Are you Brexit ready?

18th October 2018

Brexit in:

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Test your knowledge, take our Brexit quiz here

What do you want to do next? Do you want to continue to market your product in the EU only, or are you interested in both the EU and UK markets? Read on to find out what you need to do for both scenarios.

If you would like to continue to market your product in the EU there are a few things that need to be finalised before Brexit on the 29^th March 2019:

Reference Member State (RMS transfer)

This should have been done yesterday(!) The time it takes depends on the requested RMS’s workload.

Since July 2018 the MHRA is no longer accepting new applications with UK as RMS. However there are some currently authorised products wherein the UK is still the RMS.

If you have products and the UK is currently the RMS then it is vital a RMS transfer is initiated immediately. If there is only one CMS then this CMS should become the RMS (submission required). If there is more than one CMS, the preferred CMS needs to be consulted and a request sent asking them to be RMS. It is the responsibility of the MAH to secure a new RMS. The timeline for such transfers are solely dependent on the workload of the requested RMS.

Marketing Authorisation Holder (MAH) transfer

Needs to be done immediately – the time it takes is dependent on where the application is submitted.

From the 29^th March 2019 the MAH for a product licensed in an EU Member State (MS) other than the UK must be based in the EU. Therefore if the MAH is currently based in the UK there needs to be a MAH transfer to one based in the EU.

If this involves purely an address change (i.e. the marketing authorisation holder remains the same legal entity but they have an address in the EU) then this is a simple type IAin (A.1).
If the new MAH is a different legal entity then the MAH transfer must follow the guidelines of the currently registered RMS and CMS, at the very least documents such as transfer agreement, proof of establishment, , power of attorney(s), Pharmacovigilance (PV) update, etc., should be in place before submission of the request.

Batch release

Needs to be done within the next 4-8 weeks unless a product is a biological / immunological product in which case submission needs to be immediate.

Products that only have batch release and quality control testing sites for finished product in the UK will have to change the batch release and testing sites for their EU products. For products that have other batch release and testing sites the MAH may choose to delete the UK site(s) or may choose to replace them. For finished products manufactured in the UK an importation site (in EEA) will need to be introduced. In many cases, a single site can perform manufacturing, testing, importation and/or batch release activities.

The timelimes will follow the type IA/IB or type II (biological / immunological product) categories depending on what change is applied for. Please see https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/c_2013_2008/c_2013_2008_doc/c_2013_2804_en.doc

PV

Needs to be done asap and in association with any MAH transfers – usually a type IA or type IAin

The Qualified Person for Pharmacovigilance (QPPV) and Pharmacovigilance Site Master File (PSMF) must be based in the EU/EEA.

If you wish to continue to market the product in the UK in addition to the EU:

The MHRA have stated that after Brexit, all currently approved authorisations will be transferred into national procedures and will remain valid.

If an application is in-progress at the time of Brexit the application will need to be submitted to the MHRA again as a national application in the case of CP procedures and that for MR or DC procedures a transitional provision will be made. HOWEVER, this is contingent on a Brexit deal that allows for a transition period. This has not yet been agreed.

To ensure the product can remain on the market / licensed, the UK are proposing the following if there is a no-deal Brexit

a MAH should be established in the UK by the end of 2020. Until then, the MHRA will require a contact in the UK. A Change of Ownership will need to be submitted to MHRA to change from an EU MAH to a UK MAH for UK MAs
the Qualified Person for Pharmacovigilance (QPPV) should be established in the UK on day one, although those without a current UK presence will have until the end of 2020 at the latest to do so, but would nevertheless be required to make arrangements for providing the MHRA with access to the relevant safety data related to UK Marketing Authorisations (MAs) at any time. Companies may choose to have the EU QPPV take on responsibility for UK MAs until the UK QPPV can be established. A variation should be submitted to the MHRA to change QPPV. Exact details of this will be consulted upon
a Qualified Person (QP) for products manufactured in the UK or directly imported into the UK from outside a country on a designated country list (whitelist) must reside and operate in the UK. A QP for products manufactured in a country on a whitelist or manufactured in a third country and imported into the UK from a country on a whitelist can reside in a country on the whitelist.

(https://www.gov.uk/government/publications/how-medicines-medical-devices-and-clinical-trials-would-be-regulated-if-theres-no-brexit-deal/how-medicines-medical-devices-and-clinical-trials-would-be-regulated-if-theres-no-brexit-deal)

Do you need help with any of the above or any other regulatory issue?

Contact us! We’re here to help.

Written by Emily Fletcher

Emily Fletcher

Brexit – because it affects you too…

19th February 2019

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:

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

Written by Karolina Dobrychłop

Brexit – extension, extension, extension

19th June 2019

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.

Written by Marian Winder

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

13th February 2024

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

Tag Archive for: MHRA

Are you Brexit ready?

Brexit in:

Test your knowledge, take our Brexit quiz here

If you would like to continue to market your product in the EU there are a few things that need to be finalised before Brexit on the 29^th March 2019:

Reference Member State (RMS transfer)

Marketing Authorisation Holder (MAH) transfer

Batch release

PV

If you wish to continue to market the product in the UK in addition to the EU:

Do you need help with any of the above or any other regulatory issue?

Brexit – because it affects you too…

What is happening?

EMA

UK guidance on Brexit

MHRA guidance on Brexit

UK legislation on medicines and medical devices

EU Commission and EMA Q&As

Brexit Stakeholder Event

Brexit – extension, extension, extension

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

Related news in relation to Brexit

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

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.

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

Need help with all the regulatory jargon?

Links

Our Policy

Find Us

Tag Archive for: MHRA

Brexit in:

Test your knowledge, take our Brexit quiz here

If you would like to continue to market your product in the EU there are a few things that need to be finalised before Brexit on the 29th March 2019:

Reference Member State (RMS transfer)

Marketing Authorisation Holder (MAH) transfer

Batch release

PV

If you wish to continue to market the product in the UK in addition to the EU:

Do you need help with any of the above or any other regulatory issue?

What is happening?

EMA

UK guidance on Brexit

MHRA guidance on Brexit

UK legislation on medicines and medical devices

EU Commission and EMA Q&As

Brexit Stakeholder Event

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

Related news in relation to Brexit

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

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.

Need help with all the regulatory jargon?

Links

Our Policy

Find Us

If you would like to continue to market your product in the EU there are a few things that need to be finalised before Brexit on the 29^th March 2019: