S.L. 458.33 Art. 8Mockups.

(1) One or more mock-ups of the outer packaging and the immediate packaging of a medicinal product, together with the draft package leaflet, shall be submitted to the Licensing Authority, hereinafter called the Authority, when the marketing authorisation is requested. The results of assessments carried out in co-operation with target patient groups shall also be provided to the Authority.

(2) The Authority shall refuse the marketing authorisation if the labelling or the package leaflet do not comply with any of the provisions of these regulations or if they are not in accordance with the particulars listed in the summary of product characteristics:

Provided that the Authority shall not prohibit or impede the placing on the market of medicinal products on grounds connected with labelling or the package leaflet where these comply with the requirements of these regulations.

(3) All proposed changes to an aspect of the labelling or the package leaflet covered by these regulations which are not connected with the summary of product characteristics shall be submitted to the Authority: Provided that if the Authority does not oppose a proposed change within ninety days of receipt of the request, the applicant may put the change into effect: Provided further that the legal liability of the manufacturer and the marketing authorisation holder shall remain unaltered if the Authority, contrary to the provisions of this regulation, approves a marketing authorisation or a change to the labelling or the package leaflet.