Overview
Enables the applicant to get a positive evaluation for veterinary medicinal products that are authorised through Regulation 4(2)of Subsidiary Legislation 437.47.
What You'll Get
Certificate if the application is positively evaluated.
Eligibility
Veterinary wholesale dealers and intended authorisation holders.
Application Requirements
Fill in the online form and submit.
Required documents:
i) Copy of a Good Manufacturing Practice (GMP) granted to the manufacturer of the product (if available)
ii) Curriculum Vitae of the Qualified Person (QP) in charge of Adverse Drug Reactions (ADR) and product defects reporting
iii) Copies of the proposed Summary of Product Characteristics (SmPC), Package Information Leaflet (PIL) and mock-ups of outer and inner packs (if applicable)
iv) Proof of establishment of the proposed Authorisation Holder in an EU/EEA country
v) Proof of payment
vi) Label on the outer pack that indicated that the product is for non-food animals and which mentions the target species
Timeline
[{"Id":"9f6a516e-f542-ec11-80ed-005056867883","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":"ec6a516e-f542-ec11-80ed-005056867883","StageName":"Vetting 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":"1 month"},{"Id":"0a6b516e-f542-ec11-80ed-005056867883","StageName":"Processing of Application","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":"1 month"},{"Id":"1d6b516e-f542-ec11-80ed-005056867883","StageName":"Delivery of Service","StageNumber":4,"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":"1 month"}]
apply
