If the business you’ve chosen to go into involves the manufacture or importation of goods that fall within the description of food or drug, then be sure that you cannot legitimately carry on such trade without the appropriate registration of the product(s) by the National Agency for Food And Drug Administration And Control, NAFDAC. Anybody who has lived in Nigeria or monitored the goings-on here in recent years will definitely know that NAFDAC is one government agency that has shown full commitment to executing its mandate without fear or favour. NAFDAC is empowered by the relevant laws to ensure that no processed food shall be manufactured in, imported into, exported from, or advertised, sold or distributed in Nigeria, without NAFDAC’s approval. To do so will be in breach of the law and NAFDAC has shown it has no sympathy for such offenders. The prescribed penalties are stiff, including forfeiture of the goods. As NAFDAC has continually demonstrated, applying the full weight of the law is not an option it shies away from. If you are serious about the business you propose to engage in, the sensible way is to fully comply with the regulatory requirements.
Because the product registration process of NAFDAC is stringent, persons who require to go through it often view the process as very tasking and may complain of frustration. The major reason is lack of working information on what is required. This could lead to wasted time and energy, as the unprepared applicant goes back and forth. That is why we are are providing this guide which outlines the key requirements to enable you understand the process and go through it with minimal anxiety.
Registration Categories And General Requirements
Currently, NAFDAC registers products in two categories: drugs and food. Drugs include medical devices, vaccines, chemicals and pesticides, veterinary products, nutriceuticals and supplements, herbal preparations and cosmetics. Products may be manufactured locally or imported. However, an application for registration can only be initiated by the Nigerian manufacturer, for a locally manufactured food or drug product. In the case of a product manufactured outside Nigeria , application must be by a Nigerian representative of the foreign manufacturer and this must be a registered company or an individual. In effect, the applicant must be based in Nigeria and is expected to possess the capacity to control the circulation of the product. The representative of a foreign manufacturer must however have a duly executed Power of Attorney from the manufacturer (signed by company MD, GM, Chairman or President) appointing and authorizing him/it to act in that capacity and specifying the name(s) of the product(s).
Two-Stage Registration Process
Though the specific documentations vary for different drugs and food categories, the general procedure is similar and, broadly, is a two-stage process:
1. Application for approval to bring in samples – not applicable if locally manufactured
2. Application for full registration of product – applies whether locally manufactured or imported
Requirements – Stage one (Procurement of samples)
The registration process will require samples of the product. NAFDAC therefore grants special authorization to import such samples. Simply apply to NAFDAC for a written authorization to import samples. Also ensure that other documents required for clearing and taking delivery of samples are obtained, particularly Certificate of Analysis issued by the manufacturer and Certificate of Manufacture and Free Sale issued by the appropriate regulatory authority in the country of origin. Samples must also conform to stipulated product labeling regulations.
Requirements – Stage two (Application for full registration of product)
This starts with the procurement of an application form for each product – NAFDAC approval is granted for each specific product. This simply means that two products from the same source will still require different approvals and numbers. In fact, two different packages of the same products are processed as different products. The application form is also available at NAFDAC’s offices or online at NAFDAC’s website. The completed form is to be submitted to the registration division of the agency.
The key requirements are as follows:
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.
Other Important Requirements
Further guidelines on registration and additional requirements on product labeling are provided in the document NAFDAC – Other Important guidelines which you can download here. It’s in PDF format.
(b)Foods: Though the requirements are generally similar, the second part of this guide will deal with the specific requirements on food products.
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