NAFDAC

1.

What concerns Standards Organization of Nigeria (SON) with NAFDAC Regulated Products?

NAFDAC?s primary assignment is to regulate & control 6 products related to public Health i.e. Food, Drugs, cosmetics, Medical devices, packaged water and Chemicals, while that of S.O.N. is to set standards for all commodities. It is only natural that they (both organizations) share similarities in the process of carrying out their statutory functions.

2.

Why does SON take samples of the same products after NAFDAC has already sampled the same products for analysis?

In the course of carrying out its statutory functions, S.O.N might need to draw samples of such products for tests to be conducted on it and to ascertain that the product has conformed to standards set by the organization.

3.

Which NAFDAC office do I report to if someone in my neighbourhood manufactures fake and/or unwholesome regulated product?

Such cases of fake items being manufactured should be reported to the nearest NAFDAC Enforcement Directorate V/Island office or any other NAFDAC office where such information will forwarded to the directorate that handles them.

4.

How can I get employed into the agency? I am a graduate and I believe am qualified to work in the Agency.

Such persons should put an application for employment addressed to the Director General NAFDAC., stating his/her qualification and desire to work.

5.

What document does NAFDAC require to clear regulated Products at the Ports?

Documents required depend on the type of products imported and the country of origin. The underlisted is only a generalization. The Importer?s representative shall submit to

NAFDAC office at the port the following documents:

1) Physical Inspection Report

2) Face of Entry (SGD) carrying the NAFDAC first stamp

3) NAFDAC receipt of payment

4) Risk Assessment Report

5) Certificate of Analysis of product

6) Packing list of product

7) Invoice

8) Bill of lading

9) Import Permit

10) Chemical Permit (where applicable)

11) Permit to clear in the case of controlled chemicals.

Certificate of product registration in the case of finished product.

6.

When making payments to NAFDAC, can I pay I cash?

All payments to NAFDAC must be in Bank Draft in favour of the Agency (National Agency for Food and Drug Administration and Control ?written in full).

7.

Can I import a product registered by another company/person?

Except authorized by the company/person that registered such product, it is illegal and an offence to import a product registered by another company/person as they alone have the exclusive right over their registered product.

8.

I had already paid and received NAFDAC 1^st stamp on my Apapa Entry (SGD) and suddenly my consignment was transferred to another port. What do I do?

In such case, the importer or his representative will have to notify the Agency in writing about the development. Original copies of the old & New entry (SGD) as well as the original NAFDAC receipt of payment will be submitted to the NAFDAC office where the 1^st stamp was initially obtained.

1.

How do I register and Import regulated products?

For registration we refer them to our R&R Directorate, Oshodi.

For Importation, Guidelines are provided for the importers as how to go about their importation.

4.

Why does NAFDAC request for certificate for milk and milk products, Fish and fish products from the country of origin of the products and also conducts Radiation Analysis test on the said product in Nigeria?

This it to ensure that the appropriate regulatory authority in the exporting country attests that the products are not contaminated by Radio- active elements or materials before export into Nigeria. The second analysis done in Nigeria by NAFDAC on arrival of consignment is just for confirmation.

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QUESTION

ANSWER

1.

Why does NAFDAC have to sample and analyze NAFDAC registered products each time they are imported and request importers to pay for the analysis though the importers have paid for the analysis of the product during registration?

NAFDAC samples and analyses registered product to ascertain that the quality is same as what was registered (post-market surveillance).

2.

Why are NAFDAC Port charges so exorbitant?

The Port charge is commensurate with the services rendered by NAFDAC.

NAFDAC sometimes has to carry out 100% examination and sorting of good products from bad at importers? warehouse for days as well as other services at no additional cost to importer.

3.

Are fish meal (feed concentrate), frozen fish or stockfish heads registered by NAFDAC?

No, they are not registered by NAFDAC.

However, the Agency documents, inspects and analyses the products to ensure that they are fit for use/consumption.

Please note that tinned fish e.g. sardines, mackerel must be registered with NAFDAC before importation.

1.

Who are NAFDAC Representatives at these countries?

India ? QCS Consultants

China ? Tianjin Tianshi Ltd.

Egypt - Inspection & Testing Group

(Pls. upload detailed addresses).

2.

Why does NAFDAC appoint foreign quality assurance representatives?

They were appointed to ensure the quality safety and efficacy of drugs imported from those countries.

3.

Why is importation of Over the Counter (OTC) Drugs more costly than Prescription Only Medicines (POM?s)?

This was done to encourage local production for which the country has capacity and comparative advantage & discourage their importation.

4.

What are the charges for inspection & analysis of drugs & medical devices?

See the approved gazetted NAFDAC tariffs.

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QUESTION

ANSWER

1.

What are the functions/responsibilities of the Agency with respect to export of Nigerian products?

The National Agency for Food and Drug Administration and Control (NAFDAC) Enabling Decree 15 of 1993 (now NAFDAC CAP NI Laws of the Federal Republic of Nigeria, 2004), mandates and empowers the Agency to regulate and control the importation, exportation, manufacture, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, packaged water/drinks, chemicals, detergents (all called NAFDAC regulated products).

In August, 2003, owing to repeated Alert notifications from the E.U over Nigerian exports, particularly food commodities, the Minister of Health assigned the mandate for certification of packaged semi-processed/processed food commodities to NAFDAC. The Agency and its facilities have been well positioned to take up the challenges of this responsibility.

2.

Mention the roles of the Agency as regards facilitating export of Nigeria products?

? Inspection of manufacturing establishments, factories/ storehouses to ensure adequate Good manufacturing Practices (GMP) during production, processing, packaging and storage.

? Registration of locally manufactured food and drugs including packaged semi processed/processed food commodities if the manufacturing sites have satisfactory GMP and the products have been pronounced wholesome through NAFDAC certification.

? Sampling the products intended for export (especially semi-processed food commodities) for laboratory analysis to ensure wholesomeness. Products are analyzed for microbiological pathogens, contaminants e.g. additives, pesticide adequacy and levels of preservatives, mycotoxins (aflatoxins) etc.

? Issuing Export certificates (Combined Certificates of Manufacture and Free Sale) on registered regulated prepackaged food and drugs for export, and Health certificates on semi processed/processed food commodities with satisfactory laboratory reports. The exporters with unsatisfactory laboratory results are educated on how to improve on their products to meet international standards/requirements.

? Monitoring of the various entry points e.g. land borders, air and sea ports to ensure that only wholesome products certified by the Agency are exported.

? Receiving and investigating all Alert notifications from the European Union (E.U) on exported Nigerian semi processed/processed food products and educating the concerned exporters on international standards/requirements to prevent further destruction/rejection of Nigerian products in international markets.

? Carrying out public enlightenment programmes, workshops geared towards ensuring that products for exportation meet international standards.

3.

What are the Agency?s requirements for export?

The Agency has two Guidelines on export issued out to exporters depending on the category of export:

? Guidelines for exportation of Regulated products: food, drugs, cosmetics, medical devices, detergents etc. (attached). For this category of products which are called NAFDAC regulated products, a Combined Certificate of Manufacture and Free Sale is issued for export once the product has a current Registration Certificate and the establishment in question has a satisfactory cGMP.

? Guidelines for export of semi processed/processed food commodities (attached). Health Certificates for export are only issued on food commodities with satisfactory (NAFDAC) laboratory reports.

It is the ultimate goal of the Agency that all farms, facilities, establishments producing and packaging semi processed/processed food commodities for export be inspected and certified for satisfactory GMP by the Establishment Inspection Directorate of NAFDAC and the packaged food commodities registered by the Registration arm of NAFDAC. This is in line with international requirements (e.g. the requirements of the European Union and USA) that a competent authority regulates and certifies any food coming into their countries.

4.

What are the Agency?s charges on export?

All services rendered by NAFDAC on exports are presently at no charges to the exporter- including the analysis of all semi processed/processed food commodities passing through the Agency for export.