Directive 2004/24/EC covering ‘herbal’ products has recently passed its transition period and come into force, meaning even traditional herbal products face a process of registration .
BACKGROUND
Medicinal products made from substances known as “Herbal Medicinal Products”, despite being completely ‘natural’, may still be dangerous for patients. This is why they are covered by pharmaceutical legislation, which aims to protect public health by ensuring the safety, efficacy and quality of medicinal products. However many traditional herbal medicinal products have a long tradition of use but will still be subject to the same registration procedure.
SUMMARY
In 2004 a simplified registration procedure was introduced by Directive 2004/24/EC (now ‘the Directive) to bypass the formal pharmaceutical procedures and to ensure that registration of traditional herbal medicines is simpler and less costly. The new Directive inserted provisions relating to herbal medicines into the existing Directive 2001/83/EC which generally covers the Community code relating to medicinal products for human use.
The simplified registration procedure introduced by the Directive aims to safeguard public health, but while removing the differences and uncertainties about the status of traditional herbal medicinal products that existed in the past, while at the same time facilitate free movement through harmonised rules in this area. However it does not apply to alternative therapies and does not ban any specific substances, practitioners, books or plants.
Definitions
1) Herbal medicinal product:
“Any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations”
2) Herbal substances:
“All mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually dried, form, but sometimes fresh. Certain exudates that have not been subjected to a specific treatment are also considered to be herbal substances. Herbal substances are precisely defined by the plant part used and the botanical name according to the binomial system (genus, species, variety and author);”
3) Herbal preparations:
“Preparations 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.”
The simplified registration procedure
To be eligible for the simplified registration procedure and be defined as a “traditional herbal medicinal product” it must satisfy all of the following criteria:
- they have indications exclusively appropriate to traditional herbal medicinal products which, by virtue of their composition and purpose, are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment;
- they are exclusively for administration in accordance with a specified strength and posology;
- they are an oral, external and/or inhalation preparation;
- the period of traditional use throughout a period of at least 30 years preceding the date of the application, including at least 15 years within the Community
- the data on the traditional use of the medicinal product are sufficient; in particular the product proves not to be harmful in the specified conditions of use and the pharmacological effects or efficacy of the medicinal product are plausible on the basis of long-standing use and experience.
You can find further guidelines on the procedures here.
Committee for Herbal Medicinal Products (HMPC)
Having regard to the particularities of herbal medicinal products, a Committee for Herbal Medicinal Products (HMPC) has been established at the European Medicines Agency (EMEA). The HMPC is composed of scientific experts in the field of herbal medicinal products. It has one member and one alternate member nominated by each of the 27 EU Countries and by each of the EEA-EFTA states Iceland and Norway. The HMPC is responsible for various tasks concerning the simplified registration and authorisation of medicinal products as provided for in the Directive (and also Regulation (EC) No 726/2004), including involvement in referral procedures concerning such products.
You can search herbal substances assessed by the HMPC here.
The list
The European Commission has published lists of herbal substances, preparations and combinations in the Official Journal which are based on the scientific opinion of the HMPC:
The list was established by Commission Decision 2008/911/EC of 21 November 2008
The decision has since been amended to include:
- ‘Calendula officinalis (L.)’ and ‘Pimpinella anisum (L.)’
- ‘Eleutherococcus senticosus (Rupr. et Maxim.) Maxim’ and ‘Echinacea purpurea (L.) Moench’
- ‘Mentha x piperita L.’
IMPLEMENTATION
The Directive gave an exceptionally long transitional period of 7 years to register traditional herbal medicinal products that were already on the market on the date of entry into force of the Directive. This 7 years transitional period ended on 30 April 2011.
MORE INFORMATION
You can see a video made by the Directorate General for Health & Consumers here.
