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HMA - Heads of Medicines Agencies

  • You are here:
  • > Human Medicines
  • > Procedural Guidance
  • > Variation

Variation Procedure

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  • Chapter 1 : CMDh BPG for the allocation of the mutual recognition variation number for Type I Notifications, Type II Variations, Grouping and Worksharing (January 2020) [ Track version ]
  • Chapter 2 : Procedure for automatic validation of Mutual Recognition Procedures for Variations  (December 2022) [ Track version ]
  • Chapter 3 : CMDh BPG for the processing of Type IA Minor Variations (Notifications) in the Mutual Recognition Procedure (December 2022) [ Track version ]
  • Chapter 4 : CMDh BPG for the processing of Type IB Minor Variations (Notifications) in the Mutual Recognition Procedure (July 2023) [ Track version ]
  • Chapter 5 : CMDh BPG for the handling of Type II Variations in the Mutual Recognition Procedure (July 2023) [ Track version ]
  • Chapter 6: CMDh BPG for the processing of Grouped Applications in the Mutual Recognition Procedure (December 2023) [ Track version ]
  • Chapter 7: CMDh BPG on Worksharing (December 2023) [ Track version ]
  • Chapter 8 : CMDh BPG on CMDh Recommendations on Unforeseen Variations (February 2022) [ Track version ]
  • Chapter 9 : CMDh BPG on fast track procedure for annual update of Human Influenza Vaccines  (July 2023) [ Track version ]
  • EMA/CMDh explanatory notes on Variation Application Form - Human medicinal products only   (July 2022) [ Track version ]
  • Examples for acceptable and not acceptable groupings for MRP/DCP products (May 2022) [ Track version ]
  • Position paper on common grounds seen for invalidation/delaying day 0 for Variations  (February 2023) [ Track version ]
  • Data requested for Variations and/or Renewal 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   (December 2023 - correction of the document published on November 2023) [ Track version ]
  • Mock-ups, Specimens and Samples for variations   (December 2020) [ Track version ]
  • Languages to be used for Marketing Authorisation Application (MAA), Variations and Renewals  - Please see Application for MA
  • Requirements on submissions for Variations and Renewals within MRP and National Procedures

Questions & Answers on variations

  • Questions and answers

Templates on variations

  • Templates Type II variation ´Preliminary Variation Assessment Report´ and ´Type II variation Final Variation Assessment Report´
  • Cover letter for Variation Applications in the Mutual Recognition Procedure

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  1. Heads of Medicines Agencies: Renewals

    >CMDh >Templates >Renewals; CMDh. About CMDh; Statistics; Agendas and Minutes; Press Releases; COVID-19; BREXIT; Nitrosamine impurities; Procedural Guidance; CMDh-Referrals; ... Cover letter template for renewals (February 2023) For the United Kingdom, as of 1 January 2021, European Union law applies only to the territory of Northern Ireland ...

  2. Heads of Medicines Agencies: Application for MA

    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 ...

  3. CMDh Best Practice Guide on the processing of renewals in the Mutual

    consists of the renewal cover letter and the renewal electronic application form (without annexes) (see section 3.6.1). As the MAH has the obligation to keep the dossier up to date throughout the lifecycle of the medicinal product no submission of the consolidated dossier is expected (see further information on documentation in Annex 3).

  4. PDF Guide to Renewal of Marketing Authorisations Human Medicines

    For a standard 30-day renewal procedure, the applicant submits a cover letter following the CMDh template format and an EU application form (without annexes) with a declaration that full documentation will be available for submission upon request. Changes to MA particulars will not be accepted during the standard renewal procedure. Please

  5. CMDh Best Practice Guide on the processing of renewals in the Mutual

    follow the shortened renewal procedure as outlined in Section 3.14. i.e. a 30-day timetable (detailed in Annex 2), submitted with a cover letter and an application form (without annexes) and a declaration that full documentation will be available for submission upon request. Changes to MA particulars will

  6. Report from the CMDh meeting held on 21-22 February

    The updated BPG will be published on the CMDh website under "Procedural Guidance > Renewal". The CMDh also agreed a corresponding update of the cover letter template for renewals. The updated template will be published under "Templates > Renewals". Further guidance documents will be revised over the coming months to be aligned with the new

  7. Cmdh Cover Letter Template

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  9. Heads of Medicines Agencies: Applications for MA

    Applications for Marketing Authorisation. Template: Cover letter for new applications submitted through MRP/DCP (October 2021) Template: Letter of access for informed consent applications (April 2015)

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  20. Variation Procedure

    Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition Procedure. Chapter 1: CMDh BPG for the allocation of the mutual recognition variation number for Type I Notifications, Type II Variations, Grouping and Worksharing (January 2020) [ Track version] Chapter 2: Procedure for automatic validation of ...