MedPlants4Vet: First Lists of HVMP Plant Species Released

Current EU regulatory framework is not currently adapted to the marketing authorisation of herbal veterinary medicinal products. In line with Regulation (EU) No 2019/6, preamble 12, which identifies this regulatory need, a key objective of MedPlants4Vet is to support and facilitate the establishment of a simplified registration procedure for Herbal Veterinary Medicinal Products (HVMP).

A simplified registration procedure as an HVMP in Europe is the first priority for preparations of plant species like Achillea millefolium L., other plant species can be found in Plant list A. Foto: Simona Moosmann, FiBL

To this end, a group of experts in quality, efficacy, safety and sustainability of HVMP (project WG4) evaluated a total of 105 plant species that were provided by the team of experts in former and current regulation of HVMP in Europe (project WG2) as active constituents in HVMP that have previously been or are currently registered in Europe. Experts evaluated these species based on relevant European and national regulations and guidelines, such as i) Regulation (EU) No 37/2010, ii) European Pharmacopoeia, iii) HMPC (EMA) monographs, iv) WHO monographs, v) ESCOP monographs, vi) French list of human medicinal plants traditionally used, vii) Codex Alimentarius, viii) Food and Feed Information Portal Database, ix) EFSA Compendium of Botanicals - Botanical Summary Report, x) BelFrIt List and Belgian Royal Decree of 31 August 2021 regulating food supplements containing plants, xi) Compl'Alim – i.e.French Food Supplements Database, and xiii) Annex I of Regulation (EC) No. 396/2005 on products of plant (or animal) origin included in the regular human diet. To have sustainability among the criteria for simplified registration as an HVMP, the evaluation also included the UICN Red List status.

As a result of this work, we provide the first versions of two lists of plant species based on the current expert opinion of MedPlants4Vet WG4. Both lists will be regularly updated in the future.

Plant list A compiles plant species whose preparations are considered the first priority for a simplified registration procedure as HVMP in Europe. In several cases, this concerns specific parts and/or preparations only; further details will be announced later.

Plant list B compiles plant species whose simplified registration is not currently deemed a priority or advisable based on the available data; these plants are suggested to remain subjects of the presently existing registration procedures. However, should further data become available, the possibility exists for these plants to be re-evaluated and re-positioned within List A.