1.Feature image Regulatory Guidance Updates, 08 01 25

Regulatory Guidance updates in July 2026

Regulatory Guidance updates in July 2026 – ERA have tracked them for you!

HPRA (IE): 

  • The SoHO Regulation: all you need to know to get started guideline was published by the HPRA
    • Are you involved in activities concerning Substances of Human Origin (SoHO) intended for human applications?
    • Are you a facility where SoHO are applied to patients such as clinics, sport clinics, dentists, gynaecologists, ophthalmologists and any organisation using or processing SoHO?
    • Are you planning to commence SoHO-related activities?
    • If so, the new SoHO Regulation 2024/1938 shall apply to you as of 7 August 2027
  • The Guide to Fees for Veterinary Products has been updated
  • Labelling requirements for cosmetic products containing fragrances covered under Regulation (EU) 2023/1545
    • The HPRA has published a new information page to help members of the cosmetics industry comply with the fragrance allergen labelling requirements introduced under Regulation (EU) 2023/1545.
  • Guidance on controlled drugs requirements, this updated document follows a targeted consultation held in February 2026 including:
    • Electronic registers
    • Background checks for personnel
    • Transportation of controlled drugs
    • Clarification on the definitions of ‘Operator’ and ‘Responsible Officer’
  • HPRA to support EU Council Presidency
    • The HPRA will actively contribute to Ireland’s Presidency of the Council of the European Union from July to December 2026

MHRA (UK): 

  • Updated guidance on “Variations to marketing authorisations (MAs)”
    • Added section ‘Deadlines for new therapeutic indication variations’ to the section ‘Variations to add a new therapeutic indication’
  • Updated guidance on Clinical trials for medicines: ending a clinical trial.
    • Clarified requirements and links to additional guidance for submission of results where the trial is sponsored by the holder of a UK marketing authorisation and involves the use of that authorised medicinal product use in a paediatric population
  • Updated guidance on “Best practice in the labelling and packaging of medicines”
  • Updated guidance on ‘Best practice guidance on patient information leaflets’
  • Updated guidance on “Register to make submissions to the MHRA”
    • to change wording from ‘substantial amendments’ to ‘substantial modifications’ in text
  • Updated guidance “Register medical devices to place on the market”
    • To add clarification concerning devices put into service only.
    • This update provides a link to a new guidance document on ‘Registration of medical devices Guidance on the registration requirements for medical devices placed on the market and put into service’

EMA (EU wide):

As always the EMA regularly updates their website – here are some of the highlights from July 2026.

Medicines – Human: 

  • The presence of a Cover Letter is optional to use as from the 1st July 2026 for Type IA/IAIN variations for applications submitted via the Centralised procedure.
  • The following guideline has been amended as a result of this change:
    • European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
    • Questions and answers: Article 13 referral procedures
    • updated guidance clarifies the operational and practical handling of these procedures for marketing authorisation holders (MAHs) and applicants. Key operational steps following Committee for Medicinal Products for Human Use (CHMP) opinions are defined, including the timeline for re-examination requests, document annex submissions, and the translation check process
  • Questions and answers for biological medicinal products 
    • Section ‘Active substance specification Host cell proteins testing’ updated, under the question ‘What information on characterisation, biosimilarity, and comparability after manufacturing changes should be provided for effector functions of monoclonal antibodies’ has been updated.
      • New sections added:
        • Endotoxin Limulus Amoebocyte lysate (LAL) test
        • Biosimilar acceptance criteria
        • Vaccine potency testing
        • Extractable volume testing
        • Viral filtration
        • Pre-use filter integrity testing
        • Adeno associated virus (AAV) infectious titre test
        • Changes to master cell banks
        • Biosimilars containing recombinant hyaluronidase
        • Reference standard qualification protocols
  • Updated “Guidance for applicants for the preparation of the ‘precise scope’ section of the variation application form”
    • To reflect new regulations and align with the updated eAF submission portals

Medicines – Veterinary: 

  • New document on ‘Application for Transfer of Marketing Authorisation from Transferor to Transferee, attachment 1 (veterinary)’

Upcoming Webinars: 

    • EMA risk management information day: 8th September 2026

 CMDh (MRP/DCP):

  • The presence of a Cover Letter is no longer required as from the 1st July 2026 for Type IA/IAIN variations for applications submitted via DCP/MRP. Several guidelines including the Cover Letter Template for variations have been amended as a result of this change
  • The guidance on ‘CMDh Q&A – Post-Brexit’ was updated to:
    • clarify the information on reference medicinal products authorised in the UK (Q&A3)
  • The guidance on “Chapter 7 – CMDh Best Practice Guide on Variation Worksharing’ was updated to:
    • to clarify which worksharing procedures are included in CTS
  • The guidance on ‘Q&A – QP Declaration’ was updated to:
    • have been brought in line with the new Variations Guideline for medicinal products for human use. Answers for human and veterinary medicinal products have been aligned where possible. Other minor changes have been included.
  • Updated Type II variation Preliminary-Final Variation Assessment Report Type II variation assessment report
    • The CMDh agreed to merge the current Type II variation Preliminary Variation Assessment Report (PVAR) and Final Variation Assessment Report (FVAR) templates into one single VAR template. The updated template will give a complete overview of the procedural steps, all changes requested within the variation, and the assessment of the responses to the MSs request for supplementary information.
  • Contact Points were updated.

 eSubmissions:

Human Variation interactive PDF eAF v1.28.1.0 version available

  • Minor version 28.1.0 of the interactive PDF electronic application form (eAF) for human variation application is available on the eAF website, together with the associated release notes.
    • The new version brings the annual update checkbox (and the earliest implementation date), mandatory use of OMS for 3 sections and small bug fix.
    • The form can be used for new human variation applications submitted to EMA and NCAs from 3 August 2026. It will be mandatory to use the updated form for all new human variations submissions from 24 August 2026
      • Applicants are reminded that the version of the form should not be changed during an ongoing procedure.

Veterinary Variation interactive PDF eAF v1.28.0.0 version available

  • Minor version 28.0.0 of the interactive PDF electronic application form (eAF) for veterinary variation application is available on the eAF website. Relevant release notes will be published at a later date.
    • The new version brings a change in the display of the section 4c.
    • The form can be used for new veterinary variation applications submitted to EMA and NCAs from 3 August 2026. It will be mandatory to use the updated form for all new veterinary variations submissions from 24 August 2026.
    • Applicants are reminded that the version of the form should not be changed during an ongoing procedure.

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

Marian Winder 1

Marian Winder 1

1.Feature image Regulatory Guidance Updates, 08 01 25

Regulatory Guidance updates in June 2026

Regulatory Guidance updates in June 2026 – ERA have tracked them for you!

HPRA (IE): 

  • HPRA webinar – There was a webinar held on the 19th June 2026 on recent updates and developments in the veterinary medicine regulation
    • A recording should be made available in due course
  • Guidance on “Submitting a Request for a New National Application Procedure for a Human Medicinal Product” has been updated.
    • The HPRA has increased the non-refundable booking fee to €5,000
  • Guidance on “Submitting a Request for Ireland to Act as RMS in a Decentralised Procedure for a Human Medicinal Product” has been updated.
    • The HPRA has increased the non-refundable booking fee to €5,000 to secure a DCP slot
  • Guidance on “New Applications and Variations to Wholesale Distribution Authorisations” has had a thorough update
    • changes can be viewed in the tracked version on the HPRA website.

MHRA (UK): 

  •  Updated “National Commission into the Regulation of AI in Healthcare: research, engagement and call for evidence findings”.
    • Findings call for evidence and wider research and engagement activities
  • Updated “Regulation of AI in Healthcare“
    • Findings have now been published, alongside a report summarising the wider research and engagement activities undertaken
  • MHRA has launched “AI sandbox” to accelerate medicines development and improve safety
    • will help make medicines safer, speed up development, and reduce reliance on animal testing
  • The MHRA and FDA have announced a new liaison programme, marking a significant step forward in strengthening the regulatory partnership between the UK and the US.

EMA (EU wide):

As always the EMA regularly updates their website – here are some of the highlights from June 2026.

Medicines – Human:     

  • Updated “Member states contact points” for multiple topics
  • Updated “Checklist for the submission of day 215 translations for post-opinion linguistic review – human”
  • Updated “Timetable Safety referrals (Art 20 and Art 31PhV1 )”
  • Updated “Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) standards for the Identification of Medicinal Products (IDMP) in Europe”
  • Updated “Regulatory Procedure Management in IRIS roadmap”
  • Updated “Reform of the EU pharmaceutical legislation”
    • The adopted acts of the new pharmaceutical legislation are expected to enter into force in 2026.
    • The following two years, until 2028, will serve as a transition period.
    • In this time interval, all EU Member States will need to update their national laws to align with the new rules.
  • New guideline on “Data recommendations for herbal medicinal products and traditional herbal medicinal products used in paediatric patients”
    • This document aims to provide basic recommendations for establishment of European Union herbal monographs with a paediatric indication
  • Good manufacturing practice: “Multistakeholder workshop on expert contributions to artificial intelligence guidance development (Annex 22)”
    • Working Group organised a two-day workshop to help shape a risk-based approach to the use of generative artificial intelligence (AI) in medicines manufacturing
    • Recording will be available in due course

Medicines – Veterinary: 

  • Updated “Guideline on data requirements for authorisation of immunological veterinary medicinal products in exceptional circumstances – Scientific guideline”.
    • This guideline replaces the CVMP related guidelines (“Guideline on requirements for an authorisation under exceptional circumstances for vaccines for emergency use against bluetongue” (EMEA/CVMP/IWP/37267/2008) and the “Guideline on requirements for an authorisation under exceptional circumstances for vaccines for use in birds against avian influenza” (EMEA/CVMP/IWP/222624/2006).

Upcoming Webinars: 

    • EMA risk management information day: 8th September 2026

eSubmissions:

  • Versions 1.28.0.0 of the interactive PDF electronic application form (eAF) for human and veterinary marketing authorisation application are available on the eAF website
    • Industry must use the updated eAFs, Version 1.28.0.0, for any new CAP MAA Veterinary or Human application submitted to EMA from 28 July 2026.
    • The forms can be used for new MAA applications submitted to the NCAs for NP, MPR, DCP and Subsequent Recognition Procedure (SRP) procedures from 1st September 2026.
    • It will be mandatory to use the updated forms for all new MAA submissions to the NCAs from 1st January 2027. 

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

Marian Winder 1

Marian Winder 1

1.Feature image Regulatory Guidance Updates, 08 01 25

Regulatory Guidance Updates in May 2026

Did you know that the following Regulatory Guidance was updated in May 2026?

HPRA (IE): 

  • Promoting medicines to the public on social media – the HPRA has launched a new webpage, setting out clear information on the laws that apply to advertising human medicines for the public
  • HPRA webinar – There will be a webinar hosted by the HPRA on the 19th June 2026 on recent updates and developments in the veterinary medicine regulation

MHRA (UK): 

  • Find product information about medicines page is updated to add
    • Guidance with updated additional monitoring list April 2026
  • MHRA opens UK-wide consultation on redefining gene therapies on their proposed changes to how gene therapies are legally defined in UK legislation
    • This will ensure UK regulation keeps up with advances in gene therapy, synthetic biology, and gene editing technologies
  • MHRA launched a public consultation on a proposed new Rare Disease Therapies Framework that would introduce significant regulatory innovation to the UK’s rare disease landscape
    • MHRA is calling on the pharmaceutical and life sciences industries to play a central role in shaping the final framework.
  • MHRA welcomes submissions for participation in MHRA-NICE Real World Evidence Scientific Dialogue
    • The expression of interest form is accessible since the 20 May 2026. Expression of interest guidance for applicants is also available
  • MHRA published the latest ‘conformity assessment routes flow chart’ to help companies conform with the legal requirements for placing medical devices on the market
  • MHRA request that current or potential Marketing Authorisation Holders (MAH) provide information on planned or potential future submissions to the MHRA
    • Template spreadsheet (MS Excel) can be downloaded, filled in with as much information as possible and returned to the MHRA by email (where the information will be treated sensitively and securely)

EMA (EU wide):

As always the EMA regularly updates their website – here are some of the highlights from May 2026.

  • Medicines – Human:     
    • Revamp of marketing authorisation assessment templates
    • Q&A on implementation of Ph. Eur. Medicinal Product Monographs (MPM)
    • Updated questions and answers on periodic safety update report single-assessment (PSUSA): Guidance document for assessors
    • Good manufacturing practice: Multistakeholder workshop on expert contributions to the artificial intelligence guidance development (Annex 22).
    • Updated timetable for Initial (Full) marketing authorisation application – ATMP
    • Updated timetable for accelerated assessment request for initial marketing authorisation applications
    • Updated Product-specific bioequivalence guidance
  • Medicines – Veterinary: 
    • Updated QRD veterinary combined label-leaflet template v.9.1
    • Updated guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 and on the documentation to be submitted pursuant to those variations
  • Upcoming Webinars: 
    • Clinical Trials Information System (CTIS): Information day will be provided by the EMA on the 17 June 2026 on-line
    • Product Management Service (PMS): Information day will be provided by the EMA on the 09 June 2026 on-line
    • Good Manufacturing Practice (GMP)/Good Distribution Practice (GDP) Inspectors Working Group is organising a two-day workshop on 30th June 2026 to help shape a risk-based approach to the use of generative artificial intelligence (AI) in medicines manufacturing.

CMDh (MRP/DCP):

  • Updated – list of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
  • Contact Point List was updated
  • Updated – CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs (PSUFU procedure)
  • Correction to “Q&A – List for the submission of variations for human medicinal products according to Commission Regulation (EC) 1234/2008 as amended” to reflect the principles of Q&A 7.3.1. in the European Medicines Agency post authorisation procedural advice for users of the centralised procedure, which addresses the impact of changes in the clinical use of a product on quality documentation

eSubmissions:

  • Updates to web eAF (the most recent one released to production on 11 May 2026) is now available on the eSubmission PLM Portal eAF web page
  • As of 5 May 2026, the Readable IDs functionality is released within the European Shortages Monitoring Platform (ESMP). This improvement simplifies data entry, reduces the need for cross-referencing external lists, and enables more accurate verification of submitted information
    • Live training recording & presentation: The training webinar held on 14 April 2026 introduced the readable IDs alongside other improvements, providing practical guidance to support day-to-day activities. EMA encourage the review of this training recording and presentation on the dedicated event page on EMA’s website for familiarisation with the new features.
    • Updated guidance: The updated ESMP MAH User Guide and ESMP MAH Implementation Guide have been released to accommodate this new functionality. These documents provide detailed instructions on using readable IDs.

 

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

Marian Winder 1

Marian Winder 1

1.Feature image Regulatory Guidance Updates, 08 01 25

Regulatory Guidance updates in March and April 2026

Did you know that the following Regulatory Guidance was updated in March and April 2026?

HPRA (IE): 

  • HPRA guidance issued in relation to EMA list of ingredients restricted or prohibited for use in cosmetics from 1st May 2026
  • CTCG Guidance and Webinar: New Article 11 Workaround for Clinical Trials:
    • The Clinical Trials Coordination Group (CTCG) has published guidance for sponsors on a new workaround for Article 11 of the Clinical Trial Regulation (Regulation (EU) No 536/2014). This approach will apply from 27 April 2026.

MHRA (UK): 

  • Apply for a licence to market a medicine
    • Updated guidance on electronic submissions to the MHRA
  • MHRA Portal: register to submit forms
    • Updated guidance to add MHRA Portal registration form
  • Medicines licensing: how to apply
    • Updated guidance on varying, renewing and transferring ownership of a marketing authorisation were added
  • Clinical trials for medicines: notifiable trials.
    • Updated guidance on ‘Applications that need expert advice’ to change timeline from 14 days to 28 days
    • Addition of the Confirmation of Notifiable Trial Criteria form and clarification that IND refers to investigational new drug (no change note needed)
    • The amended Clinical Trials Regulations took full effect on 28 April 2026
      • As such, this guidance should now be considered effective and is no longer in draft

EMA (EU wide):

As always the EMA regularly updates their website – here are some of the highlights from March and April 2026.

  • Medicines – Human:     
    • A Q&A clinic on the eAF took place on the 9th March 2026
      • the slides from this session can be found on the EMA website.
      • The updated Variation Regulation Classification Guideline has been made available in both the interactive pdf eAF 28.0.0and in the PLM Portal web-based variation form January 2026 version.
      • Users are reminded to verify the accuracy and content of the selected scopes (including the conditions and documentation), before submitting the form to the relevant health authorities.
      • The EMA will introduce mandatory use for CAPs as of 1 September 2026.
    • Updated pre-authorisation guidance
    • Updated post-authorisation guidance
    • Updated guidance on Mobile scanning and other technologies in the labelling and/or package leaflet of centrally authorised medicinal products
    • Updated validation checklist for initial marketing authorisation applications – biologicals other than immunologicals (applicable to submissions under Regulation (EU) 2019/6)
    • Updated Product Management Service (PMS) – Frequently Asked Questions (FAQs)
  • Medicines – Veterinary: 
    • Updated guidance on variations not requiring assessment (veterinary medicines)
    • Updated guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations
    • Updated guidance on transferring a veterinary marketing authorisation
    • Updated pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6); Question 2.1.5 in “Preparing the dossier” section
    • Updated QRD veterinary Appendix I – Adverse event (PhV) MSs reporting details

CMDh (MRP/DCP):

  • Updated “Examples for acceptable and not acceptable groupings for MRP/DCP products” to reflect the possibility of accepting the grouping of related Type IA and Type IAIN variations outside the annual update
  • Updated “Chapter 1 – CMDh Best Practice Guide for the allocation of the Mutual Recognition variation number for Type I notifications, Type II variations, grouping and worksharing” to clarify the allocation of procedure numbers for annual update of Type IA variations
  • Updated “Chapter 6 – CMDh BPG for the Processing of (Super-) Grouped Applications in the Mutual Recognition Procedure” to reflect the agreement on the possibility of accepting the grouping of related Type IA and Type IAIN variations outside the annual update
  • Updated Questions and answers on the Paediatric Regulation to reflect update to align with the new EC guidelines on the details of the various categories of variations and operation of the procedures
  • Updated “Best Practice Guide for Article 45 and 46 – Paediatric Regulation – EU Worksharing Procedure” to align with the new EC guidelines on the details of the various categories of variations and operation of the procedures. Other clarification updates were included

eSubmissions:

  • Mandatory Use of PLM Web-Based eAF for CAPs: To continue advancing the adoption of the PLM web-based eAF, the EMA will introduce mandatory use for CAPs as of 1 September 2026.
  • EU eCTD v4.0 validation criteria v1.1 published. eCTD v4.0 tool vendors may now begin implementing the new rules, and the updated validation criteria will become applicable starting 15 July 2026.

 

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

Marian Winder 1

Marian Winder 1

1.Feature image Regulatory Guidance Updates, 08 01 25

Regulatory Guidance updates in February 2026

Here are the main highlights of Regulatory Guidance updated in February 2026

HPRA (IE): 

The HPRA promoted the Facilitating and Accelerating Strategic Clinical Trials (FAST-EU).  FAST-EU is a pilot initiative aiming to accelerate the assessment and authorisation of clinical trials running in multiple EU/EEA countries. The pilot is currently open for submissions and is expected to run until early 2027.

MHRA (UK): 

The MHRA published a few updates:

  • Medical devices regulations:
    • Targeted consultation on the indefinite recognition of CE marked devices in Great Britain.
  • Addition of the latest Additional Monitoring List for Jan 2026
  • New information on responsibilities and reporting on nitrosamine impurities

EMA (EU wide)

As always the EMA regularly updates their website – here are some of the highlights from February

  • Medicines – Human:
    • Updated validation checklist for Type II variations
    • Concept paper on the revision of the guidelines on Good
      Manufacturing Practice for medicinal products – Annex 15
      – Qualification and Validation. Public consultation began on 09th February
    • ICH M15 Guideline on general principles for model-informed drug development, document updated
    • Guidance for applicants for the preparation of the ‘precise scope’ section of the variation application form, document updated
  • Medicines – Veterinary:
    • Guideline on quality aspects of mRNA vaccines for veterinary use, Public consultation began in February
    • Question and answer on the information contained within section 4.2 of the SPC on pharmacodynamic properties for pharmaceutical products
  • Annual fees payable to the EMA, page updated
  • Reflection paper on the qualification of non-mutagenic impurities
  • FAQ document published to address common queries and provide guidance on the European Shortages Monitoring Platform (ESMP)
  • List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs) excel is updated
  • List of contact information for the national competent authorities in the EEA page updated
  • Updated PRAC report templates
  • Guidance on Good Pharmacovigilance Practices (GVP) updated
  • Summary from the industry stakeholder webinar on the revised guideline on the environmental risk assessment of medicinal products for human use
  • The next eAF Q&A will be on the 9th of March

CMDH (MRP/DCP):

  • Agenda for the 24-25 Feb Meeting
  • Report from the CMDh meeting held on 27-28 January 2026
  • Q&A – Generic Applications

eSubmissions:

  • Updated PLM Portal eAF Release notes (version: 1.2.1.6 – Release date 16/02/2026)

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

 

Written by Fiona Downey

Fiona Downey

Fiona Downey

1.Feature image Regulatory Guidance Updates, 08 01 25

Regulatory Guidance updates in January 2026

Were you aware that the following Regulatory Guidance was updated in January 2026?

 

HPRA (IE): 

  • Updated fee guidance document for Human medicinal products

MHRA (UK): 

The MHRA have been very busy updating their website in January – here are some of the highlights

  • Medicines: International Recognition Procedure
    • Updated dates indicating the submission deadlines for IRP Route B applications in the IRP Guidance page
  • Medicines: Apply for a variation to your Marketing Authorisation
    • Updated to add new section on Type II variations – ‘Variations to add a new therapeutic indication’
  • Medicines: Statement on new review of paracetamol safety during pregnancy
    • Paracetamol should be taken as directed in the patient information leaflet
  • Medicines: that you can export from the UK or hoard
    • Updated to add: Aspirin (strength: all; pharmaceutical form: all); and Ifosfamide (strength: 1g/2g; pharmaceutical form: powder for solution for injection vials)
  • Medicines: get scientific advice from MHRA
    • Removed info box at the top of the page as out of date
  • Human and Veterinary: Register of licensed manufacturing sites
    • Updated to add the MS and MANSA registers for January 2026
  • Updates to the Orphan Register
  • Early Access to Medicines Scheme: Overview
    • Updated scientific opinion dates for EAMS 2026
  • Clinical Trials: apply for authorisation in the UK
    • Updated to provide link and information under ‘Combined review of an investigative medicinal product and medical device – IMP+Device’
  • Patients to benefit sooner as UK boosts clinical trials attractiveness with faster assessment and agile regulation
  • Borderline products: how to tell if your product is a medicine
    • Updated to add Statistics table for May-October 2025

EMA (EU wide)

As always, the EMA regularly update their website – here are some of the highlights from January

  • EMA post-authorisation guidance – updated
  • Dates of 2026 Scientific Advice meetings and submission deadlines
  • Medicines: Use of Paracetamol during pregnancy unchanged in the EU
    • Recent publication confirms no increased risk of autism, ADHD or intellectual disability
  • EMA and FDA set common principles for AI in medicine development
  • IRIS guide for applicants – updated
  • Meeting highlights from Pharmacovigilance Risk Assessment Committee (PRAC)
  • Meeting highlights from Committee for Veterinary Medicinal Products (CVMP)
  • Published the Annual report of the Good Clinical Practice (GCP) Inspectors working group 2024
  • Q&A about the clinical study data proof-of-concept pilot for industry – published
  • One Health Approach
    • updated to include ‘One Health task force‘ section
  • Q&A clinic: New Variation classification in eAF (recording available)
  • 3 year rolling work plan for the Quality Innovation Group (QIG)

CMDH (MRP/DCP):

  • Updated ‘contact points’ excel
    • This excel provides names, email addresses and phone numbers for seeking advice from each member state in the EU/UK for regulatory procedures
  • National recommendations for requests to act as RMS – updated
  • Recommendation for classification of unforeseen variations according to Article 5 – corrected
  • ASMF workshare procedure user guidance – updated

eSubmissions:

  • Updated PLM Portal eAF release notes
  • European Shortages Monitoring Platform (ESMP)
    • Expanding to include: new tools and features to better support stakeholders in preventing, managing and mitigating medicine shortages
  • Updated Variation Regulation Classification Guideline
    • has been made available in the interactive pdf eAF v1.28.0.0 and in the PLM Portal web-based variation form January 2026 version
  • Go-Live announcement for EU eCTD v4.0 optional use for Centralised Procedure new MAAs

 

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

 

Written by Alice D’Alton

Alice Dalton 1

Alice Dalton 1

Training 2

Type IA Annual Reporting in the UK

Following on from our News Article: “You need to apply Type IA Annual Reporting in the EU in 2025” we can further advise that the MHRA has also adopted the EU changes in relation to Type IA variations for UK products.

 

This means that the MHRA do also require the submission of Annual Updates for Type IA variations, and these should be submitted nationally, unless the Type IA variations are submitted as part of a group with other variations applied for via the International Recognition Procedure (IRP).

 

IRP Variations:

You can use IRP during the lifecycle of UK products that have been initially authorised or subsequently varied via standalone;

  • National route
  • Decentralised and mutual recognition reliance procedure (MRDCRP) route
  • European Commission (EC) Decision Reliance Procedure (ECDRP) route

 

Conversely, where a product has been authorised via IRP, it is acceptable to submit standalone national post-authorisation procedures, including variations.

 

Variations submitted via IRP should be classified according to MHRA guidance on variations to MAs. To facilitate lifecycle management of the MA, variations should be submitted as soon as possible after approval by the Reference Regulator (RR).

 

The MHRA will be publishing updated guidance on Annual Updates very shorty. So, watch this space for a more detailed overview when it becomes available.

 

 

Written by

Fiona Downey

Fiona Downey 1

Fiona Downey 1

Windsor Framework, recd 13 02 24

MHRA – Pharmacovigilance – Categories 1 and 2 medicinal products

The Windsor Framework changed the regulation of medicinal products that were formerly in the scope of the EU centralised procedure so that these products are now licensed UK-wide under UK law.

Products not within this scope are authorised UK-wide under UK and applicable EU law (as amended by Regulation (EU) 2023/1182 and Directive (EU) 2022/642), as has been the case since 1 January 2021.

As a result, UK authorised products are now placed into one of two Categories:

Category 1 are UK products which fall under the mandatory or optional scope of the EU Centrally Authorised Procedure.

Category 2 are UK products which do not fall within the scope of Category 1 will be Category 2 products.

To assist MAHs in verifying the category of each of their products, a decision ladder has been created by the MHRA. The MHRA has also publish lists of Category 1 products and Category 2 products.

Which category your product falls under, will decide the pharmacovigilance requirements of that product.

Category 1 will be subject to UK legislation only. These products will legally be required to follow Part 11 of the HMRs for pharmacovigilance.

Category 2 will be subject to UK and EU requirements as applicable. These products will be legally required to follow Part 11 of the HMRs for pharmacovigilance with further pharmacovigilance requirements outlined in Schedule 12A of the HMRs.

However, it should be note that all existing exemptions that apply to all UK medicines remain in place irrespective of Category.

The MHRA has published Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders and the licensing authority which outlines the requirements of products classed as Category 1 or 2, they have also published guidelines to clarify ICSRs reporting  and PSUR submissions requirements for each category.

If you need assistance with any of the above or anything Windsor Framework related, please free feel to contact us.

Written By

Fiona Downey

Fiona Downey 1

Fiona Downey 1

pharma vigilance

Back to Basics – The Risk Management Plan (RMP)

The Risk Management Plan (RMP) documents the risk management system considered necessary to identify, characterise and minimise a medicinal product’s important risks.

The RMP should be updated throughout the life cycle of the product, for example;

  • if there is a change in the list of the safety concerns
  • when there is a significant change in the existing additional pharmacovigilance activities
  • if an emerging safety issue is confirmed.

The RMP should be assigned a new RMP version number and a date each time it is updated and submitted for assessment.

An updated RMP can be submitted as a standalone [currently C.I.11] variation, when necessary, but it is most often submitted as a consequence of or part of another variation.

The format and content of the RMP should follow the RMP template; Guidance on the format of the risk management plan (RMP) in the EU – in integrated format which consists of seven parts.

For a generic medicinal product, hybrid products and/or fixed combination products with no new active substance the safety concerns should be aligned to those of the originator product that are available;

  • either from the originator’s approved RMP
  • or from the list of safety concerns of the substance published on the CMDh website.

RMPs are approved per each medicinal product, not per MAH, therefore only one RMP should be submitted for an MRP or DCP with different MAHs. The RMP must remain identical in RMS/all CMS throughout the product life cycle.

The RMP should be provided in eCTD section 1.8.2. To facilitate the assessment a ‘tracked changes’ version of the RMP, in Microsoft word, should also be provided in the ‘working-documents’ folder outside eCTD.

The QPPV’s actual signature or the evidence that the RMP was reviewed and approved by the QPPV should be included in the finalised approved version of the document; for eCTD submissions this would be the RMP submitted with the last eCTD sequence of the procedure (usually the closing sequence).

UK RMP: The MHRA states you can either submit a GB/UK RMP or use the approved EU RMP with the GB/UK specific annex attached. Further information of UK RMP can be found on the MHRA website and their Guidance note on good pharmacovigilance practices.

Feel free to contact us here at ERA to assist you with all things regulatory in Ireland, UK and across the EU.

We take the pain out of regulatory so that you can take your medicine to the next level.

Written by

Fiona Downey

Fiona Downey 1

Fiona Downey 1

Windsor Framework, recd 13 02 24

UK Updates – Windsor Framework and Regulation (EU) 2023/1182 for Centralised Products

What it means for your company

  • Batches of medicinal product, authorised through the centralised procedure (CAP), that are currently lawfully on the market in Northern Ireland may remain so until their Expiry Date
    • However, these medicinal products cannot be moved from Northern Ireland to an EU/EEA Member State or be placed on the market in an EU/EEA Member State.
  • No new batches of authorised CAPs can be released on the market in Northern Ireland after Regulation (EU) 2023/1182 becomes applicable (01Jan2025)
    • Therefore the release of CAP medicinal product by your Qualified Person (QP) has to be planned accordingly and cannot be performed after this date.
  • It is recommended that companies and MAH’s anticipate any potential issues and resolve them in the next 8 months.
  • There is no possibility of multi-country packs for CAPs between Northern Ireland and any other EU/EEA member state after the regulation becomes applicable.
    • Any medicines placed on, or who are currently on the market before this happens may remain so until the expiry date is reached.
  • The product information (PI) of the CAPs will no longer require the mention of a local representative in Northern Ireland after the regulation becomes applicable.
    • The PI can be amended by way of an article 61(3) if no regulatory procedure is planned within 36 months.
    • This change should be made at the earliest opportunity.
    • The Q&As to stakeholders states ‘Additionally, it is also acceptable to request the deletion of the local representative for Northern Ireland in any regulatory procedure affecting the Annexes of the Marketing Authorisation submitted after 1 July 2024, provided that this change is only implemented after the date that Regulation (EU) 2023/1182 becomes applicable.’

Do you have a product that this may affect? There are lots of tasks that need to be done if so and these should begin this quarter!

The Legal Jargon behind it all

The Windsor Framework is a legal agreement between the European Union and the United Kingdom that was announced on February 27, 2023. It is a political declaration and a series of legal documents reached by the UK and EU in the Withdrawal Agreement Joint Committee. It covers topics such as trade, goods, services, sanitary and phytosanitary measures, and the democratic consent mechanism. The Framework was formally adopted by both parties on March 24, 2023, and came into effect on October 1, 2023.

Regulation (EU) 2023/1182 is a legal document that was passed by the European Parliament and the Council on June 14, 2023. It contains specific rules relating to medicinal products for human use intended to be placed on the market in Northern Ireland and amends Directive 2001/83/EC. Directive 2001/83/EC is aimed at ensuring that medicinal products placed on the market in Northern Ireland comply with the provisions of Union law until January 2025. The implementation of Regulation (EU) 2023/1182 has resulted in increased costs and red tape for GB-based pharmaceutical manufacturers and suppliers who are required to meet EU testing and labelling requirements in addition to UK rules.

Regulation (EU) 2023/1182 came into force on June 20, 2023 1. However, it is not applicable until January 1, 2025, provided that the UK has provided the written guarantees referred to in Article 8 of that Regulation.

This can impact centralised procedures (CAPs) as medicines can now only be placed on the market in Northern Ireland if authorised by the UK authorities in accordance with the law of the United Kingdom and under the terms of the authorisation granted by them.

Pursuant to Article 13 of Regulation (EU) 2023/1182, Article 5a of Directive 2001/83/EC is deleted with effect from the date on which the Regulation becomes applicable (01Jan2025). Article 5a allowed for the medicinal products to be temporarily authorised to supply to in Northern Ireland of a medicinal product belonging to the categories referred to in Article 3(1) and (2) of Regulation (EC) No 726/2004 provided that certain conditions were fulfilled.

If you need assistance with any of the above, contact us.

Written by Emily Fletcher

edited on 14/01/2025

Emily Fletcher 1

Emily Fletcher 1

Need help with all the regulatory jargon?

Check out our updated GLOSSARY OF ABBREVIATIONS AND ACRONYMS.

Read More
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