Directorate of Medicines and Cosmetic

Introduction

In Tanzania, no person shall manufacture for sale, offer, supply or import any drug, cosmetic, herbal drug, prepackaged or medical device unless the product is registered in accordance with the provision of the prevailing law.  This requirement applies to both locally manufactured and imported products. Product registration is preceded by an evaluation process whereby compliance of the product with set standards is ascertained.  Usually a product is not registered until samples have been analyzed by a quality control laboratory and found to be fit for the intended use.  A product, which satisfies the evaluation processes, is registered with full details of its name, chemical and microbiological composition and name and address of its manufacturer or distributor.

In Tanzania drugs, prepackaged food, cosmetics, herbal drugs, medical devices and food supplements are evaluated and registered by the Tanzania Food and Drugs Authority (TFDA)  before being approved for distribution and marketing in the country. The objective of the evaluation and registration requirement is to ensure that only safe, quality and efficacious products are approved for use in the country.

Legal Requirements for product Registration

In Tanzania product registration is a legal requirement that must be fulfilled by all those engaged in putting the specific products on the market.  The enabling legislation that empowers the Authority to ask for product registration is the Tanzania Food, Drugs & Cosmetics Act No. 1 of 2003.  One of the functions of the Authority as spelled out in section 5 of the Act is to approve and register products regulated by the Authority and these include those manufactured within or imported into, and intended for use in the United Republic of Tanzania. 

The Act provides for product specific legal requirements for registration as follows: -

(i)          No person shall manufacture, import, distribute, sell or expose for sale pre-packaged food unless that food or food product has been registered by the Authority (Section 28 of the Tanzania Food, Drugs and cosmetics Act, 2003).

(ii)        The Authority shall approve the registration of a drug medical device or herbal drug if it considers that (a) The availability of that product is in the public interest, (b) it is safe, efficacious and of acceptable quality (c) the premises and manufacturing operation complies with the current Good Manufacturing Practices (GMP) requirements as provided in the regulations, (d) It complies with any other requirements as may be prescribed by the Authority (Section 51 of the Tanzania Food, Drugs and cosmetics Act, 2003).

(iii)      No person shall, in the course of a business carried on by him import, procure, manufacture, or assemble, sale or supply any drug, medical device or herbal drug for the purposes of a clinical trial unless he is the holder of a product registration which authorizes the clinical trial in question (Section 61 of the Tanzania Food, Drugs and cosmetics Act, 2003).

(iv)       No cosmetic shall be sold, given, manufactured, imported, stored or exhibited for the purpose by being sold or given unless the cosmetic conforms to the requirements prescribed by the Authority (Section 86 of the Tanzania Food, Drugs and cosmetics Act, 2003).

 Procedures for application for product registration

TFDA has developed guidelines for submission of applications for registration of regulated products under the Tanzania Food, Drugs and Cosmetics Act, 2003.  These guidelines provide guidance to applicants for product registration who may wish to engage in the business of drugs, prepackaged food, biologicals, herbal drugs, food supplements, cosmetics or medical devices business in Tanzania.  The guidelines aim to assist applicants in the preparation of acceptable application documents.

 In general the following procedure applies to application for product registration in Tanzania:

(i)          Completing an application form as prescribed by the Authority and submitting it to the Authority (with accompanied fee).

 (ii)        Completing the registration file or dossier consisting of information as prescribed in the guidelines and submitting the same to the Authority.

 (iii)      Submitting to the Authority relevant certificates issued by Competent Authorities from the country of origin, in case of products to be imported into Tanzania.

 (iv)       Submitting to the Authority samples of the products to be registered. 

A separate application is required for each product (i.e. products containing different ingredients or manufactured by different manufacturers).  All applications for registration should to be accompanied by relevant application fees.  These fees are charged for each product to enable the Authority meet some of the costs involved in evaluation of the product, laboratory analysis, preparation of certificates and other relevant expenses.   

Assessment of products for registration

Each product for registration has specific requirements which are provided in the guidelines. The information submitted to the Authority in the form of product dossiers should normally substantiate the safety, effectiveness performance and quality of the product seeking registration.

There are product specific assessment procedures and parameters to be evaluated.  However, the general parameters to be assessed would normally include: -

v      Product particulars

v      Composition of the product (ingredients)

v      Manufacturing processes

v      Quality Control

v      Stability reports for some products e.g. drugs

v      Type of containers and their compatibilities with the product

v      Label claims and other product literature

v      Exclusion of prohibited ingredients for cosmetics

 

In addition, the samples submitted are also analyzed by the laboratory to confirm the quality of the product.  Verification of compliance to standard requirements and Good Manufacturing Practices (GMP) or Hazard Analysis Critical Control Point (HACCP) principles is also done for the manufacturing premises.

The assessment of products for their suitability for registration is done by the Authority with the guidance of Technical Committees established under the Food, Drugs and Cosmetics Act to provide the Authority with technical advice on assessment or products for registration.

Granting and validity of Registration

Once the Authority has satisfied itself of the safety, quality and effectiveness or performance of the product; it approves the product by giving a certificate of registration or marketing authorization.

The validity of registration varies from product to product and this shall be specified in the guidelines for application for registration of the specific product. All alternations in any aspect of a registered product must get prior approval from the Authority

Revocation, Cancellation and suspension of registration

The Authority may revoke cancel or suspend registration of a registered product or and the conditions of registration if it considers necessary to do so in interest of the public or if it discovers that false information was submitted to the Authority on application for registration.

The holder of the registration certificate shall be informed and will be given an opportunity to appeal or make necessary rectification where feasible.

Important publications

In order of get more information on product registration read specific guidelines for application for registration of drug, cosmetic, herbal drug, biologicals and medical devices please consult individual guidelines.