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.