Guide on How to Register a Drug Product in NAFDAC + Requirements

This post contains a detailed guide on how to process/register a food or drug product with NAFDAC. It also contains the requirements, cost, processes and rules of getting a NAFDAC number for a drug or food product with address and website of NAFDAC in Lagos

If the business you have chosen to venture into involves the manufacture or importation of goods that falls inline with the description of food or drugs, then you have to be aware that you cannot legitimately carry on such business without the prior registration of the product(s) by the National Agency for Food And Drug Administration and Control, NAFDAC.

NAFDAC is the government agency 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 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 for defaulters are stiff, including forfeiture of the goods if one fails to comply with the regulatory requirements of registering for a NAFDAC number.

Difficult Procedures of Registering Products Under NAFDAC

Due to the difficult nature of product registration process of NAFDAC, people often view the process as very tasking and may complain of difficulty. The truth is that they lack the valuable information on the requirements to such procedures which on the long-run can prove to be frustrating. As earlier said, this guide will outline 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 for 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 for 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.

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Key Requirements For Drugs NAFDAC Registration

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. Notarized 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.

Key Requirements for Food Products Manufactured in Nigeria

1. Application form and forward to the Director, stating the name of manufacturer, brand name, and product (s)

2. Comprehensive Certificate of analysis of the batch of the product submitted for registration from the manufacturer stating name and signature of the analyst.

3. Trade mark approval for brand name from Federal Ministry of Commerce (where applicable)

4. Pre-production inspection/ Certificate of Recognition issued by NAFDAC

5. Certificate of Incorporation of the company issued by the CAC (Imported Food Items)

6. An application for registration of a food product.

7. An applicant for a manufacturer outside Nigeria must file an evidence of Power of Attorney from the manufacturer

8. The applicant must submit to the office of the Director of NAFDAC, a written application, stating name of the manufacturer, the product names.

9. The original manufacturer must show evidence that they are licensed to manufacture food for sale in the country of origin and that the sale of the product does not constitute a contravention of the food laws of that country of origin.

10. Certificate of Incorporation of the representative company issued by the Corporate Affairs commission in Nigeria.

11. Trade mark registration (from the Federal Ministry of Commerce in Nigeria) evidence.Certificate of Analysis of the batch of product to be registered.

12. Permit to import samples

13. A letter of Invitation to inspect the factory abroad.

14. Terms and conditions apply, and other requirements may apply. All applications and product samples should be forwarded to NAFDAC office in Lagos for inspection, analysis and subsequent approval. Note that to register a product in NAFDAC, you must meet the requirements above.

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15. Registration Tariff.

16. All payments to the Agency shall be in bank draft in favour of National Agency for Food and Drug.

17. Food Registration Form Two hundred and fifty Naira per Food product plus 5% VAT.

18. Also for local food products:
Food – Fifty thousand naira plus 5% VAT (Value Added Tax).
Water in sachet: Thirty thousand naira plus 5% VAT.
Water in bottle: Fifty thousand naira plus 5% VAT

SOME 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 located in Lagos

(a) NAFDAC Central Laboratory Complex
3/4 Oshodi ? Apapa Expressway, Oshodi in 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 in 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: [email protected]

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?

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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 NAFDAC?
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 investigatory 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.

References: Infoguide & NAFDAC

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