The Botanicals and Novel Foods Unit (BNV) of the Medicines Evaluation Board agency has two tasks. The first concerns the assessment of herbal, homeopathic and anthroposophic medicinal products. The MEB takes decisions on marketing authorisations for these groups of products. In addition, under the Regulation on Novel Foods, the unit provides policy support to the Ministry of Health, Welfare and Sports (VWS) in connection with the authorisation of novel foods. Since 2018, this has taken place within a European system based on assessments by the European Food Safety Authority (EFSA). The Ministry of Health, Welfare and Sports decides on the authorisation 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. Through the Botanicals and Novel Foods Unit, the Netherlands is also represented in the European working group for homeopathic products, namely the Novel Foods working group in Brussels and the working group for herbal products at the European Pharmacopoeia in Strasbourg. In 2020, the Netherlands took on the chairmanship of the HMPC, for a period of three years.
The authorisation procedure for botanicals is the same as for other medicinal products for human use. A different procedure and other EU laws apply to novel foods.
Number of marketing authorisations for herbal medicinal products
The number of marketing authorisations for herbal medicinal products decreased in 2021.
Number of market authorisations for herbals
| based on complete dossier | based on traditional use | |
|---|---|---|
| 2017 | 52 | 54 |
| 2018 | 52 | 53 |
| 2019 | 49 | 55 |
| 2020 | 43 | 55 |
| 2021 | 37 | 50 |
Number of marketing authorisations for homeopathic medicinal products
In 2021, the number of homeopathic medicinal products authorised continued to fall, due to more withdrawals at the request of companies. The most widely used homeopathic products remain available as authorised homeopathic medicinal products in various forms of administration. The number of applications in 2021 was virtually the same as in the previous year.
Number of market authorisations for homeopathic medicinal products
| 2017 | 2018 | 2019 | 2020 | 2021 | |
|---|---|---|---|---|---|
| Number of market authorisations for homeopathic medicinal products | 2911 | 2132 | 2130 | 2034 | 2013 |
Number of concluded cases (including variations)
Fewer cases were concluded in 2021 than in the previous year. This is because a large number of variations of homeopathic dossiers were concluded in 2020, with the data on quality and safety updated for a large number of single homeopathic medicinal products.
Number of concluded cases
| 2017 | 2018 | 2019 | 2020 | 2021 | |
|---|---|---|---|---|---|
| Number of concluded cases | 348 | 203 | 118 | 395 | 177 |
