Authorisation of a Veterinary Medicine in Line with Regulation 4(2) of Subsidiary Legislation 437.47
ID Card No
Building Entry Point Name
Disclaimer on personal data
The 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
Quantity per unit dose
Proposed legal status
Proposed package size/s
Proposed 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 an Authorisation Holder of a product fill in only the box entitled 'Authorisation Holder Number 'with the number that has been given to you by the Department.
Authorisation Holder Number
Person / Company authorised for communication on behalf of the 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
Manufacturer Authorisation details
Manufacturer authorisation number (if applicable)
Intended local distributor (If applicable)
Number of the Intended local distributor
Declaration for placing the veterinary medicinal product on the market
I shall fulfil all obligations concerning post-licensing commitments, including submission to the Veterinary Medicines Section of any variations concerning the product.
Declaration on the use of the product:
I shall label the product in a way that it clearly indicates that the product can be administered only to small non-food animals as provided by Regulation 4(2) of Subsidiary Legislation 437.47.
Documents to be attached with the application form
* Not mandatory