The Botanicals and Novel Foods Unit has 2 assessment tasks. First, the assessment of the medicines groups herbal, homoeopathic and anthroposophic medicines. Second, under the regulations for foods, the assessment of the safety of novel foods. The Medicines Evaluation Board decides on the applications for medicines and the Ministry of VWS is responsible for the approval of novel foods.
The Botanicals and Novel Foods Unit staff members represent the Netherlands in a wide range of European bodies, such as the Committee on Herbal Medicinal Products of the EMA, the Task Force for Novel Foods in Brussels and several expert groups at the European Pharmacopoeia in Strasbourg.
Herbal medicines and homoeopathic products
In 2018 the marketing authorisations for a large number of homoeopathic remedies from a single marketing authorisation holder were cancelled on the company's initiative.
An extremely wide variety of homoeopathic raw materials is used in homoeopathy, while the turnover of some medicines after dilutions and also in several pharmaceutical forms can be low. Although the variety of simple authorised homoeopathic dilutions decreased as a result at the end of 2018, the most widely used homoeopathic products in various dosage forms are still available as authorised homoeopathic medicines and the dossiers for these products are updated at the MEB.
Valid marketing authorisation herbal medicines
| Traditional use | Full dossier | |
|---|---|---|
| 2016 | 50 | 55 |
| 2017 | 54 | 52 |
| 2018 | 53 | 52 |
Valid marketing authorisations homoeopathic medicines
| 2016 | 2017 | 2018 | |
|---|---|---|---|
| Number of marketing authorisations | 3072 | 2911 | 2132 |
Concluded cases
| 2016 | 2017 | 2018 | |
|---|---|---|---|
| Number of concluded cases | 147 | 348 | 203 |
