To the attention of Marketing Authorisation Holders
As regards imprinting with the number of NAMMD approval and date of release of advertising material to the general public, in accordance with SCD No. 31/01.11.2010, Article 5, please be advised that materials will only be imprinted with “No. ………/…………….”, ruling out the phrase “This advertising material has NAMMD approval”. Consequently, all material under assessment and yet to be submitted for assessment will contain the approval number and the date of release only (e.g. “20/01.03.2011”). Article 5 of SCD No. 31 will be brought to the attention of the SC in view of amendment at its next meeting.
As regards material meant for healthcare professionals, please be advised that the Guideline on advertising stipulates that these should contain a shortened version of the SmPC. In the following SC meeting, the NAMMD will propose a font for the SmPC information in order to ensure readability, i.e.: characters should be of minimum 3 mm in size.