S.L. 458.34 Art. 24Application for variation.

A marketing authorisation holder may apply to vary the marketing authorisation, which has been granted in accordance with regulations 22 and 23, and such application shall be submitted to the Authority and to all other Member States which have previously authorised the medicinal product concerned. This regulation shall apply by analogy to medicinal products authorised by the Authority following an opinion of the Committee given in accordance with Article 4 of Directive 87/22/ EEC before 1 January, 1995.