Due to Brexit, as of 30 March 2019, Great Britain will not be able to act as the RMS in DCP and MRP procedures. In cases where the RMS for an authorised medicinal product is Great Britain, it will be therefore necessary to transfer this role to another EU Member State by the time of Brexit, under the conditions stipulated by the CMDh guidance. SÚKL is prepared to take over the role of the RMS.
A reimbursement of costs in the amount of 100,000 CZK per each strength/pharmaceutical form of a medicinal product (code R-048) shall be made for SÚKL taking over the role of the RMS. Nevertheless, with regard to the fact that such take-over caused by Brexit represents a significant public interest driven by the effort to secure availability of medicinal products, SÚKL shall waive this payment of reimbursement of costs for each additional strength/pharmaceutical form of a medicinal product, if the marketing authorisation holder applies for such waiver. With regard to the aforementioned, as of 1 December 2018, the reimbursement of costs of taking over the role of the RMS from Great Britain will have to be made only for the entire procedure (i.e. the entire MRP number), rather than each individual medicinal product, providing the marketing authorisation holder concurrently submits a completed and justified application for waiver of reimbursement of costs, referring to Section 112, paragraph 3(b) of the Act on Pharmaceuticals – such application has to be submitted using the form provided under Annex 1 to UST-24, version 7.
The take-over of the role of the RMS is not subject to an administrative fee.
Should you have any questions regarding the take-over of the role of the RMS or the application pertaining to the RMS role take-over, please contact us at the following e-mail address: mrp@sukl
cz.
Marketing Authorisation Branch
13 November 2018
