Inspection Process and Timelines
- Within 20 business days after the examination of the application, the FVS shall assess the compliance of the manufacturer (including foreign manufacturers)/importer of veterinary medicinal products by performing an inspection. During the inspection, the conformity of the premises, equipment, devices, personnel and documentation intended for the manufacture or import of veterinary medicinal products with the requirements set out in the legislation on the manufacture and control of veterinary medicinal products, the procedures for the issuing of the good manufacturing practice compliance certificates to the manufacturer of medicinal products, and with the requirements for the qualification and professional experience of the official responsible for the manufacture of the veterinary medicinal product shall be verified.
- The inspection shall be carried out, within the scope of their competences, by authorised officials of the FVS, who have been trained to control compliance with the requirements of good manufacturing practice and have the right:
- to inspect manufacturers and laboratories that perform the control of veterinary medicinal products on commission by the licence holder (owner),
- to take samples, including for the purpose of independent analysis of veterinary medicinal products by a laboratory authorised to carry out the control of medicinal products. The costs associated with the inspection and testing of the veterinary medicinal products shall be borne by the person being examined,
- to examine the documents relating to the inspected object as regards the description of the production methods, within the limits of their authority.
- Initially, the FVS agrees with the veterinary medicinal product manufacturer/importer on the time of inspection by sending an electronic mail. Not later than within 10 business days prior to the inspection, the FVS shall send an official letter to the manufacturer/importer of the veterinary medicinal product, informing him of the time, procedure, documents to be inspected and inspectors participating in the inspection, as well as indicating that the inspection plan may be changed, depending on the deficiencies found.
- If required, the letter shall be accompanied by the list containing information on the documents that the manufacturer of the veterinary medicinal products must submit prior to the planned inspection and time limits for the submission thereof, to enable the FVS to properly prepare for the inspection.
- Depending on the size and complexity of the company, the inspection can last from 1 to 5 days.