Process description
Service requests
In order to receive a registration certificate, the owner of the registration certificate shall submit a written submission regarding the registration of veterinary medicinal products to the Food and Veterinary Service.
When submitting the registration application electronically, complete a special online form on the EUROPEAN Common Register for Medicinal Products Portal CESP or the European Medicines Agency secure file exchange system Eudralink.
The submitter of the application shall attach to the registration application the documents, which shall include administrative information, and the scientific documentation necessary to demonstrate the safety, efficacy and quality of the veterinary medicinal product to be registered in accordance with 18.07.2006 Annex 2 (for non-immunological veterinary medicinal products), Annex 3 (for immunological veterinary medicinal products), Annex 3.1 or Annex 3.2 to BOM Regulation No 600 “Procedures for the Registration of Veterinary Medicinal Products”.
An application signed electronically may be submitted by e-mail or by an e-address of the institution.
The service charge is specified in the price list.Receipt of services
Receipt of services according to the application of choice.