Non-Tariff Barriers

Non-Tariff Measure

NTM classification

B14: Authorization requirements for importing certain products 

Date when the measure came into force

01 July 2003 

Publication where the measure is specified

No.1 Tanzania Food, Drugs, Cosmetics,2003.The United Reoublic of Tanzania 

Regulation where the measure is specified

Food,Drugs and Cosmetics Act,2003 

Country/Region applying the measure

Tanzania 

Coded list of objectives

A: Protection of human life and health 

Description of the measure

22.-41) Notwithstanding the provisions of this Act or any other written laws, no person shall, on or after the appointed day, manufacture for sale, sell, offer, supply or import any product regulated under this Act unless -
(a) the product is registered in accordance with the provisions of this Act;
(b) the person holds the appropriate licence or permit required and issued by the Authority.
(2) No person shall in the course of any business carried on by him-
(a) sell or manufacture any product regulated under this Act except in accordance with a licence granted for that purpose; or
(b) manufacture or assemble any product regulated under this Act except in accordance with a manufacturer's licence granted for that purpose; or
(c) sell, supply, import or export any product by way of wholesale dealing or retail except in accordance with licence or permit granted by the Authority for that purpose.
(3) Any person who contravenes the provisions of this section relating to the manufacture, importation or wholesale of products regulated under this Act, commits an offence and upon conviction shall be liable to a fine not exceeding five million shillings or to imprisonment for a term not exceeding two years or to both such fine and imprisonment.
(4) Any person who contravenes the provisions of this section relating to retail sale of products regulated under this Act, commits an offence and upon conviction is liable to a fine not exceeding five hundred thousands shillings or to imprisonment for a term not exceeding three months or to both such fine and imprisonment.
23.-(I) The provisions of section 22 shall not apply to -
(a) anything done by a medical practitioner or dentist which:
(i) relates to a drug product specially prepared for administration or supply to his particular patient; or
(ii) relates to a drug product specially prepared by that dentist at the request of another dentist for administration to a particular patient of that other dentist; or
(iii) relates to a drug product specially prepared by that medical practitioner at the request of another medical practitioner for administration to a particular patient of that other medical practitioner.
(b) anything done by a veterinary surgeon which -
(i) relates to a drug product specially prepared for administration to a particular animal which is under his care; or
(ii) relates to a, drug product specially prepared by him at the request of another veterinary surgeon for administration to a particular animal or group of animals under the care of that other veterinary surgeon;
(c) anything which is done in a pharmacy and is done by or under the
supervision of a pharmacist and consists of preparing, dispensing, assembling or procuring a drug product in accordance with a prescription given by a medical practitioner, dentist or a veterinary surgeon;
(d) anything which is done in a pharmacy by or under the supervision of a pharmacist and consists of -
(i) preparing or dispensing a non-prescription drug for administration to a person where the pharmacist is requested by or on behalf of that person to do so in accordance with the pharmacist own judgment as to the treatment required and that person is present in the pharmacy at the time of the request in pursuance of which that product is prepared or dispensed;
29(ii) preparing a stock of drug products with a view to dispensing them as mentioned in paragraph (c) or in paragraph (d)(i);(e) anything which is done in a hospital pharmacy by or under the supervision of a pharmacist and consists of preparing a stock of drug products with a view to dispensing them as mentioned in paragraph (c); or (f) the importation of a drug product by any person for administration to himself or to any persons who are members of his house-hold or the importation of a drug product where it is specially imported by or to the order of a medical practitioner or dentist for administration to his patient:
Provided that, either case the quantity so imported shall be not greater than is reasonably necessary for the purpose and is not of commercial value; or
(g) the importation of a drug product in such circumstances as may be specified by the Authority;
(h) the importation of any drug, medical devices or poison for purposes of research institution; or for the purpose of obtaining samples for registration.
(i) anything done by a traditional health practitioner registered under the Traditional and Alternative Medicines Act, 2002, which relates to a herbal drug specifically prepared for administration, or supply to this particular patient 

Reference of the measure

Part H (c) ,22 &23 

Measure also domestic

Yes 

Products affected by the measure.

Description

Drugs 

Countries/Regions affected by the measure.

Description

All countries