RegulatoryGuideline · final

MHRA makes current eAF forms downloadable as interim measure for UK licensing applications

🇬🇧 MHRA · Fri 09 Oct 2026

The agency has published downloadable electronic Application Forms for initial MAAs, variations and renewals as a business continuity measure, with submission routes and validation requirements unchanged.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance making its current electronic Application Forms (eAFs) available for applicants to download and use. The agency describes the step as an interim business continuity measure and says it continues to accept eAFs for UK medicines licensing applications.

Three forms are offered: the initial marketing authorisation application (version 1.26.0.0), the variation application (version 1.28.1.0) and the renewal application (version 1.26.0.0). The guidance was first published on 2 October 2026 and updated on 9 October to make the 'How to Apply' section clearer.

Applicants should save the form locally and open it in Adobe Acrobat Reader, choosing to trust the document when a security warning appears so that the embedded validation features work. Where the United Kingdom is not available in a country field, the MHRA says to search for and select the relevant organisation and address record using the Organisation ID or Location ID from the EMA's Organisation Management Service (OMS) portal.

The completed form should be validated and saved as a local copy, then included in the eCTD submission package. The MHRA stresses that Adobe Reader or Adobe Reader DC should be used for filling and locking the forms. Adobe Acrobat or Acrobat Pro DC should not be used, as this may cause problems when the recipient opens the locked forms.

The agency states that existing submission routes, validation requirements and assessment processes are unchanged. It points applicants to the EU's practical user guide for eAFs and to its own guidance on applying for licences, variations and renewals, and directs questions to the relevant MHRA submission team.

What it means for your team

  • Regulatory affairs teams should check that they are using the listed form versions: MAA 1.26.0.0, variation 1.28.1.0 and renewal 1.26.0.0.
  • Use Adobe Reader or Reader DC to fill and lock forms; using Acrobat or Acrobat Pro DC may cause problems for the recipient.
  • UK-specific organisation and location data should be selected via OMS OrgID or LocID where the UK is not offered as a country.
  • No change to submission routes, validation requirements or assessment processes, so existing eCTD workflows should continue as before.

Official guideline text: MHRA ↗

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

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