Updates

From pet food to veterinary medicines: we want the best for our companion animals

Premium pet food is booming, marketed with language borrowed straight from the food aisle. But legally, pet food is not food at all: it is feed, governed by an entirely different set of EU rules on labelling, ingredients and claims. Where exactly is the line between a bag of kibble, a specialised nutritional feed and a veterinary medicinal product, and how easily can a bold marketing claim push a product across it?

New working arrangements between Dutch Food Safety Authority and Inspection Board Health Products

In the Netherlands, advertising disputes over health products rarely reach the civil courts. Instead, self-regulation by the Inspection Board plays a central role, working hand in hand with the Dutch Food Safety Authority (NVWA). New working arrangements between the two bodies, in force until the end of 2027, set out exactly when a case stays within self-regulation and when NVWA steps in directly. With the line between a lawful health claim and an unauthorised medical claim often razor-thin, knowing which route applies matters.

Oat beta-glucans and the glucose peak: a new health claim is on its way

That familiar afternoon slump after a carb-heavy lunch is not just a matter of energy levels, it is now also a matter of EU food law. Positive outcomes in the EU health claim authorisation process are rare, which makes a new EFSA opinion on oat beta-glucans and the glucose peak all the more remarkable, especially since it was obtained via a route that has produced only a handful of successes. The wording of the new claim also differs slightly but significantly from an already authorised 2012 claim, with real legal and commercial consequences.

We have conducted regulatory due diligence on behalf of a private equity firm in connection with the acquisition of a medical device manufacturer, covering MDR compliance (including notified body certificates and post-market surveillance obligations), as well as data protection aspects.

On behalf of a medical device company, we reported a personal data breach to the supervisory authority and have advised on internal communication.

We set up procedures for multiple clients continues transfers of personal data beyond the EU, including to countries without an adequate data protection regime, for various purposes.

We have assisted a client in setting up a multinational data strategy, including advice on anonymisation of personal data and interaction product regulations and the upcoming high-risk regime under the European Health Data Space Act (EHDS Act) to help them continue innovating without endangering company confidential developments.

For a client conducting a multinational clinical investigation, we have drafted informed consent notices that allow for long term use of clinical research data beyond the confines of the study.

We have trained the entire regulatory team of a medical device company on understanding GDPR compliance in a clinical research setting.

We have created the data protection strategy for a long-term registry study.