GUIDELINES FOR PROSPECTIVE IMPORTERS OF REGULATED PRODUCTS

 When a foreign regulated product is duly registered by NAFDAC, it can be lawfully imported, distributed and sold in Nigeria. The procedures for the importation of such regulated products are as follows:

Importers shall submit to the NAFDAC office whose operations cover the port (air, sea or land borders) where the goods are to be landed, the following documents prior to physical inspection and "formal" sampling of the regulated product:

• Properly completed Customs Bill of Entry.
• Evidence of registration of the regulated product.
• The original of combined Certificate of Manufacture and Free Sale issued by the appropriate Health Authority in the country of the product origin.
• The original certificate of analysis of the product.
• Other additional information required are:-
• Evidence of payment of a prescribed fees in bank draft made payable to NAFDAC.
• An undertaking duly signed by the importer that the product would not be sold until confirmed fit for human use by NAFDAC laboratory.
• Address of the importer's warehouse.
• In the case of milk, fish and fishery products, copy of certificate of radiation test issued by an appropriate government agency in the country of origin will be required in addition to (a- above.) Incase of drugs, the following additional documents will be required as well:
• Evidence that the importer is a Pharmacist or has employed the services of a Pharmacist.
• Copy of the current annual certificate of registration/retention of premises issued by the Pharmacist Council of Nigeria (PCN)
• Copy of the current annual license of the Superintendent Pharmacist issued by the PCN.
• Evidence of a permit issued by NAFDAC Directorate of Narcotics and Controlled Substances if the imported product is a controlled drug or chemical.

DRUG PRODUCTS ON THE FEDERAL GOVERNMENT IMPORT PROHIBITION LIST

• Paracetamol tablets and syrups
• Cotrimoxazole tablets and syrups
• Metronidazole tablets and syrups
• Chloroquine tablets and syrups
• Haematinic formulations:
• [i] Ferrous sulphate and ferrous gluconate tablets
  [ii] Folic acid
  [iii] Vitamin B Complex tablets [except modified release formulations]
• Multivitamin tablets, capsules and syrups [except special formulations]
• Aspirin tablets [except modified release formulations and soluble aspirin
• Magnesium trisilicate tablets and suspensions
• Piperazine tablets and syrups
• Levamisole tablets and syrups
• Clotrimazole cream
• Ampicillin/Cloxacillin combination capsules
• Ointments – Penicillin/gentamycin
• Pyrantel palmoate tablets and syrups
• Intravenous fluids (Dextrose, Normal Saline etc)