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European Directive on Traditional Herbal Medicinal Products

Healthful Living

"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 [1]. Previously, there was no formal EU wide authorisation procedure, so each EU member stated regulated these types of products at the national level [2].


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
[3].

For those herbal medicinal products that were not on the market before 30 April 2004, an authorisation must be obtained prior to marketing [4].

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 [5].

Herbal medicines must be now manufactured under Good Manufacturing Practice (GMP) to ensure the quality of the finished product and also demonstrate safety [6]." article reference. . .

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