These Regulatory Rules, consisting of 214 articles, establish all matters related to Marketing Business and Manufacturing Industry of Medicinal products and Quasi-drug. Applications for license under the stipulations in the Act, Article 12, Paragraph 1 shall be made by submitting an application form prescribed in Appended Form No. 1 with specific documents listed in the items to the Minister of Agriculture, Forestry and Fisheries. The format of the certificate of license stipulated in the Act Enforcement Ordinance on securing quality, efficacy and safety of products including pharmaceuticals and medical devices. Marketing authorization holders of medicinal products (excluding in vitro diagnostic) or quasi-drug shall display the certificate of license issued as stipulated in the Ordinance. It also regulates antimicrobial substance preparations as medical products that contain antibiotics.
Japan · 2004-12-24