S.L. 458.34 Art. 12Processing of application.

It shall be the duty of the Authority to ensure that the procedure for granting a marketing authorisation for medicinal products is completed within a maximum of two hundred and ten days after the submission of a valid application: Provided that applications for marketing authorisations in two or more Member States in respect of the same medicinal product shall be submitted in accordance with the mutual recognition and decentralised procedures.