Overview
Application of authorisation in line with regulation 4(2) of the Medicines (Marketing Authorisation) Regulations, in accordance with article 126(a) of Directive 2001/83/EC. This legal basis is to be used only on grounds of public health need and for placing products on the market in Malta only.
What You'll Get
Authorisation/Renewal in line with regulation 4(2) of the Medicines (Marketing Authorisation) Regulations, in accordance with article 126(a) of Directive 2001/83/EC.
Eligibility
Companies wishing to place a medicinal product on the Maltese market which is already authorised in another EU/EEA Member State.
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":"0fbb3950-cea4-e911-80d5-005056860673","StageName":"Approval of Application","StageNumber":3,"AddressName":"Medicines Authority","AddressLine1":"Sir Temi Zammit Buildings","AddressLine2":"Malta Life Sciences Park","AddressLine3":null,"AddressCity":"San Gwann","AddressPostalCode":"SGN 3000","AddressCountry":"Malta","AddressTelephone":"2343 9000","AddressEmail":"info.medicinesauthority@gov.mt","Duration":"1.5 months"},{"Id":"bbc93950-cea4-e911-80d5-005056860673","StageName":"Delivery of Service","StageNumber":4,"AddressName":"Medicines Authority","AddressLine1":"Sir Temi Zammit Buildings","AddressLine2":"Malta Life Sciences Park","AddressLine3":null,"AddressCity":"San Gwann","AddressPostalCode":"SGN 3000","AddressCountry":"Malta","AddressTelephone":"2343 9000","AddressEmail":"info.medicinesauthority@gov.mt","Duration":"5 days"},{"Id":"8b89225a-cea4-e911-80d5-005056860673","StageName":"Submission of Application","StageNumber":1,"AddressName":"Medicines Authority","AddressLine1":"Sir Temi Zammit Buildings","AddressLine2":"Malta Life Sciences Park","AddressLine3":null,"AddressCity":"San Gwann","AddressPostalCode":"SGN 3000","AddressCountry":"Malta","AddressTelephone":"2343 9000","AddressEmail":"info.medicinesauthority@gov.mt","Duration":null},{"Id":"de93d780-1ef7-e911-80d7-005056860f48","StageName":"Vetting of Application","StageNumber":2,"AddressName":"Medicines Authority","AddressLine1":"Sir Temi Zammit Buildings","AddressLine2":"Malta Life Sciences Park","AddressLine3":null,"AddressCity":"San Gwann","AddressPostalCode":"SGN 3000","AddressCountry":"Malta","AddressTelephone":"2343 9000","AddressEmail":"info.medicinesauthority@gov.mt","Duration":"5 days"}]
apply
