Ecolex Logo
El portal del
derecho ambiental
Resultados de la búsqueda » Legislación

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

País/Territorio
República Unida de Tanzanía
Tipo de documento
Reglamento
Fecha
2015
Fuente
FAO, FAOLEX
Materia
Ganado, General
Palabra clave
Salud pública Certificación Registro Sanidad animal Medicamentos
Área geográphica
Africa, Africa Oriental, Países menos desarrollados
Entry into force notes
These Regulations enter into force on the date of their publication.
Resumen

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.

Texto completo
Inglés
Página web
www.tmda.go.tz

Referencias - Legislación

Implementa

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

Legislación | República Unida de Tanzanía | 2003

Palabra clave: Legislación básica, Control de calidad de los alimentos/inocuidad de los alimentos, Procesamiento/manipulación, Higiene/procedimientos sanitarios, Normas, Matanza, Carne, Inspección, Envasado/etiquetado, Registro, Autorización/permiso, Procedimientos judiciales/procedimientos administrativos, Infracciones/sanciones, Sanidad animal, Medicamentos

Fuente: FAO, FAOLEX