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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.
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.
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.
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.
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.
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.
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.
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: 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.
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.
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.
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.
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.
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.
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: