Non-Tariff Barriers

Non-Tariff Measure

NTM classification

B9: TBT Measures n.e.s. 

Date when the measure came into force

31 July 2015 

Publication where the measure is specified

The Tanzania Food, Drugs and Cosmetics (Registration of Premises, Importation and Exportation of Pharmaceutical Products and Raw Materials) Regulations, 2015 GN. No. 312 

Regulation where the measure is specified

Tanzania Food, Drugs and Cosmetics (Importation and Exportation of Pharmaceutical Products and Raw materials) Regulations, 2015. 

Country/Region applying the measure

Tanzania 

Coded list of objectives

A: Protection of human life and health 

Description of the measure

10.-(1) Every importer or exporter shall, in respect to his premises, make available the following information:
(a) an appropriate inventory control system; (b) inspection reports file; (c) complaints handling book; (d) unfit medicines register; (e) controlled drugs register;(f) recall register; (g) register for customers detailed with the name of the customer, physical, postal and electronic address, Registration number, name and registration number of the superintendent;
(2) Subject to the conditions provided in sub regulation (1), an importer shall maintain the following documents:
(a) final invoices with corresponding import permits; (b) copies of delivery notes; (c) sales invoices.
12. Subject to the provisions of these Regulations, an importer shall sell pharmaceutical products in bulk to wholesalers. 17 (5) The import or export permit shall be used for a single consignment and not transferable to any other person.
17 (6) In the shipping of the consignment takes more than one shipment, three shipments shall be allowed to be covered by one import permit.
14(2) Notwithstanding sub regulations (1) importation of raw materials or packaging materials shall be restricted to pharmaceutical manufacturers.
23.-(1) Subject to other conditions set in these Regulations, application for importation of free of charge pharmaceutical products shall be accompanied by the proforma invoice indicating the unit price of each product. 

Reference of the measure

Part II Regulations 10 (1) & (2) ; Regulation 12; Regulation 14 (2)
Part III Regulation 17 (5) & (6) ; Regulation 23 (1) 

Measure also domestic

No 

Products affected by the measure.

Description

Pharmaceutical products 

Countries/Regions affected by the measure.