Regulated Products PRODUCTS (Definition): The National Agency for Food and Drug Administration and Control Decree

No 15 of 1993 as amended by Decree No. 20.of 1999 defines "Regulated Product" as "Processed Foods, Medicines for human and animal use, Cosmetics, Medical devices, detergents, packaged water and chemicals". Registration of Regulated Products For the benefit of everyone, and in order to promote compliance with the law, it is necessary to draw attention to the most fundamental and very important provision of the law, which prohibits the manufacture, importation etc of unregistered products in Nigeria. For the avoidance of doubt, registration of every regulated product is made mandatory by the Drugs and Related Products (Registration etc) Decree No 19 of 1993 as amended by Decree No.20 of 1999 which provides that no Processed Food, Drug, Drug Products, Cosmetics, Medical Device or Packaged Water shall be manufactured, imported, exported, advertised, sold or distributed in Nigeria unless it has been registered in accordance with the provisions of the Decree or regulations made under it. To understand why the law insists on registration of all regulated products by NAFDAC, it becomes necessary to elaborate on the purpose of the organization as an Agency established to protect the public from any harmful effect of unwholesome processed foods, medicines, cosmetics, packaged water and chemicals. The establishment of NAFDAC is an expression of Government's desire to ensure the well being of the generality of the society in Nigeria and the reasons are simple. The human body is composed of certain combination of chemical molecules and entities, which it is familiar with and which do not cause any harm when introduced from outside the body in small or reasonable amounts. For example, uncontaminated water does no harm to the body since a good proportion of the body mass is composed of water molecules. Apart from such familiar chemical molecules, the body is also able to tolerate varying reasonable amounts of compounds for which it has mechanism to metabolise to compounds normally present in the body. Some other chemical substances, which are Generally Regarded As Safe (GRAS), are not toxic to the body in reasonable amounts. In the preparation of processed foods, medicines, cosmetics etc, the need arises for the use of additives to get the right consistency, flavour, colour, taste or stability. In so doing, it is important that the additive does not pose any health hazard. Also it is important that the environment, machinery, packaging, personnel or manufacturing process do not introduce any contaminants to the product, which could be harmful to health. Common cases of contaminants frequently encountered are from microorganisms like bacteria, fungi or viruses. Some of these do not only produce diseases themselves but can produce toxins which can be active even when the organisms are killed e.g. by heat or other treatment. They are therefore very harmful to the human or animal body as they cannot be detoxified or converted to what the body is used to dealing with. Other examples of contaminants or contamination from the millions of substances or chemicals which can pose simple or serious hazard to health abound. The recent unexpected widely publicized Dioxin Contamination of Livestock and their products is a vivid example for the need for great caution in all stages of preparation, transport, or consumption or use of regulated products. In carrying out its mandate, NAFDAC seeks to ensure the public is protected not only from substandard and fake processed foods, medicines, cosmetics or bottled/packaged water but also from those products which contain the right composition but due to lapses in raw materials, methods of preparation, machinery, environment, or personnel may introduce contaminants whose harmful effects may be immediate or so delayed that the cause effect association may never be known even when a lot of people are affected. Methods used in the production of regulated products for public use or consumption to greatly minimize human errors, avoid contamination, and ensure consistent, effective and safe products are known as "GMP" or 'Good Manufacturing Practice' which varies in detail and scope with the product and the circumstances but the purpose is the same in all cases -an effective, consistent, and safe product is a primary guideline in preventing illnesses arising from regulated products. It is on this ground that no one can guarantee that the production process of an unregistered product meets the requirements of GMP. Consequently, in exercise of its mandate as provided in Section 5 (s) of its enabling Decree No.15 of 1993, NAFDAC pronounces such products as unfit for human or animal consumption.

Because of the relevance of GMP to public health, the Federal Government in 1974, that is 28 years ago, promulgated the Food and Drugs Decree No.35 of 1974 reinforced by Decree No. 19 of 1993, and an Amendment Decree No 20 of 1999 which require registration of regulated products i.e. medicines, processed foods, cosmetics, medical devices, packaged water and chemicals to be registered with NAFDAC before manufacture, importation, exportation, distribution, advertisement and sale etc so that during the process of registration, the level of compliance with GMP requirements can be established. This is essential as the consumer takes these products on trust and has no way of assessing or knowing their composition, usefulness or safety like ordinary commodities of commerce. Product Registration is a task undertaken by Government to evaluate, monitor and document all regulated products in order to endorse their efficacy, quality, safety or wholesomeness for the benefit of those who consume them. It entails administrative, evaluative and analytical processes as well as post marketing surveillance. In other words, a consumer in Nigeria can safely regard a registered product to be one, of which the manufacturing processes have been subjected to the scrutiny of NAFDAC and which has been evaluated, certified and documented by the Agency to be of good quality, safe and suitable for its intended purpose and is subject to continued surveillance of the agency. In cases where there is an error or discrepancy a registered product can easily be recalled from circulation. This is why regulated products are expected to be sold only in registered premises where the retailers and wholesalers know the appropriate storage conditions and are familiar with the system of recall when the need arises. So anyone purchasing regulated products from open markets cannot expect to get the desired effect even if the product is registered. Also as the premises are unregistered he/she cannot expect to get the seller to be brought to book easily if any thing goes wrong. It must be emphasized that regulated products should be purchased or sought only from registered premises. Engaging in transactions which involve unregistered regulated products is an act which is not only unlawful but also inimical to public health. Apart from the imposition of penalties provided for in the Drugs and Related Products (Registration etc) Decree, No.19 of 1993 as amended by Decree No. 20 of 1999, persons convicted of any offence under the decree are now to forfeit to the Federal Government, any assets or property derived or obtained directly or indirectly, through the commission of the offence. Furthermore, the unregistered products are seized, forfeited and dealt with in such manner as the Honourable Minister of Health may determine. An application to register a regulated product is essentially made by the Manufacturer or Importer with the mandate of the foreign Manufacturer. That manufacturer either performs all the manufacturing and packaging operations by himself or assigns one or more of these operations to someone else approved for such operations, provided that he/she has such influence over the particular product as will enable him/her to bear responsibility for the relevant information that is provided in the Form for Registration. A foreign manufacturer requires to be represented in Nigeria by a domiciled agent who possesses a notarized Power of Attorney authorizing him/her to file the application and to speak for the manufacturer on all matters relating to the product and bear responsibility and effect recalls when necessary. From what has been said previously, it is obvious that NAFDAC does not permit test marketing of an unregistered product whether manufactured locally or imported from abroad. Drugs - General Guidelines These Guidelines are for the interest of the General Public, and in particular, food and beverage industries in Nigeria. It is necessary to emphasize that no Processed Food shall be manufactured, imported, exported, advertised, sold or distributed in Nigeria unless it has been registered in accordance with Provisions Of Decree 19 of 1993 as amended by Food, Drugs and Related Products (Registration) Decree No. 20 of 1999. Guidelines for Prospective Agents Manufacturers of Regulated Products of Foreign

Again, it needs to be emphasized that it is unlawful to import into Nigeria any regulated product not duly registered by NAFDAC. Agents of foreign manufacturers are to take the necessary steps to ensure that regulated products intended for the Nigerian market are registered before consignments of such products are imported into the country. In the event of any violation in this regard, the consignment of the unregistered product would be cleared from the ports to a bonded warehouse at the expense of the importer. Thereafter the importer is prosecuted and the products forfeited to the Government together with any assets or property obtained or derived directly or indirectly from the commission of the offence. As in the case of locally manufactured products, the Agency will normally authorize the importation of small quantities of unregistered products for the purpose of submission as samples for registration. A written authorization specifying the quantity of the unregistered products to be imported can be obtained from the Registration Division of NAFDAC at the Federal Secretariat, Phase II, 2nd and 5th Floors, Ikoyi, Lagos. On arrival of the imported samples and presentation of the authorization to the NAFDAC inspectors at the ports, the consignment will be treated the same way

as other normal imported consignments. Before the consignment is therefore cleared from the ports, the importer is required to present the following:-

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Authorization to import samples of the unregistered product. Bank-draft for the prescribed port inspection fees. Properly completed Customs Bill of Entry Certificate of Analysis of the product issued by the manufacturer. Certificate of Manufacture and Free Sale issued by a Government Authority empowered by law in the country of origin to exercise regulatory control over the product.

In order to conform with labeling regulations, the imported sample has to carry the following information:

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Full Name of the Manufacturer. Full location address of the manufacturer Name of the Product (brand and generic names where applicable) Date of Manufacture Expiry Date or Best Before Date Batch Number Direction for storage and use.

It is at this stage that the Registration Form is procured on payment of appropriate fees, and when duly completed, it is submitted to the Registration Division along with the samples and other documents as specified in the Form. A very important document among the requirements is the Notarized Power of Attorney granted by the foreign product manufacturer to the domiciled agent in Nigeria. The completion and submission of the form marks the beginning of the actual registration process. The registration process now proceeds in the same manner as for locally manufactured products and in this regard, the following are all relevant. Drugs - Requirements for Registration An application for the registration of processed Food shall be made by the manufacturer. In case of a manufacturer outside Nigeria, such shall be represented in Nigeria by a duly registered company or individual with facilities to effect a recall of the product when necessary. 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 notarized and submitted to NAFDAC. NOTE The representative in Nigeria, whether a corporate body or an individual with the Power of Attorney, will be responsible for ensuring that the competent authority in the country is informed of any serious hazard newly associated with a product imported under the provisions of the decree or of any criminal abuse of the certificate in particular, to the importation of falsely labeled, spurious, unwholesome, or sub-standard processed foods. The manufacturer, in the case of imported processed foods, must show evidence that the he or she is licensed to manufacture the product(s) for sale in the country of origin (Manufacturer's Certificate). Such evidence must be by the competent Health Authority of the country of manufacture, and shall be authenticated by the Nigerian Mission in that Country. Registration Procedure The applicant must submit to the Registration Division, NAFDAC, a written application, stating the name of the manufacturer, name (brand name where applicable) of the product, and obtain the prescribed application form which must be properly filled, with all information required. This form, Labeled "FORM DREG/001" is available online for download. Completed Registration Form for each product should be returned with the following items:

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Five (5) copies of the Dossier Three packs of drug samples Superintendent and Production Pharmacists' current annual license to practice as Pharmaceutical Chemists Premises Registration License from Pharmacists Council of Nigeria (PCN). A separate application form shall be submitted for each regulated product. Drugs - Rules

A Drug Product shall not be manufactured in Nigeria, unless the factory is inspected, and a Certificate of Recognition issued by NAFDAC. In the case of Imported Products:-

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There must be evidence of registration of such product by the competent Health Authority of the country of manufacture i.e. product License/Certificate of Registration. There must be evidence from the competent Health Authority, that the sale of the Product does not constitute a contravention of the cosmetics Laws that country i.e. Free Sale Certificate The documents in respect of (a) and (b) above shall be authenticated by the Nigerian Mission in that country In the case of an imported new substance, there must be evidence that limited local clinical trials have been undertaken, and that such product is registered in the country of origin and also, in at least 2 or more developed countries. No combination drug product shall be registered or considered for registration unless there is proven evidence that such a product has clinical advantage over the single drug available for the same indication(s). An applicant should indicate the class or type of registration required - whether it is for a prescription only product or an over the counter product Products found to be of doubtful, little or no therapeutic value and those which are sometimes rather harmful and subject to misuse, shall not be considered for registration. An applicant shall not be allowed to register a drug formulation in more than one brand name even where different doses of the active ingredient(s) are used. The product information must be in Five (5) copies with hard covers per product (dossiers) made out in accordance with application format (the content of the dossier must be in compliance with the items on the format). All dosage forms of a particular brand name must contain the same active ingredient(s) or at least the major active ingredient(s) e.g. A cream - Betamethasone 10mg, A soap - Betamethasone 20mg

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y

Labeling terms

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Labeling shall be informative and accurate. Minimum requirements on the package label: Name of Product - Brand Name and generic name where applicable. The generic name must be in similar characters with the brand name. Location Address of the manufacturer. Batch No., Date of Manufacture and Best Before/Expiry Date. Dosage regimen on the package. Leaflet insert, if prescription product and hospital packs. Indications, frequency, route and conditions of administration. Quantitative listing of all the active ingredients per unit dose. Adequate warnings where necessary. Where a brand name is used, there MUST be the generic name which should be conspicuous in character, written directly under the brand name e.g. VENTOLIN,SALBUTAMOL Any drug product whose name, package or label bears close resemblance to an already registered product or is likely to be mistaken for such registered product, shall not be considered for registration. Any drug product which is labeled in a foreign language shall NOT be considered for registration unless an English translation is included on the label and package insert (where applicable). Information on indication carried on packages and leaflet insert of imported drug product shall not differ from that in other countries and in particular the country of origin of the product. Failure to comply with these requirements may result in the disqualification of the application or lead to considerable delays in processing of registration. A successful application attracts a Certificate of Registration with a validity period of Five (5) years.

NOTE * Failure to comply with these requirements may result in the disqualification of the application or lead to considerable delay in processing of registration. In case of processed food and packaged water, only manufacturing outfits situated in industrial areas will have their Registration Certificate valid for 5 years while those located in residential areas have one year validity (yearly listing).

y y

A successful applicant will be issued a Certificate of Registration with a validity period of five (5) years. Registration of a product does not automatically confer advertising permit. A separate application and subsequent approval by the Agency shall be required if the product is to be advertised. NAFDAC may withdraw the Certificate of Registration in the event that the product is advertised without express approval from the Agency. NAFDAC reserves the right to revoke, suspend or vary the certificate during its validity period.

y y

y y

Filling an application form or paying for an application fee does not confer registration status. Failure to respond promptly to queries or enquiries raised by NAFDAC on the application, will automatically lead to suspension of further processing of the application.

Cosmetics Cosmetics - General Guidelines These Guidelines are for the interest of the General Public, and in particular, food and beverage industries in Nigeria. It is necessary to emphasize that no Processed Food shall be manufactured, imported, exported, advertised, sold or distributed in Nigeria unless it has been registered in accordance with Provisions Of Decree 19 of 1993 as amended by Food, Drugs and Related Products (Registration) Decree No. 20 of 1999. Guidelines for Prospective Agents of Foreign Manufacturers of Regulated Products Again, it needs to be emphasized that it is unlawful to import into Nigeria any regulated product not duly registered by NAFDAC. Agents of foreign manufacturers are to take the necessary steps to ensure that regulated products intended for the Nigerian market are registered before consignments of such products are imported into the country. In the event of any violation in this regard, the consignment of the unregistered product would be cleared from the ports to a bonded warehouse at the expense of the importer. Thereafter the importer is prosecuted and the products forfeited to the Government together with any assets or property obtained or derived directly or indirectly from the commission of the offence. As in the case of locally manufactured products, the Agency will normally authorize the importation of small quantities of unregistered products for the purpose of submission as samples for registration. A written authorization specifying the quantity of the unregistered products to be imported can be obtained from the Registration Division of NAFDAC at the Federal Secretariat, Phase II, 2nd and 5th Floors, Ikoyi, Lagos. On arrival of the imported samples and presentation of the authorization to the NAFDAC inspectors at the ports, the consignment will be treated the same way as other normal imported consignments. Before the consignment is therefore cleared from the ports, the importer is required to present the following:-

y y y y y

Authorization to import samples of the unregistered product. Bank-draft for the prescribed port inspection fees. Properly completed Customs Bill of Entry Certificate of Analysis of the product issued by the manufacturer. Certificate of Manufacture and Free Sale issued by a Government Authority empowered by law in the country of origin to exercise regulatory control over the product.

In order to conform with labeling regulations, the imported sample has to carry the following information:

y y y y y y y

Full Name of the Manufacturer. Full location address of the manufacturer Name of the Product (brand and generic names where applicable) Date of Manufacture Expiry Date or Best Before Date Batch Number Direction for storage and use.

It is at this stage that the Registration Form is procured on payment of appropriate fees, and when duly completed, it is submitted to the Registration Division along with the samples and other documents as specified in the Form. A very important document among the requirements is the Notarized Power of Attorney granted by the foreign product manufacturer to the domiciled agent in Nigeria. The completion and submission of the form marks the beginning of the actual registration process. The registration process now proceeds in the same manner as for locally manufactured products and in this regard, the following are all relevant. Requirements for Registration An application for the registration of processed Food shall be made by the manufacturer. In case of a manufacturer outside Nigeria, such shall be represented in Nigeria by a duly registered company or individual with facilities to effect a recall of the product when necessary. 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 notarized and submitted to NAFDAC. NOTE The representative in

Nigeria, whether a corporate body or an individual with the Power of Attorney, will be responsible for ensuring that the competent authority in the country is informed of any serious hazard newly associated with a product imported under the provisions of the decree or of any criminal abuse of the certificate in particular, to the importation of falsely labeled, spurious, unwholesome, or sub-standard processed foods. The manufacturer, in the case of imported processed foods, must show evidence that the he or she is licensed to manufacture the product(s) for sale in the country of origin (Manufacturer's Certificate). Such evidence must be by the competent Health Authority of the country of manufacture, and shall be authenticated by the Nigerian Mission in that Country. Registration Procedure The applicant must submit to the Registration Division of NAFDAC, a written application, stating the name of the manufacturer, name (brand name where applicable) of the product, and obtain the prescribed application form which must be properly filled, with all information required. This form shall be obtained on payment of the prescribed amount per product in Bank Draft issued in favour of NAFDAC, Lagos. *NOTE A separate application form shall be submitted for each regulated product. Cosmetics - Local Registration

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Application for registration of cosmetics should be accompanied with a Bank Draft payable to NAFDAC covering the prescribed fees for Pre-production inspection. The Pre-production inspection is carried out to assess if manufacturing facilities, personnel and location of plant are satisfactory. Registration procedure is halted at this stage if the facilities, etc are not satisfactory. If successful, a certificate of Recognition as a producer of the product is issued to the company. This enables the producer to go ahead and get the product registered. Purchase of product registration form with the prescribed fee payable in Bank Draft. Pre-registration inspection and sampling of product for NAFDAC Laboratory analysis. Final vetting of reports and preparation of briefs for consideration by the Food & Drug Registration Committee are carried out by the Agency. Cosmetics - Rules

Cosmetics shall not be manufactured in Nigeria, unless the factory is inspected, and a Certificate of Recognition issued by NAFDAC. In the case of imported products:-

y y y y

There must be evidence of registration of such product by the competent Health Authority of the country of manufacture i.e. Product License /Certificate of Registration. There must be evidence from the competent Health Authority, that the sale of the Product does not contravene the Cosmetics Laws of that country i.e. Free Sale Certificate In the case of imported new product, there must be evidence that such product is registered in the country of origin, and that the ingredients are approved raw materials. An applicant shall not be allowed to register a cosmetic product in more than one brand name, except in cases where the manufacturers are different having different brand names for the same formulation.

Labeling Terms

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Labeling shall be informative and accurate. Minimum requirements on the package label: Name of Product - Brand Name and generic name where applicable. The generic name must be in similar characters with the brand name. Location Address of the manufacturer. Batch No., Date of Manufacture and Best Before/Expiry Date. Dosage regimen on the package. Leaflet insert, if prescription product and hospital packs. Indications, frequency, route and conditions of administration. Quantitative listing of all the active ingredients per unit dose. Adequate warnings where necessary. Where a brand name is used, there MUST be the generic name which should be conspicuous in character, written directly under the brand name e.g. VENTOLIN, SALBUTAMOL Any drug product whose name, package or label bears close resemblance to an already registered product or is likely to be mistaken for such registered product, shall not be considered for registration.

y y y y

Any drug product which is labeled in a foreign language shall NOT be considered for registration unless an English translation is included on the label and package insert (where applicable). Information on indication carried on packages and leaflet insert of imported drug product shall not differ from that in other countries and in particular the country of origin of the product. Failure to comply with these requirements may result in the disqualification of the application or lead to considerable delays in processing of registration. A successful application attracts a Certificate of Registration with a validity period of Five (5) years.

NOTE * Failure to comply with these requirements may result in the disqualification of the application or lead to considerable delay in processing of registration.

y

y y y y y y

In case of processed food and packaged water, only manufacturing outfits situated in industrial areas will have their Registration Certificate valid for 5 years while those located in residential areas have one year validity (yearly listing). A successful applicant will be issued a Certificate of Registration with a validity period of five (5) years. Registration of a product does not automatically confer advertising permit. A separate application and subsequent approval by the Agency shall be required if the product is to be advertised. NAFDAC may withdraw the Certificate of Registration in the event that the product is advertised without express approval from the Agency. NAFDAC reserves the right to revoke, suspend or vary the certificate during its validity period. Filling an application form or paying for an application fee does not confer registration status. Failure to respond promptly to queries or enquiries raised by NAFDAC on the application, will automatically lead to suspension of further processing of the application.

Tariff Registration of Imported Products Registration of Locally Manufactured Products

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y

y

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y

DRUGS: OTC Drugs =N=1,000,000 (One million naira) Breakdown =N= 10,000 permit to import =N= 890,000 processing fees =N= 100,000 registration certificate Renewal is 60% of total cost of registration Ethical Drugs =N= 250,000 (Two hundred and fifty thousand naira) Breakdown =N= 10,000 permit to import =N= 140,000 processing fees =N= 100,000 registration certificate Renewal is 100% of total cost of registration Orphan Drugs =N=90,000 (Ninety thousand naira) Breakdown =N=10,000 processing fee =N=80,000 registration certificate FOOD: =N= 750,000 (Seven hundred and fifty thousand naira) Breakdown =N= 10,000 permit to import =N= 640,000 processing fees =N= 100,000 registration certificate Renewal is 60% of total cost of registration COSMETICS: =N=750,000 (Seven hundred and fifty thousand naira) Breakdown =N= 10,000 permit to import =N= 640,000 processing fees =N= 100,000 registration certificate Renewal is 60% of total cost of registration MEDICAL DEVICES: =N=250,000 (Two hundred and fifty thousand naira) Breakdown =N= 10,000 permit to import =N= 140,000 processing fees

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y

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y

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y

DRUGS:=N= 70,000 (seventy thousand naira) Breakdown =N= 50,000 processing fees =N= 20,000 registration certificate Renewal is 50% of total cost of registration ORPHAN DRUG : =N= 25,000 (Twenty five thousand naira) Breakdown =N= 10,000 processing fees =N= 15000 registration certificate FOOD: =N= 50,000 (fifty thousand naira) Breakdown =N= 30,000 processing fees =N= 20,000 registration certificate Renewal is 50% of total cost of registration COSMETICS: =N= 50,000 (fifty thousand naira) Breakdown =N= 30,000 processing fees =N= 20,000 registration certificate Renewal is 50% of total cost of registration MEDICAL DEVICES: =N= 30,000 (Thirty thousand naira) Breakdown =N= 20,000 processing fees =N= 10,000 registration certificate Renewal is 50% of total cost of registration VACCINES/BIOLOGICALS: =N=40,000 (Forty thousand naira) Breakdown =N=30,000 processing fees =N= 10,000 registration certificate Renewal is 50% of total cost of registration WATER (BOTTLED): =N=50,000 (Fifty thousand naira) Breakdown =N=30,000 processing fees =N=20,000 registration certificate Renewal is 50% of total cost of registration CHEMICALS/PESTICIDES: =N=40,000 (Forty thousand naira) Breakdown =N=30,000 processing fees =N=10,000 registration certificate

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y

y

=N= 100,000 registration certificate Renewal is 100% of total cost of registration VACCINES/BIOLOGICALS: =N=150,000 (One hundred and fifty thousand naira) Breakdown =N= 10,000 permit to import =N= 40,000 processing fees =N= 100,000 registration certificate Renewal is 100% of total cost of registration CHEMICALS/PESTICIDES: =N=200,000 (Two hundred thousand naira) Breakdown =N= 10,000 permit to import =N= 90,000 processing fees =N= 100,000 registration certificate Renewal is 100% of total cost of registration VETERINARY PRODUCTS: =N=250,000 (Two hundred and fifty thousand naira) Breakdown =N= 10,000 permit to import =N= 140,000 processing fees =N= 100,000 registration certificate Renewal is 60% of total cost of registration

y

Renewal is 50% of total cost of registration VETERINARY PRODUCTS: =N=70,000 (Seventy thousand naira) Breakdown =N=50,000 processing fees =N=20,000 registration certificate Renewal is 50% of total cost of registration

LISTING OF IMPORTED PRODUCTS

LISTING OF LOCALLY MANUFACTURED PRODUCTS

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y

y

Herbal Preparations =N=375,000 (Three hundred and seventy five Thousand naira) Breakdown =N= 10,000 permit to import =N= 265,000 processing fees =N= 100,000 registration certificate Nutraceuticals =N=750,000 (Seven hundred and fifty thousand naira) Breakdown =N= 10,000 permit to import =N= 640,000 processing fees =N= 100,000 registration certificate Herbal preparations manufactured in ECOWAS countries =N=150,000 Breakdown =N= 10,000 permit to import =N= 40,000 processing fees =N= 100,000 registration certificate

y

y

y

y

FOOD:=N= 40,000 (forty thousand naira) Breakdown =N= 30,000 processing fees =N= 10,000 registration certificate Renewal is 50% of total cost of listing COSMETICS:=N= 40,000 (forty thousand naira) Breakdown =N= 30,000 processing fees =N= 10,000 registration certificate Renewal is 50% of total cost of listing WATER (SACHET):=N=30,000 (Thirty thousand naira) Breakdown =N=20,000 processing fees =N=10,000 registration certificate Renewal is 50% of total cost of registration HERBAL PREPARATIONS:Small scale operations =N=10,000 (Ten thousand naira) Large scale operations =N=20,000 (Twenty thousand naira)

Guidelines for prospective importers of regulated products When a foreign regulated product is duly registered by NAFDAC, it can be lawfully imported, distributed and sold in Nigeria. The procedures for the importation of such regulated products are as follows: Importers shall submit to the NAFDAC office whose operations cover the port (air, sea or land borders) where the goods are to be landed, the following documents prior to physical inspection and "formal" sampling of the regulated product:

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Properly completed Customs Bill of Entry. Evidence of registration of the regulated product. The original of combined Certificate of Manufacture and Free Sale issued by the appropriate Health Authority in the country of the product origin. The original certificate of analysis of the product. Other additional information required are:Evidence of payment of a prescribed fees in bank draft made payable to NAFDAC. An undertaking duly signed by the importer that the product would not be sold until confirmed fit for human use by NAFDAC laboratory.

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Address of the importer's warehouse. In the case of milk, fish and fishery products, copy of certificate of radiation test issued by an appropriate government agency in the country of origin will be required in addition to (a- above.) Incase of drugs, the following additional documents will be required as well: Evidence that the importer is a Pharmacist or has employed the services of a Pharmacist. Copy of the current annual certificate of registration/retention of premises issued by the Pharmacist Council of Nigeria (PCN) Copy of the current annual license of the Superintendent Pharmacist issued by the PCN. Evidence of a permit issued by NAFDAC Directorate of Narcotics and Controlled Substances if the imported product is a controlled drug or chemical.

DRUG PRODUCTS ON THE FEDERAL GOVERNMENT IMPORT PROHIBITION LIST

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Paracetamol tablets and syrups Cotrimoxazole tablets and syrups Metronidazole tablets and syrups Chloroquine tablets and syrups Haematinic formulations: [i] Ferrous sulphate and ferrous gluconate tablets [ii] Folic acid [iii] Vitamin B Complex tablets [except modified release formulations] Multivitamin tablets, capsules and syrups [except special formulations] Aspirin tablets [except modified release formulations and soluble aspirin Magnesium trisilicate tablets and suspensions Piperazine tablets and syrups Levamisole tablets and syrups Clotrimazole cream Ampicillin/Cloxacillin combination capsules Ointments ± Penicillin/gentamycin Pyrantel palmoate tablets and syrups Intravenous fluids (Dextrose, Normal Saline etc

FOOD AND OTHER REGULATED PRODUCTS ON THE FEDERAL GOVERNMENT IMPORT PROHIBITION LIST

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Live or Dead Birds Including Frozen Poultry Pork and Pork products, beef and beef products, mutton, lamb and Goat Meat. Cassava/Cassava products Fresh and dried fruits Maize, Sorgum, Millet Wheat flour Vegetable Oils and Fats(but excluding linseed and castor oils and Hydrogenated vegetable fats used as industrial raw materials Sugar Confectionaries (other than Chocolate). Chocolates are excluded because they are not locally produced. Cocoa butter powder and cakes. Spaghetti/Noodles (but excluding Lasagne, Gnocchi, Ravioli and Cannelloni. Biscuits Fruits juice in retail packs Waters, including mineral waters and aerated waters, containing added sugar or sweetening matter or flavoured, and other non-alcoholic beverages. Waters, including mineral waters and aerated waters, not containing added sugar or sweetening matter or flavoured, ice-snow. Beer (Bottled, Canned or otherwise packed) Toothpastes of all kinds Finished Soaps and Detergents (but excluding all raw materials which shall also attract 20% duty rate. Mosquito Repellant Coils, Disinfectant and Germicides Sanitary Wares of plastics and Domestic articles and wares of plastics. Toilet paper, cleansing or facial tissues, towel and similar sanitary articles.

Banned Products: These are products which have been prohibited from importation into Nigeria by Federal Government and are therefore not accepted for registration or renewal of registration

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Paracetamol tablets and syrups Cotriomxole tablets and syrups Metronidazole tablets and syrups Chloroquine tablets and syrups Harmatinic formulations: Ferrous sulphate and ferrous gluconate tablets Folic acid Vitamin B Complex tablets [except modified release formulations] Multivitamin tablets, capsules and syrups [except special formulations] Aspirin tablets [except modified formulations and soluble asprin Magnesium trisilicate tablets and suspensions Piperazine tablets and syrups Levamisole tablets and syrups Clotrimazole cream Ampicillin/Cloxacillin combination capsules Ointments - Penicillin / gentamycin Pyrantel palmoate tablets and syrups Intravenous fluids (Dextose, Normal Saline etc) Disinfectants and Germicides

Blacklisted Companies

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Comet Pharmaceuticals Pvt. Ltd. India Coral Laboratories Ltd. India Dew Healthcare Pvt Limited Henkish Chemical Pvt Limited Honest Trading Co. Ltd. China Hubei Provincial Medicines & Health Products Imports & Exports Company China Intermed 4GK Kamala Overseas Export Bombay Medico Remedies Pvt. Ltd, (manufacturers of Pharmaceutical formulations.) India. Merit Organics Ltd Milan Laboratories Milan Medical Stores, India. Mission Pharmaceuticals Ltd Novus Pharmaceuticals Ltd.India. Pharmadeal Pvt Ltd. India

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Rose Pharmacy Sangola Pharma, Owned by Raj SHAH, India Sangula Enterprises (Manufacturers of Surgical Dressing), Santacruz Medical Stores. India. Shreechem Pharmaceutical Pvt Ltd. Sinochem, Ningbo Import & Corp, China. Uma Medical Agency (Pharma Distributor), Mumbai, India. Unibios Lab Limited Unison Drugs Pvt Ltd. India Vardhman Export A-188TTC Wardex Pharm Pvt Limited Wellbert Pharmaceutical (Bombay) Pvt. Ltd. India Wellcure Drugs and Pharmaceutical Ltd. India Yantai Foreign Economic & Technical Trade Corp

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