foreign manufacturers of pharmaceuticals, quasi-pharmaceutical products or cosmetics may, when tearing, dirtying or losing their accreditation certificate, apply for reissuance of such accreditation certificate.

(2)The application under the preceding paragraph must be submitted to the Minister of Health, Labour and Welfare, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.In this case, any accredited foreign manufacturer of pharmaceuticals, quasi-pharmaceutical products or cosmetics who tore or dirtied an accreditation certificate must attach the accreditation certificate to the written application.

(3)A person making an application under paragraph (1) must pay a fee specified by Cabinet Order after taking into consideration the actual costs.

(4)Accredited foreign manufacturer of pharmaceuticals, quasi-pharmaceutical products or cosmetics must, when finding the lost accreditation certificate after having the accreditation certificate reissued, promptly return such accreditation certificate to the Minister of Health, Labour and Welfare.

Article 18-4Accredited foreign manufacturers of pharmaceuticals, quasi-pharmaceutical products or cosmetics must, when they are subject to a disposition to revoke the accreditation under Article 75-4, paragraph (1) of the Act, or when they discontinue their operations, promptly return the accreditation certificate to the Minister of Health, Labour and Welfare.

Article 18-5The Minister of Health, Labour and Welfare is to keep a registry of accreditation prescribed in Article 13-3, paragraph (1) of the Act, and Article 13, paragraph (6) of the Act, applied mutatis mutandis pursuant to Article 13-3, paragraph (3) of the Act, and enter necessary matters in it, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

Article 19(1)The Minister of Health, Labour and Welfare is to keep a registry of approval prescribed in Article 14, paragraph (1) and paragraph (9) of the Act (including as applied mutatis mutandis pursuant to Article 19-2, paragraph (5) of the Act) and Article 19-2, paragraph (1), and enter necessary matters in it, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

(2)In the application in the provisions of the same paragraph, in the case where the prefectural governor is to grant an approval pursuant to the provisions of Article 80, paragraph (1) (limited to the part pertaining to the item (i)), "the Minister of Health, Labour and Welfare" in the same paragraph is to be replaced with "the prefectural governor (or in the case where the pharmacy marketing pharmacy-made pharmaceuticals is located in a city with established health centers or a special ward, the mayor of the city or the special ward)".

(3)In the application in the provisions of the same paragraph, in the case where the prefectural governor is to grant an approval specified in paragraph (1), pursuant to the provisions of Article 80, paragraph (2) (limited to the part pertaining to item (v)), "the Minister of Health, Labour and Welfare" in the same paragraph is to be replaced with "the prefectural governor".

Article 20(1)Pharmaceuticals specified by Cabinet Order prescribed in Article 14, paragraph (2), item (iv) and paragraph (6) of the Act (including cases where those provisions are applied mutatis mutandis pursuant to paragraph (9) of the same Article (including as applied mutatis mutandis pursuant to Article 19-2, paragraph (5) of the Act) and Article 19-2, paragraph (5) of the Act; hereinafter the same applies in the following paragraph) are those other than the following pharmaceuticals, from among pharmaceuticals provided in Article 14, paragraph (1) of the Act:

(2)Quasi-pharmaceutical products specified by Cabinet Order prescribed in Article 14, paragraph (2), item (iv) and paragraph (6) of the Act are, from among quasi-pharmaceutical products provided in paragraph (1) of the same Article, those designated by the Minister of Health, Labour and Welfare as those requiring special attention for manufacturing and quality control.

Article 21The term specified by Cabinet Order prescribed in Article 14, paragraph (6) of the Act (including as applied mutatis mutandis pursuant to Article 19-2, paragraph (5) of the Act; hereinafter the same applies in this Article) is five years.

Article 22(1)A person who intends to undergo an investigation under Article 14, paragraph (6) of the Act (including as applied mutatis mutandis pursuant to paragraph (9) of the same Article (including as applied mutatis mutandis pursuant to Article 19-2, paragraph (5) of the Act) and Article 19-2, paragraph (5) of the Act) (hereinafter "compliance investigation of pharmaceuticals, quasi-pharmaceutical products or cosmetics" from this Article to Article 25) must apply for the same to the Minister of Health, Labour and Welfare, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

(2)In the application in the provisions of the preceding paragraph, in the case where the prefectural governor is to conduct a compliance investigation of pharmaceuticals, quasi-pharmaceutical products or cosmetics, pursuant to the provisions of Article 80, paragraph (2) (limited to the part pertaining to item (vii)), "the Minister of Health, Labour and Welfare" in the same paragraph is to be replaced with "the governor of the prefecture where the manufacturing facility such pharmaceuticals, quasi-pharmaceutical products, or cosmetics is located".

(3)When the Minister of Health, Labour and Welfare decides to have the Pharmaceuticals and Medical Devices Agency (hereinafter referred to as the "PMDA") conduct a compliance investigation of pharmaceuticals, quasi-pharmaceutical products or cosmetics, pursuant to the provisions of Article 14-2, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 19-2, paragraph (5) and paragraph (6) of the Act), notwithstanding the provisions of the preceding two paragraphs, a person intending to undergo such compliance investigation of pharmaceuticals, quasi-pharmaceutical products or cosmetics must apply for the same to the PMDA, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

Article 23When the person conducting a compliance investigation of pharmaceuticals, quasi-pharmaceutical products or cosmetics pursuant to the provisions of Article 14, paragraph (6) of the Act (including as applied mutatis mutandis pursuant to paragraph (9) of the same Article (including as applied mutatis mutandis pursuant to Article 19-2, paragraph (5) of the Act) and Article 19-2, paragraph (5) of the Act) or Article 14-2, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 19-2, paragraph (5) and paragraph (6) of the Act) or the provisions of Article 80, paragraph (2) (limited to the part pertaining to item (vii)) (hereinafter referred to as a "person conducting a compliance investigation of pharmaceuticals, quasi-pharmaceutical products or cosmetics") is different from a person who grants licenses for marketing the items pursuant to the provisions of Article 12, paragraph (1) of the Act or the provisions of Article 80, paragraph (2) (limited to the part pertaining to item (i)) (hereinafter referred to as a "person granting licenses for marketing pharmaceuticals, quasi-pharmaceutical products or cosmetics" in this Article), or a person who grants approval for the items pursuant to the provisions of Article 14, paragraph (1) and paragraph (9) of the Act (including as applied mutatis mutandis pursuant to Article 19-2, paragraph (5) of the Act) or Article 19-2, paragraph (1) of the Act or the provisions of Article 80, paragraph (2) (limited to the part pertaining to item (v)) (hereinafter referred to as a "person granting approval for pharmaceuticals, quasi-pharmaceutical products or cosmetics" in this Article), the person conducting a compliance investigation of pharmaceuticals, quasi-pharmaceutical products or cosmetics must give notification of the results of the compliance investigation of pharmaceuticals, quasi-pharmaceutical products or cosmetics without delay to the person granting licenses for marketing pharmaceuticals, quasi-pharmaceutical products or cosmetics or the person granting approval for pharmaceuticals, quasi-pharmaceutical products or cosmetics via the PMDA, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

Article 24(1)The Minister of Health, Labour and Welfare is to keep a registry of compliance investigations of pharmaceuticals, quasi-pharmaceutical products or cosmetics, and enter necessary matters in it, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

(2)In the application in the provisions of the preceding paragraph, when the Minister of Health, Labour and Welfare decides to have the PMDA conduct the compliance investigation of pharmaceuticals, quasi-pharmaceutical products or cosmetics pursuant to the provisions of Article 14-2, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 19-2, paragraph (5) and paragraph (6) of the Act), "the Minister of Health, Labour and Welfare" is to be replaced with "the PMDA".

(3)In the application in the provisions of paragraph (1), in the case where the prefectural governor is to conduct a compliance investigation of pharmaceuticals, quasi-pharmaceutical products or cosmetics, pursuant to the provisions of Article 80, paragraph (2) (limited to the part pertaining to item (vii), "the Minister of Health, Labour and Welfare" in the same paragraph is to be replaced with "the prefectural governor".

Article 25(1)When a person approved pursuant to the provisions of Article 14, paragraph (1) or Article 19-2, paragraph (1) of the Act intends to make a partial change in matters approved for the item, and when such change does not affect the methods to control manufacturing and quality of the items (limited to those specified by Order of the Ministry of Health, Labour and Welfare), the provisions of Article 14, paragraph (6) of the Act, applied mutatis mutandis pursuant to Article 14, paragraph (9) of the Act (including as applied mutatis mutandis pursuant to Article 19-2, paragraph (5) of the Act; hereinafter the same applies in the following paragraph) do not apply.

(2)In cases where the provisions of Article 14, paragraph (6) of the Act are applied mutatis mutandis pursuant to paragraph (9) of the same Article, "a person who intends to be approved pursuant to paragraph (1) or who has already been approved pursuant to the same paragraph" in the same paragraph is deemed to be replaced with a "person who intends to be approved pursuant to paragraph (9)", and "at the time of approval, and in every period of not less than three years specified by Cabinet Order after obtaining the approval" is deemed to be replaced with "when intending to receive such approval".

Article 26An application for approval specified by Cabinet Order prescribed in Article 14, paragraph (11) of the Act (including as applied mutatis mutandis pursuant to Article 14-5, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 19-4 of the Act) and Article 19-2, paragraph (5) and paragraph (6) of the Act) is an application for approval for the following pharmaceuticals and quasi-pharmaceutical products:

Article 27(1)In cases of having the PMDA conduct an examination for approval prescribed in Article 14, paragraph (1) or paragraph (9) of the Act (including as applied mutatis mutandis pursuant to Article 19-2, paragraph (5) of the Act) or Article 19-2, paragraph (1) of the Act, and an investigation under Article 14, paragraph (5) of the Act (including as applied mutatis mutandis pursuant to paragraph (9) of the same Article (including as applied mutatis mutandis pursuant to Article 19-2, paragraph (5) of the Act) and Article 19-2, paragraph (5) of the Act), pursuant to the provisions of Article 14-2, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 19-2, paragraph (5) and paragraph (6) of the Act; hereinafter the same applies in this Article), pharmaceuticals (excluding those intended exclusively for use on animals), quasi-pharmaceutical products (excluding those intended exclusively for use on animals), or cosmetics specified by Cabinet Order prescribed in Article 14-2, paragraph (1) of the Act are, from among pharmaceuticals (excluding those intended exclusively for use on animals), quasi-pharmaceutical products (excluding those intended exclusively for use on animals) or cosmetics provided in Article 14, paragraph (1) of the Act, those other than the following pharmaceuticals, quasi-pharmaceutical products, or cosmetics:

(2)In cases of having the PMDA conduct an investigation under Article 14, paragraph (6) of the Act (including as applied mutatis mutandis pursuant to paragraph (9) of the same Article (including as applied mutatis mutandis pursuant to Article 19-2, paragraph (5) of the Act) and Article 19-2, paragraph (5) of the Act; hereinafter the same applies in this paragraph), pursuant to the provisions of Article 14-2, paragraph (1) of the Act, pharmaceuticals (excluding those intended exclusively for use on animals), quasi-pharmaceutical products (excluding those intended exclusively for use on animals) or cosmetics specified by Cabinet Order prescribed in Article 14-2, paragraph (1) of the Act are those other than pharmaceuticals or quasi-pharmaceutical products provided in Article 80, paragraph (2), item (vii), from among pharmaceuticals (excluding those intended exclusively for use on animals), quasi-pharmaceutical products (excluding those intended exclusively for use on animals), or cosmetics provided in Article 14, paragraph (1) of the Act.

Article 28Measures specified by Cabinet Order prescribed in Article 14-3, paragraph (2) of the Act (including as applied mutatis mutandis pursuant to Article 20, paragraph (1) of the Act) are as follows:

Article 29Pharmaceuticals specified by Cabinet Order prescribed in Article 14-5, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 19-4 of the Act) (excluding those intended exclusively for use on animals) are pharmaceuticals set forth in any item of Article 14-4, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 19-4 of the Act) (excluding those intended exclusively for use on animals).

Article 30Technical replacement of terms under Article 14-5, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 19-4 of the Act) is as per the following table.

Article 31Pharmaceuticals specified by Cabinet Order prescribed in Article 14-7, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 19-4 of the Act) (excluding those intended exclusively for use on animals) are pharmaceuticals pertaining to the designation by the Minister of Health, Labour and Welfare under Article 14-6, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 19-4 of the Act) (excluding those intended exclusively for use on animals).

Article 32Technical replacement of terms under Article 14-7, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 19-4 of the Act) is as per the following table.

Article 33Pharmaceuticals (excluding those intended exclusively for use on animals), quasi-pharmaceutical products (excluding those intended exclusively for use on animals), and cosmetics specified by Cabinet Order prescribed in Article 14-10, paragraph (1) of the Act are pharmaceuticals (excluding pharmacy-made pharmaceuticals and those intended exclusively for use on animals) or quasi-pharmaceutical products (excluding those intended exclusively for use on animals) provided in Article 14-9, paragraph (1) of the Act.

Article 34(1)A person with special approval for foreign-manufactured pharmaceuticals, quasi-pharmaceutical products or cosmetics (referring to a person with special approval for foreign-manufactured pharmaceuticals, quasi-pharmaceutical products or cosmetics provided in Article 19-2, paragraph (4) of the Act; hereinafter the same applies) must, when changing their name or address, or other matters specified by Order of the Ministry of Health, Labour and Welfare, notify the Minister of Health, Labour and Welfare of the same via the governor of the prefecture where a designated holder of marketing authorization for foreign-manufactured pharmaceuticals (referring to a designated holder of marketing authorization for foreign-manufactured pharmaceuticals, quasi-pharmaceutical products or cosmetics provided in the same paragraph; hereinafter the same applies) resides (in the case of a corporation, where the principal office is located) within 30 days, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

(2)In the application in the provisions of the preceding paragraph, in the case where the prefectural governor is to grant a license for marketing pharmaceuticals, quasi-pharmaceutical products, or cosmetics provided in Article 80, paragraph (2), item (i), pursuant to the provisions of Article 80, paragraph (2) (limited to the part pertaining to item (i)), "where the person resides (in the case of a corporation, where the principal office is located)" in the same paragraph is to be replaced with "where the office for business engaged in by a marketing director of pharmaceuticals, quasi-pharmaceutical products or cosmetics provided in Article 17, paragraph (2) of the Act is located".

Article 35Beyond what is specified in this Chapter, any necessary matters concerning marketing or manufacturing pharmaceuticals, quasi-pharmaceutical products, or cosmetics (including manufacturing by persons with special approval for foreign-manufactured pharmaceuticals, quasi-pharmaceutical products or cosmetics) are specified by Order of the Ministry of Health, Labour and Welfare.

Article 43-2The valid term specified by Cabinet Order prescribed in Article 23-20, paragraph (2) of the Act is five years.

Article 43-3(1)The Minister of Health, Labour and Welfare must, when granting a license for marketing regenerative medicine products, issue a license certificate to the applicant for the license. The same applies when renewing a license for marketing regenerative medicine products.

(2)In the application in the provisions of the preceding paragraph, in the case where the prefectural governor is to grant a license for marketing regenerative medicine products provided in Article 80, paragraph (4), item (i), pursuant to the provisions of Article 80, paragraph (4) (limited to the part pertaining to item (i)), "the Minister of Health, Labour and Welfare" is to be replaced with "the prefectural governor".

Article 43-4(1)Holders of marketing authorization for regenerative medicine products may, when having a change in the matters described on the license certificate for marketing regenerative medicine products, apply for an updated issuance reflecting the change.

(2)The application under the preceding paragraph must be made by submitting a written application with a license certificate to the Minister of Health, Labour and Welfare via the governor of the prefecture where the person resides (in the case of a corporation, where the principal office is located; hereinafter the same applies in the following Article and Article 43-6), pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

(3)A person making an application under paragraph (1) must pay a fee specified by Cabinet Order after taking into consideration the actual costs.

(4)In the application of the preceding two paragraphs, in the case where the prefectural governor is to grant a license for marketing regenerative medicine products provided in Article 80, paragraph (4), item (i), pursuant to the provisions of Article 80, paragraph (4) (limited to the part pertaining to item (i)), "to the Minister of Health, Labour and Welfare via the governor of the prefecture where the person resides (in the case of a corporation, where the principal office is located; hereinafter the same applies in the following Article and Article 43-6)" in paragraph (2) is to be replaced with "the governor of the prefecture where the office for business engaged in by a marketing director of regenerative medicine products provided in Article 23-34, paragraph (2) of the Act is located", and "a fee specified by Cabinet Order after taking into consideration the actual costs" in the preceding paragraph is to be replaced with "pursuant to the provisions of Prefectural Ordinance or Municipal Ordinance, based on the provisions of Article 227 of the Local Autonomy Act (Act No. 67 of 1947)".

Article 43-5(1)Holders of marketing authorization for regenerative medicine products may, when tearing, dirtying or losing a license certificate for marketing regenerative medicine products, apply for reissuance of such license certificate.

(2)The application under the preceding paragraph must be submitted application document to the Minister of Health, Labour and Welfare via the governor of the prefecture where the person resides, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.In this case, any holder of marketing authorization for regenerative medicine products who tore or dirtied the license certificate must attach such license certificate to the written application.

(3)A person making an application under paragraph (1) must pay a fee specified by Cabinet Order after taking into consideration the actual costs.

(4)Holders of marketing authorization for regenerative medicine products must, when finding the lost license certificate for marketing regenerative medicine products after having the license certificate reissued, promptly return such of license certificate to the Minister of Health, Labour and Welfare via the governor of the prefecture where the person resides.

(5)In the application in the preceding three paragraphs, in the case where the prefectural governor is to grant a license for marketing regenerative medicine products provided in Article 80, paragraph (4), item (i), pursuant to the provisions of Article 80, paragraph (4) (limited to the part pertaining to item (i)), "the Minister of Health, Labour and Welfare via the governor of the prefecture where the person resides" in paragraph (2) and the preceding paragraph is to be replaced with "the governor of the prefecture where the office for business engaged in by a marketing director of regenerative medicine products provided in Article 23-34, paragraph (2) of the Act is located (or where the pharmacy is located in a city or a special ward establishing health centers, the mayor of the city or the special ward)", and "a fee specified by Cabinet Order after taking into consideration the actual costs" in paragraph (3) is to be replaced with "pursuant to the provisions of Prefectural Ordinance or Municipal Ordinance, based on the provisions of Article 227 of the Local Autonomy Act (Act No. 67 of 1947)".

Article 43-6(1)Holders of marketing authorization for regenerative medicine products must, when they are subject to a disposition to revoke the license for marketing regenerative medicine products under Article 75, paragraph (1) of the Act, or when they discontinue their operations, promptly return the license certificate for marketing regenerative medicine products to the Minister of Health, Labour and Welfare via the governor of the prefecture where the person resides.

(2)In the application in the provisions of the preceding paragraph, in the case where the prefectural governor is to grant a license for marketing regenerative medicine products provided in Article 80, paragraph (4), item (i), pursuant to the provisions of Article 80, paragraph (4) (limited to the part pertaining to item (i)), "the Minister of Health, Labour and Welfare via the governor of the prefecture where the person resides" is to be replaced with "the prefectural governor receiving the license".

Article 43-7(1)The Minister of Health, Labour and Welfare is to keep a registry of license prescribed in Article 23-20, paragraph (1) of the Act, and enter necessary matters in it, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

(2)In the application in the provisions of the preceding paragraph, in the case where the prefectural governor is to grant a license for marketing regenerative medicine products provided in Article 80, paragraph (4), item (i), pursuant to the provisions of Article 80, paragraph (4) (limited to the part pertaining to the item (i)), "the Minister of Health, Labour and Welfare" in the same paragraph is to be replaced with "the prefectural governor".

Article 43-8In the case where the prefectural governor is to grant a license for marketing regenerative medicine products provided in Article 80, paragraph (4), item (i), pursuant to the provisions of Article 80, paragraph (4) (limited to the part pertaining to item (i)), in the case where a person license has already obtained another license of the same type license from any other prefectural governor, the previous license that the person obtained becomes invalid.

Article 43-9The period specified by Cabinet Order prescribed in Article 23-22, paragraph (3) of the Act (including as applied mutatis mutandis pursuant to paragraph (7) of the same Article) is five years.

Article 43-10The Minister of Health, Labour and Welfare must, when granting a license for manufacturing regenerative medicine products, issue a license certificate to the applicant for the license, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare. The same applies when renewing a license for manufacturing regenerative medicine products.

Article 43-11(1)Manufacturers of regenerative medicine products may, when encountering any change to a matter stated on the license certificate for manufacturing regenerative medicine products, apply for an updated issuance of the license certificate reflecting the change.

(2)The application under the preceding paragraph must be made by submitting a written application with a license certificate to the Minister of Health, Labour and Welfare via the governor of the prefecture where the manufacturing facility is located, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

(3)A person making an application under paragraph (1) must pay a fee specified by Cabinet Order after taking into consideration the actual costs.

Article 43-12(1)Manufacturers of regenerative medicine products may, when tearing, dirtying or losing a license certificate for manufacturing regenerative medicine products, apply for reissuance of such license certificate.

(2)The application under the preceding paragraph must be submitted to the Minister of Health, Labour and Welfare via the governor of the prefecture where the manufacturing facility is located, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.In this case, any holder of a license for manufacturing regenerative medicine products who tore or dirtied a license certificate must attach such license certificate to the written application.

(3)A person making an application under paragraph (1) must pay a fee specified by Cabinet Order after taking into consideration the actual costs.

(4)Manufacturers of regenerative medicine products must, when finding the lost license certificate for manufacturing regenerative medicine products after having the license certificate reissued, promptly return such license certificate to the Minister of Health, Labour and Welfare via the governor of the prefecture where the manufacturing facility is located.

Article 43-13Manufacturers of regenerative medicine products must, when they are subject to a disposition to revoke the license for manufacturing regenerative medicine products under Article 75, paragraph (1) of the Act, or when they discontinue their operations, promptly return the license certificate for manufacturing regenerative medicine products to the Minister of Health, Labour and Welfare via the governor of the prefecture where the manufacturing facility is located.

Article 43-14The Minister of Health, Labour and Welfare is to keep a registry of license prescribed in Article 23-22, paragraph (1) and paragraph (6) of the Act, and enter necessary matters in it, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

Article 43-15Regenerative medicine products (excluding those intended exclusively for use on animals) specified by Cabinet Order prescribed in Article 23-23, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 23-24, paragraph (3) of the Act) are all of the regenerative medicine products (excluding those intended exclusively for use on animals).

Article 43-16The valid period specified by Cabinet Order prescribed in Article 23-22, paragraph (3) of the Act, applied mutatis mutandis pursuant to Article 23-24, paragraph (3) of the Act (including as applied mutatis mutandis pursuant to paragraph (7) of the same Article) is five years.

Article 43-17The Minister of Health, Labour and Welfare must, when granting an accreditation prescribed in Article 23-24, paragraph (1) of the Act, issue an accreditation certificate to a person who applied for the accreditation. The same applies when renewing an accreditation prescribed in the same paragraph.

Article 43-18(1)A person accredited pursuant to the provisions of Article 23-24, paragraph (1) of the Act (hereinafter referred to as an "accredited foreign manufacturers of regenerative medicine products)" in the following Article and Article 43-20) may, when having a change in the matters included on the accreditation certificate, apply for an updated issuance reflecting the change.

(2)The application under the preceding paragraph must be made by submitting a written application with an accreditation certificate to the Minister of Health, Labour and Welfare, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

(3)A person making an application under paragraph (1) must pay a fee specified by Cabinet Order after taking into consideration the actual costs.

Article 43-19(1)Accredited foreign manufacturers of regenerative medicine products may, when tearing, dirtying or losing their accreditation certificate, apply for reissuance of the accreditation certificate.

(2)The application under the preceding paragraph must be submitted to the Minister of Health, Labour and Welfare, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.In this case, accredited foreign manufacturers of regenerative medicine products who tore or dirtied the accreditation certificate must attach such accreditation certificate to the written application.

(3)A person making an application under paragraph (1) must pay a fee specified by Cabinet Order after taking into consideration the actual costs.

(4)Accredited foreign manufacturers of regenerative medicine products must, when finding the lost accreditation certificate after having the accreditation certificate reissued, promptly return such accreditation certificate to the Minister of Health, Labour and Welfare.

Article 43-20Accredited foreign manufacturers of regenerative medicine products must, when they are subject to a disposition to revoke the accreditation under Article 75-4, paragraph (1) of the Act, or when they discontinue their operations, promptly return the accreditation certificate to the Minister of Health, Labour and Welfare.

Article 43-21The Minister of Health, Labour and Welfare is to keep a registry of accreditation provided in Article 23-24, paragraph (1) of the Act, and Article 23-22, paragraph (6) of the Act, applied mutatis mutandis pursuant to Article 23-24, paragraph (3) of the Act, and enter necessary matters in it, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

Article 43-22The Minister of Health, Labour and Welfare is to keep a registry of approval prescribed in Article 23-25, paragraph (1) and paragraph (9) of the Act (including as applied mutatis mutandis pursuant to Article 23-37, paragraph (5) of the Act), and Article 23-37, paragraph (1) of the Act, and enter necessary matters in it, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

Article 43-23The term specified by Cabinet Order prescribed in Article 23-25, paragraph (6) of the Act (including as applied mutatis mutandis pursuant to Article 23-37, paragraph (5) of the Act) is five years.

Article 43-24(1)A person who intends to undergo an investigation under Article 23-25, paragraph (6) of the Act (including as applied mutatis mutandis pursuant to paragraph (9) of the same Article (including as applied mutatis mutandis pursuant to Article 23-37, paragraph (5) of the Act) and Article 23-37, paragraph (5) of the Act) (hereinafter referred to as "compliance investigation of regenerative medicine products" from this Article to Article 43-27) must apply for the same to the Minister of Health, Labour and Welfare, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

(2)When the Minister of Health, Labour and Welfare decides to have the PMDA conduct a compliance investigation of regenerative medicine products pursuant to the provisions of Article 23-27, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 23-37, paragraph (5) and paragraph (6) of the Act), notwithstanding the provisions of the preceding paragraph, a person intending to undergo such compliance investigation of regenerative medicine products must apply for the same to the PMDA, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

Article 43-25When the person conducting a compliance investigation of regenerative medicine products pursuant to the provisions of Article 23-25, paragraph (6) of the Act (including as applied mutatis mutandis pursuant to paragraph (9) of the same Article (including as applied mutatis mutandis pursuant to Article 23-37, paragraph (5) of the Act) and Article 23-37, paragraph (5) of the Act) or Article 23-27, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 23-37, paragraph (5) and paragraph (6) of the Act) (hereinafter referred to as a "person conducting a compliance investigation of regenerative medicine products" in this Article) is different from a person who grants licenses for marketing the items pursuant to the provisions of Article 23-20, paragraph (1) of the Act or the provisions of Article 80, paragraph (4) (limited to the part pertaining to item (i)) (hereinafter referred to as a "person granting licenses for marketing regenerative medicine products" in this Article), the person conducting a compliance investigation of regenerative medicine products must give notification of the result of the compliance investigation of regenerative medicine products marketing without delay to the person granting licenses for marketing regenerative medicine products via the PMDA, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

Article 43-26(1)The Minister of Health, Labour and Welfare is to keep a registry of compliance investigations of regenerative medicine products, and enter necessary matters in it, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

(2)In the application in the provisions of the preceding paragraph, when the Minister of Health, Labour and Welfare decides to have the PMDA conduct the compliance investigation of regenerative medicine products pursuant to the provisions of Article 23-27, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 23-37, paragraph (5) and paragraph (6) of the Act), "the Minister of Health, Labour and Welfare" in the preceding paragraph is to be replaced with "the PMDA".

Article 43-27(1)When a person approved pursuant to the provisions of Article 23-25, paragraph (1) or Article 23-37, paragraph (1) of the Act intends to make a partial change in matters approved for the item, and when such change does not affect the methods to control manufacturing and quality of the items (limited to those specified by Order of the Ministry of Health, Labour and Welfare), the provisions of Article 23-25, paragraph (6) of the Act, applied mutatis mutandis pursuant to Article 23-25, paragraph (9) of the Act (including as applied mutatis mutandis pursuant to Article 23-37, paragraph (5) of the Act; hereinafter the same applies in the following paragraph) do not apply.

(2)In cases where the provisions of Article 23-25, paragraph (6) of the Act are applied mutatis mutandis pursuant to paragraph (9) of the same Article, "a person who intends to be approved pursuant to paragraph (1) or who has already been approved pursuant to the same paragraph" in the same paragraph is deemed to be replaced with a "person who intends to be approved pursuant to paragraph (9)", and "at the time of approval, and in every period of not less than three years specified by Cabinet Order after obtaining the approval" is deemed to be replaced with "when intending to receive such approval".

Article 43-28An application for approval specified by Cabinet Order prescribed pursuant to Article 23-25, paragraph (11) of the Act (including as applied mutatis mutandis pursuant to Article 23-30, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 23-39 of the Act) and Article 23-37, paragraph (5) and paragraph (6) of the Act) is an application for approval for regenerative medicine products excluding those intended exclusively for use on animals.

Article 43-29regenerative medicine products (excluding those intended exclusively for use on animals) specified by Cabinet Order prescribed in Article 23-27, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 23-37, paragraph (5) of the Act) are all of the regenerative medicine products (excluding those intended exclusively for use on animals).

Article 43-30Measures specified by Cabinet Order prescribed in Article 23-28, paragraph (2) of the Act (including as applied mutatis mutandis pursuant to Article 23-40, paragraph (1) of the Act) are those as follows:

Article 43-31Regenerative medicine products specified by Cabinet Order prescribed in Article 23-30, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 23-39 of the Act) (excluding those intended exclusively for use on animals) are regenerative medicine products set forth in each item of Article 23-29, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 23-39 of the Act) (excluding those intended exclusively for use on animals).

Article 43-32Technical replacement of terms under Article 23-30, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 23-39 of the Act) is as per the following table.

Article 43-33Regenerative medicine products specified by Cabinet Order prescribed in Article 23-32, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 23-39 of the Act) (excluding those intended exclusively for use on animals) are regenerative medicine products pertaining to the designation by the Minister of Health, Labour and Welfare under Article 23-31, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 23-39 of the Act) (excluding those intended exclusively for use on animals).

Article 43-34Technical replacement of terms under Article 23-32, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 23-39 of the Act) is as per the following table.

Article 43-35(1)A person with special approval for foreign-manufactured regenerative medicine products (referring to a person with special approval for foreign-manufactured regenerative medicine products provided in Article 23-37, paragraph (4) of the Act; hereinafter the same applies) must, when changing their name or address, or other matters specified by Order of the Ministry of Health, Labour and Welfare, notify the Minister of Health, Labour and Welfare of the same via the governor of the prefecture where a designated holder of marketing authorization for foreign-manufactured regenerative medicine products (referring to a designated holder of marketing authorization for foreign-manufactured regenerative medicine products provided in Article 23-37, paragraph (4) of the Act; hereinafter the same applies) resides (in the case of a corporation, where the principal office is located) within 30 days, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

(2)In the application in the provisions of the preceding paragraph, in the case where the prefectural governor is to grant a license for marketing regenerative medicine products provided in Article 80, paragraph (4), item (i), pursuant to the provisions of Article 80, paragraph (4) (limited to the part pertaining to item (i)), "where the person resides (in the case of a corporation, where the principal office is located)" in the same paragraph is to be replaced with "where the office for business engaged in by a marketing director of regenerative medicine products provided in Article 23-34, paragraph (2) of the Act is located ".

Article 43-36Beyond what is specified in this Chapter, any necessary matters pertaining to marketing or manufacturing regenerative medicine products (including manufacturing by persons with special approval for foreign-manufactured regenerative medicine products) are specified by Order of the Ministry of Health, Labour and Welfare.

Article 44The prefectural governor (or the mayor of the city where, in the case of store-based distribution, the place a store is located, and in the cases of the selling or leasing of specially-controlled medical devices (referring to specially-controlled medical devices provided in Article 39, paragraph (1) of the Act; hereinafter the same applies), the business office is located in a city with established health centers or a special ward, respectively; hereinafter the same applies in the following Article to Article 48) must, when granting a license for selling pharmaceuticals, selling or leasing specially-controlled medical devices, or selling regenerative medicine products, issue a license certificate to the applicant for the license, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare. The same applies when renewing a license for selling of pharmaceuticals, selling or leasing of specially-controlled medical devices, and selling of regenerative medicine products.

Article 45(1)Sellers of pharmaceuticals, or sellers or leaser of specially-controlled medical devices, or sellers of regenerative medicine products may, when encountering any change in matters stated on the license certificate for selling pharmaceuticals, selling or leasing of specially-controlled medical devices, or selling regenerative medicine products, apply for an updated issuance of the license certificate reflecting the change.

(2)The application under the preceding paragraph must be made by submitting a written application with a license certificate to the governor of the prefecture where the store or business office selling pharmaceuticals, or the business office selling or leasing specially-controlled medical devices, or the business office selling regenerative medicine products is located (in cases of household distribution, the governor of the prefecture which includes the area planned for household distribution; hereinafter the same applies in the following Article and Article 47), pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

Article 46(1)Sellers of pharmaceuticals, or sellers or leasers of specially-controlled medical devices, or sellers of regenerative medicine products may, when tearing, dirtying or losing a license certificate for selling pharmaceuticals, or selling and leasing specially-controlled medical devices, or selling regenerative medicine products, apply for reissuance of the license certificate.

(2)The application under the preceding paragraph must be submitted to the governor of the prefecture where the store or business office selling pharmaceuticals, or the business office selling or leasing specially-controlled medical devices, or the business office selling regenerative medicine products is located, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.In this case, sellers of pharmaceuticals, or sellers or leasers of specially-controlled medical devices, or sellers of regenerative medicine products who tore or dirtied a license certificate must attach the license certificate to the written application.

(3)Sellers of pharmaceuticals, or sellers or leasers of specially-controlled medical devices, or sellers of regenerative medicine products must, when finding the lost license certificate for selling pharmaceuticals, or selling and leasing specially-controlled medical devices, or selling regenerative medicine products after having the license certificate reissued, promptly return such license certificate to the governor of the prefecture where the store or business office selling pharmaceuticals, or the business office selling or leasing specially-controlled medical devices, or the business office selling regenerative medicine products is located.

Article 47Sellers of pharmaceuticals, or sellers or leasers of specially-controlled medical devices, or sellers of regenerative medicine products must, when they are subject to a disposition to revoke the license for selling pharmaceuticals, or selling and leasing specially-controlled medical devices, or selling regenerative medicine products under Article 75, paragraph (1) of the Act, or when they discontinue their operations, promptly return the license certificate for selling pharmaceuticals, or selling and leasing specially-controlled medical devices, or selling regenerative medicine products to the governor of the prefecture where the store or business office selling pharmaceuticals, or the business office selling or leasing specially-controlled medical devices, or the business office selling regenerative medicine products is located.

Article 48The prefectural governor is to keep a registry of license prescribed in Article 26, paragraph (1), Article 30, paragraph (1), Article 34, paragraph (1), Article 39, paragraph (1), and Article 40-5, paragraph (1) of the Act, and enter necessary matters in it, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

Article 49(1)At a store or business office selling pharmacy-only pharmaceuticals, or a business office selling or leasing specially-controlled medical devices, or a business office selling regenerative medicine products, when pharmacy proprietors who are also engaged in selling or leasing controlled medical devices (excluding specially-designated medical devices requiring maintenance; hereinafter the same applies), sellers of pharmaceuticals, or sellers or leasers of specially-controlled medical devices, or sellers of regenerative medicine products apply for or make a notification pertaining to pharmacies, selling pharmaceuticals, selling or leasing specially controlled medical devices, or selling regenerative medicine products set forth in the following items regarding the pharmacy, store or business office, such persons are deemed to have made a notification pertaining to selling or leasing controlled medical devices set forth in each of those items; provided, however, that the foregoing does not apply in the case where it is otherwise offered, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare:

(2)When an application or notification of selling (excluding store-based distribution) of pharmaceuticals specified in the preceding paragraph (excluding those intended exclusively for use on animals; hereinafter the same applies in this paragraph) or selling of regenerative medicine products (excluding those intended exclusively for use on animals; hereinafter the same applies in this paragraph) is submitted to the prefectural governor, the prefectural governor must promptly notify the mayor of the city with established health centers or the special ward where the business office for selling pharmaceuticals or regenerative medicine products is located.

Article 50Deleted

Article 51Deleted

Article 52Deleted

Article 53Technical replacement of terms under Article 40, paragraph (4) of the Act is as per the following table.

Article 54The valid term specified by Cabinet Order prescribed in Article 40-2, paragraph (3) of the Act is five years.

Article 55The provisions of Article 37-8 to Article 37-12 apply mutatis mutandis to license for repairing medical devices.

Article 56When a manufacturer of medical devices is personally engaged in repairing medical devices that such manufacturer manufactures (excluding manufacturing specified by Order of the Ministry of Health, Labour and Welfare), the provisions of Article 40-2 and Article 40-3 of the Act (excluding the part to which the provisions of Article 23-2-22 of the Act are applied mutatis mutandis) do not apply.

Article 56-2Technical replacement of terms under Article 40-7, paragraph (2) of the Act is as per the following table.

Article 57Beyond what is specified in this Chapter, any necessary matters pertaining to selling of pharmaceuticals, selling, leasing, or repairing of medical devices, or selling of regenerative medicine products are specified by Order of the Ministry of Health, Labour and Welfare.

Article 58A person who intends to undergo an official verification (hereinafter referred to as an "applicant") by a person designated by the Minister of Health, Labour and Welfare, pursuant to the provisions of Article 43, paragraph (1) or paragraph (2) of the Act (hereinafter referred to as an "official verification body") of pharmaceuticals or regenerative medicine products designated by the Minister of Health, Labour and Welfare, pursuant to the provisions of Article 43, paragraph (1) of the Act, or of medical devices designated by the Minister of Health, Labour and Welfare, pursuant to the provisions of paragraph (2) of the same Article must, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare, submit a written application to an official verification body via the prefectural governor with a fee of the amount designated by the Minister of Health, Labour and Welfare.

Article 59The prefectural governor must, when accepting the written application prescribed in the preceding Article, have pharmaceutical affairs inspectors take test samples and submit these samples to an official verification body with the written application.

Article 60(1)An official verification body must conduct an official verification on test samples sent pursuant to the provisions of the preceding Article according to the standards specified by the Minister of Health, Labour and Welfare and notify the prefectural governor of the result, and if the pharmaceuticals, medical devices or regenerative medicine products pass the official verification, the official verification body must send a certificate of passing the official verification, which includes the name and address of the applicant, and other information specified by Order of the Ministry of Health, Labour and Welfare, to the prefectural governor.

(2)When receiving the result of an official verification pursuant to the provisions of the preceding paragraph, the prefectural governor must notify the applicant thereof; and, when receiving a certificate of passing the official verification, the prefectural governor must issue such certificate to the applicant.

Article 61(1)When receiving the issuance of a certificate of passing the official verification pursuant to the provisions of paragraph (2) of the preceding Article, an applicant must attach a label on the container or wrapper containing the pharmaceuticals, medical devices or regenerative medicine products that have passed the official verification indicating the fact that they have passed an official verification and other matters specified by Order of the Ministry of Health, Labour and Welfare, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare; provided, however, that this does not apply to cases where such pharmaceuticals, medical devices or regenerative medicine products are designated by the Minister of Health, Labour and Welfare as those for which it is found that there is no time available for making a label to be attached to the container or wrapper containing such pharmaceuticals, medical devices or regenerative medicine products due to emergency use, or any other cases specified by Order of the Ministry of Health, Labour.

(2)The prefectural governor must have pharmaceutical affairs inspectors confirm that the label pursuant to the preceding paragraph is attached.

Article 62Beyond what is specified in this Chapter, any necessary matters pertaining to an official verification on pharmaceuticals, medical devices or regenerative medicine products are specified by Order of the Ministry of Health, Labour and Welfare.

Article 63(1)Pharmacy proprietors, holders of marketing authorization, manufacturers or sellers of pharmaceuticals (hereinafter referred to as "pharmacy proprietors" in the following paragraph) must, when intending to receive information provided in Article 46, paragraph (3) of the Act, pursuant to the provisions of the same paragraph, indicate the type and details of a method to be used to the transferee provided in the same paragraph (hereinafter referred to as "electronic or magnetic means" in this Article) and obtain consent in writing or by electronic or magnetic means beforehand, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

(2)Pharmacy proprietors that have obtained the consent prescribed in the preceding paragraph may not, when receiving an offer from the transferee in writing or by electronic or magnetic means that the transferee will not offer information by electronic or magnetic means, receive information provided in Article 46, paragraph (3) of the Act by electronic or magnetic means from the transferee; provided, however, that this does not apply when the relevant transferee grants the consent prescribed in the preceding paragraph again.

Article 64The special diseases provided in Article 67, paragraph (1) of the Act are cancer, sarcoma and leukemia.

Article 64-2Pharmaceuticals (excluding those intended exclusively for use on animals), quasi-pharmaceutical products (excluding those intended exclusively for use on animals), cosmetics and medical devices (excluding those intended exclusively for use on animals), or regenerative medicine products specified by Cabinet Order prescribed in Article 68-13, paragraph (1) of the Act are the following items from among pharmaceuticals (excluding those intended exclusively for use on animals), quasi-pharmaceutical products (excluding those intended exclusively for use on animals), cosmetics or medical devices (excluding those intended exclusively for use on animals) or regenerative medicine products (excluding those intended exclusively for use on animals):

Article 64-3Regenerative medicine products specified by Cabinet Order prescribed in Article 68-15, paragraph (1) of the Act (excluding those intended exclusively for use on animals) or raw materials or materials for the regenerative medicine products are all of the regenerative medicine products (excluding those intended exclusively for use on animals) or the raw materials or materials for such regenerative medicine products.

Article 65Biological products (excluding those intended exclusively for use on animals) or the raw materials or materials for such biological products specified by Cabinet Order prescribed in Article 68-25, paragraph (1) of the Act are all of the biological products (excluding those intended exclusively for use on animals) or the raw materials or materials for such biological products.

Article 66(1)On-site inspection, questioning or sampling specified by Cabinet Order prescribed in Article 69-2, paragraph (1) of the Act is on-site inspection, questioning or sampling under Article 69, paragraph (1) or paragraph (5) of the Act, or on-site inspection, questioning or sampling under paragraph (4) of the same Article (excluding on-site inspection, questioning or sampling of pharmaceuticals, quasi-pharmaceutical products, medical devices or regenerative medicine products intended exclusively for use on animals).

(2)On-site inspection, questioning or sampling specified by Cabinet Order prescribed in Article 69-2, paragraph (2) of the Act is the following items:

(3)Qualification specified by Cabinet Order prescribed in Article 69-2, paragraph (4) of the Act (including as applied mutatis mutandis pursuant to Article 80-5, paragraph (2) of the Act) is that the person falls under any of the items of Article 68.

Article 66-2The laws and regulations specified by Cabinet Order prescribed in Article 73, Article 75, paragraph (1), Article 75-2, paragraph (1), and Article 75-2-2, paragraph (1), item (v) of the Act are the following:

Article 67(1)Inspection or questioning specified by Cabinet Order prescribed in Article 75-2-2, paragraph (4) of the Act is inspection or questioning prescribed in paragraph (1), item (iii) of the same Article (excluding inspection or questioning with respect to pharmaceuticals, quasi-pharmaceutical products, medical devices or regenerative medicine products which are intended exclusively for use on animals).

(2)Inspection and questioning specified by Cabinet Order prescribed in Article 75-2-2, paragraph (4) of the Act, applied mutatis mutandis pursuant to Article 75-4, paragraph (3) of the Act is inspection or questioning prescribed in Article 75-4, paragraph (1), item (ii) of the Act (excluding inspection or questioning with respect to pharmaceuticals, quasi-pharmaceutical products or regenerative medicine products which are intended exclusively for use on animals).

Article 67-2The laws and regulations specified by Cabinet Order prescribed in Article 75-4, paragraph (1), item (iv) of the Act and Article 75-5, paragraph (1), item (v) of the Act are the following:

Article 68No person may be appointed as pharmaceutical affairs inspectors specified in either of the following items unless the person falls under the following:

Article 69Beyond what is specified in the preceding Article, any necessary matters pertaining to pharmaceutical affairs inspectors are specified by Order of the Ministry of Health, Labour and Welfare.

Article 70The laws and regulations specified by Cabinet Order prescribed in Article 77-6, paragraph (2), item (iv) of the Act are the following:

Article 70-2(1)Pharmaceuticals specified by Cabinet Order prescribed in Article 80, paragraph (1) of the Act are pharmaceuticals provided in Article 20, paragraph (1), and requested by foreign governments or international organizations to demonstrate that the methods to control manufacturing and quality of the pharmaceuticals at their manufacturing facility satisfy standards specified by Order of the Ministry of Health, Labour and Welfare provided in Article 14, paragraph (2), item (iv) of the Act.

(2)Quasi-pharmaceutical products specified by Cabinet Order prescribed in Article 80, paragraph (1) of the Act are quasi-pharmaceutical products provided in Article 20, paragraph (2) of the Act, and requested by foreign governments or international organizations to demonstrate that the methods to control manufacturing and quality of the quasi-pharmaceutical products at their manufacturing facility satisfy standards specified by Order of the Ministry of Health, Labour and Welfare provided in Article 14, paragraph (2), item (iv) of the Act.

Article 71The term specified by Cabinet Order prescribed in Article 80, paragraph (1) of the Act is five years.

Article 72(1)The provisions of Article 22 and Article 24 apply mutatis mutandis to exported pharmaceuticals, quasi-pharmaceutical products or cosmetics provided in Article 80, paragraph (1) of the Act.

(2)In cases of the preceding paragraph, in the provisions set forth in the left-hand column of the following table, the terms set forth in the middle column of the same table are deemed to be replaced with the terms set forth in the right-hand column of the same table, respectively.

Article 73The prefectural governor must, when conducting an investigation provided in Article 80, paragraph (1) of the Act, pursuant to the provisions of Article 80, paragraph (2) (limited to the part pertaining to item (vii)), notify the Minister of Health, Labour and Welfare via the PMDA of the result without delay, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

Article 73-2Medical devices or in-vitro diagnostics specified by Cabinet Order prescribed in Article 80, paragraph (2) of the Act are medical devices or in-vitro diagnostics provided in Article 37-20, and requested by foreign governments or international organizations to demonstrate that the methods to control manufacturing and quality of medical devices or in-vitro diagnostics at a manufacturing facility satisfy standards specified by Order of the Ministry of Health, Labour and Welfare provided in the same paragraph.

Article 73-3The term specified by Cabinet Order prescribed in Article 80, paragraph (2) of the Act is five years.

Article 73-4(1)The provisions of Article 37-22 and Article 37-24 apply mutatis mutandis to medical devices or in-vitro diagnostics for export provided in Article 80, paragraph (2) of the Act.

(2)In cases of the preceding paragraph, in the provisions set forth in the left-hand column of the following table, the terms set forth in the middle column of the same table are deemed to be replaced with the terms set forth in the right-hand column of the same table, respectively.

Article 73-5The term specified by Cabinet Order prescribed in Article 80, paragraph (3) of the Act is five years.

Article 73-6(1)The provisions of Article 43-24 and Article 43-26 apply mutatis mutandis to regenerative medicine products for export provided in Article 80, paragraph (3) of the Act.

(2)In cases of the preceding paragraph, in the provisions set forth in the left-hand column of the following table, the terms set forth in the middle column of the same table are deemed to be replaced with the terms set forth in the right-hand column of the same table, respectively.

Article 73-7(1)In cases of having the PMDA conduct an investigation provided in Article 80, paragraph (1) of the Act, pursuant to the provisions of Article 13-2, paragraph (1) of the Act, applied mutatis mutandis pursuant to Article 80, paragraph (4) of the Act, pharmaceuticals (excluding those intended exclusively for use on animals) or quasi-pharmaceutical products (excluding those intended exclusively for use on animals) specified by Cabinet Order prescribed in Article 13-2, paragraph (1) of the Act, applied mutatis mutandis pursuant to Article 80, paragraph (4) are those other than pharmaceuticals or quasi-pharmaceutical products provided in Article 80, paragraph (2), item (vii) from among pharmaceuticals provided in Article 70-2, paragraph (1) (excluding those intended exclusively for use on animals), or quasi-pharmaceutical products provided in paragraph (2) of the same Article (excluding those intended exclusively for use on animals).

(2)In the application of the provisions of Article 80, paragraph (4) of the Act, when having the PMDA conduct an investigation provided in Article 80, paragraph (2) of the Act (limited to the part pertaining to in-vitro diagnostics), pursuant to the provisions of Article 13-2, paragraph (1) of the Act, applied mutatis mutandis pursuant to Article 80, paragraph (4) of the Act, "or medical devices (" in the same paragraph is to be replaced with ", medical devices (", "the same applies in this Article)" is to be replaced with "the same applies in this Article) or in-vitro diagnostics (excluding those intended exclusively for use on animals); hereinafter the same applies in this Article)", "or medical devices" is to be replaced with ", medical devices or in-vitro diagnostics".

(3)In cases of having the PMDA conduct an investigation provided in Article 80, paragraph (2) of the Act, pursuant to the provisions of Article 13-2, paragraph (1) of the Act, applied mutatis mutandis pursuant to Article 80, paragraph (4) of the Act, medical devices (excluding those intended exclusively for use on animals) or in-vitro diagnostics (excluding those intended exclusively for use on animals) specified by Cabinet Order prescribed in Article 13-2, paragraph (1) of the Act, applied mutatis mutandis pursuant to Article 80, paragraph (4) of the Act (including the case as applied pursuant to the preceding paragraph following the deemed replacement of terms) are medical devices (excluding those intended exclusively for use on animals) or in-vitro diagnostics (excluding those intended exclusively for use on animals) provided in Article 73-2.

(4)In cases of having the PMDA conduct an investigation provided in Article 80, paragraph (3) of the Act, pursuant to the provisions of Article 23-23, paragraph (1) of the Act, applied mutatis mutandis pursuant to Article 80, paragraph (5) of the Act, regenerative medicine products specified by Cabinet Order prescribed in Article 23-23, paragraph (1) of the Act, applied mutatis mutandis pursuant to Article 80, paragraph (5) of the Act (excluding those intended exclusively for use on animals) are all of the regenerative medicine products (excluding those intended exclusively for use on animals).

Article 74(1)A person who intends to be engaged in manufacturing, etc. (referring to manufacturing, etc. provided in Article 2, paragraph (13) of the Act; hereinafter the same applies) or importing pharmaceuticals (excluding in-vitro diagnostics; hereinafter the same applies in this Article), quasi-pharmaceutical products or cosmetics in order to export them (hereinafter referred to as an "exporter of pharmaceuticals, quasi-pharmaceutical products or cosmetics" in this paragraph) must notify the Minister of Health, Labour and Welfare via the PMDA (or the governor of the prefecture where such exporter of pharmaceuticals, quasi-pharmaceutical products or cosmetics is located (or, in the case of a corporation, where the principal office is located) in case of pharmaceuticals or quasi-pharmaceutical products intended exclusively for use on animals) of the items of such pharmaceuticals, quasi-pharmaceutical products, or cosmetics and other matters specified by Order of the Ministry of Health, Labour and Welfare beforehand.

(2)With regard to manufacturing, importing, selling, providing, storage or displaying for export of pharmaceuticals, quasi-pharmaceutical products, or cosmetics, the provisions of Article 43, Chapter 9 (excluding the provisions of Article 47, Article 48, Article 55, paragraph (2) (including as applied mutatis mutandis pursuant to Article 60 and Article 62 of the Act), Article 56 (limited to the part pertaining to item (vi) to item (viii); including as applied mutatis mutandis pursuant to Article 60 and Article 62 of the Act), Article 57 (including as applied mutatis mutandis pursuant to Article 60 and Article 62) and Article 57-2 of the Act), Article 68-17, Article 68-18, Article 68-19 (excluding the part to which the provisions of Article 42, paragraph (1) of the Act are applied mutatis mutandis) and Article 68-20 of the Act do not apply; provided however, that manufacturing or importing pharmaceuticals, quasi-pharmaceutical products or cosmetics on a regular basis for export, or selling, providing, storing or displaying pharmaceuticals, quasi-pharmaceutical products or cosmetics which have been manufactured or imported on a regular basis for export is limited to cases of manufacturing, or importing pharmaceuticals, quasi-pharmaceutical products or cosmetics, in accordance with the details of the notification under the preceding paragraph, or cases of selling, providing, storage or displaying pharmaceuticals, quasi-pharmaceutical products or cosmetics manufactured or imported in accordance with the details of the notification under the same paragraph.

Article 74-2(1)A person who intends to be engaged in manufacturing, etc. or importing medical devices or in-vitro diagnostics in order to export them (hereinafter referred to as an "exporter of medical devices" in this paragraph) must notify the Minister of Health, Labour and Welfare via the PMDA (the governor of the prefecture where such exporter of medical devices or in-vitro diagnostics is located (or, in the case of a corporation, where the principal office is located) in the case of medical devices or in-vitro diagnostics intended exclusively for use on animals) of the items of such ones and other matters specified by Order of the Ministry of Health, Labour and Welfare beforehand.

(2)With regard to manufacturing, importing, selling, providing, storage or displaying for the export of medical devices or in-vitro diagnostics, the provisions of Article 43, Chapter 9 (excluding the provisions of Article 55, paragraph (2) (including as applied mutatis mutandis pursuant to Article 64 of the Act), Article 56 (limited to the part pertaining to item (vi) to item (viii)) and Article 65 of the Act (limited to the part pertaining to item (v) to item (viii)), Article 68-17, Article 68-18, Article 68-19 (excluding the part to which the provisions of Article 42, paragraph (1) of the Act are applied mutatis mutandis) and Article 68-20 of the Act do not apply; provided, however, that manufacturing or importing medical devices or in-vitro diagnostics on a regular basis for export, or selling, providing, storing or displaying medical devices or in-vitro diagnostics which have been manufactured or imported on a regular basis for export is limited to cases of manufacturing, or importing medical devices or in-vitro diagnostics, in accordance with the details of the notification under the preceding paragraph, or cases of selling, providing, storage or displaying medical devices or in-vitro diagnostics manufactured or imported in accordance with the details of the notification under the same paragraph.

Article 74-3(1)A person who intends to be engaged in manufacturing, etc. or importing regenerative medicine products in order to export them (hereinafter referred to as an "exporter of regenerative medicine products" in this paragraph) must notify the Minister of Health, Labour and Welfare via the PMDA (or the governor of the prefecture where such exporter of regenerative medicine products is located (or, in the case of a corporation, where the principal office is located) in the case of regenerative medicine products intended exclusively for use on animals) of the items of such regenerative medicine products and other matters specified by Order of the Ministry of Health, Labour and Welfare beforehand.

(2)With regard to manufacturing, importing, selling, providing, storage or displaying for the export of regenerative medicine products, the provisions of Article 43 and Chapter 9 of the Act (excluding the provisions of Article 55, paragraph (2), Article 57 and Article 57-2, paragraph (1) of the Act, applied mutatis mutandis pursuant to Article 65-5 of the Act; and Article 65-6 of the Act (limited to the part pertaining to item (iv) to item (vi)) do not apply; provided, however, that manufacturing or importing regenerative medicine products on a regular basis for export, or selling, providing, storing or displaying regenerative medicine products which have been manufactured or imported on a regular basis for export is limited to cases of manufacturing, or importing regenerative medicine products, in accordance with the details of the notification under the preceding paragraph, or cases of selling, providing, storage or displaying regenerative medicine products manufactured or imported in accordance with the details of notification under the same paragraph.

Article 74-4(1)When a pharmacy proprietor sells or provides pharmacy-made pharmaceuticals (excluding poisonous drugs provided in Article 44, paragraph (1) of the Act and deleterious drugs provided in paragraph (2) of the same Article, and those intended exclusively for use on animals) at the pharmacy, in the case where the provisions of Article 4, paragraph (3), Article 9, paragraph (1), and Article 36-4, paragraph (1), paragraph (2) and paragraph (4) of the Act apply, "OTC pharmaceuticals" in Article 4, paragraph (3), item (iv), (b) of the Act is to be replaced with "OTC pharmaceuticals or pharmacy-made pharmaceuticals (referring to pharmacy-made pharmaceuticals provided in Article 3 of the Order for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Cabinet Order No. 11 of 1961), and excluding poisonous drugs provided in Article 44, paragraph (1) and deleterious drugs provided in paragraph (2) of the same Article, and those intended exclusively for use on animals; hereinafter the same applies in Article 9, paragraph (1), item (ii) of the Act)", "same applies)" in Article 9, paragraph (1), item (ii) is to be replaced with "same applies) or pharmacy-made pharmaceuticals", "have the pharmacist selling or providing medicine at the pharmacy provide required information, and provide instructions through a face-to-face consultation based on pharmacological findings" in Article 36-4, paragraph (1) of the Act is to be replaced with "have the pharmacist selling or providing medicine at the pharmacy provide required information", "provision and instructions" in paragraph (2) of the same Article is to be replaced with "provision", and "provide required information or instruction to the person based on necessary pharmacological findings" in paragraph (4) of the same Article is to be replaced with "provide required information".

(2)The provisions of Article 36-3, paragraph (2) and Article 36-4, paragraph (3) of the Act do not apply to cases provided in the preceding paragraph.

(3)The license prescribed in Article 12, paragraph (1) of the Act for marketing pharmacy-made pharmaceuticals is provided to each pharmacy by the Minister of Health, Labour and Welfare.

(4)In the case of the preceding paragraph, the approval prescribed in Article 14, paragraph (1) and paragraph (9) of the Act for marketing such items is provided to each pharmacy by the Minister of Health, Labour and Welfare.

(5)The provisions of Article 12-2, item (i) and item (ii) of the Act do not apply to the license for marketing pharmacy-made pharmaceuticals.

(6)In the application in the provisions of paragraph (3) or paragraph (4) where the prefectural governor (or the mayor of such city or special ward where a pharmacy marketing pharmacy-made pharmaceuticals is located in a city with established health centers or a special ward) is to provide the license or approval for marketing pharmacy-made pharmaceuticals pursuant to the provisions of Article 80, paragraph (1) (limited to the part pertaining to item (i)), "the Minister of Health, Labour and Welfare" in these provisions is to be replaced with "the governor of the prefecture where such pharmacy is located (or the mayor of such city or special ward where such pharmacy is located in a city with established health centers or a special ward)".

Article 75(1)The provisions of Article 43 of the Act do not apply to pharmaceuticals, medical devices, in-vitro diagnostics or regenerative medicine products provided in Article 80, paragraph (8) of the Act (limited to those designated by the Minister of Health, Labour and Welfare as those for which it is found that there is no time for receiving an official verification prescribed in Article 43, paragraph (1) or paragraph (2) of the Act).

(2)In the case of application of the provisions of Article 44 of the Act to, from among pharmaceuticals or in-vitro diagnostics provided in Article 80, paragraph (8) of the Act, poisonous drugs provided in Article 44, paragraph (1) of the Act or deleterious drugs provided in paragraph (2) of the same Article (limited to those designated by the Minister of Health, Labour and Welfare as those for which it is found that there is no time available for making a statement under paragraph (1) or paragraph (2) of the same Article to be attached to the immediate container or wrapper due to emergency use), "the immediate container or wrapper" specified in paragraph (1) and paragraph (2) of the same Article is to be replaced with "the inserted documents or its container or wrapper".

(3)In the case of application of the provisions of Article 50 and Article 68-17 of the Act to pharmaceuticals, medical devices or in-vitro diagnostics provided in Article 80, paragraph (8) of the Act (limited to those designated by the Minister of Health, Labour and Welfare as those for which it is found that there is no time available for making a statement under Article 50 or Article 68-17 of the Act to be attached to the immediate container or wrapper due to emergency action), "the immediate container or wrapper" specified in Article 50 and Article 68-17 of the Act is to be replaced with "the inserted documents or its container or wrapper".

(4)The provisions of Article 51 of the Act (including as applied mutatis mutandis pursuant to Article 68-19 of the Act) do not apply to pharmaceuticals, medical devices or in-vitro diagnostics designated by the Minister of Health, Labour and Welfare provided in the preceding two paragraphs.

(5)In the application in the provisions of Article 52, Article 63-2 or Article 65-3 of the Act to pharmaceuticals, medical devices, in-vitro diagnostics or regenerative medicine products provided in Article 80, paragraph (8) of the Act, "must include the following matters" in Article 52, paragraph (1) of the Act is to be replaced with "must include the following matters, and that it has been approved pursuant to the provisions of Article 14 or Article 19-2, under Article 14-3, paragraph (1) (including as applied mutatis mutandis pursuant to Article 20, paragraph (1)) in the inserted document and its container or wrapper, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare", "must include the following matters" in Article 63-2, paragraph (1) of the Act is to be replaced with "must include the following matters, and that it has been approved pursuant to the provisions of Article 23-2-5 or Article 23-2-17, under Article 23-3-8, paragraph (1) (including as applied mutatis mutandis pursuant to Article 23-2-20, paragraph (1)) in the inserted document and its container or wrapper, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare", and "must include the following matters" in Article 65-3 of the Act is to be replaced with "must include the following matters, and that it has been approved pursuant to the provisions of Article 23-25 or Article 23-37, under Article 23-28, paragraph (1) (including as applied mutatis mutandis pursuant to Article 23-40, paragraph (1)) in the inserted document and its container or wrapper, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare".

(6)The provisions of Article 52-2, Article 63-3 or Article 65-4 of the Act do not apply to pharmaceuticals, medical devices, in-vitro diagnostics or regenerative medicine products provided in Article 80, paragraph (8) of the Act.

(7)In the application in the provisions of Article 54 of the Act (including as applied mutatis mutandis pursuant to Article 64 and Article 65-5 of the Act; hereinafter the same applies in this paragraph) to pharmaceuticals, medical devices, in-vitro diagnostics or regenerative medicine products provided in Article 80, paragraph (8) of the Act, "including the inner package" in the same Article is to be replaced with "including the inner package; hereinafter the same applies in this Article", "the following matters must not be stated" is to be replaced with "matters set forth in item (i) and (iii), and purposes other than those for pharmaceuticals, medical devices, in-vitro diagnostics or regenerative medicine products pertaining to the approval prescribed in Article 14, Article 19-2, Article 23-2-5, Article 23-2-17, Article 23-25 or Article 23-37, under Article 14-3, paragraph (1) (including as applied mutatis mutandis pursuant to Article 20, paragraph (1)), Article 23-2-8, paragraph (1) (including as applied mutatis mutandis pursuant to Article 23-2-20, paragraph (1)) or Article 23-28, paragraph (1) (including as applied mutatis mutandis pursuant to Article 23-40, paragraph (1)) must not be stated; provided, however, this does not apply to any foreign language stated on a pharmaceutical, medical device, in-vitro diagnostic or regenerative medicine product designated by the Minister of Health, Labour and Welfare provided in Article 75, paragraph (2), paragraph (3), paragraph (10) or paragraph (12) of the Order for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Cabinet Order No. 11 of 1961), or their container or wrapper (excluding any outer container or outer wrapper in the case of an immediate container or immediate wrapper)".

(8)In the case of application of the provisions of Article 55, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 64, Article 65-5 or Article 68-19 of the Act) to pharmaceuticals, medical devices, in-vitro diagnostics or regenerative medicine products designated by the Minister of Health, Labour and Welfare provided in paragraph (2), paragraph (3), paragraph (10) and paragraph (12), "from Article 50 to the preceding Article" in the same paragraph is to be replaced with "Article 50, Article 52 or the preceding two Articles", "from Article 63 to Article 63-3" in the same paragraph, applied mutatis mutandis pursuant to Article 64 of the Act, is to be replaced with "Article 63, paragraph (1), Article 63-2", "from Article 52-3 to the preceding Article" is to be replaced with "the preceding two Articles", "from ... to Article 65-4" in the same paragraph, applied mutatis mutandis pursuant to Article 65-5 of the Act, is to be replaced with ", Article 65-3", "from Article 51 or Article 52-3 to the preceding Article" is to be replaced with "the preceding two Articles", and "Article 51 or Article 53" in the same paragraph, applied mutatis mutandis pursuant to Article 68-19 of the Act, is to be replaced with "Article 53".

(9)In the application of the provisions of Article 56, Article 65 or Article 65-6 of the Act to pharmaceuticals, medical devices, in-vitro diagnostics or regenerative medicine products provided in Article 80, paragraph (8) of the Act, "the following items" in Article 56 of the Act is to be replaced with "from item (vi) to item (viii)", "the following items" in Article 65 of the Act is to be replaced with "from item (v) to item (viii)", and "the following items" in Article 65-6 of the Act is to be replaced with "from item (iv) to item (vi)".

(10)In the application of the provisions of Article 63, paragraph (1) of the Act to medical devices provided in Article 80, paragraph (8) of the Act (limited to those designated by the Minister of Health, Labour and Welfare as those for which it is found that there is no time available for making a statement under Article 63 of the Act to be attached to the medical devices or its immediate container or wrapper due to emergency use), "the medical devices or its immediate container or immediate wrapper" in the same paragraph is to be replaced with "the inserted document or its container or wrapper".

(11)The provisions of Article 63, paragraph (2) of the Act do not apply to medical devices designated by the Minister of Health, Labour and Welfare provided in the preceding paragraph.

(12)In the application of the provisions of Article 65-2 of the Act to regenerative medicine products provided in Article 80, paragraph (8) of the Act (limited to those designated by the Minister of Health, Labour and Welfare as those for which it is found that there is no time available for making a statement under Article 65-2 of the Act to be attached to its immediate container or wrapper due to emergency use), "its immediate container or wrapper" in the same Article is to be replaced with "its inserted documents or the container or wrapper".

(13)The provisions of Article 51 of the Act, applied mutatis mutandis pursuant to Article 65-5 of the Act do not apply to regenerative medicine products designated by the Minister of Health, Labour and Welfare provided in the preceding paragraph.

(14)The provisions of Article 68-20 of the Act do not apply to pharmaceuticals or medical devices provided in Article 80, paragraph (8) of the Act.

Article 76(1)The provisions of Article 13-3 of the Act, and Article 55, paragraph (2) of the Act, applied mutatis mutandis pursuant to Article 62 of the Act (limited to the part pertaining to cosmetics manufactured at a manufacturing facility not accredited pursuant to the provisions of Article 13-3 of the Act (limited to a manufacturing facility in a foreign country)) do not apply to cosmetics exported to Japan and provided in Article 80, paragraph (9) of the Act.

(2)A person who intends to market cosmetics provided in the preceding paragraph must give notification of the name of the manufacturer of the cosmetics and other matters specified by Order of the Ministry of Health, Labour and Welfare, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

Article 77Substances specified by Cabinet Order prescribed in Article 80-3, paragraph (1) of the Act (excluding those intended exclusively for use on animals) are all of the substances for clinical trials (referring to substances provided in Article 80-2, paragraph (2) of the Act, excluding those intended exclusively for use on animals; hereinafter the same applies in the following Article).

Article 78Substances specified by Cabinet Order prescribed in Article 80-4, paragraph (1) of the Act are all of the substances subject to a clinical trial.

Article 79On-site inspection or questioning specified by Cabinet Order prescribed in Article 80-5, paragraph (1) of the Act is all of the on-site inspection or questioning under Article 80-2, paragraph (7) of the Act.

Article 79-2Laws and regulations specified by Cabinet Order prescribed in Article 80-9, paragraph (1), item (iii) of the Act are the following:

Article 79-3Active ingredients, etc. specified by Cabinet Order prescribed in Article 80-10, paragraph (1) of the Act are active ingredients, etc. provided in Article 14, paragraph (4) of the Act (excluding those intended exclusively for use on animals).

Article 80(1)The prefectural governor (or the mayor of such city or special ward where a pharmacy marketing or manufacturing pharmacy-made pharmaceuticals is located in a city with established health centers or a special ward) is to provide the following from among the affairs belonging to the authority of the Minister of Health, Labour and Welfare provided in the Act:

(2)Beyond what is specified in the preceding paragraph, with regard to the following affairs under the authority of the Minister of Health, Labour and Welfare pertaining to pharmaceuticals (excluding in-vitro diagnostics; hereinafter the same applies in this paragraph), quasi-pharmaceutical products or cosmetics, the affairs under the authority set forth in item (i), item (ii), item (v), item (vi) and item (viii) are to be handled by the governor of the prefecture in which the office where a marketing director of pharmaceuticals, quasi-pharmaceutical products or cosmetics provided in Article 17, paragraph (2) of the Act, who supervises a person who the Act intends to market pharmaceuticals, quasi-pharmaceutical products, or cosmetics provided in these items, is engaged in their business is located, and the affairs under the authority set forth in item (iii), item (iv) and item (vii) are to be handled by the governor of the prefecture in which the manufacturing facility is located; provided, however, that this does not prevent the Minister of Health, Labour and Welfare from personally handling the affairs under the Minister's authority set forth in item (ii) and item (iv) (limited to those provided in Article 72, paragraph (1) and paragraph (2), Article 72-4, Article 73 and Article 75, paragraph (1) of the Act) and the affairs under the Minister's authority set forth in item (vi):

(3)Beyond what is specified in the preceding two paragraphs, with regard to the following affairs under the authority of the Minister of Health, Labour and Welfare pertaining to medical devices or in-vitro diagnostics, the affairs under the authority set forth in item (i) and item (ii) are to be handled by the governor of the prefecture in which the office where a marketing director of medical devices provided in Article 23-2-14, paragraph (2) of the Act, who supervises a person who intends to market medical devices or in-vitro diagnostics provided in these items, is engaged in their business is located, and the affairs under the authority set forth in item (iii) to item (v) are to be handled by the governor of the prefecture in which a manufacturing facility or place of business is located; provided, however, that this does not prevent the Minister of Health, Labour and Welfare from personally handling the affairs under the Minister's authority set forth in item (ii) and item (v) (limited to those provided in Article 72, paragraph (1) and paragraph (2), Article 72-4, Article 73, Article 75, paragraph (1) and Article 75-2, paragraph (1) of the Act):

(4)Beyond what is specified in the preceding three paragraphs, the following affairs under the authority of the Minister of Health, Labour and Welfare pertaining to regenerative medicine products are to be handled by the governor of the prefecture in which the office where a marketing director of regenerative medicine products provided in Article 23-34, paragraph (2) of the Act, who supervises a person who intends to market regenerative medicine products, is engaged in their business is located; provided, however, that this does not prevent the Minister of Health, Labour and Welfare from personally handling the affairs under the Minister's authority set forth in item (ii) (limited to those provided in Article 72, paragraph (1) and paragraph (2), Article 72-4, Article 73, and Article 75, paragraph (1) of the Act):

(5)In the cases of paragraph (1) and paragraph (2), the provisions of Article 21, paragraph (1) and paragraph (2) and Article 75, paragraph (2) of the Act do not apply.

(6)In the cases of paragraph (3), the provisions of Article 23-2-21, paragraph (1) and paragraph (2), Article 75, paragraph (2) and Article 75-2, paragraph (2) of the Act do not apply.

(7)In the cases of paragraph (4), the provisions of Article 23-41, paragraph (1) and paragraph (2), and Article 75, paragraph (2) of the Act do not apply.

(8)In the cases of paragraph (1), the provisions regarding the Minister of Health, Labour and Welfare pertaining to the affairs dealt with by the prefectural governor, the mayor of the city with established health centers or the special ward (hereinafter referred to as "the prefectural governors, etc." in this paragraph) pursuant to the provisions of the same paragraph in the Act are to apply to the prefectural governors, etc. as provisions pertaining to the prefectural governors, etc.

(9)In cases of paragraph (2) to paragraph (4), the provisions pertaining to the Minister of Health, Labour and Welfare for the affairs dealt with by the prefectural governor in these provisions of the Act are to apply to the prefectural governor as provisions pertaining to the prefectural governor.

Article 81(1)The affairs required to be administered by prefectures pursuant to the provisions of Article 4, paragraph (1) as applied to paragraph (2) and paragraph (3) of the same Article following the deemed replacement of terms, Article 5, paragraph (2), and the same paragraph as applied to paragraph (4) and paragraph (5) of the same Article following the deemed replacement of terms, Article 6, paragraph (2) and paragraph (4), and the same paragraphs as applied to paragraph (5) and paragraph (6) of the same Article following the deemed replacement of terms, Article 7, paragraph (1), and the same paragraph as applied to paragraph (2) and paragraph (3) of the same Article following the deemed replacement of terms, Article 8, paragraph (1) as applied to paragraph (2) and paragraph (3) of the same Article following the deemed replacement of terms, Article 11, paragraph (1) as applied to paragraph (2) and paragraph (3) of the same Article following the deemed replacement of terms, Article 12, paragraph (2), and the same paragraph as applied to paragraph (4) and paragraph (5) of the same Article following the deemed replacement of terms, Article 13, paragraph (2) and paragraph (4), and the same paragraphs as applied to paragraph (5) and paragraph (6) of the same Article following the deemed replacement of terms, Article 14, paragraph (1), and the same paragraph as applied to paragraph (2) and paragraph (3) of the same Article following the deemed replacement of terms, Article 15, paragraph (1) as applied to paragraph (2) and paragraph (3) of the same Article following the deemed replacement of terms, Article 19, paragraph (1) as applied to paragraph (2) and paragraph (3) of the same Article following the deemed replacement of terms, Article 22, paragraph (1) as applied to paragraph (2) of the same Article following the deemed replacement of terms (including as applied mutatis mutandis pursuant to Article 72, paragraph (1)), Article 24, paragraph (1) as applied to paragraph (3) of the same Article following the deemed replacement of terms (including as applied mutatis mutandis pursuant to Article 72, paragraph (1)), Article 34, paragraph (1), and the same paragraph as applied to paragraph (2) of the same Article following the deemed replacement of terms, Article 37, paragraph (1) as applied to paragraph (2) of the same Article following the deemed replacement of terms, Article 37-2, paragraph (2), and the same paragraph as applied to paragraph (4) of the same Article following the deemed replacement of terms, Article 37-3, paragraph (2) and paragraph (4), and the same paragraphs as applied to paragraph (5) of the same Article following the deemed replacement of terms, Article 37-4, paragraph (1), and the same paragraph as applied to paragraph (2) of the same Article following the deemed replacement of terms, Article 37-5, paragraph (1) as applied to paragraph (2) of the same Article following the deemed replacement of terms, Article 37-8, paragraph (1) as applied to paragraph (2) of the same Article following the deemed replacement of terms (including as applied mutatis mutandis pursuant to Article 55), Article 37-9, paragraph (2), and the same paragraph as applied to paragraph (4) of the same Article following the deemed replacement of terms (including cases where these provisions are applied mutatis mutandis pursuant to Article 55), Article 37-10, paragraph (2) and paragraph (4), and the same paragraphs as applied to paragraph (5) of the same Article following the deemed replacement of terms (including cases where these provisions are applied mutatis mutandis pursuant to Article 55), Article 37-11, paragraph (1), and the same paragraph as applied to paragraph (2) of the same Article following the deemed replacement of terms (including cases where these provisions are applied mutatis mutandis pursuant to Article 55), Article 37-12, paragraph (1) as applied to paragraph (2) of the same Article following the deemed replacement of terms (including as applied mutatis mutandis pursuant to Article 55), Article 37-34, paragraph (1), and the same paragraph as applied to paragraph (2) of the same Article following the deemed replacement of terms, Article 43-3, paragraph (1) as applied to paragraph (2) of the same Article following the deemed replacement of terms, Article 43-4, paragraph (2), and the same paragraph as applied to paragraph (4) of the same Article following the deemed replacement of terms, Article 43-5, paragraph (2) and paragraph (4), and the same paragraphs as applied to paragraph (5) of the same Article following the deemed replacement of terms, Article 43-6, paragraph (1), and the same paragraph as applied to paragraph (2) of the same Article following the deemed replacement of terms, Article 43-7, paragraph (1) as applied to paragraph (2) of the same Article following the deemed replacement of terms, Article 43-11, paragraph (2), Article 43-12, paragraph (2) and paragraph (4), Article 43-13, Article 43-35, paragraph (1), and the same paragraph as applied to paragraph (2) of the same Article following the deemed replacement of terms, Article 58 to Article 60, Article 61, paragraph (2), Article 73, Article 74, paragraph (1), Article 74-2, paragraph (1), Article 74-3, paragraph (1), Article 74-4, paragraph (3) and paragraph (4) as applied to paragraph (6) of the same Article following the deemed replacement of terms, and Article 80, paragraph (1) to paragraph (4) are regarded as Type 1 statutory entrusted functions provided in Article 2, paragraph (9), item (i) of the Local Autonomy Act (Act No. 67 of 1947).

(2)The affairs required to be administered by the mayors of cities with established health centers or special wards pursuant to the provisions of Article 4, paragraph (1) as applied to paragraph (2) of the same Article following the deemed replacement of terms, Article 5, paragraph (2) as applied to paragraph (4) of the same Article following the deemed replacement of terms, Article 6, paragraph (2) and paragraph (4) as applied to paragraph (5) of the same Article following the deemed replacement of terms, Article 7, paragraph (1) as applied to paragraph (2) of the same Article following the deemed replacement of terms, Article 8, paragraph (1) as applied to paragraph (2) of the same Article following the deemed replacement of terms, Article 11, paragraph (1) as applied to paragraph (2) of the same Article following the deemed replacement of terms, Article 12, paragraph (2) applied to paragraph (4) of the same Article following the deemed replacement of terms, Article 13, paragraph (2) and paragraph (4) as applied to paragraph (5) of the same Article following the deemed replacement of terms, Article 14, paragraph (1) as applied to paragraph (2) of the same Article following the deemed replacement of terms, Article 15, paragraph (1) as applied to paragraph (2) of the same Article following the deemed replacement of terms, Article 19, paragraph (1) as applied to paragraph (2) of the same Article following the deemed replacement of terms, Article 74-4, paragraph (3) and paragraph (4) as applied to paragraph (6) of the same Article following the deemed replacement of terms, Article 80, paragraph (1) are regarded as Type 1 statutory entrusted functions provided in Article 2, paragraph (9), item (i) of the Local Autonomy Act.

Article 82(1)The authority of the Minister of Health, Labour and Welfare provided in this Cabinet Order may be delegated to the Director-General of a Regional Bureau of Health and Welfare, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

(2)The authority delegated to the Director-General of a Regional Bureau of Health and Welfare pursuant to the provisions of the preceding paragraph may be delegated to the Director-General of a Regional Branch Bureau of Health and Welfare, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

Article 83With regard to pharmaceuticals, quasi-pharmaceutical products, medical devices or regenerative medicine products intended exclusively for use on animals, "Order of the Ministry of Health, Labour and Welfare" in this Cabinet Order is to be replaced with "Order of the Ministry of Agriculture, Forestry and Fisheries", "the Minister of Health, Labour and Welfare" is to be replaced with "the Minister of Agriculture, Forestry and Fisheries", "as follows" in Article 1-3 is to be replaced with "laws and regulations set forth in item (i) through item (iii), item (v) through item (viii) and item (x)", "the prefectural governor (or the mayor of the city (hereinafter referred to as a "city with established health centers") or special ward when the place of a pharmacy is located in a city specified by Cabinet Order prescribed in Article 5, paragraph (1) of the Community Health Act (Act No. 101 of 1947), hereinafter the same applies in this Chapter)" in Article 1-4, and "the prefectural governor (or the mayor of the city or special ward when the place of a pharmacy marketing pharmacy-made pharmaceuticals is located in a city with established health centers or a special ward; hereinafter the same applies in paragraph (4) of the following Article, Article 6, paragraph (5), Article 7, paragraph (2), Article 8, paragraph (2), and Article 19, paragraph (2))", and "the prefectural governor (or the mayor of the city or special ward when the place of a pharmacy marketing pharmacy-made pharmaceuticals is located in a city with established health centers or a special ward)" in Article 4, paragraph (2), "the prefectural governor (or the mayor of the city or special ward when the place is located in a city with established health centers or a special ward)" in Article 5, paragraph (4), Article 6, paragraph (5), Article 12, paragraph (4), and Article 13, paragraph (5), "the prefectural governor (or the mayor of the city or special ward who received the license when the place of a pharmacy marketing pharmacy-made pharmaceuticals is located in a city with established health centers or a special ward)" in Article 7, paragraph (2), "the prefectural governor (or the mayor of the city or special ward when the place of a pharmacy marketing pharmacy-made pharmaceuticals is located in a city with established health centers or a special ward)" in Article 8, paragraph (2) and Article 19, paragraph (2), "the prefectural governor (or the mayor of the city or special ward when the place of a pharmacy manufacturing pharmacy-made pharmaceuticals is located in a city with established health centers or a special ward; hereinafter the same in paragraph (4) of the following Article, Article 13, paragraph (5), Article 14, paragraph (2) and Article 15, paragraph (2))", and "the prefectural governor (or the mayor of the city or special ward when the place of a pharmacy manufacturing pharmacy-made pharmaceuticals is located in a city with established health centers or a special ward)" in Article 11, paragraph (2), and "the prefectural governor (or the mayor of the city or special ward who received the license when the place of a pharmacy manufacturing pharmacy-made pharmaceuticals is located in a city with established health centers or a special ward)" in Article 14, paragraph (2), and "the prefectural governor (or the mayor of the city or special ward when the place of a pharmacy manufacturing pharmacy-made pharmaceuticals is located in a city with established health centers or a special ward" in Article 15, paragraph (2) is to be replaced with "the prefectural governor"; "each item of Article 1-3" in Article 41-2, item (iii), Article 66-2, item (iii), Article 67-2, item (iii), Article 70, item (iii) and Article 79-2, item (iii) is to be replaced with "from Article 1-3, item (i) to item (iii), item (v) to item (viii) and item (x)", "the prefectural governor (or the mayor of the city where, in the case of store-based distribution, the place of a store is located at, and in the cases of selling or leasing of specially-controlled medical devises (referring to specially-controlled medical devices provided in Article 39, paragraph (1) of the Act; hereinafter the same applies), the business office is located in a city with established health centers or a special ward, respectively; hereinafter the same applies from the following Article to Article 48) must, when granting a license for selling pharmaceuticals, selling or leasing specially-controlled medical devices" in Article 44 is to be replaced with "the prefectural governor must, when granting a license for selling pharmaceuticals, selling or leasing specially-controlled medical devices (referring to specially-controlled medical devices provided in Article 39, paragraph (1) of the Act; hereinafter the same applies)", "and Article 40-5, paragraph (1)" in Article 48 is to be replaced with ", paragraph Article 40-5, (1) and Article 83-2-3, paragraph (1)", "the prefectural governor (or the mayor of such city or special ward where a pharmacy marketing pharmacy-made pharmaceuticals is located in a city with established health centers or a special ward)" in Article 74-4, paragraph (6), and "the prefectural governor (or the mayor of such city or special ward where such pharmacy pharmaceuticals is located in a city with established health centers or a special ward)", "the prefectural governor (or the mayor of such city or special ward where a pharmacy marketing or manufacturing pharmacy-made pharmaceuticals is located in a city with established health centers or a special ward)" in Article 80, paragraph (1), and "the prefectural governor, the mayor of a city with established health centers or a special ward (hereinafter referred to as "the prefectural governors, etc." in this paragraph)" in paragraph (8) of the same Article and "the prefectural governors, etc." is to be replaced with "the prefectural governor".