3.2.1: About CMD(h) (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: CMD(h)-Referrals
3.2.6: Product Information
3.2.7: Advice from CMD(h)
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)

Variation Procedure

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Draft Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure (Revision 7, March 2010)
Clean version Click here

Track changes Click here

Note: The Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure, taking into account Commission Regulation No 1234/2008, is published as a draft document and subject to review following the publication of the relevant Commission guidelines.

Please note that the Chapter 1 has been reviewed and can be considered as final.

Timetables for request to CMD(h) for a recommendation on the classification of an unforeseen variation - Article 5 (April 2009)
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For the template of the Article 5, please refer to Variations

           For the templates Type II variation ´Preliminary Variation Assessment
          Report´ and ´Type II variation Final Variation Assessment Report´,
           please refer to Assessment Report

EMA/CMDh explanatory notes on Variation Application Form - Human medicinal products only (Latest update: February 2010)
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Common grounds seen for invalidation/delaying day 0 for Variations (September 2008)
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Cover letter for Variation Applications in the Mutual Recognition Procedure (Latest update: December 2009)
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Questions & Answers - List for the Submission of Variations according to Commission Regulation (EC) 1234/2008 (February 2010)
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Implementation of Variation Regulation 1234/2008 in each Member State for Medicinal Products authorised by purely national procedures (Latest update: February 2010)
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