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Drugs - General Guidelines

These Guidelines are for the interest of the General Public, and in particular, food and beverage industries in Nigeria. It is necessary to emphasize that no Processed Food shall be manufactured, imported, exported, advertised, sold or distributed in Nigeria unless it has been registered in accordance with Provisions Of Decree 19 of 1993 as amended by Food, Drugs and Related Products (Registration) Decree No. 20 of 1999.

Guidelines for Prospective Agents of Foreign Manufacturers of Regulated Products

Again, it needs to be emphasized that it is unlawful to import into Nigeria any regulated product not duly registered by NAFDAC. Agents of foreign manufacturers are to take the necessary steps to ensure that regulated products intended for the Nigerian market are registered before consignments of such products are imported into the country. In the event of any violation in this regard, the consignment of the unregistered product would be cleared from the ports to a bonded warehouse at the expense of the importer. Thereafter the importer is prosecuted and the products forfeited to the Government together with any assets or property obtained or derived directly or indirectly from the commission of the offence. As in the case of locally manufactured products, the Agency will normally authorize the importation of small quantities of unregistered products for the purpose of submission as samples for registration. A written authorization specifying the quantity of the unregistered products to be imported can be obtained from the Registration Division of NAFDAC at the Federal Secretariat, Phase II, 2nd and 5th Floors, Ikoyi, Lagos. On arrival of the imported samples and presentation of the authorization to the NAFDAC inspectors at the ports, the consignment will be treated the same way as other normal imported consignments. Before the consignment is therefore cleared from the ports, the importer is required to present the following:-

  • Authorization to import samples of the unregistered product.
  • Bank-draft for the prescribed port inspection fees.
  • Properly completed Customs Bill of Entry
  • Certificate of Analysis of the product issued by the manufacturer.
  • Certificate of Manufacture and Free Sale issued by a Government Authority empowered by law in the country of origin to exercise regulatory control over the product.

In order to conform with labeling regulations, the imported sample has to carry the following information:

  • Full Name of the Manufacturer.
  • Full location address of the manufacturer
  • Name of the Product (brand and generic names where applicable)
  • Date of Manufacture
  • Expiry Date or Best Before Date
  • Batch Number
  • Direction for storage and use.

It is at this stage that the Registration Form is procured on payment of appropriate fees, and when duly completed, it is submitted to the Registration Division along with the samples and other documents as specified in the Form. A very important document among the requirements is the Notarized Power of Attorney granted by the foreign product manufacturer to the domiciled agent in Nigeria. The completion and submission of the form marks the beginning of the actual registration process. The registration process now proceeds in the same manner as for locally manufactured products and in this regard, the following are all relevant.

Drugs - Requirements for Registration

An application for the registration of processed Food shall be made by the manufacturer.

In case of a manufacturer outside Nigeria, such shall be represented in Nigeria by a duly registered company or individual with facilities to effect a recall of the product when necessary.

An applicant for a manufacturer outside Nigeria must file evidence of Power of Attorney from the manufacturer which authorizes him to speak for his principal on all matters relating to the latter's specialties. The original Power of Attorney is to be notarized and submitted to NAFDAC. NOTE The representative in Nigeria, whether a corporate body or an individual with the Power of Attorney, will be responsible for ensuring that the competent authority in the country is informed of any serious hazard newly associated with a product imported under the provisions of the decree or of any criminal abuse of the certificate in particular, to the importation of falsely labeled, spurious, unwholesome, or sub-standard processed foods.

The manufacturer, in the case of imported processed foods, must show evidence that the he or she is licensed to manufacture the product(s) for sale in the country of origin (Manufacturer's Certificate). Such evidence must be by the competent Health Authority of the country of manufacture, and shall be authenticated by the Nigerian Mission in that Country.

Registration Procedure

The applicant must submit to the Registration Division, NAFDAC, a written application, stating the name of the manufacturer, name (brand name where applicable) of the product, and obtain the prescribed application form which must be properly filled, with all information required. This form, Labeled "FORM D-REG/001" is available online for download.

Completed Registration Form for each product should be returned with the following items:

  • Five (5) copies of the Dossier Three packs of drug samples
  • Superintendent and Production Pharmacists' current annual license to practice as Pharmaceutical Chemists
  • Premises Registration License from Pharmacists Council of Nigeria (PCN).
  • A separate application form shall be submitted for each regulated product.

 

 

Drugs - Rules

A Drug Product shall not be manufactured in Nigeria, unless the factory is inspected, and a Certificate of Recognition issued by NAFDAC.

In the case of Imported Products:-

  • There must be evidence of registration of such product by the competent Health Authority of the country of manufacture i.e. product License/Certificate of Registration.
  • There must be evidence from the competent Health Authority, that the sale of the Product does not constitute a contravention of the cosmetics Laws that country i.e. Free Sale Certificate
  • The documents in respect of (a) and (b) above shall be authenticated by the Nigerian Mission in that country
  • In the case of an imported new substance, there must be evidence that limited local clinical trials have been undertaken, and that such product is registered in the country of origin and also, in at least 2 or more developed countries.
  • No combination drug product shall be registered or considered for registration unless there is proven evidence that such a product has clinical advantage over the single drug available for the same indication(s).
  • An applicant should indicate the class or type of registration required - whether it is for a prescription only product or an over the counter product
  • Products found to be of doubtful, little or no therapeutic value and those which are sometimes rather harmful and subject to misuse, shall not be considered for registration.
  • An applicant shall not be allowed to register a drug formulation in more than one brand name even where different doses of the active ingredient(s) are used.
  • The product information must be in Five (5) copies with hard covers per product (dossiers) made out in accordance with application format (the content of the dossier must be in compliance with the items on the format).
  • All dosage forms of a particular brand name must contain the same active ingredient(s) or at least the major active ingredient(s) e.g. A cream - Betamethasone 10mg, A soap - Betamethasone 20mg

Labelling terms

  • Labeling shall be informative and accurate.
  • Minimum requirements on the package label:
  • Name of Product - Brand Name and generic name where applicable. The generic name must be in similar characters with the brand name.
  • Location Address of the manufacturer.
  • Batch No., Date of Manufacture and Best Before/Expiry Date.
  • Dosage regimen on the package.
  • Leaflet insert, if prescription product and hospital packs.
  • Indications, frequency, route and conditions of administration.
  • Quantitative listing of all the active ingredients per unit dose.
  • Adequate warnings where necessary.
  • Where a brand name is used, there MUST be the generic name which should be conspicuous in character, written directly under the brand name e.g. VENTOLIN,SALBUTAMOL
  • Any drug product whose name, package or label bears close resemblance to an already registered product or is likely to be mistaken for such registered product, shall not be considered for registration.
  • Any drug product which is labeled in a foreign language shall NOT be considered for registration unless an English translation is included on the label and package insert (where applicable).
  • Information on indication carried on packages and leaflet insert of imported drug product shall not differ from that in other countries and in particular the country of origin of the product.
  • Failure to comply with these requirements may result in the disqualification of the application or lead to considerable delays in processing of registration.
  • A successful application attracts a Certificate of Registration with a validity period of Five (5) years.

NOTE * Failure to comply with these requirements may result in the disqualification of the application or lead to considerable delay in processing of registration. In case of processed food and packaged water, only manufacturing outfits situated in industrial areas will have their Registration Certificate valid for 5 years while those located in residential areas have one year validity (yearly listing).

  • A successful applicant will be issued a Certificate of Registration with a validity period of five (5) years.
  • Registration of a product does not automatically confer advertising permit. A separate application and subsequent approval by the Agency shall be required if the product is to be advertised.
  • NAFDAC may withdraw the Certificate of Registration in the event that the product is advertised without express approval from the Agency.
  • NAFDAC reserves the right to revoke, suspend or vary the certificate during its validity period.
  • Filling an application form or paying for an application fee does not confer registration status.
  • Failure to respond promptly to queries or enquiries raised by NAFDAC on the application, will automatically lead to suspension of further processing of the application.
   

 
 
 

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