Order No. 1.107 of the Ministry of Agriculture, Forests, Water and Environment validating the Regulation on the establishment of principles and guidelines regarding good manufacturing practice for veterinary medicinal products.

This Veterinary Sanitary Regulation lays down the principles and guidelines of good manufacturing practice for veterinary medicinal products the manufacture of which requires authorization in accordance with the "Veterinary Sanitary Regulation on the transposition of the Community Code on veterinary medicinal products". This veterinary health rule shall apply to medicinal products defined in accordance with the provisions of the "Veterinary health rule on the transposition of the Community Code relating to veterinary medicinal products". Through repeated inspections in accordance with the provisions of the "Veterinary Sanitary Regulation on the transposition of the Community Code on veterinary medicinal products", the central veterinary authority of Romania shall ensure that their manufacture complies with the principles and guidelines of good practice. By applying these principles and guidelines of good manufacturing practice, producers and the central veterinary authority of Romania must ensure compliance with the detailed guidelines in accordance with the normative acts in force. These detailed guidelines must be published by the Romanian central veterinary authority in the "Guide to good manufacturing practice for veterinary medicinal products" and in its annexes. Manufacturers shall ensure that manufacturing operations are carried out in accordance with good manufacturing practice and the manufacturing authorization. manufactured by duly authorized producers and in accordance with the standards of good manufacturing practice, at least equivalent to those established by the central veterinary authority of Romania. The manufacturer must ensure that all manufacturing operations subject to a marketing authorization are carried out in accordance with the information set out in the marketing authorization dossier, as accepted by the competent authorities. regularly review their manufacturing methods, to adapt them to scientific and technical progress.