Overview
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.
Eligibility
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.
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
5 days
Approval of Application
20 days
Delivery of Service
5 days
