In Industry News, Panacea News

A multitude of BREXIT guidance has been published by the UK government via the MHRA, and by the European Union via the EMA. To be helpful, we’ve collated links to some of the documents which relate specifically to Marketing Authorisation Holders and pharmacovigilance professionals here:

https://www.ema.europa.eu/en/news/questions-answers-eu-actions-prevent-medicine-shortages-due-brexit

https://www.gov.uk/government/collections/mhra-guidance-and-publications-on-a-possible-no-deal-scenario#history

https://www.ema.europa.eu/en/about-us/united-kingdoms-withdrawal-european-union-brexit


https://www.gov.uk/government/publications/guidance-on-pharmacovigilance-procedures-in-the-event-the-uk-leaves-the-eu-without-a-deal/further-guidance-on-pharmacovigilance-procedures-in-the-event-the-uk-leaves-the-eu-without-a-deal

https://www.gov.uk/guidance/guidance-on-qualified-person-responsible-for-pharmacovigilance-qppv-including-pharmacovigilance-system-master-files-psmf-if-the-uk-leaves-the-eu-w

https://www.cancerresearchuk.org/sites/default/files/future_of_clinical_trials_after_brexit.pdf

https://www.gov.uk/guidance/regulating-medical-devices-in-the-event-of-a-no-deal-scenario

https://www.gov.uk/government/publications/how-to-make-regulatory-medicines-submissions-to-the-mhra-if-the-uk-leaves-the-eu-with-no-deal

https://www.ema.europa.eu/en/about-us/uks-withdrawal-eu/brexit-related-guidance-companies

https://www.gov.uk/government/publications/how-medicines-medical-devices-and-clinical-trials-would-be-regulated-if-theres-no-brexit-deal/how-medicines-medical-devices-and-clinical-trials-would-be-regulated-if-theres-no-brexit-deal

https://www.gov.uk/government/publications/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal#medical-devices

Recent Posts