European Commission outlines the impact of Brexit on Good Laboratory Practice

From 1st November 2019, it is likely that the United Kingdom (UK) will no longer be a member of the European Union (EU). The European Commission has outlined the consequences of how EU rules in the field of Good Laboratory Practice (GLP) will no longer apply to the UK after Brexit, however an EU-wide “Mutual Acceptance of Data” (MAD) system will apply. Read more “European Commission outlines the impact of Brexit on Good Laboratory Practice”

EMA provides update on Brexit in their March 2019 Management Board meeting

Following the agreement between the United Kingdom (UK) and the European Union (EU) to extend the Brexit deadline, during the European Medicines Agency’s (EMA) Management Board meeting in Amsterdam they stated that the prospect for centrally authorised products to be at risk of shortage “continues to decrease”. However, the agency has warned that if the UK were to leave the EU with no-deal, then there is still a high risk of supply issues with some medicines. Read more “EMA provides update on Brexit in their March 2019 Management Board meeting”

How to register clinical trials for investigational medicinal products and publish trial results if the UK leaves the EU with no-deal

The Medicines and Healthcare Products Regulatory Agency (MHRA) has released guidance about registering clinical trials, publishing trial results and future requirements if the United Kingdom (UK) leaves the European Union (EU) without a deal. The guidance will apply from exit day subject to the Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2019 being passed. The guidance will only apply in the event of ‘no-deal’ scenario. Read more “How to register clinical trials for investigational medicinal products and publish trial results if the UK leaves the EU with no-deal”

How to submit ICSRs and SUSARs to the MHRA if the UK leaves the EU with no-deal

The Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance for all pharmaceutical companies involved in the submission of Individual Case Safety Reports (ICSRs) or Suspected Unexpected Serious Adverse Reactions (SUSARs) in the event of a no-deal Brexit. Read more “How to submit ICSRs and SUSARs to the MHRA if the UK leaves the EU with no-deal”

Making submissions to the MHRA if the UK leaves the EU without a deal

The Medicines and Healthcare Products Regulatory Agency (MHRA) are making preparations to ensure that if the United Kingdom (UK) does leave the European Union (EU) with no deal, companies can continue to submit regulatory and notification information to the UK. Currently the only areas enabled on the MHRA Submissions home page are the User Maintenance and Pharmacovigilance Gateway Management. Read more “Making submissions to the MHRA if the UK leaves the EU without a deal”

EMA provides procedural update on submission of Type 1 variations in March, April and May 2019

The European Medicines Agency (EMA) is encouraging Marketing Authorisation Holders (MAHs) who intend to submit Brexit-related Type IA and Type IB variations in March 2019, to submit these variations as soon as possible during the month. This will ensure that the EMA can process the submissions before 29th March, so that MAHs can receive confirmation of compliance with the regulatory and legal requirements before the United Kingdom (UK) leaves the European Union (EU). Read more “EMA provides procedural update on submission of Type 1 variations in March, April and May 2019”

European Commission provides update on post-Brexit batch testing requirements

A letter to the European Medicines Agency (EMA) and EU27 Heads of Medicines Agencies (HMA), written by the European Commission’s Directorate-General for Health and Food Safety (Sante), outlines an exemption to certain batch testing requirements for medicine manufacturers who currently perform batching test in the United Kingdom (UK). Read more “European Commission provides update on post-Brexit batch testing requirements”

How will medicines, medical devices and clinical trials be regulated if the UK leaves the EU with no agreement?

In the event that the United Kingdom (UK) leaves the European Union (EU) with no deal, contingency legislation has been published which outlines the regulation of medicines, medical devices and clinical trials. The legislation has been released to ensure that the Medicine and Healthcare Products Regulatory Agency (MHRA) can take on regulatory processes for human medicines and devices that are currently undertaken by the European Medicines Agency (EMA) and other bodies. Read more “How will medicines, medical devices and clinical trials be regulated if the UK leaves the EU with no agreement?”

MHRA releases response to consultation on EU exit no-deal legislative proposals

With the United Kingdom (UK) leaving the European Union (EU) on 29th March 2019, the Medicines and Healthcare Products Regulatory Agency (MHRA) has released updated guidance which outlines the UK’s proposed arrangements for medicine, medical device and clinical trial regulation if the UK leaves the EU with no deal. Read more “MHRA releases response to consultation on EU exit no-deal legislative proposals”