01
Seven questions
HOW
Answer for the product as you intend to sell it — the claims you will make, not the ones you could defend. Classification turns on presentation as much as on formulation, so a product becomes a medicine the moment you say it treats something, whether or not it does.
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02
Result
Most likely regime
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How the regimes score
RELATIVE WEIGHTWhat drove this
What that regime requires
The classification is free · the reasoning and route are the paid part
LIMITS
Classification is decided case by case by a competent authority, not by a tool. The MHRA, and each Member State authority, assess the whole picture — claims, composition, mode of action, presentation, and how a consumer would actually use the product. Two products with identical formulas can land in different regimes because of how they are described, and the same product can be classified differently in different Member States.
This weighs the answers you gave against the legal definitions. It has not seen your formula, your artwork or your advertising. Where the answer is close, that is a signal to get a written view from the authority before you commit — not to pick the regime you prefer. Under Article 2(2) of Directive 2001/83/EC, where a product could fall under both the medicinal definition and another regime, the medicinal legislation applies.
This weighs the answers you gave against the legal definitions. It has not seen your formula, your artwork or your advertising. Where the answer is close, that is a signal to get a written view from the authority before you commit — not to pick the regime you prefer. Under Article 2(2) of Directive 2001/83/EC, where a product could fall under both the medicinal definition and another regime, the medicinal legislation applies.