A notification of variation should be provided to the competent agency in case of changes affecting labelling, packaging or SmPC of medicinal products imported through the parallel import process.

What you'll get

The changes will be notified to the competent authority.


Parallel import licence holders.

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.