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MHRA update on COVID-19

Message on behalf of MHRA


This information updates you on details of recently published guidance on the coronavirus (COVID-19) pandemic aimed at supporting healthcare partners contributing to the essential global action needed to protect public health at this challenging time.

We would welcome your further feedback on what other information you would find useful – please email engagement@mhra.gov.uk.

The British Pharmacopoeia (BP) and COVID-19
During the COVID-19 outbreak the BP is committed to keeping users updated and supporting the wider healthcare response. Regular updates for customers will be published on this page.

Specification for ventilators to be used in UK hospitals during the COVID-19 outbreak
We have added an HTML version of the specification. This guidance sets out the clinical requirements based on the consensus of what is ‘minimally acceptable’ performance in the opinion of the anaesthesia and intensive care medicine professionals and medical device regulators.


IV vitamin drips enforcement notice
We worked closely with Advertising Standards Authority (ASA) to ban all promotion of IV drips with direct or implied references to treat or prevent COVID-19 to UK customers. The Committee of Advertising Practice (CAP) Code requires that medicinal claims and indications can be made only for medicinal products licenced by the MHRA or under the auspices of the European Medicines Agency (EMA).

Please see the ASA’s website for information on the rulings against The Private Harley Street Clinic, Cosmetic Medical Advice UK Ltd t/a Dr Rita Rakus Clinic and REVIV UK Ltd.


Managing clinical trials during COVID-19 
This guidance sets out how investigators and sponsors should manage clinical trials during COVID-19. We have added content on accountability of investigational medicinal products and urgent safety measures, and updated guidance around managing ongoing and halted trials, remote monitoring and signatures.


MHRA approves COVID-19 vaccine trial in 7 working days
We are giving tailored scientific advice and prioritising potential treatments for COVID-19. We were able to approve the COVID-19 Oxford Vaccine Trial request in a little over one working week.

Please see our website for more information.

Yellow Card reporting during the COVID-19 response
We are continuing to request that all reports to our Yellow Card scheme (the system for reporting suspected side effects of medicines or possible problems with a medical device) be submitted electronically instead of on paper.

Guidance for industry
We are working quickly to respond to the operational challenges posed by COVID-19 and will continue to update our guidance page for industry on GOV.UK as our response to COVID-19 evolves.

Subscribing to updates on GOV.UK
You can sign up for email updates about the MHRA’s work – you will then receive an email every time the MHRA publishes a new page or makes a significant edit to an existing page.

Contacting the MHRA
Most of our workforce is now working from home, although NIBSC is continuing essential laboratory activities on site. If you need to get in touch with the MHRA during this period, please email or phone us.
For more information please visit www.mhra.gov.uk 

Kind regards,

Patient, Public and Stakeholder Engagement team
Communications division

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone: 0203 080 6000

gov.uk/mhra


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28 Oct 2020
8:12 pm