In order to receive an opinion, an application (in a free form) must be submitted with a request to perform an evaluation of the product and to provide an opinion regarding its compliance with the definition of veterinary medicinal products.
An application signed with an e-signature may also be submitted electronically by e-mail.
It may also be submitted via the e-address of the institution.
The costs of the assessment shall be covered by a person who has submitted an application for conformity assessment of the product. The service charge is specified in the price list.
The PVD may request from the manufacturer or distributor of the product under assessment:
- the name, address and registration number of the manufacturing or distribution authorisation;
- the name, component and quantity of the product in the same packaging in units of mass or volume;
- a description of the characteristics, composition of the product, the specific ingredients determining the characteristics and effects of the product and the quantities of these ingredients in the product;
- the recommended use and dose or exposure of the product (product quantity and duration of exposure at the same time of treatment of the animal);
- the type and size of the packaging;
- the labelling text and, if necessary, a sample of the instructions for use, as well as other information about the product to be evaluated.
Receipt of services
Within the working day following the preparation of the opinion, the PVD shall send it to the person requesting the opinion and, in the form of an electronic document, to the competent authority on the initiative of which the product has been evaluated. If the product complies with the definition of veterinary medicinal products in accordance with the opinion of the PVD, the requirements of the regulatory enactments regulating the circulation of veterinary medicinal products shall apply to the