Nigeria - Register with NAFDAC National Agency for Food and Drug Administration and Control
- 1 Procedure
- 2 Required Documents
- 3 Office Locations & Contacts
- 4 Eligibility
- 5 Fees
- 6 Validity
- 7 Documents to Use
- 8 Sample Documents
- 9 Processing Time
- 10 Related Videos
- 11 Instructions
- 12 Required Information
- 13 Need for the Document
- 14 Information which might help
- 15 Other uses of the Document/Certificate
- 16 External Links
- 17 Others
Stages involve to register products with NAFDAC in Nigeria is procedural. Every process needed to register any product must be followed to the later.First, know that NAFDAC categories registration of products basically into two parts; namely,
Imported products and locally manufactured products
Again, each part has classes under which products are registered such as Drugs, Foods, Cosmetics, Medical Devices, Herbal products, Narcotics, Pesticides, Packaged Water e.t.c. Now, there five(5) stages each imported product must pass in order to license number:
- Stage one
Here you are required to present the necessary documents specified by NAFDAC to register each products. These documents differ in some aspect depending on the class of product you want register.
- Some of the documents include Power of Attorney or contract manufacturing Agreement;
- Manufaturing license and free sale certificate,
- Trademark registration,certificate of incoporation/business name and many more.
Note: All the necessary documents must be found satisfactory before any other process can be carried out.
- Stage two
- Import Permit:
If the documents complied with the NAFDAC requirements, permit to import samples of products is issued to the applicant. The applicant is requited to import specified samples to be used for vetting and Lab analysis.
- Stages Three
- Vetting of samples:
At this stage, samples of products presented are vetted. Such vetting includes checking the labels, leaflets, drugs information.
There are minimum requirements for product labeling such as
- name of the medicine brand name,
- name and address of the manufacturer,
- production and expiry date,
- batch no, provision for NAFDAC NO and so on.
Documents to be submitted during the vetting are:
a. copies of import permit and receipt of payment
b. dossier according to NAFDAC format for drugs and pesticides
c. 3 samples for each product
d. Letter of invitation for inspection.
e. Comprehensive Certificate of Analysis
- Stage Four
- Lab Analysis:
After the vetting is done, you are required to bring some samples for lab analysis. Youve to submit specified quantities of sample products along with copies of receipt for the processing fee and application letter for the submission of samples.
Then your product(s) goes to lab for analysis to ensure compliance with standard specification.
- Stage Five
At this stage, if the product(s) successful meets the lab test, then the product will be presented at the meeting. Here, decisions are taken on whether the product qualifies to be given NAFDAC license Number or not. They usually seat two times over the product. If the product meets all the requirements, license number will be issued.
- Stage Six
- Collection of Notification Number:
Once the product is given license number, you will go ahead to collect the notification number. Youve to pay the specified amount for the license certificate and present the receipt and your notification number will be given to you. You are now qualified to import the product for commercial purpose while you wait for the certificate to come out. It takes six months or so for your certificate to be ready. The certificate usually last for the period of five (5) years
To register imported drugs and other related products with NAFDAC, there are basic documents and requirement you must have. These requirements must meet NAFDAC set standard. They include the followings:
(a)Power of Attorney or Contract Manufacturing Agreement. This is legal agreement between manufacturer and applicant. It must be Notarized by Notary Public in the country of manufacture and issued by the manufacturer of the products which is duly signed by most senior management.
(b)Manufacturing License/ Certificate (for India and China Only). This is a license or certificate issued by relevant authority in the country of manufacture that empowers the manufacturer to produce such drug products. It also state that the product produced are sold in the country of origin and can be freely sold in other countries.
(c)Certificate of Pharmaceutical Products ( COPP; WHO FORMAT)
(d)Current Good Manufacturing Practice (GMP) Certificate of the manufacturing facility.
Note: Nos; b,c & d shall be issued by a relevant health /regulatory body and authenticated by the Nigeria Embassy in the country of origin. In countries where no Nigeria Embassy exists, British High Commission or any Commonwealth or ECOWAS country commission can authenticated.
(e) Brand Letter Confirmation. This issued by manufacturer if the brand name(s) belong to the applicant stating that the brand name(s) belong to the applicant and the pplicant should go ahead to register it with NAFDAC.
(f)Comprehensive Certificate of analysis: issued by the manufacturer with the name and designation of the analysts.
(g)Certificate of registration of brand name with the trademark Registry in the ministry of Commerce in Nigeria.
(h)Certificate of incorporation with Corporate Affairs Commission in Nigeria .
(i)Current pharmacists License to practice issued by the pharmacists council of Nigeria.
(j)Valid pharmacists premises license to practice issued by pharmacists council of Nigeria.
(k)Application letter for import permit by the applicant.
(l)Notarized Declaration stamped by notary public here in Nigeria.
(m)A letter of invitation to inspect the factory abroad. This is submitted by the Applicant and shall state the full location address of the manufacturer, name of contact person, e-mail address, phone and fax numbers and nearest airport; and also the full name and address of the applicant
- The full location address of the manufacturer,
- name of contact person,
- e-mail address,
- phone and fax numbers and nearest airport; and also
- the full name and address of the applicant
Office Locations & Contacts
Please list down the office locations that can be approached for applying. External links can also be used for specifying office locations.
All Individual or companies interested in importing and exporting the right quality of food,drugs and other related products in Nigeria.
Explain the fees structure which is required
Explain the time until which the certificate/document is valid. e.g. Birth Certificate Valid Forever
Documents to Use
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Videos explaining the procedure or to fill the applications. Attach videos using the following tag <&video type="website">video ID|width|height<&/video&> from external websites. Please remove the "&" inside the tags during implementation. Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver, sevenload, viddler, vimeo, youku, youtube width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed. e.g In the following url "http://www.youtube.com/watch?v=Y0US7oR_t3M" Video ID is "Y0US7oR_t3M".
NAFDAC, the National Agency for Food and Drug Administration and Control is the body in Nigeria that the statutory responsilbility of regulating and controlling the manufacture, importation, exportation, distribution, advertisement, sale and use of drugs, food, packaged water, medical devices, chemicals, raw materials, cosmetics, and agrochemicals (called regulated products).
NAFDAC in Nigeria is a scientific and research organisation with a mandate to protect consumers from the use and consumption of unwholesome and dangerous regulated products. It does this by assigning NAFDAC numbers to satisfactory products as well as continuous regulatory activities at production and distribuion locations and the ports of entry.
The key information required is 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.
Need for the Document
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.
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