New regulation on homeopathic drugs passed by parliament

A new regulation pertaining to homeopathic drugs has been passed in parliament. The amendment stipulates that homeopathic products licensed before 1 May 2004 will be excluded from the Hungarian drug market from 1 January 2020 onwards, unless they comply with Directive 2001/83/EC of the European Parliament and Council, and the Hungarian legislation implementing the rules of the directive. This means that, in practice, the existing rules pertaining to homeopathic drugs with a therapeutic indication will, indeed, be enforced. This affects 41 drugs, or about 1% of the homeopathic products available in Hungary – all of these were licensed before 1 May 2004 without the application of the required efficacy tests, because of a loophole in the EU regulation.

Another legal provision stipulates that, from 1 January 2019 onwards, pharmacists will be obliged to provide detailed written information about the nature of a homeopathic medicine when such an item is offered to a customer. The proposed content of this information is not yet clear.