The Botanicals and Novel Foods (BNV) team has two tasks. The first is to assess herbal, homeopathic and anthroposophic medicinal products. The MEB makes decisions on marketing authorisations for these groups of products. In addition, under the Novel Food Regulation, the team provides policy support to the Ministry of Health, Welfare and Sports (VWS) in connection with the authorisation of novel foods. Since 2018, this has been done within a European system based on assessments by the European Food Safety Authority (EFSA). The Ministry of Health, Welfare and Sports makes authorisation decisions for the Netherlands.
The Committee on Herbal Medicinal Products (HMPC) of the European Medicines Agency (EMA) assesses the scientific data of herbal medicinal products and draws up European herbal monographs.
Number of marketing authorisations for herbal medicinal products
In 2022, the number of marketing authorisations for herbal medicinal products was comparable to the year before.
Number of marketing authorisations for herbal medicinal products
| based on full dossier | based on traditional use | |
|---|---|---|
| 2018 | 52 | 53 |
| 2019 | 49 | 55 |
| 2020 | 43 | 55 |
| 2021 | 37 | 50 |
| 2022 | 37 | 48 |
The number of herbal medicinal products with a marketing authorisation that are marketed in the Netherlands has been gradually declining in recent years. This is probably related to the marketing of herbal products, which, being supplements, are regulated under the Commodities Act. Herbal products are not assessed by the MEB for quality, safety or efficacy, but are also not traditional herbal medicinal products. This can be confusing for consumers.
Five new herbal medicinal products were registered in 2022. Four of these were registered via the decentralised procedure, based on an assessment from a reference member state that was accepted by the MEB. The HMPC’s herbal monographs increasingly play a role in this procedure.
Number of marketing authorisations for homeopathic medicinal products
The total number of marketing authorisations for homeopathic medicinal products has remained stable over the years.
Number of marketing authorisations for homeopathic medicinal products
| 2018 | 2019 | 2020 | 2021 | 2022 | |
|---|---|---|---|---|---|
| Number of marketing authorisations for homeopathic medicinal products | 2132 | 2130 | 2034 | 2013 | 2041 |
