Brexit Corner Here you can find "Brexit"-related information that is relevant to you as a QP. Useful Links: UK government technical notes laying down its plans for a "no-deal Brexit" in relation to medicines. These are part of more than 70 technical notes covering all sorts of sectors: How to prepare if the UK leaves the EU with no deal. Guidance published by the European Medicines Agency (EMA). This site comprises several links to documents published by the Commission and Heads of Medicines Agencies as well as EMA itself: Brexit-related guidance for companies. Presentations: International Developments and their Impact on GMP and Manufacturers David Cockburn, European QP Association, at the QP Forum 2018 Relevant GMP News: 30 August 2022 Great Britain plans a New "Mark" for Medical Products as a Replacement to the CE Mark With UK's exit from the EU (Brexit), a transition period also started with regard to medical devices. The MHRA has now published plans on how to proceed after this transition period. 3 May 2022 Brexit: Legal Proposals adopted on the Supply of Medicines in Northern Ireland, Cyprus, Ireland and Malta The European Parliament and Council agree to proposals from the EU Commission to ensure the continued supply of medicines to Northern Ireland, Cyprus, Ireland and Malta..Both a directive and a regulation are now in place. 5 January 2022 Brexit and Northern Ireland - what's new? In the course of the Brexit negotiations, the role of Northern Ireland was always in focus. The aim of the EU in particular was to avoid a hard border on the island of Ireland. Now there are further announcements and publications. 7 July 2021 Brexit: EU defines possible Solutions for Northern Ireland The European Commission tries to find "creative solutions" for issues related to the implementation of the Protocol on Ireland and Northern Ireland. 17 February 2021 Brexit Guideline from CMDh updated The Co-ordination Group for Mutual Recognition and Decentralised procedures - Human (CMDh) of the HMA has updated a recently published Guideline on Brexit. 3 February 2021 New EU Commission Brexit Notice on Medicinal Products The EU Commission published a new notice in the Official Journal of the EU on 25 January 2021. Although Brexit was a long time coming, there are supply problems for some medicinal products. The Covid-19 pandemic has therefore also prompted the EU to act.Cyprus, Ireland, Malta and Northern Ireland in particular have not yet fully adapted their supply chains. 13 January 2021 Brexit Agreement - what now? Brexit: The agreement on the future relationship between the European Union and the United Kingdom is here. What are the consequences for medicinal products? 2 December 2020 EMA Publishes New Q&A Guide on Brexit There are only a few days left until the UK will leave the EU. On 01. January 2021 the UK will be considered a "Third Country" with massive consequences for the GMP environment for medicinal products and APIs. Now the EMA published a new Question and Answer Document which clarifies a number of questions which have been raised during the Brexit negotiations. Please read more about EMAs Q&A Document. 18 November 2020 Brexit: Phased Process for implementing Medicines Regulation in Northern Ireland An agreed approach had been reached on a phased process for implementing medicines regulation in Northern Ireland up to 31 December 2021. 28 October 2020 Brexit: MHRA updates Guidance MHRA has issued/ updated a set of guidance documents for UK companies, which will also have impact on EU companies supplying medicines into UK. 9 September 2020 Brexit: How to import Medicines into UK The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has just published a Guidance for Wholesaling and Importing Activities after the end of the Transition Period. 2 September 2020 EU: Checklist for Brexit Preparation The European Commission has published a 'Brexit Readiness Checklist' for companies doing business with the UK. 6 August 2020 Brexit: Sponsors Need to Establish an EU-QP Sponsors of EU clinical trials, where the QP is currently located in the UK, need to establish an EU-QP by the end of the transition period. In addition the sponsor of a clinical trial or a legal representative must be established in the EU. Read more here. 5 August 2020 Brexit is approaching: Regulations for Pharmaceuticals defined The European Commission has published a communication to prepare for the end of the transition period. There are also indications for the pharmaceutical sector. 1 April 2020 Brexit: New Notice to Stakeholders EU has published a new Notice to Stakeholders on the withdrawal of the UK which summarises the most important aspects in three parts. 4 March 2020 Brexit: MRA will be needed soon Some major European industry associations call for a UK-EU Mutual Recognition Agreement to avoid drug shortages and other problems. 5 February 2020 Brexit: Consequences for Batch Release During the transition period, all EU laws remain applicable in the UK. Does that mean that QP certification by UK QPs will still be valid across the EU? Not really, as a statement by the EQPA explains. 24 October 2019 Brexit: RPs for Import from the EU MHRA gives further guidance for a new Responsible Person function, the RPi - Responsible Person (import). 19 August 2019 Hard Brexit: MHRA Preparations The Biritsh Medicines and Healthcare products Regulatory Agency (MHRA) has published several guidelines for a possible no-deal scenario. 31 July 2019 Brexit: Industry should keep Timelines for Batch Testing Facilities The EMA points out that — independent from the Brexit postponement — MAHs should use the remaining time to complete all necessary preparations. 4 April 2019 Brexit: MHRA clarifies UK PV rules for the no deal scenario The MHRA recently published guidance on QPPVs, PSMFs and MHRA PV registrationin the event of a no-deal Brexit. 4 April 2019 Brexit: Importation of IMPs from approved countries in a no deal scenario The MHRA recently provided guidance on how the management and oversight of the import of investigational medicinal products (IMPs) from listed countries will work in a no deal scenario. 3 April 2019 Drug Shortages due to Brexit: EU gives Answers The EMA has published a question-and-answer document on possible supply bottlenecks after Brexit.. 13 March 2019 EU Commission: How to prepare for a "Hard Brexit" The European Commission is fostering its support in preparing EU companies for a no deal scenario ("Hard Brexit"). 6 March 2019 Brexit: Handling Pharmacovigilance Data from the UK How should reports of adverse reactions from the UK be handled after the withdrawal date? New Q&As give a clear answer. 6 March 2019 Brexit: EU supports pharmaceutical Companies In a letter, the EU Commission explains possible exemptions for future batch testing in the UK. 6 March 2019 Brexit: Handling Pharmacovigilance Data from the UK How should reports of adverse reactions from the UK be handled after the withdrawal date? New Q&As give a clear answer. 27 February 2019 Brexit: Will UK Inspection Reports and GMP Certificates still be valid? Will EU-based pharmaceutical companies still be able to use a manufacturing site for which the GMP Certificate has been issued by a UK authority? The answer is yes - but with restrictions. 26 February 2019 Brexit: Safety Features & Multi-Country Packs Will it be necessary to transfer information about the unique identifier uploaded to the UK repository between 9 February 2019 and the Brexit date to another repository? EMA recently published the answer to this and other related questions. 6 February 2019 Brexit: OMCL Release Decisions still valid? What happens if a certificate is issued before the withdrawal date but released after this date? New Q&As give a clear answer. 30 January 2019 Hard Brexit: UK amends GMP and GDP Regulations To face a possible Hard Brexit, UK plans to amend EU GMP Guidance. 16 January 2019 Clinical Trials if there is no Brexit Deal To face the possibility of a Hard Brexit, the MHRA has issued updated guidance proposing some necessary arrangements in regard of Clinical Trials of IMPs.. 9 January 2019 Hard Brexit: MHRA proposes necessary Arrangements To face the possibility of a Hard Brexit, the British MHRA has issued an updated guidance proposing some necessary arrangements.. 21 November 2018 Brexit: EMA to focus on Medicines Evaluation and Supervision End of September the EMA together with the European Commission organised a meeting with industry stakeholders to discuss the UK's withdrawal from the European Union ("Brexit"). Now the report of the EMA-Industry stakeholder meeting was published. 10 October 2018 Brexit: Insulin Stockpiles are built up Pharmaceutical companies have started to build up stockpiles of lifesaving medications to be prepared for a hard Brexit. 4 October 2018 Pharmacovigilance: Be prepared for "Hard Brexit" The UK Government has released some information regarding the consequences of the Brexit on pharmacovigilance and the establishment of the Qualified Person for Pharmacovigilance (QPPV). 25 September 2018 Will the CTR be implemented in UK in case of a "Hard Brexit"? The UK Government has released advice regarding the consequences of the Brexit on clinical trials. 29 August 2018 Will UK accept EU QP Certification after a "hard" Brexit? The UK Government has published a notice discussing the consequences for batch testing, QP certification and batch release with an interesting statement. 15 August 2018 Brexit: EMA to lose 30% Staff? The European Medicines Agency (EMA) has published a press release and announced the next phase of its business continuity plan. According to this release the Agency will need to further scale back and suspend activities. 7 August 2018 Brexit: EMA updates information for holders of centralized marketing authorizations The European Medicines Agency (EMA) has published updated versions of the documents provided to help marketing authorization holders prepare for Brexit. 27 June 2018 Brexit: Two new Documents published by EMA The European Medicines Agency (EMA) has published two updated documents on U.K.´s withdrawal from the EU - giving a lot of new Questions and Answers on Brexit. 1 June 2018 Brexit: UK commits to align with EU rules on clinical trials The UK Government recently confirmed that it is committed to implementing the EU CTR into UK law to the extent possible after Brexit. 23 May 2018 Brexit: EMA still clear on Timelines Despite the currently discussed "transition period", the European Medicines Agency (EMA) has emphasised that industry should be well prepared even for a so-called "hard Brexit". 25 April 2018 Brexit: EMA appoints new rapporteurs for centralized authorizations In the course of Brexit, the EMA has already appointed new rapporteurs and co-rapporteurs for approx. 370 centralized authorizations. Read more about EMA's procedure for appointing new rapporteurs. 21 March 2018 Will UK stay in EMA after Brexit? In the last weeks there were stories about the UK remaining in the EMA even after Brexit. Would this be possible? 30 August 2017 Brexit: the British comment After the European Medicines Agency EMA in particular spoke out on the possible future of the trade with medicinal products on European Union level, the British now provide some input - e.g.. about the role of the Qualified Person (QP). Read how the Britisch imagine the trade with medicinal products in the future. 16 August 2017 Brexit: EMA prioritises Activities The European Medicines Agency (EMA) expects some uncertainty and higher workload because of the Brexit. Now, the EMA has defined three categories to prioritise activities in a business continuity plan. 3 August 2017 What does Brexit mean for the QP? The decision of the U.K. to leave the EU has caused a high uncertainty throughout industry - and also in the pharmaceutical industry. The European QP Association has received a number of questions on what Brexit actually means for QPs. For that reason the EQPA leadership team has prepared some information. 17 May 2017 Brexit: U.K. will become 'Third Country' according to EU Statement The EU Commission and EMA made a clear statement that after 30 March 2019, the Unit Kingdom will become a 'third country'. Both expect marketing authorisation holders to prepare accordingly. EMA Webinar on „Brexit“ related Manufacturing and Supply: EMA Webinar on „Brexit“ related Manufacturing and Supply On 12th December 2017 the European Medicines Agency (EMA) conducted a webinar on ““Brexit” related manufacturing and supply" – with the objective to discuss with Industry stakeholders (Human and Veterinary Industry) manufacturing and supply questions linked with Brexit preparedness activities. Industry associations were invited to forward questions in advance. David Cockburn participated in this webinar and provided a summary of the questions asked by industry associations and the answers provided by the EMA (login required). Your "Brexit"-related Questions in the Discussion Forum: To discuss your "Brexit"-related questions, please use the online discussion forum in the members' area (login required).