United States: EMA Publishes Results Of Study On Brexit Preparedness

In January 2018, the European Medicines Agency (the EMA), as part of its Brexit preparations, launched a survey to gather information from companies on their Brexit preparedness plans, and to identify concerns that may impact public or animal health. The results of the study were published earlier this week.

Implications of Brexit

The implications of Brexit for the life sciences industry are huge. A survey by EFPIA noted that medicines across the EU have integrated supply chains: over 2,600 final products have some stage of manufacture in the UK, while 45 million patient packs are supplied from the UK to the EU27 each month, and over 37 million patient packs are supplied from the EU27 to the UK each month. Further, over 12,000 centrally authorised marketing authorisations (MA) will require separate UK authorisations, and 17% of such authorisation are currently held by UK MA holders and so will need to be transferred. Each of these products and authorisations will be affected by the changing regulatory landscape.

EU law requires that centralised MA holders are established in the EU or EEA (EU plus Norway, Iceland or Liechtenstein), and that certain activities must be performed in the EU or EEA, for example activities relating to pharmacovigilance, batch release and quality control. Following the UK's notification of its intention to leave the EU, and subject to any arrangement being agreed during the ongoing negotiations, on 30 March 2019, all EU law ceases to apply to the UK, and UK entities and MA holders will no longer be part of the EU. Therefore, MA holders will need to amend certain processes and/or terms of their MAs so they remain valid post-Brexit. Further, as of the date of Brexit, medicinal products manufactured and placed on the market in the UK will be considered imported products when moved to other countries in the EU. MA holders will therefore need to specify an authorised importer established in the EU or EEA, and submit the corresponding variation to their centralised MA.

The EMA's survey

The EMA sent two questionnaires to a number of companies to gather information on their intentions to amend MAs or manufacturing sites as a result of Brexit. These included over 180 MA holders of 694 human and veterinary products that are located in the UK, or which have quality control, batch release, and/or importation sites or a qualified person for pharmacovigilance (QPPV) or pharmacovigilance system master file (PSMF) in the UK. The EMA received feedback from over 90% of MA holders surveyed.

The results of the survey show that for the 694 affected products:

  • 58% of products are on track to ensure their MAs remain valid once the UK leaves the EU.
  • 400 products require an MA transfer to an MA holder based in the EU or EEA. Of these, 373 MA holders (93%) intend to submit the transfer application so the transfer is fully implemented before 30 March 2019.
  • 335 products have a QPPV based in the UK, and 376 have their PSMFs in the UK. 282 of QPPVs (84%) and 152 of PSMFs (40%) are on track to make the requisite changes before Brexit.
  • Batch releases sites of 119 medicines, and quality control sites for 41 medicines, need to be transferred. 96 (81%) and 35 (85%) of submissions respectively are expected to be submitted on time.
  • For 18 products, the importation site into the EU is currently the UK, which will need to be relocated, and only 4 of these (22%) are expected to be amended in time.
  • For 108 medicines (16%), all or a major part of the medicines' batch release sites, quality control sites and/or importation sites are in the UK, but changes are not on course to be submitted in time. This raises major concerns that if plans are not adapted, these products may no longer be available on the EU market after Brexit.

A summary of the position was set out in the report as follows:

The EMA will follow up directly with the MA holders that have batch release, quality control and/or importation sites located in the UK, but that have indicated they do not plan to submit requests for the changes required before 30 March 2019, as this could potentially lead to supply disruptions.

The EMA will also monitor and track the submissions of required changes for the affected centrally authorised medicines, and conduct a workload analysis to ensure adequate resource planning within the EMA. However, the survey identified that the majority of the necessary submissions to the EMA are scheduled for Q1 2019, which is the same time as the EMA will be relocating to the Netherlands. Pharmaceutical companies are, therefore, advised to submit their change requests as early as possible, and before the end of Q4 2018, to ensure processing in due time.

In the meantime

The EMA has a dedicated webpage on the consequences of the UK's withdrawal from the EU, and has prepared Q+As and practical guidance for industry addressing many of the key questions for MA holders to assist with their preparations for Brexit.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions