S.L. 437.47 Art. 39Manufacturing authorisation for veterinary medicinal products and active substances.

(1) (a)No veterinary medicinal product, biological active substance, or active substance to be used directly as an investigational veterinary medicinal product, may be manufactured in Malta unless there is, in respect of such product or substance, a

Manufacturing Authorisation.

This Manufacturing Authorisation shall also be required for the processes of sterilisation of active substances.

(b) The Manufacturing Authorisation shall also be required for the manufacture of veterinary medicinal products intended for export.