Regulatory Guidance updates October – 10th to 31st October 2026 – ERA have tracked them for you!

HPRA (IE): 

• Updated “Guide to Transfers of Marketing Authorisations, Parallel Import Licences and Dual Pack Import Registrations for Human Medicines”
  • option to send new applications on CD/DVD or memory stick has been removed

MHRA (UK): 

• Updated guidance on “Medicines: apply for a variation to your marketing authorisation”
  • added in text: (viii) where the change involves the deletion of a batch release site and affects the product information
• Updated guidance on “Electronic Application Forms (eAF) for UK medicines licensing applications”
  • updated to make ‘How to Apply’ section more clear

EMA (EU wide):

Medicines – Human: 

• Updated “Guidance on good manufacturing practice and good distribution practice: Questions and answers”
  • Question on ‘What are the requirements for batch numbers appearing on the packaging of medicinal products subject to parallel trade?‘ updated in section ‘EU GMP guide part I: Basic requirements for medicinal products: Chapter 5: Production’
• Updated guidance on “How to prepare and review a summary of product characteristics”
  • section on ‘Guidance for assessors’ updated.

Medicines – Veterinary:

• Updated guidance on “Pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6)”. Questions updated:
  • what is the procedure for establishment of maximum residue limits (MRLs)?
  • when shall I submit my application?

 CMDh (MRP/DCP):

• Updated “Blue- Box” requirements”
  • updated requirements for labelling for Finland & Greece & updated requirement for PIL for Finland
• Updated “Request for MRP/RUP Template” to request an Assessment Report from RMS to include updated clarifications that:
  • the ERA provided in Module 1.6 should be up to date
  • if the ASMF/DMF or CEP has been superseded by a new version, a variation is to be filed prior to the MRP/RUP
• Updated form on “Request for RMS in a decentralised procedure for medicinal products for human use” including multiple changes
• Updated “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”
  • clearly highlights which are the validation issues (preventing the procedure start and the non-validation issues (not preventing procedure start)
• Updated “Data requested for New 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”
  • clearly highlights which are the validation issues (preventing the procedure start and the non-validation issues (not preventing procedure start)
• Updated guidance on “Validation of MR/Repeat use/DC procedures”
  • updated to empower the RMS to start the procedure, in the exceptional case where CMSs do not react to validation responses within a given timeframe
• Updated “CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008, as amended”
  • deletion of a batch size of the finished product” can be submitted as a type IA variation under Q.II.b.4.z (certain conditions apply)

PLM Portal eAF:

•  Updated PLM Portal eAF Release notes now available
  • An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the versions 1.2.1.21 (released to production on 13 October) and 2.1.22 (released to production on 26 October 2026) is now available on the PLM portal and eSubmission PLM Portal eAF.
• Marketing authorisation application and Variation electronic application forms (eAF) for centrally authorised products – naming convention reminder
  • Applicants and Marketing Authorisation Holders (MAHs) are reminded that the prescribed naming convention for electronic application forms (eAFs) must be followed. Compliance with this convention enables the correct identification of eAF files within submission sequences received by EMA and supports their automated processing.
  • For human medicinal products, the applicable naming convention for marketing authorisation applications (MAAs) and Variations is described in:
    • eCTD 3.2.2 – EU Module 1 Implementation Guide (v3.1.1, page 34); and
    • The corresponding validation criteria, specifically the worksheet “File-folder structure and names.”
• For veterinary marketing authorisation application (MAA) submissions to EMA, the electronic Application Form (Vet MAA interactive PDF eAF) included in the VNeeS package must also follow a specific naming convention. The filename must contain the text “ema-form-eaf”. Additional elements may be included in the filename, provided that the string “ema-form-eaf” remains present. Important:
  • The string “ema-form-eaf” must be used only for the MAA or Variation eAFs.
  • No other file within the submission package should contain “ema-form-eaf” in its filename.

EMA’s internal systems (IRIS) identify the eAF through an automated search for the string “ema-form-eaf”. If the naming convention is not followed, the system may be unable to   correctly identify the eAF, which could affect processing.

As part of the validation process, submissions will be checked for compliance with this requirement. Where the naming convention has not been respected, applicants may be  requested to resubmit the package with the correct filename.

Applicants are therefore strongly encouraged to verify the eAF filename before submission to avoid validation issues and potential processing delays.

For any support you might need to navigate the latest guidance or just for assistance with your EU and UK procedure preparations, submissions, responses, etc., you can contact us on info@eureg.ie

 

Written by

Marian Winder