Commission Directive 91/412/EEC laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products.

This Directive lays down the principles and guidelines of good manufacturing practice for veterinary medicinal products whose manufacture requires the authorization referred to in article 24 of Directive 81/851/EC. The manufacturers shall ensure that the manufacturing operations are carried out in accordance with good manufacturing practice and with the manufacturing authorization. The manufacturer shall establish and implement an effective pharmaceutical quality assurance system, involving the active participation of the management and personnel of the different services involved. At each manufacturing site, the manufacturer shall have competent and appropriately qualified personnel. Premises and manufacturing equipment shall be located, designed, constructed, adapted and maintained to suit the intended operations.