S.L. 458.33 Art. 11Suspension of marketing authorisation.

The Authority shall suspend the marketing authorisation if, after the serving of a notice on the marketing authorisation holder, the labelling and the package leaflet of the medicinal product in question do not comply with any of the provisions of these regulations. Such suspension shall cease to be effective as soon as the labelling and package leaflet of the product in question have been made to comply with the requirements of these regulations.