In accordance with the European Commission’s decision (16 July, 2015), MHRA has suspended 13 products. A further 12 products have not been suspended as they are necessary to maintain continuity of supplies for patients at this time or further data has been provided in support of the marketing authorisation.
The European Commission has endorsed the recommendation of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to suspend a number of licences for generic medicines, for which authorisation was based on clinical studies conducted at GVK Biosciences’ site in Hyderabad, India. Twenty-seven of these products are currently approved for sale in the UK.
This action is being taken as a precautionary measure. There is no evidence of safety concerns or loss of efficacy with these products.
People should continue to take their medicines as prescribed. Only generic medicines are affected, therefore alternatives to all suspended medicines are readily available and people should not experience any difficulty getting the medicines they need. If anyone has any questions about their medication they should speak to their doctor or pharmacist.
See the press release published on 23 January 2015 for background information.
You can also see the decision on the European Commission’s website.
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