THMPD Implementation

UK herbal industry concerns raised by THMPD deadline

02-May-2011 - Last updated on 03-May-2011 at 13:13 GMT

The completion this week of the seven-year window for over-the-counter botanical products to comply with the 2004 Traditional Herbal Medicinal Products Directive (THMPD) has only raised anxiety in the UK for the 1000s of products that haven’t as yet achieved registration under the scheme.

While member states like Germany and France say most products are in compliance with the regulation, the UK market is very different with most products not registered – a situation local trade groups, retailers and manufacturers are understandably concerned about.

Massive product recalls, restricted consumer choice, multi-herb blend bias and retailer closures have been predicted by various parties, perhaps none more vehemently than the Alliance for Natural Health Europe (ANH-EU), which has raised more than €100,000 for a legal challenge against the Directive.

“We have been working hard with stakeholders across Europe to bring this challenge and we are nearly ready to file,” said the group’s executive and scientific director, Robert Verkerk, PhD.

“But the complexity of the case has meant that we are taking a little longer than planned, given we'd hoped to file our case by the end of April.”

The regulation is being felt differently in different countries, depending on existing policies and procedures toward traditional medicines of botanical origin.

“In some EU countries, such as the Netherlands and the Czech Republic, that have liberal regimes, we will expect to see no change for the time being as these countries seem content to regard Traditional Chinese Medicines (TCMs) and Ayurvedic products as food supplements. Others, such as the UK and Germany, the two countries that have registered the most products under the THMPD, have a different view,” Verkerk said.

While the UK and German medicine agencies take the same position that all non-prescription botanical supplements must be registered, all but a few hundred of the estimated 2500 products on the German market have had previous national registrations accepted under the THMPD.

The opposite is true in the UK, and the UK Medicine and Healthcare products Regulatory Agency (MHRA) has issued only 105 THMPD registrations, out of 211 applications. Dossiers backing individual products can cost more than €50,000 to prepare and process. The registration focuses on safety and tradition of use and demonstration of efficacy is not required.

To date there have been no rejections.

Food v medicine

Leading up to the deadline, the UK Health Food Manufacturers’ Association (HFMA) warned of ongoing ambiguity about the way certain herbs are to be treated, such as peppermint.

“There are many herbal ‘lists’ currently circulating within the industry, none of which are consistent or in any way definitive,” its executive director, Graham Keen stated.

“The reason for this is that simply stating that a particular herb is ‘medicinal’ or ‘food’ from the end of April is not the answer. This is because the great majority of herbs can be marketed as foods and as medicines.

“So, no question, there are challenging times ahead for botanical products as some companies try to maintain the unlicensed ‘food’ status of their products, whilst others seek to protect the traditional herbal registrations they have invested so heavily in."

Under the Directive, products already on shelves before April 30, are allowed to sell-through.

2 comments

THMPD's are medicines, not food supplements

Posted by Bert Schwitters, 03 May 2011 - 13:40 GMT

In the mess called "botanicals," many seem to forget that THMP's are medicines and that THMP's have nothing to do with food supplements. THMP's arose under EU medicines law, not under food law. As the THMP Directive unequivocally states, THMP's are medicines that differ from regular - fully registered - medicines because of their traditional use, not because they are "herbals" of "botanicals." Framing the problems of traditionally used medicines in terms of "botanicals" only creates a hell of a confusion. The issue here is traditional medicinal use.

Report abuse

Costs for THMP registration

Posted by M. Schmidt, 03 May 2011 - 13:23 GMT

50,000 € would be quite inexpensive for the preparation of the quality dossier: Just the stability testing for the three batches required for registration usually costs 40 k€. Add the costs for the development of analytical methods and their validation (including contaminants), the costs of GMP-conform manufacturing and its validation, and you will very rarely end up with less than 120 k€. In case of combination products these costs will be considerably higher (figures from recent German experience).
As a result, not a single German provider of grey market products has made the switch. Insofar it is simply not true that the THMPD has no effect on the German market structure. The official comment relates to products which had drug status before, and which remain drugs, but not to the supplements. For the latter the future is not bright, due to the pending EFSA's health claim assessment.

Report abuse