Belgium
06 April 2020 - Posted by: Tine Carmeliet
As in several other European countries, Belgium has a system in place to allow the temporary use of certain innovative medicines on the Belgian market when no reimbursement decision has been taken due to the therapeutic effectiveness of the medicine not yet being proven. This system of “managed entry agreements” is institutionalised through the so-called › Read More
Amendment of Belgian legislation on medicines shortages
20 March 2020 - Posted by: 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
26 February 2020 - Posted by: 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
21 February 2020 - Posted by: 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
13 February 2020 - Posted by: 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