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 question.
- The relevant medicine in the country of origin.
- The relevant reference medicine in Belgium.
As regards on-going files where the old authorisation form was used, the FAMHP has requested that importers file the new form during the processing of their files. The new form is available on the FAMHP’s website.
This article was co-authored by Claire Caillol.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, February 2020 Issue (Thomson Reuters).