On 8 September 2025, the Court of Justice of the European Union (CJEU) received a preliminary request from the Bundesverwaltungsgericht, the German Federal Administrative Court BVerwG, referring a series of questions seeking interpretation on the applicability of certain rules to parallel trade of medicines, including whether German language and packaging requirements are proportionate or compatible with EU law.  The request follows an order for a preliminary reference made by the BVerwG in March 2025.  Notably, the request does not disclose the identity of the parallel importer, the manufacturer of the medicinal product, or the name of the product itself.Continue Reading CJEU to Clarify Rules on Packaging Requirements in Parallel Trade of Medicines

The European Commission published a Proposal for a Regulation on Packaging and Packaging Waste (the Proposed Regulation) to tackle the growing amount of packaging waste, the low levels of recyclability, and the re-use and uptake of recycled content. If adopted, the rules will apply to all companies involved in the packaging life cycle that place packaging and packaging waste in the EU internal market regardless of whether these companies are based in the EU.  While there are various exceptions for manufacturers of medicinal products and medical devices sectors, if adopted, the Proposed Regulation will require life sciences companies to make significant amendments to their current and future product packaging, with resulting cost impacts. We set out the key requirements and takeaways from the Proposed Regulation in our Advisory, and will continue monitoring and reporting on new developments as the legislative process evolves.

We have also prepared this helpful summary for your reference. Continue Reading Proposal for Revision of EU Legislation on Packaging and Packaging Waste

In three separate preliminary rulings delivered by the Court of Justice of the European Union (CJEU) on 17 November 2022 (Novartis v Abacus Medicine, Bayer v kolpharma, and Merck Sharp & Dohme (MSD) v Abacus Medicine), the pharmaceutical industry received welcome guidance as to the extent to which brand owners may oppose the repackaging of medicinal products to comply with EU rules on tamperproof packaging.Continue Reading Tampering with the packaging? Further EU Court of Justice guidance for parallel traders