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发表于 2013-2-13 12:01:00
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NAFDAC办公室在OSHODI 那边,楼主自己打电话去问 LAGOS HEAD-OFFICE
3/5 OSHODI EXPRESSWAY, OSHODI LAGOS
Telephone : 01-4524259, 01-4524270, 01-4731018,NAFDAC在中国是否跟SONCAP一样在上海和香港有分支机构,如果有拿到国内的联系方式和地址 去问办理细节问题,如果没有把球踢给客户 说自己也想帮忙办理NAFDAC证书 可是国内没有办理机构所以爱莫能助了,让客户在当地去询问细节办理吧 如果需要你配合寄样品到NIGERIA NAFDAC办公室检测 就寄给他吧 总之他是主导你是配合,客户也会综合考虑办理时间和费用与清黑关相比哪个更划算,能办理更好,如果 周期漫长耗钱多 也会之难而退走回原路, HOW DO U THINK?
以下是流程供参考
Key Requirements
The key requirements are as follows:
(a) DRUGS (b)Foods: Though the requirements are generally similar, the second part of this guide will deal with the specific requirements on food products
1. Application is on single product basis
2. Written application stating name of manufacturer and name (and brand, if applicable) of product.
3. Completed NAFDAC application form (Form D-REG/001)
4. Certificate of Incorporation with the Corporate Affairs Commission, if a company
5. Five (5) copies of the product dossier
6. Three (3) packs of the products samples
7. Notarised original copy of the duly executed Power of Attorney from the product manufacturer (imported product)
8. Certificate of Manufacture issued by the competent health or regulatory authority in country of origin and authenticated by the Nigerian Mission in that country (if foreign import). Where there is no Nigerian mission, The British High Commission or an ECOWAS country Mission will authenticate.
9. If contract-manufactured, Contract Manufacturing Agreement, properly executed and notarized by a Notary Public in the country of manufacture.
10. Current World Health Organisation Good Manufacturing Practice Certificate for the manufacturer, authenticated by the Nigerian Mission.
11. Certificate of Pharmaceutical Products (COPP) duly issued and authenticated
12. Current Superintendent Pharmacists license to practice issued by the Pharmaceutical Council of Nigeria
13. Premises Registration License from Pharmacists Council of Nigeria (PCN)
14. Certificate of Registration of brand name with trademark registry in the Ministry of Commerce here in Nigeria
15. Letter of invitation from manufacturer to inspect factory abroad, stating full name and location of plant.
16. The applicable fee payable only if documents are confirmed to be satisfactory.
Nutriceuticals, medical devices and other regulated drug products have similar requirements, with minor variations. Specific details can be obtained from NAFDAC.
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