NAFDAC | March 05, 2015
All drug products imported into Nigeria must be registered with NAFDAC (See Guidelines for Registration of imported Drug Products). NOTE: All controlled drugs require a special permit from the Narcotics Control Division of NAFDAC All importation of Drugs must be by pharmaceutical companies whose premises are duly registered with the Pharmacists’ Council of Nigeria. 3. All drug importers must make available to NAFDAC Ports Inspectorate Directorate (PID) the following pre-shipment information, before any drug consignment arrives Nigeria from any part of the world. (i) Name of the drug product (ii) Manufacturer’s Name and Address (iii) Quantity being imported (iv) Various pack sizes, strength of the drug and the dosage form (tablets, capsules, Injectables etc) (v) Batch number, Manufacture and Expiry dates (vi) Conveying Vessel and expected date of arrival This preshipment information will help NAFDAC to inspect, analyse and release imported products on time. 4. To ensure the quality, safety and efficacy of the drugs imported from India, NAFDAC has appointed foreign analytical laboratories to inspect and analyse products at the country of origin before shipment to Nigeria. All drug products imported into Nigeria from India must be certified to be of acceptable standards by the coordinator of all NAFDAC appointed laboratories in India. The coordinator’s name and address is: QCS Consultants Swavalambh Clinic, 1st Floor Matruchayya Gulmchar Road Chunabhatti San Mumbai-400 022 India. 2 All importers from India are therefore to advise their suppliers to comply fully with the laid down procedure for inspection, laboratory analysis and subsequent issuance of ‘Clean Report of Inspection and Analysis’ by QCS. The supplier is therefore expected to send an inspection and sampling request to QCS, accompanied by import/export order, packing list and full payment for inspection, sampling and analysis. Any shipment of drugs and other regulated products leaving India from the 1st of June 2002 must be accompanied by the confirmed Clean Report of Inspection and Analysis issued by QCS. 5. The superintendent pharmacist of the importing company shall present: (i) Single Goods Declaration (SGD) Form, and (ii) Original Copy of all relevant shipping documents, to the NAFDAC Port Office. If (i) and (ii) are satisfactory, the following fees shall be paid • Inspection fee of N20,000.00 per consignment and a Laboratory Analysis Fee of N50,000.00 per sample of an ethical (prescription) drug. • Inspection fee of N100,000.00 per consignment and a Laboratory fee of N200,000.00 per sample of a non-prescription (OTC) drug. A consignment is defined as packaged goods in not more than 20 feet container. NOTE: All payments must be in bank draft in favour of National Agency for Food and Drug Administration and Control. 6. In addition to (3) above, the following documents are required before a pre-release first stamp is endorsed on the original SGD form. 3(i) A letter of undertaking stating that: (a) The products will be forfeited if found unsatisfactory by NAFDAC (b) The products will not be sold/used/distributed until certified fit for human consumption by NAFDAC. (ii) The address of the warehouse where product will be stored shall be stated. (iii) Photocopy of the SGD Form containing name(s) of the imported products typed on the Form. (iv) Evidence of payment of the assessed fee. (v) Photocopy of the Current Annual Licence to practice as a Pharmaceutical Chemist. (vi) Evidence of the premises registration with the Pharmacists Council of Nigeria. (vii) Evidence of the Products Registration with NAFDAC (viii) Photocopy of Certificate of Pharmaceutical Product (COPP) (ix) Certificate of Analysis (Original) issued by the manufacturer (x) Clean Report of Inspection and Analysis (CRIA) issued by Quality Consultancy Services (QCS) for all drug imports from India. (xi) Photocopy of Packing List. (xii) Photocopy of Narcotics Permit to import and Permit to clear (where applicable). (xiii) Photocopy of attested Invoice (xiv) Photocopy of Bill of Lading/Airway Bill (xv) Photocopy of Clean Report of Inspection/Import Duty Report (xvi) Photocopy of Form M. (xvii) Photocopy of the Clearing Agent’s Custom authority card (Form C30) NOTE: Originals of documents (xi) – (xvii) must be presented for sighting. 7. The Original SGD Form after the endorsement shall then be taken to the Custom Processing Unit at the relevant port of entry. 8. The drug is then released to the importer pending satisfactory laboratory analysis within two weeks of sample collection.