Regulations Governing Licensing of public and private Manufacturers, Distributors, Wholesalers and Retailers of Medical Products

The purpose of these Regulations, which is stated by Chapter 1 of the text, is to provide a detailed framework for the implementation of the law n° 003/2018 establishing the Rwanda FDA, for the effective and efficient regulation of the licensing of public and private manufacturers, distributors, wholesalers and retailers of Medical Products. These regulations shall apply to domestic, public, and private manufacturers, distributors, wholesalers and retailers of medical products involved in the manufacture, storage, sale, distribution, and dispensing of medical products.
The text sets up provisions on licensing, particularly on requirements for authorization to license Public and Private Manufacturers, Distributors, Wholesalers and Retailers of Medical Products as well as requirements on premises. It also disposes on the refusal to grant an authorization and on the validity of it. The text also regulates in details the premises inspections for their suitability for wholesale and retail selling of medical products (routine inspection; enforcement inspection; follow-up inspection; special inspection).
The Regulations treat, in their last part, final and miscellaneous issues such as administrative sanctions and other Regulatory Actions, warning, suspensions and revocations, appeals and review etc.