RegulatoryOfficial

BASG newsletter: CMDh lets RMS start procedures without CMS validation replies in exceptional cases

🇦🇹 BASG · Sat 31 Oct 2026

Austria's latest RMS NEWS reports updated CMDh validation advice, revised RMS request templates for DCP and MRP/RUP, and national requirements now tagged as validation-relevant or not.

The Austrian Federal Office for Safety in Health Care (BASG) has published a new issue of its RMS NEWS newsletter, dated 31 October 2026. It summarises three recent developments from the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) that affect applicants using Austria as Reference Member State.

The CMDh has updated its procedural advice on validation of mutual recognition, repeat-use and decentralised procedures. The main change is that, in exceptional cases, the RMS may start a procedure even if the concerned member states (CMS) have not responded to the validation replies within the set deadline. The revised document is available on the CMDh website.

The CMDh has also revised its RMS request templates. The DCP request form has been reworked, and only forms that are correctly and fully completed will be considered. For Article 10a applications, applicants must say whether a suitable reference product for an Article 10 application is available in the EU, and if so justify choosing the Article 10a legal basis. For bioequivalence or other equivalence studies, the (expected) completion date must be given, and ASMF applications must state the ASMF number.

The MRP/RUP form has changed as well. The footnote on certificates of suitability (CEPs) was adjusted; it concerns the need to update the dossier to the current CEP version by variation before an MRP/RUP begins. Requirements for the environmental risk assessment in Module 1.6 were also clarified. Both templates are on the CMDh and BASG websites.

Finally, the CMDh updated its two overview documents on national requirements, one for new applications and one for variations and renewals in MRP/DCP. Member states have now classed each requirement as either a validation issue that prevents a procedure from starting or a non-validation issue that does not. Some national requirements were deleted. Both documents are on the CMDh website.

What it means for your team

  • Check whether any planned procedure could be affected by the new option for the RMS to start without CMS validation replies, which applies only in exceptional cases.
  • Update internal submission checklists and use the revised DCP and MRP/RUP request forms; incomplete or incorrectly completed DCP forms will not be considered.
  • For Article 10a DCP applications, prepare a justification where a suitable Article 10 reference product exists in the EU, and have study completion dates and ASMF numbers ready.
  • Review the CMDh national requirements overviews to see which items are validation-relevant, and confirm CEP versions are current before an MRP/RUP starts.

Official source: BASG ↗

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

More Regulatory All →