Freedom of Information request on information as to how you support the overseas territory with a Yellow Card report. (FOI 22/543)
Published 1 June 2022
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FOI 22/543
Gibraltar and Other British Overseas Territories
28 March 2022
Dear
Thank you for your FOI request dated 15th March 2022, where you requested the following information:
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Please could you provide information as to how you support the overseas territory with a Yellow Card report.
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Please include the correct information that needs to be attached to a Yellow Card report that arrives to the Yellow Card MHRA received from the overseas territory of Gibraltar.
Firstly, it may be useful to note that the MHRA continues to support and encourage Yellow Card reporting throughout the UK and British Overseas Territories.
It may also be useful to provide some background on the Yellow Card scheme to help answer your first question. As you are aware, the Yellow Card scheme, which is run by the MHRA, is the UK system for collecting suspected side effects from healthcare professionals and patients and is used to monitor the safety profile of all medicines and vaccines. All Yellow Card reports of a suspected side effect to a medicine or vaccine, including reports from British Overseas Territories such as Gibraltar, are made available for a process called signal detection. We evaluate the reports on a weekly basis in order to identify previously unidentified potential hazards, and new information on recognised side effects. We also evaluate information from additional sources such as the world-wide medical literature, and data from a number of world-wide databases.
When we identify a new possible side effect or learn more about a recognised one, we carefully consider this in the context of the overall side effect profile for the medicine or vaccine. We also consider this in comparison with the side effects of other medicines or vaccines and compare the risks with the benefits of the medicine or vaccine. Should any new safety issues be identified, appropriate regulatory action will be taken to ensure that the medicine or vaccine is used in a way which minimises risk and maximises benefits to patients.
Where a safety concern has been identified and regulatory action has been taken, appropriate communication will be made to both healthcare professionals and patients. This often includes updating the product information that accompanies the medication, such as the patient information