Overview
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.
Eligibility
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.
Applications must be sent to the Malta Medicines Authority through the Common EU Submission Portal https://cespportal.hma.eu.
Timeline
Submission of Application
Vetting of Application
12 days
Assessment of Application
1 day
Approval of Application
1 month
Delivery of Service
5 days
