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REQUIREMENTS FOR IMPORTATION AND EXPORTATION OF NAFDAC REGULATED PRODUCTS A Paper Presented by Dr Paul Botwev Orhii MD

REQUIREMENTS FOR IMPORTATION AND EXPORTATION OF NAFDAC REGULATED PRODUCTS A Paper Presented by Dr Paul Botwev Orhii MD, JD, Phd Director-General, NAFDAC . Introduction. NAFDAC MANDATE

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REQUIREMENTS FOR IMPORTATION AND EXPORTATION OF NAFDAC REGULATED PRODUCTS A Paper Presented by Dr Paul Botwev Orhii MD

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  1. REQUIREMENTS FOR IMPORTATION AND EXPORTATION OF NAFDAC REGULATED PRODUCTSA Paper Presented by Dr Paul BotwevOrhii MD, JD, PhdDirector-General, NAFDAC

  2. Introduction • NAFDAC MANDATE • NAFDAC was established by Decree No. 15 of 1993 (now NAFDAC Act CAP N1 LFN, 2004) to regulate and control the importation, exportation, manufacture, distribution, advertisement, sale and use of Foods, Drugs, Cosmetics, Medical Devices, Chemicals, Detergents and packaged water. This mandate places on us as the competent authority the huge responsibility of ensuring that the above products leaving or entering our shores meet prescribed quality standards.

  3. Introduction (Cont’d) • In view of this, the Agency controls the importation and exportation of all the products covered by this Act at the Ports and Land borders and as a result the Ports Inspection Directorate which is an arm of NAFDAC is responsible for NAFDAC operations at the various Ports of entry in the country.

  4. Introduction (Cont’d) • It is necessary to emphasize that no NAFDAC regulated product shall be imported into and exported out of Nigeria unless it has been duly registered and/or issued a permit or certificate in accordance with the provisions of Act Cap F33 LFN 2004 and the accompanying guidelines.

  5. REQUIREMENTS FOR IMPORTATION OF NAFDAC REGULATED PRODUCTS The following documents are required for importation and exportation of NAFDAC regulated products • Electronic Single Goods declaration containing the Customs C-Reference number • Invoice • Risks Assessment Report (RAR) • Form M • Bill of Lading • Certificate of Manufacture and Free sale for drugs and food, Phytosanitary Certificate, Radiation Certificate, Health Certificate for food products, Clean Report of Inspection and Analysis for drugs, Permits for chemicals.

  6. REQUIREMENTS FOR IMPORTATION OF NAFDAC REGULATED PRODUCTS • Packing List • Letter of Introduction with Photocopy of Identification Card from Importer or Importer representative. • Certificate of Analysis containing batch number, manufacturing and expiry dates, pack size and details of analytical tests conducted. • Evidence of valid product registration with NAFDAC and/or Global Listing Certificates for Supermarket and Restaurant Operators. • Receipt of Payment of NAFDAC Port Charges for Inspection, Analysis and Radiation if applicable. • It is important that products imported or exported are properly labelled to meet the regulatory requirements.

  7. REQUIREMENTS FOR THE EXPORTATION OF NAFDAC REGULATED PRODUCTS In August 2003, owing to repeated alert notifications from the European Union over Nigeria exports, particularly food commodities, the then Minister of Health assigned the mandate for certification of packaged semi processed/processed food commodities to NAFDAC. An essential element of an export control and Inspection system is a requirement that exporters inform the Agency by applying in writing stating their intention to export..

  8. REQUIREMENTS FOR THE EXPORTATION OF NAFDAC REGULATED PRODUCTS (Cont’d) The following Certificates are issued on satisfying the requirements for export. • Combined Certificate of manufacture and free sale(for registered products) • Health Certificate for processed and semi processed food commodities. • Export Certificate for personal items, cigarettes and machine trials. • Free sale Certificates for products not manufactured in Nigeria but sold in Nigeria.

  9. REQUIREMENTS FOR THE EXPORTATION OF NAFDAC REGULATED PRODUCTS (Cont’d) • Export Certificate for goods transported through Land Borders for ECOWAS Market. The following are required from exporters to obtain any of the above certificates; • NAFDAC Registration Certificate were applicable • Nigeria Export Proceeds (NXP) form • Nigeria Export Promotion Council Certificate. • Certificate of Analysis • Packing List. • Proforma Invoice

  10. REQUIREMENTS FOR THE EXPORTATION OF NAFDAC REGULATED PRODUCTS (Cont’d) • Current Tax Clearance Certificate • Phytosanitary Certificate were applicable • Factory cGMP Certificate were applicable.

  11. CONCLUSION NAFDAC as a competent Authority will continue in its statutory role of safeguarding the health of the consumers by assuring that products imported and exported are of right quality and can compete favourably in the world market. THANK YOU

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