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The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) was set up in 2005. contains further information on the CMDh and its work, including statistics, guidance documents, question-and-answer documents, work plans, annual reports and information on the applications referred
CMDh Recommendation on the Summary of the Pharmacovigilance System and Risk Management Plan in the Mutual Recognition and Decentralised Procedures (October 2015) [Track version]. CMDh Best Practice Guide for the Public Assessment Report and Summary Public Assessment Report in MRP / DCP (September
Guidance Documents. Paediatric Worksharing. Recommendations on submission and assessment in paediatric worksharing (March 2013) [Track version]. Paediatric Regulation: Article 45. Best Practice Guide Article 45 - EU Worksharing procedure (February 2012) [Track version]. Paediatric Regulation: Article 46.
12 Feb 2018 Observer status can be granted in line with the CMDh Rules of Procedure to other institutions (e.g. accession countries). The Chairperson of the CMDh is elected for a term of three years. According to the Rules of Procedure, the CMDh has one elected Vice-Chairperson elected for a term of three years.
CMDh Best Practice Guide on the use of eCTD in the MRP / DCP (July 2017) [Track version] Any change requests for the document should be handled in accordance with the change request instructions given on the EMA eSubmissions website. Q&A on Mandatory eCTD in MRP and how to manage changes to eCTD
Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition Procedure (Please note: for purely national Marketing Authorisations these Best Practise Guides will apply from 4 August 2013). Chapter 1: CMDh BPG for the allocation of the mutual recognition variation number for
CMDh Guidance Document for Submission of Summary of the Pharmacovigilance System (July 2015) [Track version]. Requirements on submissions (number and formats) for New Applications within MRP , DCP or National procedures · Languages to be used for Marketing Authorisation Application (MAA), Variations and
Annons