Non-Tariff Barriers

Non-Tariff Measure

NTM classification

A84: Inspection requirement 

Date when the measure came into force

12 March 2013 

Publication where the measure is specified

Guidelines for conduct of Ectoparasiticide Trials 

Regulation where the measure is specified

National Drug Policy and Authority, Act Cap 206 

Country/Region applying the measure

Uganda 

The rationale of the measure

4) to establish the efficacy and safety of products used on animals against ectoparasites of veterinary importance; and
5) to ascertain that the ectoparasiticide is safe for the environment and the people exposed to the products 

Coded list of objectives

A: Protection of human life and health, B: Protection of life and health of animals and E: Protection of the environment 

Description of the measure

10. Importation and release of ectoparasiticide trial products
10.1 The shipping of an investigational product shall be conducted according to instructions given by or on behalf of the Sponsor in the shipping order.
10.2 A pre-clearance inspection shall be carried out at the port of entry by the Authority.
10.3 The pre-clearance inspection shall include the shipping documentation and overall physical condition of the consignment as in schedule 5 of this guideline.
10.4 If specific storage conditions are essential to ensure the quality of the product, a device that will confirm that storage temperatures are not exceeded during transport shall be included with the shipment.
10.5 Any person who supplies false or misleading information in connection with his/ her application for a trial product import permit commits an offence under section 60 of the National Drug Policy and Authority Act.
11. Documentation for ectoparasiticide trail product release
11.1 The Authority Inspector at the port of entry shall base on the documentation accompanying the consignment of ectoparasiticide trial product to release the product to the sponsor as in checklist 2 of this guideline.
11.2 The checklist 2shall be completed by the Sponsor and it shall accompany each consignment of trial product.
11.3 The inspector at the port of entry shall cross checklist 2 filled in by the sponsor to ensure that the required document are attached and correct.
11.4 The documentation shall include:
1) a copy of the letter of approval of trial; and
2) the Certificate of Analysis of each batch of the investigational product as well as the comparator where applicable;
3) a copy of a valid Certificate of Manufacture issued by the competent regulatory Authority in the country of origin of the trial product. 

Reference of the measure

Part II Sections 10 & 11 

Measure also domestic

Yes 

Products affected by the measure.

Description

ectoparasiticid 

Countries/Regions affected by the measure.

Description

All countries