Process description
Service requests
An application for conformity assessment of a wholesaler of veterinary medicinal products or a veterinary pharmacy shall be submitted.
• wholesalers of veterinary medicinal products must submit an application and ensure:
1) appropriate appropriate facilities, technical equipment and equipment, including control equipment, in order to properly preserve and distribute veterinary medicinal products in accordance with the requirements specified in regulatory enactments regarding the distribution and control of veterinary medicinal products;
2) the submitter has at his or her disposal personnel and a responsible official who conforms to the requirements specified in the Pharmaceutical Law and the regulatory enactments regarding the distribution and control of veterinary medicinal products;
3) the circulation of veterinary medicinal products in conformity with the requirements specified in regulatory enactments regarding the distribution and control of veterinary medicinal products;
4) if alcohol is distributed - the circulation of alcohol in conformity with the requirements specified in the regulatory enactments regarding the procedures for the circulation of alcohol in pharmaceutical and veterinary pharmaceutical undertakings;
5) an internal quality system instruction or procedure has been developed in order to ensure the distribution of veterinary medicinal products in accordance with the regulatory enactments regarding the distribution and control of veterinary medicinal products.
• pharmacies of veterinary medicinal products must submit an application which must be accompanied by:
1) a statement regarding the conformity of premises, equipment, personnel and documentation with the requirements of these Regulations,
2) information attesting that the submitter has at his or her disposal: appropriate appropriate facilities, technical equipment and equipment, as well as documentation in order to ensure the distribution of veterinary medicinal products in accordance with the regulatory enactments regarding the distribution and control of veterinary medicinal products; an official responsible for the circulation of veterinary medicinal products in a pharmacy who complies with the requirements specified in Section 40, Paragraph four of the Pharmaceutical Law; and personnel ensuring the distribution and manufacture of veterinary medicinal products (if performed); an internal quality system instruction or procedure has been developed, in which the activities to be performed in the veterinary pharmacy have been specified, in order to ensure the distribution of veterinary medicinal products in accordance with the regulatory enactments regarding the distribution and control of veterinary medicinal products.
After the conformity assessment examination, an application for the receipt or re-registration of a special permit (licence) shall be submitted.
An application may also be submitted by e-mail, signed with an e-signature.
It may also be submitted via the e-address of the institution.
The service charge is specified in the price list. National licence fee EUR 13,52; re-registration EUR 7.11.Service Processing
Verification of conformity assessment
The Licensing Commission shall review the application, examine the conformity of the submitter with the requirements specified by the Law and take a decision regarding the granting of the licence and prepare a special permit (licence).Receipt of services
Receipt of services according to the application of choice.