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The European Directive on Traditional Herbal Medicinal Products

The Traditional Herbal Medicinal Products Directive passed in April 2004, was established to provide a regulatory approval process for herbal medicines in the European Union (EU) but finally comes into force in April 30th this year. This will change the way we currently buy herbal medicines and in May 2011, you will see many herbal products in health stores disappear from the shelves.

 

Under this regulation, all herbal medicinal products will now be required to obtain an authorisation to market within the EU. Herbal medicines must be now manufactured under Good Manufacturing Practice (GMP) to ensure the quality of the finished product and also demonstrate safety.

Under the Traditional Herbal Medicinal Products Directive, a company needs to demonstrate the safety and efficacy of the herbal medicine through traditional use within the EU for at least 30 years or 15 years within the EU and 30 years outside the EU.

The only herbal medicines that are exempted from the provisions of the Traditional Herbal Medicinal Products Directive are those unlicensed remedies that are made up for a patient following a consultation with a herbalist who has access to their own herbal dispensary. This legislation will not effect my practice for example as I am a qualified herbalist with my own dispensary using single tincture start up materials.

There is concern that some herbal remedies of 30 years ago, which are no longer in widespread use, could still be sold, but that valid new herbs which cannot meet the 30 year rule may require to be withdrawn from sale. The rule could also mean that it may not be possible to license some traditional herbal medicines, which were in common use more than 30 years ago, but have since fallen into disuse.

Previously also, the sale of unlicensed manufactured herbal remedies such as Chinese medicines and external dispensaries (i.e. not in the practitioner's own clinic) have been allowed. This new legislation will in effect make many Chinese medicines illegal and put an end to external dispensaries. Therfore, if you are a practitioner who currently requests a herbal supplier to send prescriptions to your patients, or if you are the patient in receipt of these, this will no longer be possible. The Chinese herbal formulas I prescribe in my practice will remain unchanged.

In regard to internet purchases, it will only be legal for practitioners and patients to buy licensed medicines only and it will be illegal to buy herbal products from outside of the EU.

Under the EU directive, only health professionals who are regulated by the government (statutorily regulated) will be able to prescribe or sell “finished” unlicensed medicines, i.e. get third party dispensary services to send out prescriptions to their patients, or ask these companies to make up pills, tablets, capsules and mixes for them. That is why complementary medicine regulatory bodies should be calling for Statutory Regulation (SR) for herbal medicine.

Carahealth Galway Ireland. Acupuncture, Naturopathy, Homeopathy, Herbal Medicine,  Nutritional therapy, Flower essences, Iridology, Short Courses, Cosmetic Acupuncture

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