site.btaMPs Approve Changes to Veterinary Medicine Act Related to Medicinal Products

On Wednesday, MPs voted at a second reading on changes to the Veterinary Medicine Act, related to veterinary medicinal products. Both projects were introduced by Hristo Daskalov (Continue the Change-Democratic Bulgaria) and a group of MPs. With the voted changes, the term "veterinary medical products" is replaced by "veterinary medicinal products".

The current licensing regimes for use, manufacturing, wholesale and retail of veterinary medicinal products are replaced by indefinite permits for trade, manufacture, wholesale and retail, respectively. The licensing regimes of homeopathic and immunological veterinary medicinal products become object to registration. 

The permits to trade in veterinary medicinal products will be valid only on the territory of Bulgaria, and under certain circumstances the head of the Bulgarian Food Safety Agency will be able to issue a trade permit for a limited market, valid for five years, or a trade permit in exceptional circumstances, valid for one year. The conditions and procedure for submitting information, the procedures for processing the signals and the evaluation of the results related to the pharmacovigilance system , will be determined by an ordinance of the Minister of Agriculture and Food.

The Bulgarian Food Safety Agency has been designated as the competent authority for the control of veterinary medicinal products.