Regulation No 64 of 16 May 2006 on terms and procedure for the submission of information on pharmacovigilance.

This Regulation sets out the conditions, order and frequency of the mandatory submission of information on the observed adverse reactions in animals and/or humans arising from the use of veterinary medicinal products.
Also analysis of residues of veterinary medicinal products, the maximum residue limit of veterinary medicinal products in raw materials from treated animals or products thereof are object of this text.
The official marketing authorization holder shall be responsible for organizing and maintaining a system for tracking and evaluating all reports on suspected adverse reactions occurring during routine use of veterinary medicinal products, a process including various participants, from veterinary services to animal holders.
The Annex is part of this publication (administrative forms; list of minimum emergency response information).