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内容

备注

1        

申请人声明（申请人为企业时，由企业的负责人声明），其不存在以下情形：

a person judged incompetent, or addicted to narcotics, cannabis, opium, or stimulants;

a person who suffers from physical or mental impairments and is not able to appropriately perform the duties as a proprietor of a pharmacy specified by Order of the Ministry of Health, Labour and Welfare.

2        

工厂负责人履历

3        

拟在日本上市的产品清单及生产过程的相关文件

Ø  由于AFM认证是分Drugs或Quasi-Drugs等不同分类的，所以要说明拟上市产品的分类。

Ø  生产过程的相关文件，通常只需要描述产品经过几个什么生产工序即可，不用详述。

4        

工厂的布局和设备相关文件

Ø  厂区周边、厂区、车间、实验室、仓库等的布局图（包含面积、房间内的设备布局等）。

Ø  关键设备仪器清单。

Ø  厂区内自行处理废气、废水、废弃物的，通常需要相关的处理流程或布局图。

Ø  以上这些全都只需要准备与拟在日本上市的产品有关的，无关的不用写。

5        

中国的生产许可证

6        

组织架构图

7        

翻译者声明

看提交给ICC的是什么语言，一般汉译英或汉译日。

8        

给ICC的授权书

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施行規則

Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices

昭和三十六年二月一日厚生省令第一号

Order of the Ministry of Health, Labour and Welfare No. 1 of February 1, 1961

Documents to Be Attached to Applications for Accreditation of Foreign Manufacturers of Drugs and Quasi-Drugs

PFSB/ELD Notification No. 1024002

October 24, 2005

Provisional Translation (as of December 14, 2007)

第三十五条法第十三条の三第一項の医薬品等外国製造業者の認定の申請は、様式第十八による申請書（正副二通）を提出することによつて行うものとする。

Article 35(1) An application for accreditation of a foreign manufacturer of pharmaceuticals, quasi-pharmaceutical products or cosmetics prescribed in Article 13-3, paragraph (1) of the Act is to be made by submitting written applications based on Form No. 18 (the original and a duplicate).

这个Form No. 18一般是由ICC完成的。

２前項の申請書には、次に掲げる書類を添えなければならない。ただし、申請等の行為の際厚生労働大臣に提出された書類については、当該申請書にその旨が付記されたときは、この限りでない。

(2) The following documents must be attached to the written application prescribed in the preceding paragraph; provided, however, that this does not apply to documents submitted to the Minister of Health, Labour and Welfare at the time of application and other acts, if the written application has a supplementary note to that effect:

一申請者（申請者が法人であるときは、その業務を行う役員）が法第五条第三号ホ及びヘに該当しないことを疎明する書類

(i)documents which show the applicant (an officer responsible for the business if the applicant is a corporation) does not fall under Article 5, item (iii), (e) and (f) of the Act;

其中Article 5, item (iii), (e) and (f) of the Act指的是：

ホ成年被後見人又は麻薬、大麻、あへん若しくは覚醒剤の中毒者

(e)a person judged incompetent, or addicted to narcotics, cannabis, opium, or stimulants;

ヘ心身の障害により薬局開設者の業務を適正に行うことができない者として厚生労働省令で定めるもの

(f)a person who suffers from physical or mental impairments and is not able to appropriately perform the duties as a proprietor of a pharmacy specified by Order of the Ministry of Health, Labour and Welfare.

二製造所の責任者の履歴書

(ii)a resume of a person in charge of the manufacturing facility;

The responsible person shall be a person with a direct responsibility for manufacturing control and quality control at the manufacturing establishment, and the document shall describe the name of the responsible person, his/her past career and responsibility at this manufacturing establishment, etc. The information in the document shall be necessary and sufficient to support the judgment that the person has an appropriate ability for manufacturing control and quality control at the manufacturing establishment.

In addition, if the person has a short career/work experience at the manufacturing establishment, information relating to his/her previous employment shall be also provided.

三製造品目の一覧表及び製造工程に関する書類

(iii)a list of items to be manufactured and documents concerning the manufacturing process;

The list of product(s) to be manufactured shall contain the product items to the extent that they are known at the time of the accreditation application.

The descriptions in the documents on the manufacturing process shall indicate which kinds of operations are included in the manufacturing processes for each of the product(s) to be manufactured at the relevant establishment. The documents shall provide necessary and sufficient information to make a judgment that the accreditation category and the buildings and facilities are adequate for the product(s) to be manufactured at the manufacturing establishment.

四製造所の構造設備に関する書類

(iv)documents concerning structure and equipment at the manufacturing facility;

The documents to be submitted shall be prepared in accordance with application documents for a license for manufacturing drugs and quasi-drugs pursuant to the Notification of Director-General, Pharmaceutical Affairs Bureau, MHW: “Enforcement of Ministerial Ordinance etc. of Partial Revision of the Regulations for Manufacturing Control and Quality Control of Drugs and Regulations for Buildings and Facilities for Pharmacies, etc.” (PAB Notification No. 1332, dated October 9, 1980).

五放射性医薬品を取り扱おうとするとき（厚生労働大臣が定める数量又は濃度以下の放射性医薬品を取り扱おうとするときを除く。）は、放射性医薬品の種類及び放射性医薬品を取り扱うために必要な設備の概要を記載した書類

(v)when the pharmacy intends to deal with radioactive pharmaceuticals (excluding the case where the pharmacy intends to handle radioactive pharmaceuticals below the quantity or concentration specified by the Minister of Health, Labour and Welfare), documents showing the types of radioactive pharmaceuticals and the outline of equipment required to handle radioactive pharmaceuticals;

六当該外国製造業者が存する国が医薬品、医薬部外品又は化粧品の製造販売業の許可、製造業の許可、製造販売の承認の制度又はこれに相当する制度を有する場合においては、当該国の政府機関等が発行する当該制度に係る許可証等の写し

(vi)if a country where the foreign manufacturer exists has a system of marketing license, manufacturing license, marketing approval of pharmaceuticals, quasi-pharmaceutical products, or cosmetics, or a system corresponding to the same, a copy of a license certificate, etc. issued by a governmental organization of the country.