Ireland: Brexit And The Irish Life Sciences Industry

Last Updated: 4 October 2017
Article by Colin Kavanagh and Ciara Farrell

As the largest net exporter of pharmaceuticals in the EU and one of the largest in the world and given that most of the world's largest pharmaceutical and medical device companies have substantial operations in Ireland, it is clear that the industry will be significantly impacted by Brexit.

At a recent meeting hosted by the Irish Health Products Regulatory Authority (HPRA), Ireland's Competent Authority, representatives from industry, government and the regulator discussed the potential effects of Brexit on the sector.

Overall, the general message was pragmatism and preparation. The HPRA reaffirmed that it is open for business and will assist the industry through their Brexit planning. However, stark warnings were issued to companies to approach them early to discuss their plans, and avoid a backlog of applications on the eve of Brexit, currently set to be March 2019. A key concern and driver behind these messages is to ensure continued supply of medicines post-Brexit.

Some of the other key issues identified at the HPRA meeting and which life sciences businesses should be working on right now are outlined below.


To market medicinal products in the EU it is a requirement to have a marketing authorisation (MA), which may only be held by entities established in the European Economic Area (EEA). MAs can be granted by the European Commission or the national authorities.

Centralised MAs granted by the European Commission allow companies to market products throughout the EU under that single MA which, at the moment, includes the UK. When the UK leaves the EU, UK companies can no longer hold these MAs as they will no longer be an entity established in the EEA. To continue to market the product throughout the EU, the MA must be transferred to an entity established in the EEA.

When the UK leaves the EU, products may no longer be placed on the UK market on the basis of MAs granted via the current EU regulatory framework. Conversely, the national MAs granted by the UK competent authority, the MHRA, may not be recognised by other EU Member States for the purposes of placing products on their markets as part of mutual recognition or decentralised procedures.

The HPRA confirmed that it is happy to take over the role of Reference Member State (RMS), at no additional cost, for products where the UK MHRA is currently the RMS and the HPRA is a Concerned Member State.

While the EU and the UK may adopt some form of mutual recognition procedure as negotiations progress, the message for industry now is to prepare for a hard Brexit (as the EU regulatory network are). It is critical that businesses conduct a mapping exercise of MAs currently held by its various entities, the market in which those MAs are operating and engage early with the HPRA to discuss plans for MA and RMS transfers arising out of this exercise.


As the UK will no longer be part of the EEA after Brexit, medicinal products manufactured in the UK will require an import authorisation before they can be placed on the EEA market. Products must also undergo batch control and testing at a site in the EEA to ensure they have been manufactured in accordance with EU Good Manufacturing Practices. Therefore, companies will need to identify batch release locations within the EEA.

Aside from the resulting regulatory and operational burdens, associated costs and delays will need to be considered.


Products that are parallel imported into Ireland from the UK may also be affected due to the UK's status as a third country. Many products in Ireland are imported from the UK and registered under the Dual Pack import Registration scheme and parallel product authorisation. The HPRA also recognises that joint packaging is a critical issue and one on which they will take a pragmatic approach by assessing these products on a case by case basis depending on the level of divergence.


The HPRA reaffirmed the guidance issued by the EMA earlier this year in relation to the Qualified Person responsible for Pharmacovigilance (QPPV). After Brexit, QPPVs can no longer be based in the UK and companies will need to appoint EEA based QPPVs.

Similarly, the Pharmacovigilance System Master File must also be located within the EEA, and will need to be transferred if currently held in the UK.


The UK is one of Ireland's largest export markets for medical and pharmaceutical products. Relationships between Irish and UK suppliers, finishing plants, distribution hubs and third party customers are inextricably linked. These relationships will need to be re-examined as transactions between the UK, a country that will no longer be in the customs territory of the EU, and Ireland, may have customs duty and VAT implications.

Territorial rights and potential exchange rate, customs and import duty implications will also need to be examined.


The most obvious regulatory impact in the medical device sector is whether the CE Certificates of Conformity granted by the UK notified bodies (a necessary prerequisite for placing certain devices on the EEA market) will continue to be recognised for marketing purposes in the EU. Companies that hold certificates from UK notified bodies will need to consider alternative options should these certificates no longer be effective for EU marketing purposes.


Another area of impact involves Authorised Representatives (ARs). ARs are established in an EU Member State and allow non-EU medical device manufactures access to the EU market. Following Brexit, UK ARs will no longer be able to represent non- EU manufacturers thus forcing those companies to seek ARs elsewhere in the EU or, alternatively, establish a presence within the EU.



A key issue in the sector will be the relocation of the European Medicines Agency (EMA) from London. The EMA plays a vital role in the evaluation of the safety, efficacy and quality of new products, whose assessment the European Commission rarely fails to follow when approving a medicinal product for use in the EU. 19 Member States, including Ireland, have expressed an interest in attracting the EMA and their submissions have been published on the website of the Council of the European Union.

Relocation of the EMA, an agency employing 890 staff and hosting valuable scientific expertise, to Ireland would have immediate positive impacts for the industry in Ireland. There would be much to gain from shared expertise between the EMA and the HPRA, a highly respected agency in the EU network. An English speaking educated population, a dynamic manufacturing and development cluster, a wellrespected competent authority and proximity to London gives Ireland a number of advantages in the decision on the relocation of the EMA.


Finally, there is also uncertainty over the UK's transposition of the new EU Medical Device Regulations and Clinical Trials Regulation.

The EU Medical Device Regulations will apply in 2020 for medical devices and 2022 for IVDS. The UK played a key role in drafting these Regulations.

The Clinical Trials Regulation, designed to streamline the conduct of clinical trials within the EU, provides a single application procedure for multi-site trials conducted across the EU. It was adopted in 2014, but is due to come into effect during 2019.

It is hoped that both of these Regulations will be captured within the Great Repeal Act in the UK and automatically apply as UK law. However, the status of the Regulations in a post Brexit landscape remains unclear

This article contains a general summary of developments and is not a complete or definitive statement of the law. Specific legal advice should be obtained where appropriate.

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

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

In association with
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
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

*** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.