This means that the MHRA do also require the submission of Annual Updates for Type IA variations, and these should be submitted nationally, unless the Type IA variations are submitted as part of a group with other variations applied for via the International Recognition Procedure (IRP).
IRP Variations:
You can use IRP during the lifecycle of UK products that have been initially authorised or subsequently varied via standalone;
National route
Decentralised and mutual recognition reliance procedure (MRDCRP) route
European Commission (EC) Decision Reliance Procedure (ECDRP) route
Conversely, where a product has been authorised via IRP, it is acceptable to submit standalone national post-authorisation procedures, including variations.
Variations submitted via IRP should be classified according to MHRA guidance on variations to MAs. To facilitate lifecycle management of the MA, variations should be submitted as soon as possible after approval by the Reference Regulator (RR).
The MHRA will be publishing updated guidance on Annual Updates very shorty. So, watch this space for a more detailed overview when it becomes available.
Written by
Fiona Downey
Fiona Downey 1
https://eureg.ie/wp-content/uploads/2023/10/Training-2.jpg306628ERAadministratorhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgERAadministrator2025-05-13 09:40:452025-05-13 09:40:45Type IA Annual Reporting in the UK
The Windsor Framework changed the regulation of medicinal products that were formerly in the scope of the EU centralised procedure so that these products are now licensed UK-wide under UK law.
Products not within this scope are authorised UK-wide under UK and applicable EU law (as amended by Regulation (EU) 2023/1182 and Directive (EU) 2022/642), as has been the case since 1 January 2021.
As a result, UK authorised products are now placed into one of two Categories:
Category 1 are UK products which fall under the mandatory or optional scope of the EU Centrally Authorised Procedure.
Category 2 are UK products which do not fall within the scope of Category 1 will be Category 2 products.
To assist MAHs in verifying the category of each of their products, a decision ladder has been created by the MHRA. The MHRA has also publish lists of Category 1 products and Category 2 products.
Which category your product falls under, will decide the pharmacovigilance requirements of that product.
Category 1 will be subject to UK legislation only. These products will legally be required to follow Part 11 of the HMRs for pharmacovigilance.
Category 2 will be subject to UK and EU requirements as applicable. These products will be legally required to follow Part 11 of the HMRs for pharmacovigilance with further pharmacovigilance requirements outlined in Schedule 12A of the HMRs.
However, it should be note that all existing exemptions that apply to all UK medicines remain in place irrespective of Category.
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
https://eureg.ie/wp-content/uploads/2024/02/Windsor-Framework-recd-13-02-24.jpg640960ERAadministratorhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgERAadministrator2024-02-13 13:24:342024-02-13 13:25:45UK updates to your Medicine – Windsor Framework and Regulation (EU) 2023/1182
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).
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:
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.
https://eureg.ie/wp-content/uploads/2019/01/Brexit2.jpg413640ivowenadminhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgivowenadmin2021-04-21 13:25:462023-11-06 11:15:36New UK National Procedure – Expedited 150 day procedure
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.
https://eureg.ie/wp-content/uploads/2020/12/Christmas-image-17-12-20.jpg12192000ERAadministratorhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgERAadministrator2020-12-17 15:52:012023-11-06 11:18:17Merry Christmas from Ivowen
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.
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.
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
https://eureg.ie/wp-content/uploads/2020/07/Brexit-clock-image-22-07-20.jpg422750ERAadministratorhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgERAadministrator2020-11-06 12:15:002023-11-06 11:15:33BREXIT – MHRA post-transition period information
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: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 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.
If you require any assistance for UK products please contact us: info@eureg.ie
Written by Emily Fletcher
Emily Flecther
https://eureg.ie/wp-content/uploads/2020/07/Brexit-clock-image-22-07-20.jpg422750ERAadministratorhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgERAadministrator2020-07-22 12:42:222023-11-06 11:08:37BREXIT – No extension to the transition period
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
https://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svg00ERAadministratorhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgERAadministrator2020-02-10 11:40:492023-11-06 11:08:32BREXIT – EVERYTHING stays the same for 2020
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
Step 1: MAHs should conduct a risk evaluation to identify products at risk of N-nitrosamine formation or (cross-)contamination and report the outcome by 26 March 2020 at the latest.
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.
https://eureg.ie/wp-content/uploads/2019/12/Hot_Air_Baloon.jpg356570ERAadministratorhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgERAadministrator2019-12-06 09:52:522023-11-06 11:08:332019 – What a year
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.
