Herbal product registration concerns remain

By Shane Starling

- Last updated on GMT

Related tags: United kingdom

European botanicals group the Herbal Forum remains concerned about aspects of the process that is due to bring herbal products under the remit of the Traditional Herbal Medicinal Products Directive (THMPD) by 2011.

In a letter to the Medicines and Healthcare products Regulatory Agency (MHRA), Herbal Forum chairman Penny Viner said a streamlining of the registration process had won the acceptance of many of her group’s members, but time and money issues remained.

The MHRA recently issued draft guidance to which the Herbal Forum said it was “concerned about the additional workload” ​in the proposals. It said there were “time and cost implications” ​it was “anxious” ​were kept to a minimum.

Products that held marketing authorisations under pre-THMPD regulations should not have to build new dossiers for Traditional Herbal Registrations (THR), Viner said.

“They should not have to reinvent the wheel,” ​Viner told NutraIngredients.com, of the registration process that can cost upwards of €100,000, depending on the product and the type of data backing its efficacy and claims.

“If the marketing authorisation is held then the transfer should be as cheap as possible. To be fair to the MHRA, it seems this is what they are trying to do.”

In the letter, Viner cited the example of one of its members that had conducted testing for its existing marketing authorisation and did “not want to have to repeat the process when transferring these licences to THR status.”

Television time

Viner said there were additional concerns products may be prohibited from advertising on television once they had achieved THR status because the THRs may not fit advertiser criteria.

While not naming examples, Viner said some products currently advertising on television may have their marketing campaigns put in jeopardy upon achieving THRs.

“There is concern as to whether [companies] will continue to be able to [keep advertising] under THR status, because it is understood that the Broadcast Advertising Clearance Centre (BACC) is less than keen to accept advertising for THR products,”​ Viner wrote. BACC authorises advertising that appears on UK TV.

Viner added: “This is clearly a very important issue for such licences: the change in status to THR could have seriously negative commercial implications. Therefore, assuming any proposed advertising for a THR product accords with the legal requirements, we trust that MHRA will use its best efforts to ensure that it can indeed be advertised on television.”

The THMPD​ has a 2011 deadline, by which time all herbal products in the EU’s 27 member states seeking to make claims must register through the appropriate national medicines agency.

In the UK, most medicinal herbal products have previously fallen under a marketing authorisation system that has governed drugs and other products.

The THMPD became law in the UK in 2005.

Herbal Forum members include the British Herbal Medicine Association, the UK Council for Responsible Nutrition, the European Herbal Practitioners Association, the UK Health Food Manufacturers Association and the Proprietary Association of Great Britain.

Related topics: Regulation & Policy, Suppliers, Botanicals

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