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.
Application Requirements
Fill in the online form.
Applications must be sent to the Malta Medicines Authority through the Common EU Submission Portal
https://cespportal.hma.eu.
Timeline
[{"Id":"1fba3950-cea4-e911-80d5-005056860673","StageName":"Approval of Application","StageNumber":4,"AddressName":"Malta Medicines Authority","AddressLine1":"Medical Device Unit","AddressLine2":"Sir Temi Zammit Buildings","AddressLine3":"Malta Life Sciences Park","AddressCity":"San Gwann","AddressPostalCode":"SGN 3000","AddressCountry":"Malta","AddressTelephone":"2343 9000","AddressEmail":"mdforms.medicinesauthority@gov.mt","Duration":"1 month"},{"Id":"ffc13950-cea4-e911-80d5-005056860673","StageName":"Assessment of Application","StageNumber":3,"AddressName":"Malta Medicines Authority","AddressLine1":"Medical Device Unit","AddressLine2":"Sir Temi Zammit Buildings","AddressLine3":"Malta Life Sciences Park","AddressCity":"San Gwann","AddressPostalCode":"SGN 3000","AddressCountry":"Malta","AddressTelephone":"2343 9000","AddressEmail":"mdforms.medicinesauthority@gov.mt","Duration":"1 day"},{"Id":"79c83950-cea4-e911-80d5-005056860673","StageName":"Delivery of Service","StageNumber":5,"AddressName":"Malta Medicines Authority","AddressLine1":"Medical Device Unit","AddressLine2":"Sir Temi Zammit Buildings","AddressLine3":"Malta Life Sciences Park","AddressCity":"San Gwann","AddressPostalCode":"SGN 3000","AddressCountry":"Malta","AddressTelephone":"2343 9000","AddressEmail":"mdforms.medicinesauthority@gov.mt","Duration":"5 days"},{"Id":"4988225a-cea4-e911-80d5-005056860673","StageName":"Submission of Application","StageNumber":1,"AddressName":"Malta Medicines Authority","AddressLine1":"Medical Device Unit","AddressLine2":"Sir Temi Zammit Buildings","AddressLine3":"Malta Life Sciences Park","AddressCity":"San Gwann","AddressPostalCode":"SGN 3000","AddressCountry":"Malta","AddressTelephone":"2343 9000","AddressEmail":"mdforms.medicinesauthority@gov.mt","Duration":null},{"Id":"d193225a-cea4-e911-80d5-005056860673","StageName":"Vetting of Application","StageNumber":2,"AddressName":"Malta Medicines Authority","AddressLine1":"Medical Device Unit","AddressLine2":"Sir Temi Zammit Buildings","AddressLine3":"Malta Life Sciences Park","AddressCity":"San Gwann","AddressPostalCode":"SGN 3000","AddressCountry":"Malta","AddressTelephone":"2343 9000","AddressEmail":"mdforms.medicinesauthority@gov.mt","Duration":"12 days"}]
apply
