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Regulations Governing Registration of Medicinal Products.

Country/Territory
Rwanda
Document type
Regulation
Date
2021
Source
FAO, FAOLEX
Long title
Regulations Governing Registration of Medicinal Products. (Rwanda FDA law N° 003/2018 of 09/02/2018, Article 9).
Subject
Livestock, General
Keyword
Authorization/permit Disinfection/disinfestation Enforcement/compliance Packaging/labelling Procedural matters Public health Registration Vaccination Animal health Drugs Pests/diseases
Geographical area
Africa, Eastern Africa, Landlocked Developing Nations, Least Developed Countries
Abstract

These Regulations, which are organized in 4 Chapters, have the purpose, established by Chapter 1, to enforce the legal framework to ensure effective and efficient registration of medicinal products, and to provide an open, transparent and non-discriminatory process for the registration of medicinal products. They cover human and veterinary medicinal products, vaccines and biological products for human and animal use, herbal medicinal products, disinfectant and antiseptics excluding cosmetics as well as laboratory and household chemicals.

Full text
English

References - Legislation

Implements

Loi nº 003/2018 du 09/02/2018 portant création de l’Office Rwandais des produits alimentaires et pharmaceutiques et déterminant sa mission, son organisation et son fonctionnement.

Legislation | Rwanda | 2018

Keyword: Basic legislation, Institution, Food additives, Food quality control/food safety, Monitoring, Transport/storage, Internal trade, International trade, Authorization/permit, Animal health, Drugs, Plant protection, Pesticides

Source: FAO, FAOLEX

Implemented by

Guidelines on submission of Documentation for Registration of Veterinary Medicinal Products

Legislation | Rwanda | 2020

Keyword: Animal health, Authorization/permit, Data collection/reporting, Packaging/labelling, Procedural matters, Registration, Research, Transport/storage, Vaccination, Drugs

Source: FAO, FAOLEX