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

Environmental Risk Assessment (ERA) – revised guideline to assess risk of human medicines for the environment…….

13th May 2019

An Environmental risk assessment (ERA) of medicines ensures that the potential effects of pharmaceuticals on the environment are studied and that adequate precautions are taken in case specific risks are identified.

The EMA has published a revision of its guideline on the environmental risk assessment (ERA) of human medicines for a six-month public consultation. Stakeholders are invited to send their comments by 30 June 2019 to era_dg@ema.europa.eu using the template provided.

Dossier Expectations due to ERA revised guidance

An ERA is required for all new marketing authorisation applications for a medicinal product through centralised, mutual recognition, decentralised or national procedures.

In the case of medicinal products comprised of naturally occurring substances such as vitamins, electrolytes, amino acids, peptides, proteins, nucleotides, carbohydrates and lipids as active pharmaceutical ingredient(s) (API), the ERA may consist of a justification for not submitting ERA studies.

For type II variations and extension applications, the ERA dossier should be updated if there is an anticipated increase in the environmental exposure. The environmental data previously submitted in the original dossier of the same marketing authorisation holder (MAH) may serve as a basis for the revised ERA for the variation or extension application.

An ERA is not required for renewals of marketing authorisations or Type IA/IB variations.

Applicants are required to submit an ERA irrespective of the legal basis. Generic medicinal products are therefore not exempted from providing an ERA. However, cross reference to the ERA dossier of the originator is permitted with consent from the originator.

In order to avoid unnecessary repetition of studies, and in particular animal studies, applicants are encouraged to share their data. If the current applicant has access to an ERA that was performed earlier by another marketing authorisation holder, this ERA (including study reports) may be submitted, including a letter of access. If the reference ERA is not complete in accordance with the current guideline (e.g. studies are missing, or increased environmental exposure may be anticipated) the applicant should conduct the missing studies and/or update the ERA.

Public Assessment Reports (PARs and EPARs) and reviews or summary data from other regulatory frameworks cannot be used in the ERA dossier without the underlying study reports. All data submitted (whether study reports or peer reviewed literature) should contain enough information to permit assessment of the reliability of the study performed.

The applicant may request scientific advice on issues related to environmental risk assessment and on possible precautionary and safety measures to be taken with respect to the use and disposal of a medicinal product.

Structure of the ERA report

The ERA report should be presented in Module 1.6 of the eCTD dossier.

The ERA report should start with a clear identification of the active ingredient, including company name/code, IUPAC name, CAS number, empirical formula, structural formula, SMILES code, and molecular weight.

The full study reports and references should be provided in the annex of the ERA. There may be cases in which the absence of environmental studies could be justified. In these cases, the expert should provide a rationale for the absence of studies.

A dated signature of the author, information on the author’s educational, training and occupational experience, and a statement of the author’s relationship with the applicant, must be included.

Are you in search of advice and support on ERA?

Please contact us, Ivowen Regulatory are available to offer advice and support on Health Product Regulatory compliance.

Written by Nanda Naik

HPRA update on Batch-specific requests for safety features

25th March 2019

The recent medicinal products newsletter (issue 61) published by the HPRA includes an article about batch-specific requests (BSRs) and safety features. This is an update on the Falsified Medicines Directive safety features information.
The Commission Delegated Regulation (EU) 2016/161 with detailed rules for the safety features appearing on the packaging of medicinal products for human use, came into force in Ireland on the 9^th February 2019.

BSRs will be considered for medicines for the Irish market that come within the scope of the regulation but do not bear safety features (UI and ATD).

The article outlines the details the MAH must provide in the BSR application.
Furthermore, the MAH must confirm that safety features have already been registered with the HPRA and if not a simultaneous Article 61 (3) notification must be submitted with the BSR application.

For full details on this issue the full article can be found here: https://www.hpra.ie/homepage/about-us/publications-forms/newsletters/item?id=55950b26-9782-6eee-9b55-ff00008c97d0&t=/docs/default-source/publications-forms/newsletters/hpra-medicinal-products-newsletter—issue-number-61

Written by:

Claire Brown

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… it’s getting closer…

16th January 2019

Ivowen have provided some practical guidance and documents below, which may help you prepare for Brexit for products authorised by the DCP and MRP procedures.

Take our Brexit quiz to see if you are ready.

Do you still need to change your MAH(s) in any of the EU Member States because of Brexit?

If so, refer to the following updated guidance issued in January 2019 which details the documentation and requirements to submit a Marketing Authorisation Holder transfer:

CMDh guidance on Brexit, Jan 2019

If you need any clarification or support to complete a Marketing Authorisation Holder transfer, Ivowen will gladly assist you in a timely manner. Contact us for more information or to make an enquiry.

Is the UK your current RMS?

If so, you need to initiate an RMS switch as soon as possible. The guidance issued in July 2018 along with the template issued in June 2018 is required to complete this process. This template needs to be completed and sent to a specific e-mail address at the proposed new RMS. The list of contacts points to send the completed template is provided below:

Guidance:

CMDh guidance on changing RMS

Template for RMS change

List of RMS contacts can be found in the excel spread sheet in the link Contact Points, which can be found here:

MS contact points

If you need any clarification or support a RMS switch, Ivowen will gladly assist you in a timely manner. Contact us for more information or to make an enquiry.

Do you need to change your UK batch release site, etc., if it currently within the UK?

If so, you can refer to the updated guidance document issued in December 2018, which provides information on the type of variation that is required to change functions such as batch release site(s), QC testing site(s), packaging site(s), deletion of site(s) for batch release and changes to the QP for Pharmacovigilance (QPPV) and PSMF where these functions still reside within the UK:

CMDh practical guidance for Brexit & DCP/MRP

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.

Do you supply product to Cyprus?

If so, the Cypriot Competent Authority has issued a newsletter to Stakeholders on the 14 January 2019 which lists 105 products authorised via an exceptional marketing authorisation affected by Brexit which are considered critical. The Drugs Council in Cyprus recommends that pharmaceutical companies register these products via an exceptional marketing authorisation using another reference state other that the UK.

If you need any clarification or support to complete an Exceptional Marketing Authorisation to avoid no supply of these critical products on the Cypriot market, Ivowen will gladly assist you in a timely manner. Contact us for more information or to make an enquiry.

Written by Marian Winder

To 2019 and beyond (Brexit)…

4th December 2018

With the festive season upon us and 2019 on the horizon, Ivowen are setting our sights on the year ahead. So what’s going on in 2019 and beyond, including and excluding Brexit…

What’s happening in early 2019?

We will be attending the Medicines for Europe Regulatory and Scientific Affairs and Pharmacovigilance conferences in January and we encourage you to contact us before mid-January with any specific questions you might like us to ‘ask the regulators’.

Brexit follows quickly on the tail of the new year, and we will all be hopefully ready and able for this new challenge. Take our Brexit quiz here to see if you are Brexit ready and contact us to help.

What’s happening in later on in 2019?

We are also looking forward to attending the annual TOPRA symposium this year, hosted in Dublin, and we hope to see you at our stand to discuss how we can assist you with your regulatory needs in 2019 and beyond.

What about us?

Ivowen consists of an amazing team with extensive experience of the pharmaceutical industry. Our aim is to understand our customer’s needs and offer services that meet those needs in a timely and efficient way.
As part of EuDRAcon, a pan European network of regulatory consultants, we can provide expert advice on all matters regulatory for the EU and beyond, including Brexit

We hope that in 2019 Ivowen can help you with your specific and unique requests.

And for now…

The office will be closed from the afternoon of Friday 21st December 2018 until Wednesday 2nd January 2019. Merry Christmas and a Happy New Year for 2019!

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

Written by Mary Canning

HPRA’s support as you prepare for Brexit……

21st November 2018

Brexit in:

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The Health Products Regulatory Authority (HPRA) of Ireland is geared up and ready to support MA holders as they prepare for Brexit.

What happens if UK leaves the EU with no deal?

The implications of Brexit with regard to the UK’s role in the licensing of medicines will be determined by the terms of the ongoing exit negotiations. However, in accordance with Directives 2001/82/EC and 2001/83/EC:

For marketing authorisations issued through the mutual recognition procedure (MRP) or decentralised procedure (DCP), the Reference Member State (RMS) must be based in the EU/EEA.
The marketing authorisation holder (MAH) must be located within the EU/EEA.
MAHs will need to ensure that their EU qualified person responsible for pharmacovigilance (QPPV) and their pharmacovigilance system master file (PSMF) are located within the EU/EEA.
The batch release/testing site must be located within the EU/EEA.

HPRA are working “extraordinarily” hard on preparing for all scenarios

HPRA are Brexit ready

– Willing to act as RMS for all products where Ireland (IE) is currently CMS and a change of RMS is required. No fees will apply to the process for changing RMS to IE. The HPRA commits to an efficient and simple process for handling these requests (for example allowing the inclusion of multiple products in one request where applicable).

– To encourage the use of multilingual labelling the HPRA will proactively work with other European regulators to help optimise opportunities for multilingual labelling. The HPRA ‘Guide to labels and leaflets of Human Medicines’ has been updated (Oct 2018) to give specific guidance on the development of multilingual labelling

– HPRA MAH transfer procedures have recently been changed to allow MAHs up to 6 months to implement packaging changes following issue of the transferred authorisation, for Brexit related transfers. In addition the HPRA no longer requires stock to be recalled from wholesaler level six months following the issue of the transferred authorisation/ licence/registration.

Timeline for changing RMS

Can be completed within a matter of days. The critical issue will be the timing of when the change in RMS should occur as it is required to occur when there are no open regulatory activities for a product.

Procedures for MAHs to transfer MAH to EU/EEA based MAH

The transfer procedure must be used where the legal entity of an authorisation/licence holder is changed as marketing authorisations are transferred to a new company number. It is possible to transfer the MAH while there are ongoing/open variations. If the transfer is processed/issued, the new MA holder details will transfer onto the open/ongoing variations

Bulk transfers are accepted by the HPRA for Brexit and reduced fees apply.
New PA number is provided in advance of application.
Word version of an updated package leaflet is acceptable.

If the only changes proposed relate to MAH details and a new PA number, an Article 61(3) application is not required. However, if there are additional changes to the labels and package leaflet an Article 61(3) application must be submitted. This can be submitted in parallel to the transfer.

Medical devices containing an ancillary medicinal substance

Transfers of medical devices containing a medicinal ancillary substance with a valid CE certificate are considered administrative only. Transfers typically take less than 30 days from validation of the submission to be completed. No fees will apply to this transfer process.

Parallel Product Authorisations

If the UK is listed as one of a number of source countries on a PPA, this will need to be removed by way of a type IA variation (category 4).

Where the holder of PPA is located within the UK, the authorisation will need to be transferred to holder located within the EEA.

Qualified person certification of repackaging activity must take place within the EEA. Variations to change the site of batch certification can be submitted using the PPA variation category No 9a and 9b.

Variations to Marketing Authorisations to change Qualified Person Responsible for Pharmacovigilance (QPPV), manufacturing site or/and batch release sites.

Any variations required for a marketing authorisation (MA), e.g change in location of QPPV or site of batch release, should be completed prior to the date of the UK’s departure from the EU (prior to the 29 March 2019).

Changes in the QPPV, including contact details (telephone, and fax numbers, postal address and email address) may, for medicinal products for human use, be updated through the Article 57 database only (without the need for a variation)

Changes to the location of the PSMF (street, city, postcode, country) may be updated through the Article 57 database only (without the need for a variation)

Are you in search of advice and support on Brexit?

Please contact us, Ivowen are available to offer advice and support on HPRA compliance.

Written by Nanda Naik

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

Company Announcement – Majella Ryan FTOPRA

17th October 2018

Majella Ryan FTOPRA

Ivowen are pleased to announce that Fellowship of The Organisation for Professionals in Regulatory Affairs (FTOPRA) has been conferred on Majella Ryan. According to TOPRA:

“The award of a Fellowship is intended to recognise a contribution in which the individual has used his/her professional knowledge and experience to influence, guide or develop the profession in a proactive way.
While clearly the individual’s regulatory experience and current senior position achieved are important, what is also looked for is a consistent record of activities or influences extending beyond the confines of the individual’s day-to-day activities.”

Majella Ryan has been in the regulatory affairs business for over 20 years and in this time has worked in both small and large multi-national companies, setting up Ivowen in 2002. Since then, Majella was involved in the set-up of TOPRA in Ireland, acting as the inaugural Chair in 2001/2011, as well as speaking at various conferences and providing extensive regulatory training to companies around the world. In addition, Majella is actively engaged in the publication and explanation of regulatory and guidance updates via Ivowen’s website, and via Ivowen’s EU network, EuDRAcon. As part of Ivowen’s daily work, Majella is involved in the high level regulatory strategy and support of complex projects and products like biosimilars, paediatric investigation plans and clinical trials, eCTD implementation, regulatory pathways to approval, Brexit planning, and much more.

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

Preparing for Brexit

31st July 2018

As the date for the withdrawal of the UK (also known as Brexit) from the EU approached closer, it pays to hope for the best and prepare for the worst. With this in mind, the EMA have issued a guidance document on “Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure, EMA, 19 June 2018” to prepare for the UK’s exit from the EU by the 30 March 2019.

http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2017/11/WC500239369.pdf

What does it mean?

For marketing authorisation applications (MAAs) that are expected to receive a Commission Decision (i.e. be approved) after 29 March 2019, the QPPV, PSMF (for medicines for human use), batch release sites, batch control sites, intended OMCL (if applicable) and nominated local representatives for Member States other than UK must be located in in the Union (EEA).

As published on the EMA website on the 10 July, a recent European Medicines Agency (EMA) survey shows that marketing authorisation holders for more than half (58%) of the 694 centrally authorised products (CAPs) with an important step in their regulatory processes in the United Kingdom (UK), are on track with their regulatory planning to ensure that their marketing authorisation remains valid once the UK leaves the European Union (EU).

This also means that 42% are NOT ready… Are you one of the 42%

The EMA urges those companies who have not yet informed EMA of their Brexit preparedness plans to do so as soon as possible to mitigate any risks to the continuous supply of medicines for human and veterinary use within the EU.

We can help…

Ivowen can help Clients prepare to implement the required changes by providing the following services:

Provide practical guidance on what needs to be in place by the above date to address situations where the UK is the current MAH, batch release site, batch control sites, location of QPPV& PSMF, transfer of orphan designation, etc.
Act as a MAH in the EU
Provide Pharmacovigilance (QPPV) services in the EU
Provide Pharmacovigilance System Master File and backup services located in the EU
Assist Clients in selecting and transferring RMS to another EU member state where the UK is current MAH
Preparation of Brexit related variations to be ready for above timelines
Assistance in changes needed to Product Information to reflect changes such as new MAH, batch release site(s), amend names of local representatives

Please contact us for further information at any time.

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.

Dossier Expectations due to ERA revised guidance

Structure of the ERA report

Are you in search of advice and support on ERA?

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

Do you still need to change your MAH(s) in any of the EU Member States because of Brexit?

Is the UK your current RMS?

Do you need to change your UK batch release site, etc., if it currently within the UK?

Do you supply product to Cyprus?

What’s happening in early 2019?

What’s happening in later on in 2019?

What about us?

And for now…

Brexit in:

What happens if UK leaves the EU with no deal?

HPRA are working “extraordinarily” hard on preparing for all scenarios

Timeline for changing RMS

Procedures for MAHs to transfer MAH to EU/EEA based MAH

Medical devices containing an ancillary medicinal substance

Parallel Product Authorisations

Variations to Marketing Authorisations to change Qualified Person Responsible for Pharmacovigilance (QPPV), manufacturing site or/and batch release sites.

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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:

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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: