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.

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: -

1. 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).
2. 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).
3. 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).
4. 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).

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:-

1. Completing an application form as prescribed by the Authority and submitting it to the Authority (with accompanied fee).
2. Completing the registration file or dossier consisting of information as prescribed in the guidelines and submitting the same to the Authority.
3. Submitting to the Authority relevant certificates issued by Competent Authorities from the country of origin, in case of products to be imported into Tanzania.
4. Submitting to the Authority samples of the products to be registered.