(Article 1.29 and all criteria in Article 16 a (1) of Directive 2004/24/EC)
Section 5 a of the Medicines Act defines a traditional herbal substance as a medicinal product for human use that contains herbal substances, herbal preparations or a combination of these as its active agents. In addition, it must fulfil all the criteria for registration set out in section 22, paragraph 1 of the Medicines Act. A traditional herbal medicinal preparation may also contain vitamins or minerals if they promote the effect of herbal active agents.
Registration for Traditional herbal medicinal products can nevertheless only be used when the marketing authorisation procedure under the human medicines directive is not possible. If there is sufficient scientific literature to prove established medicinal use, recognised efficacy and an acceptable safety level, the applicant should apply for a marketing authorisation for the product. Neither can the registration procedure for Traditional herbal medicinal products be used if the product can be granted a marketing authorisation or it can be registered as a homeopathic or anthroposophic preparation.
Further information can be found in the Finnish Medicines Agency administrative regulation Application for marketing authorisation and registration of a pharmaceutical product and their renewal: 3.7 Traditional 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.
Instructions on labelling and package leaflet including specific instructions
Detailed instructions on the administrative regulations and normative guidelines relating to Traditional herbal medicinal products can be found in the Finnish Medicines Agency administrative regulation 3/2019 ‘Labelling and package leaflet for a medicinal product’ and in the Finnish Medicines Agency normative guideline 1/2019 ‘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 is needed to all herbal medicinal products and traditional herbal medicinal products; the registration number follows the format R xxx FI; obligatory additional labelling ’PERINTEINEN KASVIROHDOSVALMISTE – TRADITIONELLT VÄXTBASERAT LÄKEMEDEL’ [Traditional herbal medicinal product] and ’Ota yhteys lääkäriin, jos oireet jatkuvat tai jos hoidon aikana esiintyy haittavaikutuksia’ [Contact a physician if the symptoms continue or if you experience adverse effects during the treatment]