CRED ERP 25

6. Traditional Herbal Medicinal Products

Herbal Medicines are regulated under Directive 2001/83/EC Article 16a to 16i; as amended • Transitional period ended in 2011 • Simplified Procedure • List of Herbal Monographs • Herbal Medicinal Products Committee (HMPC) Applications for registration of traditional herbal medicinal products have to fulfil the same requirements as applications for a marketing authorisation with regard to the manufacturing of these products and their quality. The long tradition of use of a herbal product makes it possible to reduce the need for clinical data, in so far as the efficacy of the product is plausible on the basis of its long-standing use and experience as testified by bibliographic or expert evidence. Approval can be based upon one of three categories: • “ Traditional use” accepted on basis of sufficient safety data and plausible efficacy • “ Well established use” provision of scientific literature and used for at least 10 years in EU with recognised efficacy and acceptable safety • Safety and efficacy data provided from own development “stand alone” or combined with literature “mixed” .

Further reading (see Section 3.4): https://ec.europa.eu/health/system/files/2019-07/vol2a_chap1_en_0.pdf

References & Further Reading: •

VOLUME 2A Procedures for marketing authorisation Chapter 1 Marketing Authorisation December 2016. https://ec.europa.eu/health/system/files/2019-07/vol2a_chap1_en_0.pdf

Legal basis for all types of application is set out in Directive 2001/83/EC and in Regulation (EC) No 726/2004: • https://ec.europa.eu/health/sites/health/files/files/eudralex/vol- 1/reg_2004_726/reg_2004_726_en.pdf

• 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, consolidated eversion as amended https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX%3A32001L0083 7. Questions? If you have questions/clarifications then please note them here and raise them during Q&A or alternatively send any questions you would like to raise during the course to the following e-mail address: meetings@topra.org