A-z sme export workshop victoria island lagos PRESENTATION BY UGWU DECLAN AGU, DESK OFFICER, SMALL BUSINESS SUPPORT DESK, REGISTRATION & REGULATORY AFFAIRS DIRECTORATE NAFDAC 9th AUGUST 2016

CONTENTS MANDATE NAFDAC Structure Structure of R&R: Divisions / Units Essence of Regulation R & R Small Business Support Desk (SBSD) Youth Enterprise With Innovation in Nigeria (YOU WIN) Conclusion

MANDATE NAFDAC was established by Decree 15 of 1993 as amended by Decree 19 of 1999 and now the National Agency for Food and Drug Administration and Control Act Cap N1 Laws of the Federation of Nigeria, 2004. This Act mandates NAFDAC to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of food, drugs, cosmetics, chemicals, detergents, medical devices and packaged water (known as NAFDAC regulated products). 11/26/2018 NAFDAC Product Registration Outreach

MANDATE… Mission Statement: To safeguard public health by ensuring that only safe, quality and efficacious NAFDAC regulated products are manufactured, imported, exported, distributed, advertised, sold and used. 11/26/2018 NAFDAC Product Registration Outreach

NAFDAC Structure NAFDAC comprises of thirteen (13) Directorates: Administration and Human Resource Management Presence in all 36 States and the Federal Capital Territory, Abuja) Finance & Accounts Ports Inspection Planning Research & Statistics Laboratory Services Registration & Regulatory Affairs Investigation & Enforcement. Chemical Evaluation & Research Narcotics & Controlled Substances Food Safety & Applied Nutrition Drug Evaluation & Research Pharmacovigilance and Post Marketing Surveillance Veterinary Medicine & Allied Products

Structure of R&R: Divisions / Units The Directorate is divided into the following Divisions : Imported Food and Packaged Water (IFPW) Food Products (Others) – (FPO) Drugs, Herbals and Cosmetics (DHC) Imported Drugs, Biologicals and Medical Devices (IDBM) Animal Health Products and Finished Chemicals (AHC) Regulatory Affairs Division (RA) Adverts Control Division (AC) 11/26/2018 NAFDAC Product Registration Outreach

Structure of R&R contd… Small Business Support Desk organizes and liaises with small businesses to foster greater understanding of regulatory procedures and also serve as enquiry point for clients on regulatory issues. Regulatory Intelligence Desk updates and keeps the Directorate informed about regulatory decisions taken by other jurisdictions on issues that have the potential to impact on public health and to serve as a focal point with pharmacovigilance. Expedited Processing Desk co-ordinates all functions of the Directorate that pertain to expedited processes such as Administrative Approvals and fast track approvals. In-house Capacity Building Desk organizes in-house trainings to build regulatory capacity of officers within the Directorate. International Desk was created January, 2013 to drive international collaboration and regional harmonization.

Essence of Regulation To protect public health By ensuring that only quality regulated products that are: safe Efficacious wholesome reach the market, and ultimately the consuming public. This is an immense task that requires undying commitment and comes with its own numerous challenges.

FUNCTIONS OF R & R R & R Directorate is one of the thirteen (13) Directorates of the Agency, whose functions are anchored on the provisions of the Drugs and Related Products (Registration, Etc) Decree No. 19 of 1993 as amended: ...No NAFDAC Regulated products shall be manufactured, imported, exported, distributed, advertised, sold or used except it is registered in accordance with the provisions of this decree.

Functions of R&R Registration of foods, drugs, cosmetics, medical devices, chemicals, detergents and packaged water. Other functions are as follows: Formulating, Updating, Compiling and periodic review of standard specifications, regulations and guidelines for the production, importation, exportation, advertisement, sale and distribution of food, drugs, cosmetics, medical devices, bottled water and chemicals. Approval and control of advertisement of food, drugs, cosmetics, medical devices, bottled water and chemicals to ensure that advertisements are not exaggerated, deceptive or detrimental to the consumer. Monitoring of advertisement to ensure compliance and identify illegal advertisements.

Small Business Support Desk (SBSD) Small Business Support Desk (SBSD) organizes and liaises with small business to foster greater understanding of regulatory, registration procedures and also serve as enquiry point for clients on regulatory issues. Function To improve access to information. To promote productive interaction. To provide timely feedback. To clarify NAFDAC laws and regulations. To foster greater collaboration and understanding. To organize R&R Open days / Stakeholders fora.

Activities of SBSD Hosted several stakeholders’ fora. R&R Zonal Stakeholders’ Forum for South-South. Federal Institute of Industrial Research (FIIRO), Oshodi, Lagos. Nigeria Chamber of Commerce Industry Mines and Agriculture – Women Group (NACCIMA-WG). Pan West African Food and Beverages Exhibition Trade Fair (Food Bex) The NECA’s Network of Entrepreneurial Women Workshop. Small Medium Enterprise Development Agency of Nigeria (SMEDAN). The Trade Mission of the Turkish Pharmaceutical & Medical Sector. Nigeria-Pakistan Pharma Investment Forum Participation at International Trade and Investment Fora Lisbon, Portugal Bangkok, Thailand Belgrade, Serbia

Youth Enterprise With Innovation in Nigeria (YOU WIN) There were four hundred and twenty eight (428) beneficiaries with NAFDAC regulated products. YOU WIN 1 – 166 YOU WIN 2 - 262 The 428 beneficiaries of the YOU WIN were all contacted. Two hundred and seven (207) of them responded.

Conclusion Effective regulation is key to ensuring quality and safety of regulated products. NAFDAC is relentlessly working with all relevant stakeholders to ensure that all NAFDAC registered products, irrespective of their origin are of good quality, wholesome, safe and efficacious.

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