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. The regulation is aimed at ensuring that medicinal products placed on the market in Northern Ireland comply with the provisions of Union law. This 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

Emily Fletcher 1

Emily Fletcher 1

UK updates to your Medicine – Windsor Framework and Regulation (EU) 2023/1182

Initially this is what you need to know:

  • From the implementation of the Windsor Framework on 1 January 2025, the MHRA will regulate medicines across a UK-wide licensing regime.
  • Most new Marketing Authorisation Applications (MAAs) will be granted as PL licences covering the whole of the UK.
  • The MA number will have just a PL prefix (as it was before Brexit).

No action is necessary for this conversion for Marketing Authorisation Holders who only hold a PLGB licence for a particular product.

  • If a MAH currently holds both a PLNI and a PLGB for the same product and wishes to retain UK-wide authorisation, the PLNI will need to be cancelled in order for the existing PLGB to be converted to a PL.

Where an MAH only holds a PLNI and subsequently seeks authorisation for the whole of the UK, the PLNI will need to be cancelled prior to the granting of the PL.

MAHs involved in EU procedures, with NI included as a CMS, will need to notify the RMS to withdraw NI as a CMS from the procedure. This must occur before the cancellation of the PLNI and the granting of the new PL.

  • UK Only’ is required to be printed on the UK packaging from 01Jan2025, a sticker is allowed to be placed on packaging for a period of 6 months (until 30June2025) but this must be replaced with direct printing on the packaging after this.
  • And from 1 January 2025, the EU Falsified Medicines Directive (FMD) will no longer apply in Northern Ireland.
  • From 1 January features included for the purposes of compliance with EU FMD requirements may be removed or covered.

MHRA Overview:

Current position From 1 January 2025 Action required from MAHs
New MAA for product in scope of the Centrally Authorised Procedure GB: national applications, reliance/recognition applications, PL

EC no longer able to authorise for NI.

For products entering the market from 1 January 2025, MAHs may apply for PL licences only. Must comply with labelling and packaging requirements.
New MAA for product in scope of the Centrally Authorised Procedure NI: EC authorisation.
Supply of GB authorised products may be permitted through routes, e.g., NIMAR, Reg 174, Reg 167.
PL

EC no longer able to authorise for NI.

For products entering the market from 1 January 2025, MAHs may apply for PL licences only. Must comply with labelling and packaging requirements.
New MAA for Non-CAP product authorisations UK-wide authorisation or option to apply for PLGB or PLNI PL

Or

PLNI through the MRP/DCP

For products entering the market from 1 January 2025, MAHs may apply for PL licences or PLNI only if using the MRP/DCP. Must comply with labelling and packaging requirements.
Products with existing authorisations granted before 1 January 2025. UK-wide licence PL Must comply with labelling and packaging requirements.
Products with existing authorisations granted before 1 January 2025. Separate PLGB and PLNI for the same product. Option A:

PL only

By 30 September 2024 the MAH should request that the MHRA cancel the PLNI, effective on 31 December 2024. PLGB licences will convert to PL by 1 January 2025.

Must comply with labelling and packaging requirements.

Products with existing authorisations granted before 1 January 2025. Separate PLGB and PLNI for the same product. Option B:

Retain NI only through the MRP/DCP.

No action required from MAH.

PLGB will be cancelled by the MHRA on 31 December 2024 as cannot hold a PL and PLNI simultaneously for the same product.

Must comply with labelling and packaging requirements.

Products with existing authorisations granted before 1 January 2025. PLNI through the MRP/DCP, with no PLGB for the same product. PLNI through the MRP/DCP only. Where a MAH subsequently applies for a PL, the PLNI will need to be cancelled prior to the granting of the PL. The MAH should inform the RMS of its intention to withdraw NI as a CMS from the MRP/DCP.

Must comply with labelling and packaging requirements.

Products with existing authorisations granted before 1 January 2025. PLGB only PL only No action required from MAH.

PLGBs will be converted to PL by 1 Jan 2025.

Must comply with labelling and packaging requirements.

CAP Bridging Mechanism Permits supply of GB-licensed product in NI for up to 6 months if no equivalent available. Not applicable as the MHRA will license novel/CAP medicines in NI through a UK-wide licensing route. Not applicable.
Existing Stock in Existing Packaging on the market Continues as currently. Can continue to be supplied to patients until the product’s date of expiry in the territory for which the product was valid for supply prior to 1 Jan 2025. Not applicable.

More on Windsor Framework in the weeks to come……

If you need any help to navigate this new min field of UK updates, don’t hesitate to contact us for support.

Written by

Emily Fletcher

Emily Fletcher 1

Emily Fletcher 1

New UK National Procedure – Expedited 150 day procedure

There are now several routes to obtain a marketing authorisation in the United Kingdom (UK), Great Britain (England, Scotland and Wales) or Northern Ireland. The options available will be determined by the intended market and the type of application. In this article we will discuss the purely National procedure.

To help you to decide what type of license you will require, here is a brief explanation of the new types of MA you can obtain:

MA prefix for UK Possible MA types Territory Leg & Guidance
PL UK wide Authorised for use in United Kingdom (Great Britain & Northern Ireland) EU & MHRA rules apply
PLGB GB Authorised for use in Great Britain only (England, Scotland and Wales only) MHRA rules apply
PLNI NI Authorised for use in Northern Ireland only EU rules apply

One option you can pursue is the National procedure (a 150-day procedure) to obtain a marketing authorisation (MA) in the UK, Great Britain or/in Northern Ireland. The MHRA has introduced this accelerated procedure aimed at expediting the availability of medicines for patients in the UK and proposes to reach its opinion on marketing authorisation applications (MAAs) within 150 days of filing an application (excluding the time taken to provide further information or data required).

Applications should be submitted via the MHRA Submission Portal, and the appropriate national fee will apply.

The accelerated assessment is available for all high-quality new MAAs for both new, and existing active substances, as well as orphan designations. Interested applicants should contact the MHRA in advance of submitting the application.

For medicines containing new active substances or biosimilar products, the MHRA encourages applicants to provide a summary of the dossier to share their intentions and to verify the new active substance status.

The pre-submission meeting offers the opportunity to discuss the arrangements for the UK Compliance Check (CC) on Paediatric Investigation Plans (PIPs). Additionally, it also offers the opportunity to enhance joint discussion with National Institute for Health and Care Excellence (NICE) Health Technology Assessment (HTA) evaluation process.

The MHRA will operate a ‘fixed submission date’ system to facilitate consultation with the Commission on Human Medicines (CHM) and will publish a set of dates to facilitate planning the submissions to coordinate with appropriate meeting dates of CHM. The submission slots will be linked to the dates of CHM meetings.

The assessment timetable will begin after the validation of the application. The assessment process will run in two phases totalling 150 days like so:

  • Phase I: completed 80 days after the clock starts. Issues that arose or requiring clarification from the initial assessment will be raised with the applicant and should be addressed within the clock off period of 60 days.
  • Phase II: commence on receipt of the applicant’s responses. The MHRA will provide a decision on the acceptability of the product by day 150.

If the MHRA refuses to grant the MA-based on advice from CHM, there is an opportunity for the applicant to request a review of the decision.

The conclusion of the assessment will lead to the publication of a UK Public Assessment Report for the product.

Here are some useful links to obtain further information:

https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk#national-procedure

https://www.gov.uk/guidance/guidance-note-on-new-assessment-routes

https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines

https://services.intralinks.com/branding/3997623225/?clientID=3997623225

https://www.gov.uk/government/publications/mhra-fees

https://www.gov.uk/government/organisations/commission-on-human-medicines/about/membership

https://www.gov.uk/guidance/marketing-authorisation-application-submission-dates-for-150-days-national-and-european-commission-decision-reliance-procedures

If you need any clarification or support to help you to navigate the new post Brexit procedures, please contact us and Ivowen will gladly assist you in a timely manner.

BREXIT – MHRA post-transition period information

The UK has left the EU and the transition period after Brexit comes to an end this year.

The MHRA have issued new guidance for industry and organisations effective from 01st January 2021.  From this date the MHRA will be the UK’s standalone medicines and medical devices regulator.

Areas covered in the new guidance include:

Clinical Trials

From 1 January 2021, for registering clinical trials, existing and established international registers will still be used, such as ISRCTN registry (UK), or ClinicalTrials.gov (USA), to ensure the public is aware of your trial. For trials involving both UK and EU sites a record in the EU Clinical Trials Register will exist (other than adult Phase 1 studies).  In the UK, any favourable opinion given by a research ethics committee is subject to the condition that the clinical trial is registered on a publicly accessible database. The time frame for publishing the summary of results is within 6 months of the end of trial for paediatric clinical trials or within one year of the end of trial for non-paediatric clinical trials. You do not need to submit this clinical trial summary report to the MHRA as well; however, you must send a short confirmatory email to CT.Submission@mhra.gov.uk once the result-related information has been uploaded to the public register and provide a link.

 

Pharmacovigilance

Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) from 1 January 2021

From 1 January 2021, the following legal obligations will apply to holders of UK marketing authorisations (MA). These include those that cover the whole of the UK, or are specific to Northern Ireland or to Great Britain (England, Wales and Scotland):

  • To operate a pharmacovigilance system for UK authorised products.
  • To have an appropriately qualified person responsible for pharmacovigilance (QPPV) that resides and operates in the EU or the UK and is responsible for the establishment and maintenance of the pharmacovigilance system for UK authorised products.
  • To maintain and make available upon request a pharmacovigilance system master file (PSMF) that describes the pharmacovigilance system for UK authorised products. The PSMF must be accessible electronically or physically from the UK at the same site at which reports of suspected adverse reaction may be accessed.

Statutory guidance concerning the QPPV for UK authorised products is described in the Good Pharmacovigilance Practices (GVP) Module I. This guidance will be supplemented by the ‘Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders’, which will be published in due course.

Updated guidance on pharmacovigilance procedures

Detailed guidance on pharmacovigilance procedures from 1 January 2021 is published on the MHRA website: https://www.gov.uk/government/publications/guidance-on-pharmacovigilance-procedures-in-the-event-from-1-january-2021/updated-guidance-on-pharmacovigilance-procedures

 

Marketing Authorisations

New guidelines have been outlined for Marketing Authorisations, to include Conditional MAs, registering new packaging information, guidance on the handling of applications for Centrally Authorised Products (CAPs),  Article 29 applications, converting parallel distribution notices to UK parallel import licences, handling of ASMFs and CoS from January 2021, reference medicinal products, converting CAPs to UK MAs, guidance on licencing biosimilars, bioequivalence/therapeutic equivalence studies and renewing marketing authorisations.

 New Submission Registrations

For planned applications for submission to the UK (for example, a Marketing Authorisation for the UK market), you will need to submit the information through the MHRA national portals.

All current Eudravigilance Gateway users who wish to gain access to the new MHRA Gateway will need to first gain access to MHRA Submissions. The steps for gaining MHRA Gateway access are contained within MHRA Submissions.  MHRA Submissions will not be used to send or receive ICSRs.

A useful webinar on how to gain access to MHRA submissions portal is available on the MHRA website at the following link https://www.gov.uk/government/publications/webinars-preparing-to-make-submissions-to-the-mhra-from-1-january-2021

Within the recent MHRA guidelines, the following areas are also covered:

  • Devices
  • Importing and Exporting
  • IT Systems
  • Paediatrics

IN DEPTH DETAILS ON THE NEW MHRA GUIDANCE CAN BE FOUND ON THE LINK BELOW:-

https://www.gov.uk/government/collections/mhra-post-transition-period-information

 

If you need any clarification or support to help you to navigate the end of transition period please contact us and Ivowen will gladly assist you in a timely manner.

 

Written by Mary Canning

mary