Restriction of possibilities for product information on the packaging of veterinary medicinal products
Under the regulations before 28 January 2022, it was possible to include additional information on the packaging of a veterinary medicinal product. This information was provided in addition to the prescribed product information. The possibilities for this are limited under the new regulations.
For example, it was possible that a commercial product name (private label) was mentioned on the packaging next to the product name of the authorised veterinary medicinal product. In addition, it was allowed to mention the distributor. However, it was no other authorisation for a veterinary medicinal product. It was only a different label supplementing the product information of an existing veterinary medicinal product.
Under the new regulations, the possibilities have been limited. The Veterinary Medicinal Products Regulation lays down clear and limited requirements for the packaging texts. In addition, the European Union’s veterinary medicinal product database (UPD) has only one product name per marketing authorisation. There is no data field for a private label name. As a result, veterinarians and animal owners will not find the product in the UPD if they search by the private label name.
Possibilities under the Veterinary Medicinal Products Regulation
Under the current regulation, the placing on the market of an identical veterinary medicinal product under a different product name is only possible if:
- a marketing authorisation is obtained. For example through an application based on informed consent or through a duplicate application;
- the marketing authorisation holder of a veterinary medicinal product transfers this marketing authorisation to another party.
For information: The marketing authorisation holder of a veterinary medicinal product must also comply with the applicable pharmacovigilance requirements.
What do you need to do before 1 September 2023?
If you have granted private label marketing rights to third parties or if you have obtained private label marketing rights for a veterinary medicinal product from the marketing authorisation holder, you must do the following by 1 September 2023:
- submit an application based on informed consent;
- submit an application for the transfer of the marketing authorisation holder of the veterinary medicinal product;
- terminate the current process. Thereafter, the national agreements on clearance time limits as stated under the withdrawal of a marketing authorisation will apply.
For any further enquiries, please submit your questions to the Veterinary Medicinal Products Unit using our contact form. Please list the subject as ‘Other’ and state that your question relates to private label marketing rights.