13.01.2012
To the attention of Marketing Authorisation Holders/ Applicants
Please be advised that, as of 16.01.2012, the marketing authorisation/MA renewal applications submitted through mutual recognition procedure (MRP) and decentralised procedure (DCP), applications for variation/change in accordance with Article 61 (3)/MA transfer/change in accordance with Order 1205/2006 for medicinal products authorised through European procedures, as well as variation applications submitted through national procedure in accordance with Order 1483/2010 are only processed on condition cover letters and payment forms have been submitted in accordance with legal provisions in force. The procedure will be renewed immediately after completion of the dossier.