Any decision referred to in this Directive, taken by the competent authorities of the Member States, may only be taken on the grounds set out in this Directive and shall state in detail the reasons on which it is based.

Such a decision shall be notified to the party concerned who shall at the same time be informed of the remedies available to him under current legislation and the time allowed for seeking such remedies.

F1Decisions to grant or revoke a marketing authorisation shall be made publicly available.