Following the amendment to Article 65quater of the Royal Decree of 14 December 2006, the procedure for approval of risk minimisation activities (RMA) has been adapted. Accordingly, the RMA evaluation and approval deadlines have also been adapted. Moreover, fees must now be paid for the submission of applications for approval.
Article 65quater of the Royal Decree of 14 December 2006 on medicinal products for human and veterinary use establishes the procedure for approval of additional risk minimisation activities (RMA) i.e. information or educational materials, programmes or services for healthcare professionals or patients required for marketing certain medicinal products.
This article was amended to adapt the deadlines for the evaluation and approval of RMAs. Henceforth, submitting or not submitting the dossier to the Committee for medicines for human use for an opinion will no longer have an impact on the dossier evaluation deadline.
Furthermore, each application is now subject to the payment of a fee. Two different amounts are stipulated depending on the type of dossier. These amounts can be consulted under the heading Fees.
The new procedure is detailed in circular 635 on the RMA approval procedure by the national competent authorities. This new circular replaces circular 603, dated 23 September 2013, which no longer applies.
The form (see Dutch or French) to be filled in for submission of a RMA approval application has also been adapted.