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

IE EU flag

Applying for Marketing Authorisation via national route or DCP procedure in Ireland – HPRA slot booking

The HPRA is now moving towards a system of slot allocation (expected submission dates) for new national product registration applications, in addition to the existing DCP slot requirement.

Upon request, applicants will be given a submission slot in an agreed month.

This will help capacity planning for timely assessment of applications and will help maintain access for products on the Irish and European markets.

Slot-booking for national product authorisation applications

Applicants should contact RMS@hpra.ie no later than two months before their preferred submission date to request their preferred slot. The email subject title should include ‘National MA submission’.

The following documents should be provided when requesting a slot.

  • A CMDh common request form for reference Member States (RMS) which is available on the CMDh website.
  • A justification of the relevance of the application to the Irish market.
    • This should make reference to the unmet medical need your product will address and you may be asked if you intend to market the product in Ireland as part of your justification for applying to HPRA.

It is important that dossiers are complete before making a request, as delayed submissions may result in the loss of a slot.

If your preferred slot is not available, the next available slot will be allocated within a six-month window. Applicants will receive an email confirmation of a successful slot booking. While the HPRA are adapting to this new process we will try to facilitate applications which require an earlier start date.

Slot-booking for DCP authorisations

If you would like the HPRA to function as an RMS, please contact RMS@hpra.ie at least three months before your preferred submission date to request your preferred slot. The email subject title should include ‘DCP submission’.

When requesting a DCP slot applicants should also provide the completed CMDh common request form for an RMS.

Again, It is important that dossiers are complete before making a request, as delayed submissions may result in the loss of a slot.

If your preferred slot is not available, the next available slot will be allocated, within a two-year window. Applicants will receive an email confirmation of a successful slot booking. The HPRA also operates a cancellation list for slots which become available at short notice.

Scientific advice

Due to the complexities of Article 10a applications, applicants should obtain national scientific advice before submitting requests for such new applications. Further information can be found on our national scientific and regulatory advice page.

Ireland as a CMS

Furthermore, IE routinely participates as a Concerned Member State (CMS) in standard DCP procedures. A zero-day procedure as a CMS may be possible for medicines where Ireland is experiencing a critical shortage of a particular medicine.

Need support

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

Alice D’Alton

Alice Dalton 1

Alice Dalton 1

 

Ivowen - Pharmacovigilance

How to get an Assessor’s opinion before you contact the Competent Authorities

Firstly, in this very unusual time for us all I want to let you know that our dedicated team are all healthy, safe and working from home, business as usual, to ensure that we continue to provide you with the high quality and efficient service you have come to expect from Ivowen.

Have you ever wished you could get the opinion of an Assessor before you go to the National Competent Authorities with your queries? 

Well, I am delighted to introduce you to to our newest team member Claire Brown.

Claire has come directly to Ivowen from the Health Products Regulatory Authority (HPRA) and brings with her a wealth of experience as a pharmaceutical assessor of human medicinal products. Claire has been part of the team here in Ivowen since 2019 and has more than 12 years experience working in the HPRA. She started there as a Scientific Officer working mostly on veterinary medicinal products and was promoted to Pharmaceutical Assessor after 3 years.

Claire completed her undergraduate work in Chemistry and her postgraduate work in Neuropharmacology and Industrial Pharmaceutical Science.

Claire adds her extensive experience to our knowledgeable team so that we can enhance the services we provide to you and continue to give you an ‘Assessor’s eye’ opinion on your applications before you submit them.

I invite you to visit our updated Meet the Team page to see all the talented people who enable us to guide you through all aspects of regulatory strategy, dossier preparation, MA submissions through to national phase, post-approval variations, product development, quality overviews, medical devices and much much more.

If you could use some assistance to navigate the complex world of regulatory, please feel free to contact us for further information.

Written by Alice D’Alton.

Alice Dalton

2019 – What a year

Ivowen attended the Medicines for Europe conference in January (Regulatory and Pharmacovigilance), the annual EuDRAcon conference in May, exhibited at TOPRA in October and joined our clients from around the world at CPhI in November.

We all saw Brexit come and go, Twice !! We wait to see what lies in store for the next deadline in January 2020.

The FMD came into effect across Europe in February in most member states.

Bulgaria joined CESP, eCTD became mandatory for all human procedures, lots of new guidance was published (to keep us all on our toes) and Nitrosamines in medicinal products moved to the top of everyone’s agenda.

With the festive season now upon us and 2020 on the horizon, Ivowen are setting our sights on the year ahead.

We will be attending the Medicines for Europe conference in January 2020 (Regulatory and Pharmacovigilance) and we encourage you to contact us before mid-January with any specific questions you might like us to ‘ask the regulators’. This is a great opportunity to ask those difficult questions that you just could not get a straight answer to in 2019, on the ever present grey areas of Regulatory procedures.

To help you to plan ahead here are some helpful updates, in brief, as full articles will be posted in 2020:

Falsified Medicines Directive – Where we are now:

  • Implemented on 9th Feb 2019 in all MS except Greece, Italy and Belgium
  • The European Commission has produced a video to explain more about the safety features.
  • The HPRA have extended the use and learn period, initially to Sep 2019 and extended it again to end on a phased basis starting from 31st January 2020.
  • The MHRA is also taking a pragmatic, flexible approach to how they enforce the new legal requirements.

Nitrosamines

 

Ivowen are here to assist you in 2020 and will continue to provide the top quality service you have come to expect from us.

For more information on Ivowen’s services and how we can help you, contact us.

Written by Alice D’Alton.

Alice Dalton

News from the HPRA

The HPRA are always striving to improve their processes and ways of working.  The following updates in the Human Medicines Department should help us all in our dealings with each other.

New electronic workflow system

The human medicines department within the HPRA have transitioned to using a new (internal) electronic workflow system. Due to this the following changes are worth noting for MA (marketing authorisation) applications and the issuing of licences and summary of product characteristics (SmPCs) by the HPRA:

  • Product Specific Details (PSD)

The product specific information (which included the product composition and the manufacturers’ details) will no longer form part of the product licence document that is issued by the HPRA.
Previously the product licence document consisted of the licence cover page, PSD and Summary of Product Characteristics (SmPC). In future, the product licence document will consist of the licence cover page and the SmPC only. The information previously detailed in the PSD will be logged on the HPRA database and remain a registered part of the product marketing authorisation.

  • Summary of Product Characteristics (SmPC)

Updated SmPCs and Package Leaflets will publish on the website 24 hours after case closure.
(For details relating to the font/format of SmPC documents, further details are found in HPRA newsletter number 62).

  • PA numbers 

PA, or Product Authorisation numbers, are the Irish version of the MA number.  Newly allocated PA numbers for new holders will now contain 5 digit prefix.

  • Case Reference Number (CRN)

Previously CRNs were displayed as seven digits. These will now be alpha numerical for any new cases e.g. CRN00011X. The HPRA will still be able to identify any closed or ongoing cases using the old CRN.

  • Digital communications

All cases on the new system will be assigned a dedicated e-mail address e.g. [CaseNumber]@case.hpra.ie. This will enable you to send the HPRA case specific communications directly to the case and the allocated team. E-mail correspondence sent to you from the HPRA that is relevant to the case will come from this dedicated e-mail address. The European e-mail boxes will still be used where applicable.  You should consult with your IT department to ensure that e-mails of this nature are not blocked in your organisation.

 

National Scientific Advice Guide

The HPRA have recently updated their National Scientific Advice Guidance (which commenced in 2017) to include additional therapeutic areas for stakeholders. These areas include: anti-infective products, vaccines, disorders of haemostasis and thrombosis, cardiovascular diseases, common allergic conditions, advanced therapies in certain clinical indications and biostatistics. The updated guidance can be found at the following link:

(Guide for national scientific advice)

 

Written by:

Claire Brown

 

Need help with all the regulatory jargon?

Check out our updated GLOSSARY OF ABBREVIATIONS AND ACRONYMS.

Read More
European Regulatory Affairs Logo

Links

Home
Meet the Team
Services
News
Vacancies
Contact Us
Sitemap

Our Policy

Privacy Statement
Cookie Policy

eudracon small

Find Us

Dungarvan Enterprise Centre,
Fairlane Roundabout
Dungarvan,
Co. Waterford,
Ireland.
X35 FC60

LinkedIn

Request a Quote