Applicants should never migrate from the comprehensive to the national model. Do . Question 2.4 Currently, no variations should be submitted during ongoing Repeat Use Procedures (RUP). For repeat mutual recognition procedures, so called ‘repeat use’ procedures, the renewal timetable should follow that of the first procedure (see also Section 3.3). - Existing European MA Currently, no variations should be submitted during ongoing Repeat Use Procedures (RUP). The Coordination Group for Mutual Recognition and Decentralised Procedures - Human was set up in 2005.It replaced the informal Mutual Recognition Facilitation Group.. Q&A on MRP/DCP CMDh/274/2012,Rev3, November Rev4, December 2012 Page 4/15 and EU enlargement This document was developed to address the enlargement of the EU on 1st May 2004, it was further revised, where appropriate, to consider the accession of … procedure, the applicant will have to obtain harmonisation of the package leaflet and labelling of the medicinal product concerned by a notification present to Article 61(3) of Directive 2001/83/EC prior to start the repeat use. Appropriate times for migration from the national to the comprehensive model are at a Repeat Use Procedure or a change of RMS but it can also, after consultation with the RMS, occur at another time point in the procedure. product using the optional procedure. (CMDh) has agreed to promote the use of zero-day mutual recognition procedure/repeat use procedure to expand national marketing authorisations to new Member States who need these medicinal products. 29 October 2014 Coordination Group for Mutual Recognition and Decentralised Procedures - Human: the group responsible examination coordination of questions relating to marketing authorisation human medicines in two or more Member States accordance with mutual recognition decentralised procedure. Further procedural guidance on applications for decentralised procedures is available on the CMDh website. The CMDh examines questions relating to the marketing authorisation of human medicines in two or more European Union (EU) Member States in accordance with the mutual recognition or the decentralised procedure… BUT: different initial authorisation procedures MRP/RUP – New Timetable Differences MRP/RUP - Existing national MA - Existing German product information - Dossier update (if necessary) on national level - All CMS involved in procedure - Dossier/product information changes made during the procedure are immediately effective! More information can be found under 'Coordination Human (CMDh)'. The procedure number is the Mutual Recognition Procedure number allocated by the RMS. has to be submitted to the RMS and all CMS. For those products already licensed nationally via a harmonising procedure, agreement should be sought on a common renewal date. The Co-ordination Group for Mutual recognition and Decentralised procedures (CMDh) has published several Guidance documents regarding MRP and DCP. What about the annual reports or Type IA variations with immediate notification? “First Use” means the first Mutual Recognition Procedure. HPRA. CMDh BPG on the use of the eCTD Recommendations are given in relation to the repeat-use procedure on the coordination group website. The procedures will not be started before the RMS has received the dispatch list with the dispatch date for all CMS including a statement of the applicant that the fees have been paid, where applicable. The Co-Ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) ... renewals and repeat-use procedures. Mutual recognition procedure (MRP / Repeat Use Procedure) In the case of the Mutual recognition procedure (MRP), the RMS has already issued a marketing authorisation. All the concerned Member states should be indicated. Requests for repeat use must also be sent to RMS@hpra.ie and the HPRA will contact you by return. Please consult the HPRA website regularly for any updates and further developments in this area.
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