UK ends 6-month medicinal herb supplement sell-through period; local group sues

29-Apr-2014 - Last updated on 11-May-2014 at 12:45 GMT

MHRA: “The public should only buy herbal medicines that they know have met standards..."

Supplement-like products that do not possess a registration under the European Union Traditional Herbal Medicinal Products Directive (THMPD), including Ayurvedic and Traditional Chinese Medicines (TCMs), will be banned in retail environments in the UK after a 6-month sell through period expired.

Some will however continue to be available via practitioners.

The UK Association of Traditional Chinese Medicine and Acupuncture (ATCM) says the action is discriminatory, misinformed, non-transparent and is taking the matter to the courts.

300 approved products

The MHRA said the time was up for unlicensed herbal medicines in the UK.

“The public should only buy herbal medicines that they know have met standards which can be identified by the THR [THMPD registration] or PL [medical registration] number on the product,” said Dr Linda Anderson, from the MHRA Licensing Division.

She added: “Natural doesn’t always mean safe. Some unlicensed herbal medicines can cause serious side effects or may interact with other medicines that a patient is taking.”

“Over 300 products are now registered under the THR scheme. This provides consumers with a wide range of products from which to choose.”

In its statement today, the UK Medicines and Healthcare products Regulatory Agency (MHRA) quoted chairman of the British Herbal Medicines Association (BHMA), Dick Middleton, stating:

“The BHMA is pleased that sell-through of unlicensed herbal medicines to the public is coming to an end. The availability exclusively of only regulated herbal medicines will ensure that consumers can safely choose to treat minor ailments appropriately, safe in the knowledge that they are of high quality with accompanying reliable information.”

Legal challenge

Responding to the ban ATCM said it was suing in UK courts.

It said the sell-through period had been ambiguous and that the assumption of shelf-life for the products should have been 4-5 years, not 18-24 months.

Commenting on that legal action Dr Robert Verkerk, executive and scientific director of the Alliance for Natural Health International (ANH-I), said the MHRA had ignored genuine industry concerns about the food-medicine borderline.

“ATCM indicated its intention to challenge the MHRA in the Courts earlier this month. The MHRA appears to have completely ignored the fact that representatives from the traditional medicines sector have made clear that many manufactured products have shelf lives that are as long as five years,” he said.

“The MHRA and the Department of Health have now created a very uncertain future for products sold in the UK that are neither eligible for the THMPD – that even the European Commission considers not fit for its originally intended purpose – and those that benefited previously from exemption under the now defunct Section 12(2) of the 1968 Medicines Act.”

EU herbal landscape

The THMPD became active in May 2011, but its market implementation has differed among the EU’s 28 member states, giving products differing sell-through periods. Interpretation of what constitutes a herbal product has also varied.

Jean-Christophe Mano, executive manager at French firm Pharmanager, told us last year that EU law implied the maintenance of a dual route to market, and he noted that the precedent had been established in Spain and other EU member states.

A summary of responses to an MHRA consultation on the matter can be found here.