Articles for the ‘General’ Category

An amendment to the Act on Medicinal Products entered into effect as of 1 January 2024, imposing numerous new obligations on marketing authorisation holders, distributors and pharmacies, and expanding the existing powers of administrative authorities. The changes are primarily aimed at ensuring the availability of medicinal products for the needs of patients in the Czech Republic and increasing the resilience of the market to supply shortages of medicinal products.

This blog post mainly focuses on the CJEU’s findings regarding the responsibility of parallel importers for ensuring the display of the original batch number on the product packaging.

Food law is extensively harmonized throughout the EU, but national law still has a role to play. In this short article, we look at three developments in Belgian food law that have taken place in 2023: the amendments to the Food Safety Agency’s administrative fining regime, the introduction of nutrivigilance, and the announced revision of the food hygiene legislation.

The Clinical Trials Regulation (CTR), effective from January 31, 2022, introduced a pivotal change in the EU’s clinical trial landscape. Transitioning from the previous Clinical Trial Directive (CTD) to the CTR involves submitting a streamlined “transitioning application” before January 30, 2025. This regulatory evolution underscores efficiency and transparency in clinical trials, urging sponsors to initiate the transition process promptly for uninterrupted trial continuity under the CTR.

Both the Belgian legislator and government have played an active role in 2023 when it comes to pharma legislation, which has led to a number of changes in the legal framework. In this article, we look back and discuss five noteworthy developments in Belgian pharma law.