Guidance on New Provisions for Traditional Herbal Medicinal Products and Homoeopathic Medicinal Products from 1 January 2021

How traditional herbal medicines and homoeopathic medicines will be treated by the MHRA from 1 January 2021.

The MHRA may expand the list of countries from which it will accept evidence for traditional herbal medicines. From 1 January 2021, the MHRA may be able to accept the 15 years of traditional evidence from a wider range of countries.

Only the EU list will be relevant for applicants wanting to market a traditional herbal medicine in Northern Ireland. The definition of a homoeopathic medicinal product will be expanded.

The definition will cover products prepared from homoeopathic stocks made in accordance with a homoeopathic manufacturing procedure described in the European Pharmacopoeia or, in the absence of a description there, in accordance with a procedure described in the British pharmacopoeia or in a pharmacopoeia used officially in a country that is included in a list published by the MHRA.

It is anticipated that the list will include the:

  • British Pharmacopoeia
  • European Pharmacopoeia
  • Pharmacopoeia used officially in an EEA country

Source: MHRA guideline on Guidance on new provisions for traditional herbal medicinal products and homoeopathic medicinal products from 1 January 2021


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