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CMDh lets RMS start MR/DC procedures when CMS fail to answer validation queries

🇦🇹 BASG · Sat 31 Oct 2026

Austria's BASG newsticker says CMDh has revised its validation advice, updated RMS request templates and flagged which national requirements actually block the start of a procedure.

The Austrian medicines agency BASG has summarised recent CMDh decisions in its RMS newsticker of 31 October 2026. The main change is an update to CMDh's procedural advice on validation of mutual recognition, repeat-use and decentralised procedures. In exceptional cases, the Reference Member State may now start a procedure if the Concerned Member States do not react to the validation responses within the set deadline.

CMDh has also revised the RMS request form for decentralised procedures. Only correctly and fully completed forms will now be considered. For Article 10a applications, applicants must state whether a suitable EU reference product exists for an Article 10 application and, if so, justify choosing Article 10a. Bioequivalence or other equivalence studies require an expected or actual completion date, and ASMF applications must give the ASMF number.

The MRP/repeat-use form was reworked too. Its footnote on CEPs now reflects the need to update the dossier to the current CEP version by variation before the procedure begins, and the environmental risk assessment requirements in Module 1.6 have been clarified. Both templates are available on the CMDh and BASG websites.

CMDh also updated its two overviews of national requirements, one for new applications and one for variations and renewals in MRP/DCP. Member States have now classed each requirement as a validation issue that prevents the start of a procedure or a non-validation issue that does not. Some national requirements were deleted.

Other items include the end of the cover letter obligation for Type IA variations from 1 July 2026, with several CMDh guidance documents being updated. Version 1.28.0.0 of the MAA electronic application form, aligned with the ISO IDMP model, may be used from 1 September 2026 and becomes mandatory for all new MAA submissions to national authorities from 1 January 2027. The form version should not be changed during an ongoing procedure.

What it means for your team

  • Regulatory teams should check completed RMS request forms against the new fields (Article 10a justification, study completion dates, ASMF number) because incomplete forms will not be considered.
  • Use the CMDh's new validation-versus-non-validation classification of national requirements when planning submissions, as only validation issues prevent a procedure from starting.
  • Prepare for the eAF version 1.28.0.0: it is optional from 1 September 2026 and mandatory for new MAAs to national authorities from 1 January 2027, with no version switch mid-procedure.
  • Type IA variation submissions no longer need a cover letter from 1 July 2026, so internal templates and procedures should be updated.

Official source: BASG ↗

Article written by VigiEye from the official source (BASG). AI-assisted; check the source before acting.

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