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- Decentralised Procedure Members States' Standard Operating Procedure(September 2020) [Track version]
- Recommendations on submission dates in 2020 for Applicants of the DCP(October 2019)
- Recommendations on submission dates in 2021 for Applicants of the DCP (October 2020)
- Flow chart of the Decentralised Procedure (June 2020) [Track version]
- National recommendations for requests to act as RMS(February 2020)
New information regarding allocation of DCP slots The Coordination Group for Mutual Recognition and Decentralised Procedures ( CMDh ) develops and publishes corresponding guidelines on the DCP on its website, where further information on the procedure can be found, e.g. The Invoke-WebRequest cmdlet sends HTTP and HTTPS requests to a web page or web service. It parses the response and returns collections of links, images, and other significant HTML elements. This cmdlet was introduced in PowerShell 3.0. Beginning in PowerShell 7.0, Invoke-WebRequest supports proxy configuration defined by environment variables.
In order to view some of the documents on this website you need Acrobat Reader
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- Best Practice Guide for the Decentralised and Mutual Recognition Procedures (September 2020) [Track version]
- Best Practice Guide on the Assessment Report for Mutual Recognition and Decentralised Procedures (September 2020) [Track version]
- Best Practice Guide on Break-out Sessions/Hearings (April 2016) [Track version]
- Best Practice Guide for authorisation of non-prescription medicines in the Decentralised and Mutual Recognition procedures (January 2019) [Track version]
Cmdh Slot Request Form 9465
- Recommendations on Informed Consent Applications in Mutual Recognition and Decentralised Procedures(April 2015) [Track version]
- Recommendations on Multiple/Duplicate Applications in Mutual Recognition and Decentralised Procedures(May 2016) [Track version]
- MSs Recommendations on Extension Applications in Mutual Recognition and Decentralised Procedures (September 2020) [Track version]
- Position Paper concerning Applicants’ request of submission of multiple applications during ongoing DCPs or inclusion of new CMS or additional strength(s) in an already ongoing DCP(October 2017) [Track version]
- CMDh Guidance Document for Submission of Summary of the Pharmacovigilance System(July 2015)[Track version]
- Languages to be used for Marketing Authorisation Applications (MAAs), Variations and Renewals - National, Mutual Recognition and Decentralised applications (July 2020) [Track version]
- Mock-ups, Specimens and Samples for new applications(October 2016) [Track version]
Cmdh Slot Request Form Sss
- 'Blue-box' requirements (September 2020) [Track version]
- CMDh SOP on decision-making process for new active substance status or extension of marketing protection or data exclusivity [Track version](October 2017)
- User Guide for the electronic Application Form for a Marketing Authorisation (July 2018) [Track Version]
- (June 2020) [Tracked version]
- Procedural advice on Validation of MR/Repeat-use/DC Procedures (June 2019)
- Data requested for New Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/Recommendation papers(November 2020) [Track version]
- Member States Recommendations on the Cover Letter for New Applications submitted through MRP/DCP (January 2018) [Track version]
- CMDh Best Practice Guide on the compilation of the dossier for New Applications submitted in Mutual Recognition and Decentralised Procedures (Febuary 2020) [Track version]
- CMS Validation Checklist for human medicinal products in DCP(March 2020)
- RMS Validation Checklist for human medicinal products in DCP(April 2020)
Introduction to Published Papers on Validation has been taken off the website as it was considered to be obsolete.