Homeopathics Can No Longer Be Marketed as Medicinal Products in Hungary

In 2015, the Hungarian Academy of Sciences stated that “Homeopathic remedies don’t meet the criteria of evidence based medicine”  and that homeopathic products should follow the same strict scientific standards as conventional drugs. In 2017, the Scientific Advisory Board of European Academies (EASAC) concluded that there is no substantial evidence that homeopathy works and may even be harmful to our health.

Now, Hungary is about to act. New regulation is tightening the marketing of homeopathic products in Hungary. From Wednesday this week, homeopathic remedies can only be distributed in Hungary without a therapeutic indication or claim. The reason for this move is that none of the products’ efficacy have been adequately confirmed by rigorous clinical trials.

In a statement, the Hungarian National Institute of Pharmacy and Nutrition (OGYÉI) said the changes are due to a law amendment that came into effect last year. 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, if they have complied with the EU regulations on the marketing of these medicines.

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.

The move by the Hungarian authorities is, of course, most welcome. It brings Hungary finally in line with the rest of the EU. The many enthusiasts of homeopathy will no doubt suspect a worldwide conspiracy against homeopathy. If so, they merely disclose how far they have put their heads into the sand. Such measures are nothing but the long overdue actions towards abolishing double standards that have existed far too long and have helped nobody except the homeopathic industry.