Non-Tariff Barriers

Non-Tariff Measure

NTM classification

P13: Production and post-production requirements to export 

Date when the measure came into force

15 March 2013 

Publication where the measure is specified

Tanzania Food, Drugs A nd Cosmetics (Clinical Trials Control) G.N. No. 53 (contd.) 1 GOVERNMENT NOTICE NO. 53 .published on 15/03/2013 

Regulation where the measure is specified

Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 

Country/Region applying the measure

Tanzania 

Coded list of objectives

X: For purposes n.e.s. 

Description of the measure

20 (1) No person, other than a person issued with a license or permit under the provisions of the Act, shall manufacture, assemble, import or export any investigational medicinal product.
(2) Notwithstanding the provision of sub-regulation (1), investigational medicinal products
shall be manufactured in accordance with Good Manufacturing Practices.
(3) The provisions under sub-regulation (1) shall not apply to the assembly of an investigational medicinal product where such assembly is carried out in a hospital or health centre which is a clinical trial site for the clinical trial in which the product is to be used.
21 Any application for the grant of a manufacturing, importation or exportation license or permit for an investigational medicinal product shall be made in accordance with the provisions of the Act.
22.-(1) The Authority may by a notice in writing to the holder of a license or permit, forthwith or from a date specified in the notice, suspend or revoke the license or permit for such period as may determine, on one or more of the following grounds-
(a)the holder is not carrying out, or has indicated by a notice in writing that he is no longer willing to carry out, the manufacturing, assembly or importation operations to which the license or permit relates;
(b)the particulars accompanying the application in accordance with this regulation, were false or incomplete in a material particular;
(c)a material change of circumstances has occurred in relation to any of those matters or particulars;
(d)the holder of the license or permit has failed to any material extent to comply with any provision of these Regulations;
(e)the holder of the license or permit has manufactured, assembled or, as the case may be, imported investigational medicinal products other than in accordance with the terms of the license or permit;
(f)the holder of the license or permit has manufactured or assembled investigational medicinal products other than in accordance with–
(i) in the case of products manufactured for the purpose of export, the specification for the product provided by the person to whom the order of the products are manufactured, or
(ii) in any other case, the specification for the product contained in the investigational medicinal product dossier;
(g) the investigational medicinal product has not been manufactured in accordance with Good Manufacturing Practices.
(2) The suspension or revocation of a license or permit under this regulation may be-
(a) total;
(b) limited to investigational medicinal products-
(i) of one or more descriptions, or
(ii) manufactured, assembled or stored in any particular premises or in a particular part of any premises.
(3) Any notification given under sub-regulation (1) shall include a statement of the intention of the Authority and the reasons thereof.
(4) A person to whom notification has been given under sub-regulation (3) may, within the time shown in the notice, show cause to the Authority as to why revocation or suspension of the license or permit may not be effected.
(5) The provisions of sub-regulation (1) shall have effect after the Authority has not been satisfied by the representation made to show cause as to why suspension or revocation cannot be issued 

Reference of the measure

Part V 20-22 

Measure also domestic

Yes 

Products affected by the measure.

Description

Medicinal Products 

Countries/Regions affected by the measure.

Description

All countries