A new regulation is tightening the marketing of homeopathic products in Hungary and these can now only be sold without advertising a therapeutic indication.
From Wednesday, homeopathic remedies can only be distributed in Hungary without a therapeutic indication, as none of the products’ efficacy have been confirmed by clinical trials.
In a statement to news wire MTI, the National Institute of Pharmacy and Nutrition (OGYÉI) said the changes are due to a law amendment that came into effect last year.
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The new regulation only allows homeopathic medicines with therapeutic indications authorized before Hungary’s accession to the EU (2004), to be marketed after July 1, 2020 only if they have complied with the EU regulations on the marketing of these medicines.
In a statement in 2015, the Hungarian Academy of Sciences Section of Medical Sciences concluded that homeopathic products should follow the same strict scientific standards as ‘normal’ drugs. In 2017, the Scientific Advisory Board of European Academies (EASAC) stated that there is no substantial evidence that homeopathy works and may even be harmful to our health.
In total, 41 homeopathic medicinal products with a therapeutic indication are affected. In 2019, the refusal of 22 such medicinal products’s marketing authorization was initiated, and in eight cases an unregulated, simplified registration procedure was set in place. Of the latter, six products were processed and licensed in 2019.
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Currently, Hungary has no homeopathic product with therapeutic efficacy proven in clinical trials.
The product license of homeopathic products – in compliance with the legislation of the European Union – can be obtained by two different procedures in Hungary.
The so-called simplified procedure can be used for “high-dilution products” marketed without a therapeutic indication, in which case the effectiveness of the product does not need to be certified.
The “normal” procedure is applicable to homeopathic medicinal products marketed for a therapeutic indication, in which case, just as any other medicinal products, therapeutic efficacy must be clinically proven.
OGYÉI emphasized that from July 1st, the advertising of marketable homeopathic remedies may only contain the label text of the product, no additional information.
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