Botanicals and Novel Foods

• The assessment of medicinal product groups: herbal medicinal products and homeopathic and anthroposophic medicinal products.
• The assessment of the safety of novel foods under the regulations for novel foods.

The Medicines Evaluation Board makes decisions on the applications for medicinal products and the Ministry of Health, Welfare and Sport is responsible for the approval of novel foods.

BNV 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 Food in Brussels and several expert groups at the European Pharmacopoeia in Strasbourg.

Herbal medicinal products: increasingly in line with Europe

The number of authorised herbal medicinal products based on traditional use rose by 11 in 2016, the biggest increase since 2008. Five of the traditional herbal medicinal products were authorised via a decentralised procedure. Three of the herbal medicinal products with a complete dossier were authorised via a decentralised procedure. The Netherlands was able to follow the assessment of a different Reference Member State in each of these cases. The Herbal Monographs published by the Committee on Herbal Medicinal Products played a clear role in each of these procedures.

In 2016, the Netherlands concluded one decentralised procedure for a herbal medicinal product with a complete dossier as a Reference Member State with the agreement of all Member States concerned. The mutual recognition between Member States for herbal medicinal products worked better than ever in 2016.

The number of authorised homeopathic medicinal products had decreased to 3074 by the end of 2016. This decrease is attributable to the fact that a single marketing authorisation holder requested the withdrawal of approximately 600 products. These mainly concerned forms of administration used in homeopathy. There was no change to the number of different homeopathic substances available.

During the EU presidency

The Botanicals and Novel Foods unit organised an EU meeting for the Committee on Herbal Medicinal Products in Utrecht in April 2016. At the request of several Member States, one of the topics addressed was ‘medicinal cannabis’. The MEB also hosted a meeting of the European Homeopathic Medicinal Products Working Group in Utrecht.

Novel Foods: towards 2018

In 2016, staff members of the Novel Foods unit were often called in to support the Ministry of Health, Welfare and Sport in preparing for the new assessment system for novel food safety. The new system will come into effect from 1 January 2018. 2016 was the first transitional year with many meetings in Brussels. Experts in Member States with a clear overview of this field were in high demand in 2016. The Netherlands made a substantial contribution in various areas, and will need to contribute again in 2017.

Members of the Committee for the Safety Assessment of Novel Foods (CVNV) in 2016

Prof. G.J. Mulder, Chairman
Dr. ir. M. Dekker
Dr. ir. E.J. Kok
Dr. C.F. van Kreijl
Dr. F.M. Nagengast
Dr. ir. J.M.A. van Raaij
Dr. G.J.A. Speijers
Dr. ir. E.H.M. Temme
Prof. R.A. Woutersen
Prof. ir. M.H. Zwietering

Here is an overview of several important figures for botanicals and novel foods. This is not a complete reflection of all activities of the Botanicals and Novel Foods unit.