UK still permitting unregistered herbal medicines

Medically active products like St. John’s wort must meet pharmaceutical quality and safety standards in order to improve patient safety, demands Diapharm’s Dr. Karim Sultan.

It is still the case that not all herbal products used in the UK for medicinal purposes have been licensed as medicinal products. “A year after the end of the transitional period on 30 April 2011, many manufacturers have still failed to upgrade their products to medicinal product status. As a result, these products are still not subject to the quality and safety requirements which are important for improving patient safety,” explains Dr. Sven Oliver Kruse from the medicinal product laboratory at Diapharm ( Diapharm has offices in the UK, Germany, Austria and Romania, and one of the company’s services is to test and develop herbal medicines (THMPs), food supplements and medical devices.

Authorities increase pressure on unlicensed products

A seven-year transitional period for so-called unlicensed herbal products expired on 30 April 2011. Products with medicinal action, for example St. John’s wort, Echinacea or Valerian, must now be registered as medicinal products. However, the Medicines and Healthcare Products Regulatory Agency (MHRA) has been too slow to enforce this regulation complains Simon Mills, a director of the British Herbal Medicines Association: “Some companies have been pulled up, but there are still products on the shelf that look like they should be herbal medicinal products but are sold as food supplements.”

The MHRA has begun to act against some unlicensed products, observes Dr. Karim Sultan, Director of the pharmaceutical service provider Diapharm UK Ltd. in London: “In the past weeks, the MHRA has targeted manufacturers and retailers and demanded that they remove several products from the market. These products are packaged as medicinal products or even contain medically active components, without having to fulfil the relevant quality and safety requirements. This increased action is an encouraging sign for more consumer protection and patient safety in the UK: Products with medicinal action should also be subject to medicinal standards. Unfortunately there are still many evading the legislation and the MHRA still has much more to do.” 

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