(三)医薬品(体外診断用医薬品を除く。)又は医薬部外品の医薬品等外国製造業者の認定の場合
動物用医薬品(医薬部外品)医薬品等外国製造業者認定申請書
Application for accreditation of foreign
animal drug(quasi-drug) manufacturer
年 月 日
Year Month Day
農林水産大臣 殿
To Minister of Agriculture, Forestry and Fisheries
住所
Address
氏名 (法人にあっては、名
称及び代表者の氏名)
Name (Name and name of its representative
in case of a corporation)
医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律第13条の3第1項の規定により動
物用医薬品(医薬部外品)の医薬品等外国製造業者の認定を受けたいので、下記により申請します。
I hereby apply for the accreditation of the foreign animal drug(quasi-drug) manufacturer
pursuant to Article 13-3, Paragraph 1 of the Act on Securing Quality, Efficacy and Safety of
Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy
Products, and Cosmetics, indicated following.
記
1 製造所の名称及び所在地
Name and location of the manufacturing establishment
2 受けようとする認定の区分
Accreditation categories in which the application is made
3 製造所の構造設備の概要
Outline of the buildings and facilities of the manufacturing establishment
4 製造所の責任者の氏名及び住所
Name and address of the person responsible for the manufacturing establishment
5 申請者(申請者が法人であるときは、薬事に関する業務に責任を有する役員を含む。)が法第5条第3
号イからトまでに該当することの有無
Whether or not the applicant(if the applicant is a corporation, include the serving executive
responsible for the services of pharmaceutical affairs) corresponds to Article 5, Item 3 of
the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices,
Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics
6 参考事項
Reference matters
(日本産業規格A4)
(Japanese Industrial Standards Size A4)