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Here is what I have learned so far about the directive in EU for alternative health
care...similar legislation is being proposed in the US...we need to be
aware and prepared to go vote, sign petitions or what ever is needed to
protect our industry:
The Traditional Herbal Medicinal Products Directive, 2004/24/EC, was established to provide a regulatory
approval process for herbal medicines in the European Union (EU), and
came into force on 30 April 2004 . Previously, there was no formal EU
wide authorisation procedure, so each EU member stated regulated these
types of products at the national level. http://en.wikipedia.org/wiki/European_Directive_on_Traditional_Herb...
Under this regulation, all herbal medicinal products are required to obtain
an authorisation to market within the EU. Those products marketed
before this legislation came into force can continue to market their
product until 30 April 2011, under the transitional measures defined in
the Traditional Herbal Medicinal Products Directive. Once this time
limit has expired, all herbal medicinal products must have prior
authorisation before they can be marketed in the EU. http://en.wikipedia.org/wiki/European_Directive_on_Traditional_Herb...
For those herbal medicinal products that were not on the market before 30 April 2004, an authorisation must be obtained prior to marketing. http://en.wikipedia.org/wiki/European_Directive_on_Traditional_Herb...
The only herbal medicines that are exempted from the provisions of the
Traditional Herbal Medicinal Products Directive are those unlicensed
remedies that made up for a patient following a consultation with a
herbalist. http://en.wikipedia.org/wiki/European_Directive_on_Traditional_Herb...
Herbal medicines must be now manufactured under Good Manufacturing Practice
(GMP) to ensure the quality of the finished product and also
demonstrate safety. http://en.wikipedia.org/wiki/European_Directive_on_Traditional_Herb...
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. http://en.wikipedia.org/wiki/European_Directive_on_Traditional_Herb...
Jenny
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