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Image header Agence Europe
Europe Daily Bulletin No. 8132
Contents Publication in full By article 16 / 48
GENERAL NEWS / (eu) eu/internal market

Commission proposes partial harmonisation of conditions for registering plant-based medicines

Brussels, 18/01/2002 (Agence Europe) - On Thursday, the European Commission adopted a proposal of directive aimed at partially harmonising the conditions for registration and marketing of "traditional plant-based medicines". The proposal of directive, which will come under codecision procedure, partly meets an oft-repeated request of the European Parliament and of over-the-counter medicine manufacturers. It also completes revision of the legislation on the medicine that the Commission proposed six months ago. The proposal of directive should allow a first stage to be crossed towards a single market for this kind of product but does not establish any centralised marketing authorisation procedure. Given the great differences between Member States, it does not provide for a mutual recognition mechanism either. The Member States would be entitled to register these products on the basis of harmonised conditions in the context of a simplified procedure, taking into account monographs that should be established by a plant-based medicinal products committee to be created within the Medicinal Products Agency in London. The products covered by the directive are exclusively traditional medicines, that have been used for at least thirty years within the Community (or fifteen years within the Community if the applicant can demonstrate that a thirty-year period may be reached if account is taken of use outside the Community), and intended to be used without the intervention of a professional doctor for diagnosis, prescriptive or follow-up treatment purposes. The labelling and the notice of directions should mention that: (1) the product is a traditional plant-based medicine with specific indications and whose effectiveness has not been clinically demonstrated but which is exclusively based on usage and experience; (2) the user is invited to consult a doctor or a qualified practitioner if symptoms continue while the product is being used.

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