Non-Tariff Barriers

Non-Tariff Measure

NTM classification

B31: Labelling requirements 

Date when the measure came into force

31 July 2015 

Publication where the measure is specified

The Tanzania Food, Drugs and Cosmetics (Registration of Premises, Importation and Exportation of Pharmaceutical Products and Raw Materials) Regulations, 2015 GN. No. 312 

Regulation where the measure is specified

Tanzania Food, Drugs and Cosmetics (Importation and Exportation of Pharmaceutical Products and Raw materials) Regulations, 2015. 

Country/Region applying the measure

Tanzania 

Coded list of objectives

A: Protection of human life and health and B: Protection of life and health of animals 

Description of the measure

26. Every importer shall ensure that all imported pharmaceutical products adhere to the following labeling requirements:-
(a) the information printed on labels are indelible, engraved or embossed on a primary and secondary container;
(b) the immediate outer packaging of the pharmaceutical products is clearly labeled in English or Swahili language or both;
(c) the trade or brand name where appropriate is stated;
(d) the international non-proprietary name (generic name) shall be clearly stated;
(e) quantities of active ingredients in the given formulation;
(f) date of manufacture and expiry;
(g) batch or lot number;
(h) storage conditions;
(i) name and address of manufacturer;
(j) registration number of the product issued by the authority in both outer and inner package of the product(s) where applicable;
(k) package insert literature must be in English or Kiswahili language;
(l) active pharmaceutical ingredient specification such as (BP, USP, JP, PhEur or PhInt). 

Reference of the measure

Part III Regulation 26 

Measure also domestic

No 

Products affected by the measure.

Description

Pharmaceutical products 

Countries/Regions affected by the measure.