Regulatory Focus™ > News Articles > 2020 > 5 > MHRA launches dedicated COVID-19 Yellow Card site

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Posted 21 May 2020 | By Kari Oakes 

MHRA launches dedicated COVID-19 Yellow Card site

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday launched a dedicated site for reporting side effects and incidents related to medicines and medical devices used in patients infected with SARS-CoV-2, the novel coronavirus that causes COVID-19.
The COVID-19 Yellow Card reporting site is meant to “enable the MHRA to rapidly identify new and emerging side effects and medical device incidents in COVID-19 treatment, including side effects for medicines taken by patients to manage long-term or pre-existing conditions.”
“Understanding of the COVID-19 virus is limited, including possible interactions with medicines patients might be taking,” MHRA says. “By reporting suspected side effects of any medicines used in the context of COVID-19, healthcare professionals and patients can provide valuable evidence to inform decisions on the safe and effective use of medicines as the pandemic evolves.”
The dedicated COVID-19 Yellow Card reporting site is part of the UK’s larger Yellow Card scheme for voluntary reporting of adverse drug reactions by healthcare professionals and patients.
The new COVID-19 Yellow Card site should be used to report side effects suspected to be associated with any patient with confirmed or suspected COVID-19. This includes chronic medicines, unlicensed medicines, and off-label use of medicines.
Medical device incidents deemed related to COVID-19 should also be reported via the dedicated website. Adverse effects noted in clinical trials should be reported per the clinical trial protocol.
Non-coronavirus-related side effects should be reported through the usual Yellow Card mechanisms.


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