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

Pays/Territoire
République-Unie de Tanzanie
Type du document
Règlement
Date
2015
Source
FAO, FAOLEX
Sujet
Bétail, Général
Mot clé
Santé publique Certification Enregistrement Santé des animaux Médicaments
Aire géographique
Afrique, Afrique Orientale, Pays les moins avances
Entry into force notes
These Regulations enter into force on the date of their publication.
Résumé

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.

Texte intégral
Anglais
Site web
www.tmda.go.tz

Références - Législation

Implemente

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

Législation | République-Unie de Tanzanie | 2003

Mot clé: Législation de base, Contrôle de qualité alimentaire/innocuité des produits alimentaires, Transformation/manutention, Hygiène/procédures sanitaires, Normes, Abattage, Viande, Inspection, Emballage/étiquetage, Enregistrement, Autorisation/permis, Procédures judiciaires/procédures administratives, Infractions/sanctions, Santé des animaux, Médicaments

Source: FAO, FAOLEX