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How To Process A Product Registration With NAFDAC
Getting a Food Or Drug Product Registered With Nigeria's Regulator

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.
Stringent Process
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.
Key Requirements
The key requirements are as follows:
 (a) DRUGS
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.


 

FREQUENTLY ASK QUESTIONS
How long is the registration process?
Three months if all requirements are met as and when due.

How do I begin the process of registration?
You begin with the purchase of the relevant registration application form from the NAFDAC office closest to you and pick up the applicable guidelines.


Where is the NAFDAC registration Office?
In Lagos, with the following addresses.

(a) NAFDAC Central Laboratory Complex

3/4 Oshodi ? Apapa Expressway, Oshodi ? Lagos.

(for Registration and Regulatory Affairs Directorate, Legal Unit, Establishment Inspection Directorate, Food Laboratory, Narcotics and Controlled Substances Directorate).

(b) NAFDAC Central Drug and Vaccines Laboratory (CDVL)

Edmund Crescent, Yaba ? Lagos (for Drug Laboratory and Ports Inspection Directorate).

(c) NAFDAC Enforcement Directorate.

Ahmadu Bello Way (Behind Nigerian Air Force Camp by Legico B/stop), Victoria Island - Lagos.

Whom do I call to report a complaint?
Call the Director (Registration and Regulatory Affairs) on 01-4748627, 01- 4772452

What is NAFDAC?s website and e-mail address?
Website: www.nafdac.gov.ng

E-mail: nafdac@nafdac.gov.ng This e-mail address is being protected from spambots. You need JavaScript enabled to view it



HOW LONG WILL IT TAKE TO REGISTER MY FOOD PRODUCT?

.The registration of food products takes maximum of three(3) months provided all documents and other requirements as stated in the food registration guidelines are found to be satisfactory

IS THERE ANY CONCESSION IN REGISTRATION TARIFF FOR VARIANTS OF IMPORTED FOOD PRODUCTS?
.YES, registration of food variants e.g. flavour, colour, e.t.c. have concessionary tariff charges

HOW LONG WILL IT TAKE FOR MY PRODUCT REGISTRATION CERTIFICATE TO BE READY?
Product registration certificates takes a maximum of six(6) months after the date of approval to be ready.
 
CAN I DO TEST MARKETING OF MY PRODUCT BEFORE REGISTRATION?
NO, TEST MARKETING OF FOOD PRODUCTS ARE NOT PERMITTED.

WHAT IS THE AGENCY DOING ABOUT THE LITERING OF THE ENVIRONMENT WITH EMPTY SACHET PACKAGING?
THE AGENCY ENSURES THAT THE SACHET PACKAGING BEARS THE LOGO & INSCRIPTION ?DISPOSE PROPERLY: AND IT IS THE RESPONSIBILITY OF THE MINISTRY OF ENVIRONMENT AT STATE AND LOCAL GOVERNMENT LEVEL TO ENSURE PROPER WASTE DISPOSAL.
 

CAN PEOPLE NOT JUST PUT NAFDAC NUMBER THAT DOES NOT EXIST ON THEIR OWN?
Yes they do. But they are fake numbers. And they also claim they are going to secure NAFDAC Registration Number very soon. But this is not true.

HOW DO I KNOW THE GENUINE NAFDAC NO.?
Cross check from NAFDAC website, NAFDAC green pages and from NAFDAC offices in all the states of the Federation.
 


WHERE CAN I FIND THE LIST OF REGISTERED PRODUCTS?
Gazzette, NAFDAC green pages and NAFDAC website, also NAFDAC offices in Nigeria.


WHERE DO I REPORT ANY NEFARIOUS ACTIVITY WHEN PEOPLE ARE TRYING TO FAKE NAFDAC REGULATED PRODUCT?
Report to any NAFDAC office and Enforcement Directorate in Lagos. Call NAFDAC hotlines.


CAN I REGISTER MY PRODUCT MYSELF WITHOUT KNOWING ANYBODY IN NAFDAC OR GOING THROUGH AN AGENT?

Yes.


HOW DO I KNOW THAT THE NAME I WANT TO USE FOR REGISTRATION OF MY PRODUCT WILL BE ACCEPTED BY NAFDAC?
Write formally to NAFDAC for clearance of Name which can hold for 2 weeks only.
 


WHEN IS THE PRODUCT LIKELY TO COME OUT OF THE LABORATORY?
6-8 weeks




WHY CAN'T OUR PRODUCT WHICH IS AN INTERNATIONAL PRODUCT BE ACCEPTED AS SOLD ALL OVER THE WORLD.

Because products must comply with the labeling regulations developed to meet the needs of Nigeria.


HOW AND WHERE ARE CLINICAL TRIALS CONDUCTED?

Clinical trials are conducted in accordance with good clinical practice (GCP) and are conducted in research institutions.

WHAT ARE THE REQUIREMENTS TO CONDUCT CLINICAL TRIALS IN NIGERIA?

The requirements for clinical trials can be obtained from our website: www.nafdacnigeria.gov.ng.


ARE CLINICAL TRIALS DIRECTLY SUPERVISED BY NAF
DAC?
Yes.


DO FOREIGN DRUGS GET SUBJECTED TO CLINICAL TRIALS BEFORE THEY ARE ALLOWED FOR USE IN THE COUNTRY?

Yes. Particularly if the drug does not have adequate and well documented use in black population or it has some race specific properties or its efficacy, safety and usefulness needs to be proven in our population.


DO NAFDAC CHOOSE INVESTIGATORS TO CONDUCT CLINICAL TRIALS?

No. Sponsors and applicants are responsible for the choice of their trial investigators.

HOW MANY STUDY SITES ARE CLINICAL TRIALS ARE SUPPOSED TO BE CONDUCTED?

At least two centers.


HOW LONG DOES IT TAKE TO CONDUCT CLINICAL TRIALS?
It depends on t a number of factors, some of which are:

? The design of the trial.

? The nature of the investigational product.

? The investigational product.

? The rate of recruitment of trial participants, etc.


HOW MANY PEOPLE ARE SUPPOSED TO PARTICIPATE IN CLINICAL TRIALS?
The number of participants to be involved in a study depends on the phase of the study (I, II, III or IV) and the trial design.


HOW MUCH DOES IT TAKE TO CONDUCT CLINICAL TRIAL IN NIGERIA?
The applicant need to pay NAFDAC N200, 000.00 plus 5% VAT for imported products and N50, 000.00 plus 5%VAT for local and herbal products. Other monetary expenses related to the conduct of the trial are handled between the sponsors and the investigators.


HOW MANY DRUGS ARE CURRENTLY UNDERGOING CLINICAL TRIALS NOW?
Five products.


LIST OF BANNED FOOD COLOURS AND / OR ADDITIVES.
This is in accordance with Codex, EU, and FDA list of Banned Colours and / or food additives. This is usually downloaded On www.codexalimentarius.net, www.fda.gov , and www.eu.net .
 


CODEX LIST OF FOOD CONTAMINANTS AND MAXIMUM LIMIT IN DIFFERENT CATEGORIES OF FOODS
This is in accordance with Codex, EU, and USFDA position on maximum limit of contaminants in foods. However, in some cases it depends on country?s position as some external factors can contribute to high values of contaminants in foods. These values can be downloaded on the websites given above.