Source: European Parliament
The EU ensures that traditional remedies are accessible, safe, and of high quality through a regulatory framework tailored to their specific nature.
Directive 2001/83/EC[1], as amended by Directive 2004/24/EC, has established a simplified registration process, under the responsibility of Member States, for herbal medicinal products with a long tradition of medicinal use (at least 30 years, including 15 in the EU), which do not fulfil the ‘well established use’ requirements for marketing authorisation.
The registration is further simplified in case of herbal medicines that are included in the Community list of herbal substances, preparations and combinations thereof. All those measures facilitate the availability of these products to citizens seeking alternative or complementary treatments.
With regard to the manufacturing and quality of traditional herbal medicines, applications for registration of these products have to fulfil the same requirements as applications for a marketing authorisation.
This is important as natural is not always equal to safe and herbal remedies may interact with other treatments or may be inappropriate for individuals with certain medical conditions.
In addition, the EU under its flagship research and innovation programme Horizon Europe[2] funds research into traditional remedies through the EthnoHERBS Project[3] on medicinal properties of plants of the Balkan Peninsula.
- [1] Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use OJ L 311, 28.11.2001, p. 67-128.
- [2] https://research-and-innovation.ec.europa.eu/funding/funding-opportunities/funding-programmes-and-open-calls/horizon-europe_en
- [3] See EthnoHERBS Project Fact sheet at: https://cordis.europa.eu/project/id/823973