Herbal medicinal products

(Article 1.30 of Directive 2004/24/EC)

Herbal medicinal products are medicinal products that contain herbal substances, herbal preparations or a combination of these as their active agents.

Applications for marketing authorisations for herbal medicinal products are based primarily on established medicinal use. Further information can be found in the Finnish Medicines Agency administrative regulation 3/2015 ‘Application for marketing authorisation and registration of a pharmaceutical product and their renewal’: 3.6 Herbal medicinal products.

If it is unclear whether the product to be placed on the market is a medicine or not, the Finnish Medicines Agency will, on request, classify the product. Information on the product should be submitted to the Pharmacovigilance Activities unit of the Finnish Medicines Agency for the decision on classification. The decision is subject to a fee. For more detailed instruction on the classification process, see ‘Classification and list of medicines’ on the Finnish Medicines Agency website.

Instructions on labelling and package leaflets, including specific instructions

Detailed instructions on the administrative regulations and normative guidelines relating to herbal medicinal products can be found in the Finnish Medicines Agency administrative regulation 3/2013 ‘Labelling and package leaflet for a medicinal product’ and in the Finnish Medicines Agency normative guideline 1/2013 ‘Labelling for a medicinal product’. The following matters should also be taken into account: The active agent is the herbal medicinal product as a whole; the strength of the active agent is only indicated in combination with the trade name when the compound or group of compounds causing the therapeutic effect is known; a Vnr number should be applied for the product.