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Increase in unlicensed medicines sold in UK

MHRA says drugs from Eastern Europe finding their way to UK stores

The UK is seeing an increase in the number of unlicensed medicines sold in retail outlets, according to the country's regulatory body.

The Medicines and Healthcare products Regulatory Agency (MHRA) said it investigated 74 cases involving medicines from Poland and other Eastern European countries, including both OTC and prescription drugs, that were sold in shops during 2012.

This compared to 39 cases in 2011 and 20 cases in 2010.

The sale of these products violated rules that only medicines licensed for sale in the UK and labelled in the English language, with an accompanying patient information leaflet, can be sold and supplied legally in the UK.

“We urge people not to buy medicines that are not labelled in English,” said Nimo Ahmed, the MHRA's acting head of enforcement.

“Medicines are not ordinary consumer products. There are also specific health concerns with certain medicines that should be prescribed and dispensed under the supervision of a healthcare professional, such as a doctor or a pharmacist. Anyone who self-medicates and buys these medicines from shops that are not registered pharmacies could be endangering their health.”

As part of its actions to handle the availability of these medicines, the MHRA said it was working with its Polish counterpart to investigate how the drugs ended up in UK stores.

In a statement to PMLiVE, the MHRA said the reasons behind the increase may have been "due to a number of factors", including the possibility that MHRA enforcement visits taking place to retail shops have led to an increased awareness to other European shops in those areas.

"Our aim is to highlight the risk to the public in buying and selling these unlicensed medicines and ensuring that UK legislation is adhered to," said an MHRA spokesperson.

Rules for the sale of medicines are laid out in the Human Medicines Regulations 2012, which sets out legislation for how medicines are authorised for human use; how they are manufactured, imported, distributed, sold and supplied; all labelling and advertising rules; and pharmacovigilance requirements.

8th February 2013

From: Regulatory



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