Non-Tariff Barriers

Non-Tariff Measure

NTM classification

A81: Product registration and approval requirement 

Date when the measure came into force

31 July 2015 

Publication where the measure is specified

The Tanzania Food, Drugs and Cosmetics (Registration of Medicinal Products) Regulations, 2015 ; GN. No. 314 

Regulation where the measure is specified

The Tanzania Food, Drugs and Cosmetics (Registration of Medicinal Products) Regulations, 2015 

Country/Region applying the measure

Tanzania 

Coded list of objectives

A: Protection of human life and health 

Description of the measure

4.-(1) No person shall manufacture for sale, sell, offer, supply or import medicinal products by either wholesale or retail unless it is in accordance with the provisions of these Regulations, and that person holds the appropriate license or permit required and issued by the Authority.
5.-(1) Every application for registration of a medicinal product shall be made in hard and electronic copies and shall be accompanied by the following:
(a) cover letter; (b) a dully filled in application FORM MP A as provided in First Schedule to these regulations; (c) a table of contents listing all sections of the dossier and documents and their corresponding page numbers; 

Reference of the measure

Regulations 4 (1) ; 5 (1) (a,b,c); Form MP A , First schedule 

Measure also domestic

No 

Products affected by the measure.

Description

Medicinal products 

Countries/Regions affected by the measure.