Overview
A final national stage that enables applicants to obtain a Marketing Authorisation according to the Decentralised procedure (DCP), or the Mutual Recognition Procedure (MRP).
What You'll Get
Certificate if the application is positively evaluated.
Eligibility
Market Authorisation Holders (MAH).
Application Requirements
Fill in the online form and submit.
Required documents:
i) Proof of payment
ii) Curriculum Vitae of Qualified Person
iii) Copies of the Summary of Product Characteristics (SmPC) and Package Information Leaflet (PIL)
iv) Mock-ups of the outer and immediate labelling of the product. The Maltese Marketing Authorisation number should be clearly visible on the outer pack
v) Letter of access of Market Authorisation Holders (MAH)
Timeline
[{"Id":"6e936c5a-37d7-ec11-80f1-da8f3f5f197c","StageName":"Submission of Application","StageNumber":1,"AddressName":"Animal Health and Welfare Department","AddressLine1":"Abattoir Street","AddressLine2":null,"AddressLine3":"Albertown","AddressCity":"Marsa","AddressPostalCode":"MRS1123","AddressCountry":null,"AddressTelephone":"+ 356 2095 3791 / + 356 2095 3804","AddressEmail":"veterinarymedicine@gov.mt","Duration":null},{"Id":"81936c5a-37d7-ec11-80f1-da8f3f5f197c","StageName":"Vetting and Approval of Application","StageNumber":2,"AddressName":"Animal Health and Welfare Department","AddressLine1":"Abattoir Street","AddressLine2":null,"AddressLine3":"Albertown","AddressCity":"Marsa","AddressPostalCode":"MRS1123","AddressCountry":null,"AddressTelephone":"+ 356 2095 3791 / + 356 2095 3804","AddressEmail":"veterinarymedicine@gov.mt","Duration":"15 days"},{"Id":"94936c5a-37d7-ec11-80f1-da8f3f5f197c","StageName":"Delivery of Service","StageNumber":3,"AddressName":"Animal Health and Welfare Department","AddressLine1":"Abattoir Street","AddressLine2":null,"AddressLine3":"Albertown","AddressCity":"Marsa","AddressPostalCode":"MRS1123","AddressCountry":null,"AddressTelephone":"+ 356 2095 3791 / + 356 2095 3804","AddressEmail":"veterinarymedicine@gov.mt","Duration":"15 days"}]
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