Belgium

Amendment of Belgian legislation on medicines shortages

Tine Carmeliet

The Law of 20 December 2019 modifying various laws related to medicines shortages was published in the Belgian Official Journal on 3 February 2020. The aim of this law is to tackle certain issues related to the problem of medicines shortages. The Law introduces a set of measures in order to address deliberately created medicines Read More

Belgium – FAMHP issues new authorisation form for parallel import of medicines

Kaat Van Delm

On 17 December 2019, the Belgian Federal Agency for Medicines and Health Products (FAMHP) issued a new mandatory form for obtaining authorisation for the parallel import of medicinal products. Importers have been obliged to use this new form since 1 January 2020. The new form contains three sections requesting information on:  The parallel imports in Read More

French Constitutional Council censors National Assembly’s ‘historic’ amendment on transparency

Eveline Van Keymeulen

On 20 December 2019, the French Constitutional Council issued a decision to censor, among other things, a historic amendment to the 2020 Social Security Financing Bill on transparency of medicinal product pricing and public contribution in research and development (R&D). Accordingly, the amendments requiring pharmaceutical companies to publicly disclose any public R&D contributions they have Read More

Belgium – FAMHP issues updated guidance document for clinical trial sponsors

Kaat Van Delm

On 19 December 2019, the Belgian Federal Agency for Medicines and Health Products (FAMHP) issued updated guidance for clinical trials sponsors. This document (and each of its previous versions) was adopted in the context of a pilot project that aims to prescribe the procedures and rules for the collaboration between the FAMHP, the Belgian Clinical Read More

Belgium – PharmaStatus: new online platform on availability of medicines

Tine Carmeliet

The Federal Agency for Medicines and Health Products (FAMHP) has launched PharmaStatuts a new online platform that collects and publicly discloses information about the availability of medicines in Belgium. The platform aims at reducing the impact of unavailable medicines on patients. In addition, it aims to facilitate the flow of information between all parties involved Read More