Non-Tariff Barriers

Non-Tariff Measure

NTM classification

B31: Labelling requirements 

Date when the measure came into force

24 March 2014 

Publication where the measure is specified

Statutory Instruments 29 of 2014. 

Regulation where the measure is specified

The National Drug Policy and Authority (Registration) Regulations, 2014. 

Country/Region applying the measure

Uganda 

Coded list of objectives

A: Protection of human life and health 

Description of the measure

10 (1) The applicant shall at the time of applying for registration of a product provide a sample of the labelling and packaging for the product which shall contain—
(a) the brand name, where applicable;
(b) the international non-proprietary name or generic name of the product;
(c) the quantity of active ingredient per dosage unit;
(d) the pharmaceutical form and the quantity of active ingredient per dosage unit;
(e) the total contents of the primary, secondary and tertiary container;
(f) the date of manufacture of the product;
(g) the date of expiry of the product;
(h) the batch number of the product;
(i) the storage conditions;
(j) the product information for health professionals;
(k) the patient information and package leaflet; and
(l) the name and address of the manufacturer of the product. (2) The Authority shall not consider an application for registration of a product unless the words used in the labelling and packaging of the product are in English.
(3) The name and address of the manufacturer, the date of manufacture or the conditions of storage may be omitted from the primary packaging if the primary packaging is a blister, strip pack or a vial or an ampoule of less than ten millilitres.
(4) The name of the manufacturer may be substituted with a trade mark or other symbol associated with the manufacturer.
(5) Where the name and address of the manufacturer, the date of manufacture or the conditions of storage are omitted from the primary packaging under subregulation (3), they shall appear in full on the secondary packaging.
(7) The Authority shall only register a product with a clear, easily legible and comprehensible label. 

Reference of the measure

Part II Regulation 10(1),(2),(3), (4), (5) & (7) 

Measure also domestic

Yes 

Products affected by the measure.

Description

Drugs 

Countries/Regions affected by the measure.