Windsor Framework, recd 13 02 24

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

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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.

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Merry Christmas from Ivowen

I am sure you will agree that 2020 has been a very trying year for all of us. Despite the restrictions, politics and challenges of working from home the regulatory world keeps on spinning. Check back in January for the latest updates from our amazing team

This year, in lieu of Christmas gifts for staff and clients, and instead of a Christmas party, the team at lvowen have each nominated a charity to receive a donation. The following are our team’s and lvowen’s chosen charities for 2020. We wish all our staff and customers a happy and safe Christmas 2020 and look forward to working with you, in 2021!

  • Alzheimer Society of Ireland
  • Concern
  • Cuan Saor (Women’s Refuge, Clonmel)
  • Cystic Fibrosis Ireland
  • Down Syndrome Ireland
  • Focus Ireland (Challenging homelessness)
  • Irish Cancer Society
  • Irish Kidney Association
  • Jigsaw (Youth Mental Health Ireland)
  • Paws Animal Rescue
  • Plan International Ireland (Because I am a girl fund)
  • Safe Ireland
  • St. Vincent de Paul (poverty and disadvantage)

Ivowen will be closed for Christmas this year from 24/12/20 to 03/01/21, inclusive.

Written by Alice D’Alton.

 

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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

Brexit clock image 22 07 20

BREXIT – No extension to the transition period

It seems that Brexit is on course for 1st January 2021….

The 30th June 2020 came and the legal deadline for agreeing to an extension of the transition period has passed with no request from the UK. Therefore the Brexit trade deal transition phase will come to an end on the 31st December 2020. At this stage there will be one of two possible outcomes: Brexit image 22 07 20 3 The next important dates are the 15-16th October (European Council Meeting) and 26th November (penultimate plenary session of 2020. European lawmakers have stated that a trade deal must be negotiated, checked, translated and presented to the European Parliament by this date if the transition period is to end by 31 December 2020). If the UK exits without a trade deal, trade between the UK and EU will change immediately on the 1st January 2021 (i.e. Hard Brexit).

The European Commission (EC), European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have recently reminded clinical trial sponsors that they must comply with EU clinical trial rules following the Brexit transition period that expires on 31 December 2020 https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/brexit_technicalnotice_ct_en.pdf

The UK Government launched a major new public information campaign to give everyone the facts that they will need to be ready for 1 January 2021. A straightforward checker tool at gov.uk/transition will help identify some of the specific steps any business or individual needs to take to be ready, and will allow companies to sign up for bespoke updates.

To keep up to date with all EMA advice on Brexit please refer to the following: https://www.ema.europa.eu/en/about-us/brexit-united-kingdoms-withdrawal-european-union

For more detailed information about how 2020 currently looks with regard to Brexit please see: https://eureg.ie/brexit-everything-stays-the-same-for-2020/

If you require any assistance for UK products please contact us: info@eureg.ie

Written by Emily Fletcher

Emily Fletcher

Emily Flecther

 

BREXIT – EVERYTHING stays the same for 2020

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 The United Kingdom has formally left the EU as of 31 January 2020 and has become what is referred to as a third country.

On 1 February 2020 a transition period started which is due to end on 31 December 2020.

During the transition period, EU pharmaceutical law will continue to be applicable to the UK, meaning that pharmaceutical companies can continue to carry out activities in the UK until the end of 2020.

Companies have until 31 December 2020 to make the necessary changes to ensure that their authorised medicines comply with EU law and can remain on the EU market.

  • The UK will remain on CESP for the duration of transition period (after that, if no further extension to the transition period is proposed, it will be necessary to use the MHRA portal for submissions https://pclportal.mhra.gov.uk/)
  • Marketing authorisation holders and applicants can still be established in the UK in 2020
  • Qualified Persons for Pharmacovigilance (QPPVs) and pharmacovigilance system master files (PSMFs) can still be based in the UK until the end of 2020.
  • Manufacturing sites, Quality control testing and Batch release sites can also still be based in the UK until the end of 2020
  • orphan designation holders can still be located in the UK until 31 December 2020
  • minor use/minor species (MUMS)/limited markets classification holders can still be located in the UK until 31 December 2020

The withdrawal agreement foresees that following its departure from the EU on 31 January 2020, the UK will no longer participate in EU institutions and their decision-making. For the CMDh this means that as of 1 February 2020, no one who represents the UK, or is appointed or nominated by the UK can systemically participate in the CMDh meetings.

During the transition period, the UK will not be able to act as RMS in MRP/DCP, but the UK can participate in MRP/DCP as CMS.

Ivowen are here to assist you with all your Brexit related needs and dossier amendments.

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

Written by Alice D’Alton

Alice Dalton

Hot Air Baloon

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

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Ivowen attended TOPRA Symposium 2019

This year’s TOPRA Annual Symposium was held in Dublin in October. The Annual Symposium is an essential meeting for regulatory professionals to gain both an understanding of current and evolving regulatory requirements, as well as insights into future plans for regulations in the Human medicines, Veterinary medicines and Medical Device sectors.

Three members of our Team attended the Symposium this year, Majella Ryan, Alice D’Alton and Nanda Naik. This year was particularly satisfying for Ivowen as we had an exhibition stand at the three day event.

As well as exhibiting, Ivowen attended the sessions including ‘Life after Brexit’. This session was a live discussion of predictions and concerns about the possible outcome of ongoing negotiations with the EU.

Now that an extension has been granted, which will delay the UK exit until January 2020, we are left wondering if we will finally know the UK position when Ivowen attend the Medicines for Europe regulatory conference being held in Amsterdam on 29th – 31st January.

In the meantime, we await instruction from the regulators on whether UK will still be available on the CESP portal later this week. Ivowen is registered on the new MHRA submissions portal so either way we have you covered.

Ivowen will keep you up to date in the coming days and weeks

Please contact us, Ivowen are dedicated to keeping you up to date with the latest regulatory updates and innovations. We remain at your disposal to assist in all of your regulatory endeavours today and into the future.

Written by Alice D’Alton.

deadline extension

Brexit – extension, extension, extension

Brexit extension date is now 31 October 2019, but there’s not time to be complacent.

Are you planning to submit a Marketing Authorisation Application (MAA) for a Non-Prescription Medicine?

If you are preparing an MAA for a Non-Prescription Medicine for a Decentralised (DCP) or Mutual Recognition Procedure (MRP) you will need to prepare a ‘Justification for Non-Prescription Classification’ document in accordance to CMDh best practice guide issued in January 2019 (CMDh/250/2012, Rev 1).

 https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_for_MA/CMDh_250_2012_Rev.1_2019_01_clean_-_BPG_for_NPM_in_DCP_MRP.pdf

Ideally this document should be submitted as part of the initial MAA.  Otherwise, you will be requested to provide it at the validation stage.

This document should be titled, “Justification for Non-Prescription Classification” and should be provided in Module 1.2.  It should contain all the supporting data and evidence required to justify classification of the medicinal product as not subject to medical prescription as set out in the Guideline on Changing the Classification for the Supply of a Medicinal Product for Human Use [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/c/switchguide_160106_en.pdf].

If you need any clarification or advise to prepare a justification for Non-Prescription classification report to support a Marketing Authorisation Application, Ivowen will gladly assist you in a timely manner. Please contact us.

 

Related news in relation to Brexit

The current Brexit extension date is 31 October 2019.  The UK remains an EU Member State for the duration of the extension, with all the rights and obligations set out in the treaties and under EU law.

Nevertheless, all pharmaceutical companies in the EU are reminded to continue their preparedness for the UK’s withdrawal.

Based on the European Council decision, the deadline of 29 March 2019 referred to in Brexit related guidance should be understood as referring to 31 October 2019.

 

  • The MHRA have updated guidance on Exporting active substance manufactured in the UK in a no deal scenario on 03/06/2019.

https://www.gov.uk/government/publications/exporting-active-substance-manufacturer-in-the-uk-if-we-leave-the-eu-without-a-deal

A template for the Written Confirmation can be found on the European Commission website,

https://ec.europa.eu/health/sites/health/files/files/gmp/2013_01_28_template.pdf

In the event of a no deal EU exit, the UK will be recognised as a Third Country for the export of active substances for human use to the EEA.

In the event of a no deal scenario, the UK will continue to accept importation of active substances into the UK without a Written Confirmation from the same list of countries as currently (namely the European Economic Area (EEA) countries, USA, Japan, Brazil, Australia, Israel and Switzerland).

A Written Confirmation will then be required for each shipment of active substances manufactured in the UK that is exported to the EEA.

Please contact us if you need any clarification or support to supply Written Confirmation(s) for the orderly import of Active Substances, Ivowen will gladly assist you in a timely manner.

  

  • The MHRA have issued a guidance on the Handling of Active Substance Master Files and Certificates of Suitability in the event of no deal published 18 March 2019.

After Brexit, the UK will no longer participate in ASMF work-sharing procedures with EU Member States or have access to the EU Communication and Tracking System (CTS) assessment report repository. Any reference in the above guideline to the CTS ASMF assessment repository or to EU/ASMF/XXXXX reference numbers will not be applicable to UK national applications after the UK leaves the EU.

Certificates of Suitability (CEPs) are not affected by the UK leaving the EU as they are issued by the European Directorate for the Quality of Medicines and Healthcare (EDQM), which is a Directorate of the Council of Europe and a body that is independent of the EU. On leaving the EU, the UK will remain a member of the Council of Europe and a signatory to the Convention on the Elaboration of a European Pharmacopoeia.

Please contact us if you need any additional information or if you need any clarification or advise on ASMFs or CEPs, Ivowen will gladly assist you in a timely manner.

 

marian

 

 

Written by Marian Winder

 

 

 

 

 

 

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Brexit – because it affects you too…

The European Union is arguably the world’s most powerful bloc and very soon it’s about to lose the United Kingdom, one of its biggest members. How and when the UK leaves the EU will have further implications that ripple around the globe.

So if you’ve heard about Brexit but haven’t been keeping up with every twist and turn of the developments, no worries! Ivowen team will provide you with everything you need to know to have your products designed for UK and Brexit affected markets authorised successfully.

What is happening?

EMA

The European Medicines Agency (EMA) will physically relocate to the Netherlands in early March 2019.

https://www.ema.europa.eu/documents/press-release/ema-relocation-updates_en.pdf

EMA will leave its premises in London on 1 March 2019.

It was confirmed that from 4 to 8 March, the Agency will operate on the basis of extended teleworking. During the course of the following week  EMA staff will gradually move into the Spark building.

From 4 March 2019 onwards the official address of EMA will be that of the permanent building, located in Amsterdam Zuidas:

European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands

Meetings and visits will take place at the Spark building:

Orlyplein 24, 1043 DP Amsterdam, The Netherlands

 

UK guidance on Brexit

Following the outcome of the EU referendum, MHRA still feels responsible for playing a crucial role in medicines and devices regulations as well as vigilance and market surveillance.

As part of the MHRA response to exiting the EU the following Brexit guidance was issued:

Technical information on what the implementation period means for the life science sector

Update on negotiations and further guidance for pharmaceutical companies planning in advance of the final negotiated settlement

Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal

If you need any clarification or support to complete variations to support changes needed as a result of Brexit, Ivowen will gladly assist you in a timely manner.  Contact us for more information or to make an enquiry.

 

MHRA guidance on Brexit

Bearing in mind the worst-case scenario if the UK leaves the EU with no deal, the UK would no longer be part of the EU medicines and medical devices regulatory networks and  consequently submissions related to human medicines would need to be submitted directly to the MHRA.

The webinar below is relevant for all pharmaceutical companies involved in making medicines regulatory submissions and vigilance activities. It also ensures that stakeholders can be informed of any IT plans and preparations. There is also a section on how all medicines related clinical trial sponsors will register and submit:

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/772918/Making_submissions_to_the_MHRA.pdf

If you need any clarification or support to complete variations to support changes needed as a result of Brexit, Ivowen will gladly assist you in a timely manner.  Contact us for more information or to make an enquiry.

 

UK legislation on medicines and medical devices

Legislation has been published which, in the event of the UK leaving the EU with no agreement, will cover the regulation of medicines, medical devices and clinical trials and allow for the continued sale.  The Brexit guidance is available here:

  1. Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc) (EU Exit) Regulations 2019
  2. The Medical Devices (amendment) (EU exit) Regulations 2019
  3. The Medicines for Human Use (Clinical Trials) (amendment) (EU exit) Regulations 2019

The 2012 Regulations (as amended by the 2019 Regulations) make reference to various pieces of EU guidance, as that stood immediately before the exit day (29 March 2019).

If you need any clarification or support to complete variations to support changes needed as a result of Brexit, Ivowen will gladly assist you in a timely manner.  Contact us for more information or to make an enquiry.

 

EU Commission and EMA Q&As

The EU Commission & EMA have published an updated list of questions and answers related to the UKs withdrawal from the EU on the 1st February:

https://ec.europa.eu/info/sites/info/files/medicinal_products_for_human_and_veterinary_use-qa_en.pdf

This confirms that dual labelling between UK & Ireland is acceptable where the labels meet the requirements of the Directive and reflect the SPC in Ireland (see Q24).

The focus of this Q&A is on the regulation of medicinal products  within the centralised procedure.

If you need any clarification or support to complete variations to support changes needed as a result of Brexit, Ivowen will gladly assist you in a timely manner.  Contact us for more information or to make an enquiry.

 

Brexit Stakeholder Event

Brexit Stakeholder Event – Ivowen was there

Following the UK’s departure from the European Union, the HPRA, together with medicines agencies in Europe, is making preparations to ensure continuity to deliver on patient and animal health remits even if the UK fully exits the current systems as scheduled. There are potential implications for the European network as a whole and particularly for Ireland with its shared marketplace, see meeting agenda below:

Agenda for Brexit Stakeholder event 1 Feb 2019

Contact us if you would like some more information on this event or Brexit in general

 

KD

Written by Karolina Dobrychłop

Need help with all the regulatory jargon?

Check out our updated GLOSSARY OF ABBREVIATIONS AND ACRONYMS.

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