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3.2.1: About CMDh (ALT-O)
3.2.2: Statistics (ALT-S)
3.2.3: Press Releases (ALT-P)
3.2.4: Procedural Guidance (ALT-L)
- 3.2.4.1: General Info (ALT-G)
- 3.2.4.2: Application for MA (ALT-T)
  - 3.2.4.2.1: DCP
  - 3.2.4.2.2: MRP
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- 3.2.4.8: USR
- 3.2.4.9: Art 61.3 Procedure (ALT-6)
- 3.2.4.10: Consultation with target patient groups
- 3.2.4.11: Post Referral Phase
- 3.2.4.12: Pandemic Plan
3.2.5: CMDh-Referrals
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3.2.7: Advice from CMDh
3.2.8: Templates
3.2.9: CMD subgroups / working groups (ALT-K)
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3.2.11: Questions & Answers (ALT-Q)
3.2.12: Contact Form
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3.2.14: What's new history (ALT-Y)

Application for Marketing Authorisation (MA)

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Best Practice Guide for the Decentralised and Mutual Recognition Procedures (March 2010)

Best Practice Guide on the Assessment Report for Mutual Recognition and Decentralised Procedures (July 2011) [Track version]

Best Practice Guide on Break-out Sessions (December 2009) [Track version]

Recommendations on Informed Consent Applications in Mutual Recognition and Decentralised Procedures (September 2010) [Track version]

Recommendations on Multiple Applications in Mutual Recognition and Decentralised Procedures (June 2007)

MSs Recommendations on Extension Applications in Mutual Recognition and Decentralised Procedures (November 2011) [Track version]

Procedural Advice on Repeat Use (July 2011) [Track version]

Declaration form for the submission of DDPS already approved by a competent authority (June 2011) [.dot]

CMDh guidance for Declaration form submission DDPS already approved by a competent authority (June 2011) [Track version]

Requirements on electronic submissions and paper documentation for New Applications within MRP, DCP or National procedures

Validation Procedure

Member state agreement upon conditions under which the RMS can start MRP/DCP (October 2011)

Procedural advice: Automatic validation of MR/Repeat-use/DC Procedures (March 2009) [Track version]

Additional Data requested for New Applications in the Mutual Recognition and Decentralised Procedures (September 2011) [Track version]

Common Grounds for Invalidation/Delaying Validation (September 2010) [Track version]

Member States Recommendations on the Cover Letter for New Applications submitted through Mutual Recognition and Decentralised Procedures (April 2008)

CMDh Best Practice Guide on the compilation of the dossier for New Applications submitted through the Mutual Recognition and Decentralised Procedures (March 2008)

Templates for the cover letter for new applications in MRP/DCP

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