Decision

MHRA enforces European Commission decision to suspend medicines for which authorisation based on clinical studies conducted at GVK Biosciences

MHRA has suspended a number of licences for generic medicines.

Document

List of affected products

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Detail

In accordance with the European Commission’s decision (16 July 2015), MHRA has suspended a number of products deemed non-critical to continuity of supply to the UK market (see attached Table 1). Products necessary to maintain continuity of supplies (Table 2) and those non-critical products for which further data in support of the marketing authorisation has been provided, have not been suspended at this time.

The European Commission 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.

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.