Accredited Foreign Manufacturers (AFM)

	JAPAN APPROVALS DATABASE (JAD)
Jouhou Koukai Publishing, a Jouhou Koukai business	ISSN 1550-3399
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PAL definition: Accreditation of Foreign Manufacturers

Article 13-3 of Pharmaceutical Affairs Law (Accreditation of Foreign Manufacturers)

Paragraph 1. Persons, who manufacture in foreign countries drugs, quasi-drugs, cosmetics and medical devices with intention to import them to Japan from abroad (hereafter "Foreign Manufacturer") may be accredited by the Minister as an Accredited Foreign Manufacturer.

Paragraph 2. The accreditation specified in the preceding paragraph shall be granted for each manufacturing facility in accordance with categories specified in MHLW Ordinance.