Non-Tariff Barriers

Non-Tariff Measure

NTM classification

B83: Certification requirement 

Date when the measure came into force

28 March 2014 

Publication where the measure is specified

Statutory Instruments 35 of 2014. 

Regulation where the measure is specified

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

Country/Region applying the measure

Uganda 

Coded list of objectives

A: Protection of human life and health 

Description of the measure

19 (2) A manufacturer who manufactures drugs in Uganda or outside Uganda for importation into Uganda shall comply with the Good Manufacturing Practice Guidelines adopted by the Authority.
(3) The manufacturer shall, prior to manufacturing drugs or importation of drugs, as the case may be, make an application to the Authority for assessment of the facility to be used for manufacturing drugs, for compliance with Good Manufacturing Practice Guidelines.
(4) An application for assessment for compliance with Good Manufacturing Practice Guidelines shall be made using Form 20 in the Schedule to these Regulations.
(5) Where a manufacturer complies with the Good Manufacturing Practice Guidelines, the Authority shall issue to the manufacturer a certificate of compliance with Good Manufacturing Practice Guidelines in Form 21 in the Schedule to these Regulations. 

Reference of the measure

Part V Regulation 19 (2), (3), (4) & (5)
Forms 20 & 21 

Measure also domestic

Yes 

Products affected by the measure.

Description

Drugs 

Countries/Regions affected by the measure.