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Thursday 27th June 2019

EU herbal law to hit Chinese clinics

3rd May 2011

Starting this month, it is no longer legal to sell herbal medicines in the EU without undergoing a costly licensing process.


The controversial directive will now effectively block the spread of Traditional Chinese Medicine (TCM) around the world.

Other herb-based alternative medicines will also be heavily regulated in EU countries, including the UK, France, Italy, and Belgium.

The EU Traditional Herbal Medicinal Products Directive was adopted in 2004 with a seven-year transition period that has just come to a close.

Though the law made provisions for what it called a simplified registration procedure, no single Chinese herbal medicinal product was granted a license during the seven year period.

Professor Lin Bin, director of a well-known TCM clinic in the Netherlands, said that for the time being, his clinic would be limited in terms of which herbs it could stock.

The directive limits people's ability to buy herbal medicines to those which have been used for at least 15 years in the EU.

However, documentation is slim even for the herbal supplements that do have a history of use in the EU.

Lin said that the directive made it difficult and expensive for TCM practitioners to register their herbs as medicines.

Within the EU, the need to register varies from country to country.

In the Netherlands and the Czech Republic, there is no need to register herbal supplements, since the law considers them items of food.

Frederic Vincent, health spokesman for the EU, said that the European Commission was fully aware of the importance of TCM, and that authorities from both sides had cooperated with each other on the issue.

At present, TCM exports to the EU account for only a small fraction of China's total output.

Most TCM exports are sold to Hong Kong, Japan, and the USA.

Lin said he believed that, in the long run, TCM needed to go through the medical registration procedure.

He said that once it did so, TCM-based treatments would be covered by medical insurance systems.

Experts said that some herbal medicines made by the world's largest TCM company, Tongrentang, established in China in 1669, should reach maturity in the EU market at some point in the near future.

Lin said that the new directive could offer TCM the opportunity to gain respect as a medical practice within the EU.


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Martin John

Wednesday 4th May 2011 @ 20:17

This is EU regulation gone mad, fueled by big pharmaceutical business interests.

The Directive doesn't have the provision for licencing of multi-ingredient formulas such as those used in Chinese Medicine, so in that respect it discriminates against TCM and other traditional medicines that have been used around the world for hundreds, even thousands of years.

Statutory regulation of herbalists in the UK next year is a welcome (if not somewhat overdue) development for the industry. It should be noted that practitioners of Chinese Herbal Medicine in the UK are still legally able to dispense herbs and herbal formulas for their clients although the range of pre-prepared pills, tablets, and strangely enough, linaments will be severely restricted.

The massive cost of obtaining a single licence for every product is prohibitive for the industry and represents a serious freedom of choice issue for the consumer.

Herbal medicine in the EU will survive although the strain on the industry from this EU directive will be enormous!
If you care about the future of natural herbal medicine in Europe please sign one of the many petitions that are doing the rounds - google it!

Alison Downey

Thursday 14th July 2011 @ 3:23

My friend who just moved to France from the US no longer has access to the Chinese Herbal Formula she was taking. As her practitioner in the States, is it illegal for me to send it to her privately? I do not know how to find out the answer to this. Thank you in advance for clarification/ideas.

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