NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL. NAFDAC Safeguarding the Health of the Nation!!!

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1 NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL NAFDAC Safeguarding the Health of the Nation!!!

2 THE ROLE OF NAFDAC IN FOOD PROCESSING AND AGRO-ALLIED BUSINESS IN NIGERIA PRESENTED BY EVA.O. EDWARDS DEPUTY DIRECTOR FOOD SAFETY AND APPLIED NUTRITION (FSAN) DIRECTORATE NAFDAC, NIGERIA 29 TH MARCH 2018 AT 4 TH INTERNATIONAL TRADE EXHIBITION ON AGRIFOOD, PLASTICS, PRINTING AND PACKAGING LANDMARK CENTRE, LAGOS 2

3 OUTLINE OF PRESENTATION INTRODUCTION OVERVIEW OF NAFDAC THE ROLE OF NAFDAC IN FOOD PROCESSING AND AGRO-ALLIED BUSINESS IN NIGERIA FOOD PRODUCT REGISTRATION PROCEDURES SUPPORT FOR MSMEs SUPPROT FOR AGRO-ALLIED BUSINESS IN NIGERIA CONCLUSION

4 INTRODUCTION FOOD PROCESSING Food processing is any method used to transform raw ingredients into food products. This can be one or a combination of washing, chopping, pasteurising, freezing, fermenting, packaging and many more. Also includes adding components to food for specific purposes e.g. to extend shelf life, to improve the nutritional quality of the food (by addition of vitamins and minerals).

5 INTRODUCTION AGRO-ALLIED BUSINESS Agro-allied businesses depend on agriculture for their raw materials. Agriculture creates a market for industrial products: farm machinery & equipment, pesticides, fertilizers.. One of the main thrusts of the GoN is to diversify the Nigerian economy with a strong focus on agro-allied businesses. This is in realization of the potential of this sector for rapid enterprise development. The role of the Government is to create the right environment for the off-take and sustainability of such enterprises.

6 OVERVIEW OF NAFDAC NAFDAC Public service Agency Parastatal of FMOH established by Decree 15 of 1993 as amended by Decree 19 of 1999 now cited as the NAFDAC Act Cap N1 LFN THE MANDATE regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of food, drugs, cosmetics, medical devices, chemicals, detergents and packaged water (known as Regulated Products).

7 OVERVIEW OF NAFDAC In summary, the mandate is to ensure safety, quality, efficacy and wholesomeness of regulated products.

8 NAFDAC EXTERNAL STAKEHOLDERS FGoN TRADERS INDUSTRY NAFDAC NGOs INTERNATIONAL BODIES CONSUMERS Relationship between NAFDAC and external Stakeholders

9 THE ROLE OF NAFDAC IN FOOD PROCESSING AND AGRO-ALLIED BUSINESS The role of NAFDAC in food processing and agro-allied businesses is essentially: regulation and control

10 ESSENCE OF REGULATION AND CONTROL To guide the activities of the Agency with respect to the control and management of the products under her mandate. To ensure fair play in the regulated environment. To guard against production and sale of unsafe, substandard and spurious products to the public. To ensure availability of safe and good quality products that meet approved standards..

11 ESSENCE OF REGULATION AND CONTROL To ensure that the location of the premises, manufacturing processes, quality assurance systems and release procedures meet Good Manufacturing Practice (GMP) standards. To contribute to the growth and upgrade of business enterprises to attain internationally acceptable standards. To protect public health..

12 ESSENCE OF REGULATION AND CONTROL In summary, regulation and control is to ensure that regulated products offered for sale to the public meet the required standards of safety and quality with the primary aim of protecting public health. So how is this achieved?

13 PRODUCT REGISTRATION Product registration is one of the key tools with which NAFDAC effects regulation and control. The Food, Drugs and Related Products (Registration, Etc.) Act Cap F33 LFN 2004 provides that no NAFDAC regulated product shall be manufactured, imported, exported, distributed, sold or used except it is registered in accordance with the provisions of this Act. 13

14 REGISTRATION PROCESS PATHWAY FOR MADE-IN-NIGERIA FOOD PRODUCTS Filing/Submission of application/supporting documents Vetting of product labels Facility inspection (GHP/GMP compliance) Laboratory evaluation Product Approval meetings Issuance of NAFDAC Registration number Product Registration Certificate

15 REGISTRATION PROCESS Documentation (Food) Application form (purchase online) Certificate of Incorporation of the company in Nigeria Certificate/Acceptance of Trademark Registration Contract Manufacturing Agreement (if applicable) Coloured artwork of label/packaging material for vetting Comprehensive certificate of analysis

16 REGISTRATION PROCESS The mandatory procedures for Registration of NAFDAC regulated products are: i. Documentation ii. Vetting of Product Labels for compliance iii. Facility Inspection (GHP, GMP) iv. Laboratory Analysis If satisfactory, the product is scheduled for approval, once approved, NAFDAC Registration Number is assigned. Registration timeline is 90 days. Registration tariff for food domestic (N52,500 incl. 5% VAT). Guidelines for 16 product registration:

17 POST REGISTRATION Following product registration, food establishments are audited (unannounced facility inspection) to assess compliance with GHP/GMP standards. Post-market surveillance activities are carried out to assess products in trade to ensure that registration standards are being maintained.

18 SUPPORT FOR MSME (EASE OF DOING BUSINESS) MSMEs: Recognized as engine of growth and catalyst for socio-economic transformation. Drivers of sustainable industrial development and growth. Need to support MSMEs launch their NAFDAC regulated products into the market speedily without compromising regulatory requirements and standards.

19 SOME IDENTIFIED CHALLENGES OF MSME (PRODUCT REGISTRATION) Difficulty in meeting the regulatory requirements for suitable and acceptable production facilities Difficulty in meeting documentation requirements Personnel qualification (PM) Knowledge and understanding of the regulatory requirements Registration cost

20 SOME IDENTIFIED CHALLENGES OF MSME (PRODUCT REGISTRATION) NAFDAC RESPONSE EO1 Streamlined and simplified guidelines making it easier to meet regulatory requirements of establishing manufacturing outfits without compromising standards. Aims at reducing processing times, cut out administrative bottlenecks & facilitate product registration. Guidelines are published on the website and displayed in the premises to inform and guide the public.

21 SOME IDENTIFIED CHALLENGES OF MSME (PRODUCT REGISTRATION) NAFDAC RESPONSE Review of SOPs to cut time losses in processing. Application of 50% reduction in cost of registration for micro-scale enterprises. Creation of Small Business Support Desk (SBSD) to liaise with small business and serve as enquiry point on regulatory issues to foster greater understanding of our procedures.

22 SOME IDENTIFIED CHALLENGES OF MSME (PRODUCT REGISTRATION) NAFDAC RESPONSE NAFDAC Product Registration outreach (NAPro) Attend MSME Clinics (MDAs, MSMEs) Engage with sectoral groups (various sectors) - interact, understand challenges, capacity building. Commenced nationwide Stakeholder Consultative Forum for MSMEs sensitize on NAFDAC reforms towards EoDB

23 UPDATE ON PRODUCT REGISTRATION FOR MSME Decentralized registration process for MSMEs at NAFDAC Zonal level. Bread Packaged Water (bottle and sachet) renewal only Dry finger foods chin-chin, popcorn, plantain and potato chips Locally grown rice and other packaged farm produce Seasoning and spices Palm oil Honey Dried Fish and fish products

24 SUPPORT FOR AGRO-ALLIED BUSINESS Keyed into Government diversification from dependence on oil to non-oil products (agric products). Support agribusiness by ensuring improved compliance to regulatory requirements particularly in the trade and exportation of value added agric products. Strengthened collaboration and synergy with relevant MDAs, intensive training and sensitization of produce marketers and other stakeholders in agribusines on key areas such as food storage, ideal packaging practices and relevant quality control measures with a view to achieving compliance with standards and specifications of agro allied commodities for their target markets.

25 SUPPORT FOR AGRO-ALLIED BUSINESS Facilitating export of processed and semi-processed agric products and other regulated products to support businesses involved in production, processing and exportation of food and agric products regulated by NAFDAC. All NAFDAC services related to export certification (Laboratory analysis, facility inspection) are offered FREE at no cost to the exporters.

26 CONCLUSION NAFDAC is fully alive to her responsibility of regulatory system strengthening and its bearing on national economic growth. The Agency is thus fully committed to supporting food processing and agribusiness industries to thrive by providing a service-oriented and user-friendly regulatory system. There is therefore no time like now for food processing and agro-allied businesses to take advantage of, and leverage on, the various regulatory strategies and reforms put in place by NAFDAC.

27 ADDITIONAL INFORMATION ON PRODUCT REGISTRATION Who can apply? Applications for registration of a food product shall be made by the manufacturer or their appointed designate. In case of a manufacturer outside Nigeria such shall be represented in Nigeria by a duly registered company. An applicant for a manufacturer outside Nigeria, must file evidence of Power of Attorney from the manufacturer which authorizes him to speak for his principal on all matters relating to the latter s specialties. The original Power of Attorney is to be

28 ADDITIONAL INFORMATION ON PRODUCT REGISTRATION REGISTRATION PATHWAY FOR IMPORTED FOOD PRODUCTS Filing/Submission of application/supporting documents Issuance of Import Permit Submission of product samples Vetting of product labels Laboratory evaluation Facility inspection Product Approval meeting Issuance of NAFDAC Registration number

29 FEEDBACK MECHANISM Complaints can be forwarded to the Reforms Unit of NAFDAC through the following addresses: OR The nearest NAFDAC OFFICE Suggestion boxes in the premises SERVICOM Desk

30 THANK YOU THANK YOU FOR LISTENING