Medicine or supplement? The classification question that decides your European launch
The same formula can be a medicinal product in one market and a food supplement in another — and the classification must be settled before packaging starts.
Insights
Practical notes on European market access, regulatory routes and pharmacy commercialisation — written by the team that runs it operationally.
The same formula can be a medicinal product in one market and a food supplement in another — and the classification must be settled before packaging starts.
Market size is the wrong first criterion. Regulatory route, pharmacy channel structure and pricing reference effects usually decide the better entry order.
Temperature control is the part everyone knows. Qualification, documentation and recall readiness are where audits are lost.
Under the EU Claims Regulation most marketing copy for supplements is not defensible. A practical framework for compliant messaging.
Margins, pack sizes, PZN registration and rotation expectations — the criteria behind a listing decision.
Four partnership structures, what each demands of you operationally, and when the leanest option stops being the cheapest.
Working on a launch?
Product, target markets, timeline — you get a clear next step.