A herbal medicinal product is any medicinal product exclusively containing as active ingredients one or more herbal substances and/or one or more herbal preparations.
Herbal substances can be either whole, fragmented or cut plants, plant parts, algae, fungi and lichen in an unprocessed form; usually they are dried, but sometimes also fresh. Certain plant exudates that have not been subject to a specific treatment are also considered to be herbal substances. The term ‘herbal substance’ corresponds to the term ‘herbal drug’ in the European Pharmacopoeia.
Herbal preparations are obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. These include comminuted or powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates.
In respect of whether the efficacy has been demonstrated by appropriate clinical studies, herbal medicinal products are divided as follows:
- those that meet the same criteria of efficacy as other medicinal products (usually medicinal products with a well-established medicinal use);
- traditional herbal medicinal products whose efficacy is plausible only on the basis of long-standing use and is not proven by appropriate clinical studies.
HERBAL MEDICINAL PRODUCTS WITH PROVEN EFFICACY
Herbal medicinal products that meet the same criteria of efficacy as other (e.g. synthetic) medicinal products are subject to the same requirements for marketing authorisation as other medicinal products; see the tabs “National procedure”, “MRP” and “DCP”. For quality requirements, the provisions of Article 10 of the Rules on traditional medicinal products of herbal origin also apply mutatis mutandis (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 55/2006).
In preparing documentation, the guidelines and monographs of the European Union prepared by the Committee on Herbal Medicinal Products (HMPC) at the European Medicines Agency, in those parts relating to well-established medicinal use, should be taken into account.
TRADITIONAL HERBAL MEDICINAL PRODUCTS
Traditional herbal medicinal products must, in addition to the general conditions laid down by the Medicinal Products Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 17/2014), fulfil all the following criteria:
- they have therapeutic indications exclusively appropriate for traditional herbal medicinal products, which by virtue of their composition and purpose are suitable for self-medication;
- they are exclusively for administration in accordance with the specified strength and posology;
- they are intended for oral or external use or inhalation;
- they have been in traditional use for at least 30 years and at least 15 years in the European Union;
- the data on the traditional use of the medicinal product must be sufficient; in particular the product proves not to be is harmful in the specified conditions of use and pharmacological effects or the efficacy of the medicinal products are plausible on the basis of long-standing use and experience.
Traditional herbal drugs may also contain vitamins and minerals, provided that there is well-documented evidence of their safety, and that the vitamins or minerals are ancillary to the herbal active ingredients regarding the specified claimed therapeutic indications.
All herbal medicinal products may be placed on the market only after they have been granted marketing authorisation in the Republic of Slovenia.
Obtaining, renewal, transfer and termination of marketing authorisation for traditional herbal medicinal products under the simplified procedure
The simplified procedure for obtaining marketing authorisation or registration means that rather than the standard pharmaco-toxicological and clinical documentation, evidence of traditional use and a review of the safety data and plausible efficacy should be enclosed instead. However, the quality must be ensured in the same way as in other medicinal products, taking into account the specifics of the herbal medicinal products.
The documentation for an application for marketing authorisation for a traditional medicinal product must be prepared in accordance with the Rules on traditional herbal medicinal products (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 55/2006). The application and the structure of the documentation are the same as with other medicinal products, also taking into account the instructions in the document “Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products”. See also the following link.
The same application form for marketing authorisation as for other medicinal products is used.
In preparing documentation, the guidelines and monographs of the European Union prepared by the Committee on Herbal Medicinal Products (HMPC) at the European Medicines Agency, in those parts relating to traditional medicinal products, and the Community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products should be taken into account.
When the application for marketing authorisation for traditional herbal medicinal products relates to a herbal substance, a herbal preparation or a combination thereof which is on the Community list, there is no need to submit data on the traditional use, safety and plausible efficacy.
For traditional herbal medicinal products, the mutual recognition procedure and the decentralised procedure are used only when the traditional herbal medicinal products consist of herbal substances, herbal preparations and combinations thereof from the Community list or when a relevant monograph of the European Union has been adopted. Even if those conditions aren’t met the mutual recognition procedure and the decentralised procedure are possible. However, the applicant shall obtain agreement by all member states involved in the procedure (see ‘Q&A Traditional Herbal Medicinal Products’).
Other important features of traditional medicinal products of herbal origin
The labelling and patient information leaflet of traditional herbal medicinal products
Traditional herbal medicinal products must be labelled and must have a patient information leaflet in compliance with the regulations on the labelling of medicinal products and patient information leaflets. Furthermore, the packaging and patient information leaflet must contain a statement that:
- the product is a traditional herbal medicinal product intended for use in specified indication(s) exclusively based upon long-standing experience;
- users are advised to consult a physician or a pharmacist if the symptoms persist during the use of the medicinal product or if adverse effects not mentioned in the patient information leaflet occur.
In some cases, JAZMP may require that information on the type of tradition be provided on the labelling and in the patient information leaflet.
Advertising of traditional medicinal products of herbal origin
In addition to the requirements laid down by the regulations on the advertising of medicinal products, any advertisement for traditional herbal medicinal products must contain the following statement: – “… is a traditional herbal medicinal product intended for use in the specified indication(s) exclusively based on long-standing experience”.