Action in the Case of Non-Compliance

In cases where the manufacturer/importer fails to comply with the principles and guidelines of good manufacturing practice, the FVS is entitled to make the following decisions regarding:
 
  • certificate of good manufacturing practice:
    • a temporary suspension of the issue, stating the reasons and the time period within which the required remedial measures must be implemented, 
    • a refusal to issue a certificate of good manufacturing practice, by issuing a statement of non-compliance with good manufacturing practice. 
 
The action after the issuing of a statement of non-compliance with good manufacturing practice has been prescribed in the Compilation of Community Procedures on Inspections and Exchange of Information.
 
 
In the event of significant violations in the manufacture/importing and distribution of veterinary medicinal products, the FVS shall be entitled to make a decision on:
 
  • the refusal to issue a special permit (licence),
  • the suspension of the validity of the special permit (licence) until the deficiencies have been eliminated,
  • the withdrawal of the special permit (licence).