NATIONAL AGENCY FOR FOOD & DRUG ADMINISTRATION & CONTROL PORTS INSPECTION DIRECTORATE GUIDELINES FOR CLEARANCE

OF IMPORTED DRUG(S) (HUMAN AND VETERINARY) AND RELATED PRODUCT(S) IN NIGERIA NAFDAC/PID/001/00 A. 1. 2. 3 GENERAL These guidelines are for the interest of the general public and in particular importers of registered pharmaceutical and related product(s) into Nigeria. Please be informed that all importation of Drugs and related products must be by pharmaceutical companies that registered the products. These guidelines are also intended for importers of registered medical devices except that pharmacist and retention of premises licenses issued by Pharmacist Council of Nigeria are exempt documents for clearance from the port of entry. It is necessary to emphasize that, no drugs and related products should be manufactured, imported, exported, advertised, sold or distributed in Nigeria unless it has been registered in accordance with the provisions of Act Cap F33 LFN (formerly decree 19 of 1993) and the accompanying guidelines. Please note that the importation of unregistered drug product(s) or registered drug products by persons or companies other than those that registered the products should be regarded as a violation. Vaccines and biologicals must be accompanied by functional cold chain monitoring devices at the ports of entry and must be maintained according to stipulated conditions at companys warehouse. APPLICATION The application should be by the company that registered the product(s) with NAFDAC or company granted Letter of Authorisation by the party that registered the products. It should be noted that such importations are restricted to only registered source(s) as stated on the Product Registration Certificate(s). The applicant should make available to Ports Inspections Directorate, NAFDAC the following pre-shipment information before any drug consignment arrives Nigeria from any part of the world:a. b. c. d. e. Name of the drug product(s) Manufacturers Name and Address Quantity being imported Various pack sizes, strength of the drug(s) and the dosage form Batch number(s), Manufacture and Expiry dates 1

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Conveying Vessel and expected date of arrival

DOCUMENTATION To ensure that the quality, safety and efficacy of the drugs imported from India, China and Egypt, comply, NAFDAC appointed analysts to inspect and analyze products in these countries before shipment into Nigeria as follows. 1 . 2 . 3 . INDIA CHINA EGYPT QCS Consultants NHU LABS LTD Inspection & Testing Group (ITG)

a. All drugs and related product(s) from the listed countries should be issued Clean Report of Inspection and Analysis before shipment into Nigeria. b. The Current Pharmacists Annual License to Practice as a Pharmaceutical Chemist issued by Pharmacist Council of Nigeria c. The Current Premises/Retention Certificate issued by Pharmacist Council of Nigeria d. The following shipping documents should be submitted for obtaining First Stamp: i. ii. iii. iv. v. vi. Single Goods Declaration (SGD) Form, Commercial Invoice Risk Assessment Report Form M Bill of Lading/Airway Bill Packing List

e. Photocopy of Narcotics Permit to import and Permit to clear (where applicable) f. Evidence of valid product registration certificate with NAFDAC g. Certificate of Analysis (Original) issued by the manufacturer 2 D. 1 Originals of all the above documents should be sighted TARRIFF All payments to the Agency must be in bank draft in favour of National Agency for Food and Drug Administration & Control and the following fees, as appropriate should apply per product covering inspection and analysis Inspection fee per consignment of an ethical drug (prescription) is Twenty thousand naira (N20, 000.00) plus 5% VAT, Laboratory Analysis fee per product of an ethical drug (prescription) is Fifty thousand naira (N50, 000.00) plus 5% VAT,

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Inspection fee per consignment of an OTC drug (non-prescription) is One hundred thousand naira (N100, 000.00) plus 5% VAT Laboratory Analysis fee per product of an OTC drug (non-prescription) is Two hundred thousand naira (N200, 000.00) plus 5% VAT, Inspection fee per consignment of vaccine(s) or biological product(s) is Ten thousand naira (N10, 000.00) plus 5% VAT, Laboratory Analysis fee per product of a vaccine or biological product is Forty thousand naira (N40, 000.00) plus 5% VAT, Inspection fee per consignment of medical devices is Ten thousand naira (N10, 000.00) plus 5% VAT, Laboratory Analysis fee per product of medical devices is Twenty-five thousand naira (N25, 000.00) plus 5% VAT, Inspection fee per consignment of cosmetic products is Twenty thousand naira (N20, 000.00) plus 5% VAT, Laboratory Analysis fee per product of a cosmetic product is Fifty thousand naira (N50, 000.00) plus 5% VAT, A consignment is defined as packaged goods in not more than 20ft container. PRESENTATION OF DOCUMENTS FOR PRE-RELEASE FIRST STAMP

1 In addition to the earlier listed documents, the following are required before a pre-release
first stamp is endorsed on the original SGD Form.

i.
ii. 2 F. 1 2

A letter of undertaking stating that the product(s) will be forfeited if found unsatisfactory The address of warehouse where product will be stored.

Evidence of payment for the imported consignment PHYSICAL EXAMINATION Physical examination of the consignment shall be conducted by NAFDAC with other relevant Government Agencies at the Port of Entry. Samples of the imported product(s) should be drawn during physical examination by NAFDAC and forwarded to the relevant NAFDAC laboratory for analysis and radiation test (where applicable) within 24 hours of drawing such samples. One-third (1/3) of the sample drawn should be given to the superintendent pharmacist of the company as retention sample. RELEASE OF CONSIGNMENT FROM THE PORT OF ENTRY

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The drugs should be released to the importers warehouse pending satisfactory Laboratory analysis which is within a period of ten work days from the date of sample collection. 2 The drug(s) can only be marketed after satisfactory Laboratory analysis by NAFDAC. CORRESPONDENCE

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All correspondence in respect of importation of Drugs and related products should be addressed to: The Director, Ports Inspections Directorate, NAFDAC NAFDAC Laboratory Complex, Yaba, Lagos. E-mail address: portsinspections@nafdac.gov.ng Telephone