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NAFDAC Registration 2021 See Application Requirement and Procedure

Filed in Articles by on April 19, 2021

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NAFDAC Registration 2021: Do you know about the modus operandi of NAFDAC? Are your products registered? However, irrespective of the product to be registered, NAFDAC would only issue a registration number and certificate after the product has passed the quality and standard test carried out by the agency.

NAFDAC Registration 2021 See Application Requirement and Procedure

It is unlawful to promote and market any product or consumable goods in Nigeria to the general public without a due registration with the NAFDAC according to the law establishing the Agency (NAFDAC Act).

Where a company is registered for the purpose of importing or manufacturing food or drugs or consumable products, such products must be registered with NAFDAC.

The NAFDAC Requirements for the production or importation of food, drugs, or consumable goods in Nigeria is dependent on whether such items are produced locally or abroad.

The Federal Government of Nigeria has put in place registration procedures that must be completed and complied with by any manufacturer, importer, exporter, and sellers of food and drug products.

It is mandatory that any company involved in the production, manufacturing, and distribution of food, imported foods, drugs, the export of semi-processed food, and cosmetics must incorporate a company with the Corporate Affairs Commission (CAC) before registering its company product with NAFDAC.

The registration of locally made NAFDAC Regulated Products is slightly different from the registration process for imported goods.

Where a company produces different products it will be required to register each of them separately in order to obtain the NAFDAC registration numbers for each of the products.

NAFDAC Registration 2021

NAFDAC Registration Permits cover two categories namely: Foods and Drugs. If manufactured or imported goods fall within any of these two categories registration with the NAFDAC is important.

Where the product is a foreign product, a power of attorney duly executed for a Nigerian representative of such product registered from the manufacturer and signed by the Company’s Managing Director, Chairman or President, authorizing the Nigerian agent to act in such capacity is required.

NAFDAC: What Does it Mean?

NAFDAC means the National Agency for Food and Drug Administration and Control.

NAFDAC is a Nigerian federal agency under the Federal Ministry of Health with responsibilities of regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale, and use of food, drugs, cosmetics, medical devices, chemicals, and packaged water.

The Federal Ministry of Health’s National Agency for Food and Drug Administration and Control (NAFDAC) is a federal agency responsible for regulating and managing the production, manufacture, export, marketing, supply, selling and use of food, medicines, cosmetics, medical devices, chemicals and bottled water in Nigeria.

NAFDAC: What are its Functions?

There have been several misconceptions about the function of NAFDAC. In this article, we shall look at the essential functions of NAFDAC.

  • NAFDAC collates uniform requirements, legislation, and instructions for food, medicines, medical devices, bottled water and chemicals development, importation, manufacture, sale, and distribution.
  • The Agency regulates the export from Nigeria of food, medicines, medical devices, bottled water, and chemicals. It also provides certificates for these goods of quality assurance.
  • Conducting satisfactory checks and maintaining conformity with uniform requirements established and accepted by the NAFDAC Council for successful quality control of food, medications, cosmetics, medical devices, bottled liquid, and chemicals.
  • The Agency performs audits of imported foods, medicines, cosmetics, medical devices, bottled water, and chemicals as well as developing a comprehensive program for quality assurance.

Primary Role of NAFDAC

NAFDAC has different primary roles. The Agency was authorized by the requirements of its enabling decree to:

  • Regulate or monitor the production, produce, manufacture, advertising, supply, selling and use of pharmaceutical goods, cosmetics, medical devices, bottled liquid, and chemical products
  • Compile typical requirements, legislation, and instructions for food, medicines, cosmetics, medical devices, bottled water, and chemicals development, manufacture, export, sale, and distribution
  • Document nutrition, medications, medical devices, bottled water, and chemicals.

The Registration Process for NAFDAC Permit

The registration process for NAFDAC Permit is in two general stages:

  • Application for approval to bring in samples – applicable to goods manufactured outside Nigeria
  • Application for full registration of product – applies whether the goods are locally manufactured or imported.

Application for Approval to Bring in Samples

For the purpose of registration, a foreign company needs to put forth samples of its product for inspection. However, this is impossible without proper approval to bring such samples into the shores of Nigeria.

For this, NAFDAC grants special written authorization or import permits to enable importers to bring the samples of their products.

Also, documents required for clearing and taking delivery of samples must be obtained from the Manufacturer and other appropriate bodies in the country of origin.

Application for Full Registration of Samples

First and foremost, an application form is required for each product as NAFDAC approval is granted for each specific product. After filling, this form is to be submitted to the registration division of the NAFDAC agency.

NAFDAC Registration Process Requirements 

The general requirements for the registration on either of the stages of the permit include the following:

  1. A written application for product registration shall be made to the Director (Registration and Regulatory Affairs) stating the name of the manufacturer, the generic name (and brand name, if applicable) of the product, product strength, and indications.
  2. The applicant should obtain and fill the prescribed NAFDAC application form (Form D-REG/001)
  3. Certificate of Incorporation issued by the Corporate Affairs Commission
  4. Comprehensive Certificate of analysis of the batch of the product for registration from the manufacturer stating the name and signature of the analyst.
  5. Packs of the products samples
  6. Evidence of pre-product inspection or Certificate of Recognition issued by NAFDAC
  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 the 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. Evidence of Membership of the State’s Traditional Medicines Board (Herbal Medicines)
  11. Technical Document (Herbal Medicines)
  12. Certificate of Pharmaceutical Products (COPP) duly issued and authenticated
  13. Current Superintendent Pharmacists license to practice issued by the Pharmaceutical Council of Nigeria
  14. Premises Registration License from Pharmacists Council of Nigeria (PCN)
  15. Warehouse acquisition or premises acquisition(where applicable)
  16. Certificate of Trademark Registration of brand name with trademark registry in the Ministry of Commerce here in Nigeria
  17. Letter of invitation from manufacturer to the Director-General of the NAFDAC to inspect factory abroad, stating full name and location of the plant.
  18. informative, clear and accurate labelling of the products
  19. Payment of the prescribed fees.

However, it is worthy of note that the registration of a product does not automatically confer Advertising permits. A separate approval by the Agency shall be required if the product is to be advertised.

Once the registration process is concluded, NAFDAC would assign a unique number to all the registered products. The registration is usually valid for a period of 5 years and it must be renewed before the licensee can maintain the usage.

Although how to renew the NAFDAC permit also involves some documentation and payment of prescribed fees, but this is not as significant as filing a new application.

NAFDAC Registration Procedures

It is important to note that the registration requirement for locally manufactured goods is slightly different from that of imported goods.

Note that NAFDAC has now set up an online registration portal at www.registration.nafdac.gov.ng

It is also noteworthy that if your company produces different products you will need to register each of them separately.

  1. Approach the closest zonal office of NAFDAC to get your factory inspected. You would be required to submit three samples of your product for analysis after which a certificate of recognition as a manufacturer would be issued to you.
  2. Purchase a registration form from NAFDAC for each of the products and fill them appropriately.
  3. Write an application to the agency stating your intention to register a product. The application should give details of the product name (general name), brand name, and the name of the manufacturer. Address your application to:

The Director

Registration and Regulatory Affairs

NAFDAC

Central Laboratory Complex

Oshodi, Lagos.

  • Submit the application together with your completed registration form and attach the required documents.

Depending on whether or not one follows the right information and submits the required documents, the whole process should take you about three months.

After successful registration, you will be offered a certificate of registration and NAFDAC registration number for the product.

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