Non-Tariff Barriers

Non-Tariff Measure

NTM classification

B31: Labelling requirements 

Date when the measure came into force

28 March 2014 

Publication where the measure is specified

Statutory Instruments 2014, No. 34 

Regulation where the measure is specified

The National Drug Policy And Authority (Importation And Exportation of Drugs) Regulations, 2014. 

Country/Region applying the measure

Uganda 

Coded list of objectives

A: Protection of human life and health 

Description of the measure

7 (1) The primary packaging of an imported drug shall be clearly labelled in English with the following—
(a) the trade or brand name, where appropriate;
(b) the generic name of the drug;
(c) the quantities of active ingredients in the drug;
(d) the dates of manufacture and expiry of the drug;
(e) the batch or lot number of the drug;
(f) any special conditions of storage applicable to the drug;
(g) the name and address of the manufacturer of the drug;
(h) a unique identification feature, if any; and
(i) the registration number of the drug, where applicable.
(2) The information leaflet enclosed in or accompanying the imported drug shall be in English.
(6) In subregulation (5), “evidence of alteration in the label” includes circumstances where—
(a) the entire label or a part of the label with the details such as the batch number or the date of manufacture of the
drug is removed;
(b) there is evidence of removal of the original label and evidence of attaching another label or evidence of placing a
label over the original label; or
(c) there is evidence of erasing or concealing the original details of the label and replacing the details with other
details.
15(3) The label on a primary container or package of the drug imported for donation shall be in English and where the original label on the primary container or package of the drug is not in English, the primary container or package of the drug shall bear an English translation which shall be permanently fixed to the container but which
shall not cover or erase the original label.
(4) The label referred to in sub regulation (3) shall bear—
(a) the name and address of the manufacturer of the drug;
(b) the generic name of the drug (INN);
(c) the date of manufacture of the drug and the batch or lot number of the drug;
(d) the date of expiry of the drug;
(e) the conditions under which the drug is to be stored; and
(f) the dosage, form and strength of the drug.
(5) The drug for donation shall be accompanied by the information of the prescriber of the drug, which shall be in English. 

Reference of the measure

Part II Regulation 7 (1);(2) and (6)
Part III Regulation 15 (3), (4) and (5) 

Measure also domestic

No 

Products affected by the measure.

Description

Drugs 

Countries/Regions affected by the measure.