Process description
Service requests
After the issuance of a special permit (licence) for the manufacture of veterinary medicinal products, the Service shall supervise the conformity of the manufacturing and control of veterinary medicinal products with the requirements:
• carry out repeated inspections of good manufacturing practices at least every three years. The Service shall agree with the manufacturer of veterinary medicinal products regarding the period of inspection and shall notify in writing no later than 10 working days before the inspection;
• if necessary, unannounced inspections shall be carried out. In this case, the samples shall be tested in a laboratory entitled to control the medicinal product.
The Service shall, within 10 working days of each inspection, draw up a good manufacturing practice control report indicating whether the manufacturer of veterinary medicinal products complies with the principles and guidelines of good manufacturing practice. One copy of the report shall be sent to the inspected manufacturer of veterinary medicinal products or the holder (owner) of the registration certificate for veterinary medicinal products, but the other copy, if necessary, shall be sent to the institution which has requested the examination.
The service charge is specified in the price list.Receipt of services
The Service shall, on the basis of a report, take an appropriate decision within one month of the completion of the examination:
• the issuing of a certificate of conformity for good manufacturing practice where the verification shows compliance with the principles and guidelines of good manufacturing practice;
• temporary postponement of the issue of a certificate of conformity for good manufacturing practice, stating the reasons and time-limits for taking the necessary measures;
• refusing to issue a certificate of conformity for good manufacturing practice. The decision regarding refusal to issue a certificate of conformity for good manufacturing practice shall be notified in writing to the manufacturer of veterinary medicinal products within five working days.
The Service shall issue a certificate of conformity of good manufacturing practice to the manufacturer of veterinary medicinal products after the manufacturer of veterinary medicinal products has paid for the issuance of the certificate