S.L. 437.47 Art. 5Marketing authorisation issued by the Veterinary Services.

(1) No veterinary medicinal product may be placed on the market of Malta unless a marketing authorisation has been granted by the Veterinary Services in accordance with these regulations or a marketing authorisation has been granted in accordance with

European Union Regulation (EC) No 726/2004.

When a veterinary medicinal product has been granted an initial authorisation in accordance with the first paragraph, any additional species, strengths, pharmaceutical forms, administration routes, presentations, as well as any variations and extensions, shall also be granted an authorisation in accordance with the first paragraph or be included in the initial marketing authorisation. All these marketing authorisations shall be considered as belonging to the same global marketing authorisation, in particular for the purpose of the application of regulation 13(1).

(2) The marketing authorisation holder shall be responsible for the marketing of the medicinal product. The designation of a representative shall not relieve the marketing authorisation holder of his legal responsibility.