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Tanzania Food, Drugs and Cosmetics (Scheduling of Medicines) Regulations, 2015.

Country/Territory
United Republic of Tanzania
Document type
Regulation
Date
2015
Source
FAO, FAOLEX
Subject
Livestock, General
Keyword
Public health Certification Registration Animal health Drugs
Geographical area
Africa, Eastern Africa, Least Developed Countries
Entry into force notes
These Regulations enter into force on the date of their publication.
Abstract

These Regulation consisting of 29 sections and 2 Schedules aim at regulating the registration (the official approval to be marketed or distributed) of medicinal products, for both humans and animals, in Mainland Tanzania. In particular, section 4 prohibits the sale, offering, supply, or import of medicinal products by either wholesale or retail without the license or permit required and issued by the Tanzania, Food and Drugs Authority (TFDA), except for the medical products listed in the paragraphs thereof. Application for registration of medicinal products are dealt with in section 5. Under section 7, a Pediatric Investigation Plan (PIP) is required before registering new medicinal products for use in the pediatric population. Section 11 establishes that, before authorizing the registration, the Authority shall proceed to an evaluation of medicinal products to assess their compliance with safety, quality, and efficacy requirements (procedural matters concerning the evaluation process are included in the following paragraphs thereof). The full registration takes place after the positive evaluation of a technical committee responsible for registration matters. Finally, the Authority shall cause to be published in the Government Gazette a list of registered medicinal products specifying the name under which the product is registered, the qualitative and quantitative content of its active components, the name of the marketing authorization holder, and the registration number. As provided by section 13, a registration certificate, subject to payment of prescribed annual fees, is valid for five years from the date of issuance and may be renewed. The possible causes for the suspension of registration are listed in section 19 however, the Authority may cancel or suspend the registration of a medicinal product without prior notice if it is necessary to prevent injury to the health or safety of patients, users, or other persons. Sections 25 and 26 deal with rules for labeling, packaging, information leaflet, and languages.

Full text
English
Website
www.tmda.go.tz

References - Legislation

Implements

Tanzania Food, Drugs and Cosmetics Act, 2003 (No. 1 of 2003).

Legislation | United Republic of Tanzania | 2003

Keyword: Basic legislation, Food quality control/food safety, Processing/handling, Hygiene/sanitary procedures, Standards, Slaughtering, Meat, Inspection, Packaging/labelling, Registration, Authorization/permit, Legal proceedings/administrative proceedings, Offences/penalties, Animal health, Drugs

Source: FAO, FAOLEX