Non-Tariff Barriers

Non-Tariff Measure

NTM classification

B31: Labelling requirements 

Date when the measure came into force

15 March 2013 

Publication where the measure is specified

Tanzania Food, Drugs A nd Cosmetics (Clinical Trials Control) G.N. No. 53 (contd.) 1 GOVERNMENT NOTICE NO. 53 .published on 15/03/2013 

Regulation where the measure is specified

Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 

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

23.-(1) An investigational medicinal product shall be labeled in Kiswahili or English and shall contain the following minimum information
(a) statement indicating that the product is for “clinical trial purpose only”;
(b) name, number or identifying mark;
(c) recommended storage conditions;
(d) name and address of the Sponsor;
(e) protocol code or identification.
(2) Where applicable, investigational medicinal products shall be labeled in the manner that protects the blinding.
(3) Re-labelling of any remaining investigational medicinal product from previously manufactured batches shall be performed in accordance with established written procedures and Good Manufacturing Practice principles 

Reference of the measure

Part VII para 23 

Measure also domestic

Yes 

Products affected by the measure.

Description

Medicinal products 

Countries/Regions affected by the measure.

Description

All countries