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• Best Practice Guide for the Decentralised and Mutual Recognition Procedures  (April 2022) [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 (April 2022) [Track version]

• Recommendations on Informed Consent Applications in Mutual Recognition and Decentralised Procedures (March 2023) [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 (December 2022) [Track version]

• CMDh Guidance Document for Submission of Summary of the Pharmacovigilance System (May 2023)[Track version]

• Requirements on Submissions for New Marketing Authorisation Applications within MRP, DCP and National Procedures

• Languages to be used for Marketing Authorisation Applications (MAAs), Variations and Renewals - National, Mutual Recognition and Decentralised applications(December 2020) [Track version]

• Mock-ups, Specimens and Samples for new applications (December 2020) [Track version]

• 'Blue-box' requirements  (July 2024) [Track version]

• CMDh SOP on decision-making process for new active substance status or extension of marketing protection or data exclusivity [Track version](June 2023)

• User Guide for the electronic Application Form for a Marketing Authorisation (September 2023) [Track Version]

• CMDh Best Practice Guide on Multilingual Packaging (June 2024) [Tracked version]

• Procedural advice on Validation of MR/Repeat-use/DC Procedures (July 2022) [Track version]

• 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 (August 2024) [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 (September 2022) [Track version]

• CMS Validation Checklist for human medicinal products in DCP (July 2022) 

• RMS Validation Checklist for human medicinal products in DCP (September 2022) 

• CMS validation checklist in MRP (May 2023)

Introduction to Published Papers on Validation has been taken off the website as it was considered to be obsolete.