1: Home (ALT-H)
2: HMA Joint (ALT-M)
3: Human Medicines (ALT-U)
- 3.1: Heads of Agencies (ALT-E)
- 3.2: CMDh (ALT-C)
- 3.3: MRI Product Index (ALT-R)
- 3.4: Directory (ALT-I)
4: Veterinary Medicines (ALT-V)

You are here: Human Medicines > CMDh > Procedural Guidance > General Info

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)
- 3.2.4.3: eSubmissions (ALT-N)
- 3.2.4.4: Generics
- 3.2.4.5: Applicant´s Responses
- 3.2.4.6: Renewal (ALT-W)
- 3.2.4.7: Variation
- 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
3.2.6: Product Information
3.2.7: Advice from CMDh
3.2.8: Templates
3.2.9: CMD subgroups / working groups (ALT-K)
3.2.10: Paediatric Regulation
3.2.11: Questions & Answers (ALT-Q)
3.2.12: Contact Form
3.2.13: Contact Points
3.2.14: What's new history (ALT-Y)

General Information

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Best Practice Guide for the Reference Member State in the MRP/DCP (June 2011) [Track version]

CMDh procedural advice on changing the RMS (December 2011) [Track version]

Best Practice Guide for the exchange of regulatory and administrative information regarding orphan medicinal products between EMA and National Competent Authorities (November 2011) [Track version]

CMDh agreement on sunset clause and its application to marketing authorisations granted in more than one MS (March 2011) [Track version]

Phasing in EU procedures: MRP and referrals (September 2003)

Notifications to the EMEA/CHMP in MRP/DCP (March 2006)

CMDh Recommendation for Marketing Authorisation Holders on the Pharmacovigilance System and Risk Management Plan in the Mutual Recognition and Decentralised Procedures (July 2011) [Track version]

CMDh Best Practice Guide for the Public Assessment Report in MRP/DCP (January 2006)

For the template of the Public Assessment Report and Updates, please refer to Assessment Report