Regulations Governing Post-Marketing Surveillance of Regulated Products.

The present Regulations provide a legal framework for the effective and efficient regulation of post marketing surveillance of regulated products and providing an open transparent and non-discriminatory process for the post marketing surveillance of regulated products. These regulations apply to all regulated products that are manufactured, imported, distributed, stored, sold and used in Rwanda.
The post-marketing surveillance system set by the Regulations includes provisions on its requirements, scope, coordination of stakeholders, roles and responsibilities, prohibitions, regulatory actions etc. The Regulations also establish the PMS committee and describes its powers and the procedure to appeal to it.