Non-Tariff Barriers

Non-Tariff Measure

NTM classification

B81: Product registration/approval requirements 

Date when the measure came into force

14 January 2013 

Publication where the measure is specified

Official Gazette n° Special of 17/01/2013 

Regulation where the measure is specified

Law No47/2012 Of 14/01/2013 Relating To The Regulation And Inspection Of Food And Pharmaceutical Products 

Country/Region applying the measure

Rwanda 

The rationale of the measure

This Law relates to the regulation and inspection of food and pharmaceutical products. 

Coded list of objectives

X: For purposes n.e.s. 

Description of the measure

The certificate of registration of a pharmaceutical product and a medical device shall be valid for a period of five (5) years renewable upon request by the applicant of registration of a pharmaceutical product or a medical device.
No person shall import unregistered pharmaceutical products and medical devices. 

Reference of the measure

Art 28 

Measure also domestic

No 

Products affected by the measure.

Description

Pharmaceutical products and medical devices.
Pharmaceutical product: any substance capable of preventing, treating human or animal diseases and any other substance intended for administration to a human being or an animal in order to diagnose diseases, restore, correct or carry out modification of organic or mental functions. It also means products used in disinfecting premises in which food and drugs are manufactured, prepared or stored, cleaning hospitals, equipment and farm houses.

Medical device: any device used in the medical field for the purpose of diagnosis, testing, cure, surgery or health protection 

Countries/Regions affected by the measure.

Description

All countries