Notification of Centrally Authorised Products
ID Card No
Building Entry Point Name
Disclaimer on personal dataThe Animal Health and Welfare Department collects and processes information to carry out its functions under the Veterinary Services Act (Chapter 437) together with its subsidiary legislation. All personal data collected is processed according to the principles specified in the General Data Protection Regulation (EU 2016/679) and the Data Protection Act (Chapter 586). Such data may be disclosed to other departments and/or authorities which are directly related to the functions pertaining to the Animal Health and Welfare Department and the legislation mentioned above, however it will not be disclosed to other third parties unless obliged by law.
· A separate application form needs to be completed for each strength of the product.· A separate application form needs to be completed for dosage forms with variable volumes of the same strength and with a different target species.· The same application form can be used for dosage forms with variable volumes of the same strength and with the same target species.
Route of administration
Community marketing authorisation number of the product
The language of the Summary of Product Characteristics (SmPC), Package Information Leaflet (PIL) and outer/inner pack as procured for the Maltese Market.
Quantity per unit dose
Proposed package size/s
Target species and corresponding withdrawal Period/s (mark n/a if not applicable)
Marketing Authorisation Holder
If it is the first time you are submitting an application and the details are the same as in Page 1 fill in only the field entitled 'Telephone'. If you are already a Marketing Authorisation Holder of a product fill in only the box entitled 'Marketing Authorisation Holder Number 'with the number that has been given to you by the Department.
Market Authorisation Holder Number
Person / Company authorised for communication on behalf of the Marketing Authorisation Holder
Same as above
If you have chosen 'No' fill in the fields below.
Qualified Person (QP) for Adverse Drug Reactions (ADR) and product defects
Batch release site of the product to be placed on the Maltese market (the manufacturer as indicated on the Product Information Leaflet (PIL)
Intended local distributor (If applicable)
Number of Intended local distributor
Declaration about the language of the pack
If the outer pack and package leaflet is not in English or Maltese I will re-package and/or re-label the pack with an English or Maltese or both version of the outer pack and package leaflet.
Declaration about the ‘Product Information’
The Summary of Product Characteristics (SmPC), labelling and package leaflet (PIL) are the most recently approved ones.
Documents to be attached with the application form