Overview
All medicinal products for human use manufactured or imported into Malta and the EU are to be manufactured in accordance with the principles and guidelines of Good Manufacturing Practice (GMP) concerning both production and quality control.
What You'll Get
A certificate confirming that a particular establishment is working in line with the EU Good Manufacturing Practice standards
Eligibility
Manufacturers.
Application Requirements
Fill in the online form, print it, sign it, and send it via email to:
inspectorate.adm@gov.mt
Timeline
[{"Id":"4788225a-cea4-e911-80d5-005056860673","StageName":"Submission of Application","StageNumber":1,"AddressName":"Medicines Authority","AddressLine1":"Medical Device Unit","AddressLine2":"Sir Temi Zammit Buildings","AddressLine3":"Malta Life Sciences Park","AddressCity":null,"AddressPostalCode":"SGN 3000","AddressCountry":"Malta","AddressTelephone":"2343 9000","AddressEmail":"mdforms.medicinesauthority@gov.mt","Duration":null},{"Id":"cf93225a-cea4-e911-80d5-005056860673","StageName":"Vetting of Application","StageNumber":2,"AddressName":"Medicines Authority","AddressLine1":"Medical Device Unit","AddressLine2":"Sir Temi Zammit Buildings","AddressLine3":"Malta Life Sciences Park","AddressCity":null,"AddressPostalCode":"SGN 3000","AddressCountry":"Malta","AddressTelephone":"2343 9000","AddressEmail":"mdforms.medicinesauthority@gov.mt","Duration":"10 days"},{"Id":"fdc13950-cea4-e911-80d5-005056860673","StageName":"Assessment of Application","StageNumber":3,"AddressName":"Medicines Authority","AddressLine1":"Medical Device Unit","AddressLine2":"Sir Temi Zammit Buildings","AddressLine3":"Malta Life Sciences Park","AddressCity":null,"AddressPostalCode":"SGN 3000","AddressCountry":"Malta","AddressTelephone":"2343 9000","AddressEmail":"mdforms.medicinesauthority@gov.mt","Duration":"6 months"},{"Id":"1dba3950-cea4-e911-80d5-005056860673","StageName":"Approval of Application","StageNumber":4,"AddressName":"Medicines Authority","AddressLine1":"Medical Device Unit","AddressLine2":"Sir Temi Zammit Buildings","AddressLine3":"Malta Life Sciences Park","AddressCity":null,"AddressPostalCode":"SGN 3000","AddressCountry":"Malta","AddressTelephone":"2343 9000","AddressEmail":"mdforms.medicinesauthority@gov.mt","Duration":"5 days"},{"Id":"77c83950-cea4-e911-80d5-005056860673","StageName":"Delivery of Service","StageNumber":5,"AddressName":"Medicines Authority","AddressLine1":"Medical Device Unit","AddressLine2":"Sir Temi Zammit Buildings","AddressLine3":"Malta Life Sciences Park","AddressCity":null,"AddressPostalCode":"SGN 3000","AddressCountry":"Malta","AddressTelephone":"2343 9000","AddressEmail":"mdforms.medicinesauthority@gov.mt","Duration":"2 days"}]
apply
