Marketing authorisations

Herbal remedies and medicinal products

Herbal remedies and medicinal products

Herbal medicinal products fall into one of the following groups, depending on the product. Detailed information for applying for a marketing authorisation or registration is included for each group.

Herbal medicinal product

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.

Traditional herbal medicinal product

A traditional herbal medicinal product is a medicinal product for human use that contains herbal substances, herbal preparations or a combination of these as its active agents. Requirement for the registration is that the product has been in uninterrupted medicinal use for a minimum of 30 years before the date of application, including a minimum of 15 years in the European Union.

Homeopathic and anthroposophic preparations

A homeopathic preparation is a medicinal product that has been manufactured from homeopathic stocks using the homeopathic manufacturing procedure described in the European Pharmacopoeia. Provisions on homeopathic medicinal product also apply to anthroposophic medicinal product. Either marketing authorisation or registration can be granted for homeopathic and anthroposophic product.

Nutritional supplements are subject to the Food Act. These products are monitored by Finnish Food Authority.

Herbal medicinal products Read more

Contact information list portlet

Contact information list portlet

  • Kartimo Heikki
    Coordinator for Marketing Authorisations / Fimea, Myyntiluvat, Regulatoriset prosessit -yksikkö, Hakemusten koordinaatio 2 tel. +358295223347