A borderline classification form should be requested to authorise products that do not clearly fall under the definition of a medicinal product as per Medicines Act, Act III of 2003.

What you'll get

A borderline classification before the product is placed on the market.


Prospective importers/licence holders of a product with an unclear classification.

How to apply

Fill in the online form.

Applications must be sent to the Malta Medicines Authority through the Common EU Submission Portal https://cespportal.hma.eu.