Volume 158, Part B, 2 December 2014, Pages 458–462
Regulation of herbal and traditional medicinal products – European and global strategies (International Symposium TradReg2013)
Abstract
Results:
According to Directive 2004/24/EC which amended the basic legislation
laid down in Directive 2001/83/EC a new European legislation on herbal
medicinal products was developed, in order to harmonize the use of
herbal medicinal products in Member States of the European Union. Conclusions:
The objective of this legislation was to ensure the future existence of
such products and to consider particular characteristics during the
assessment of their quality, efficacy and safety, having defined two
categories for herbal medicines: i) well-established use herbal
medicinal products, which can be granted a marketing authorization; and
ii) traditional herbal medicinal products which can be granted a
registration based on their longstanding safe and efficient use.
Graphical abstract
Abbreviations
- AR,, assessment report;
- BPH,, Benign Prostatic Hyperplasia;
- EC,, European Commission;
- EMA,, European Medicines Agency;
- EU,, European Union;
- HMP,, herbal medicinal product(s);
- HMPC,, Committee on Herbal Medicinal Products;
- IP,, interested party(ies);
- LE,, list entry;
- LoR,, list of references;
- M,, monograph;
- NCA,, National Competent Authorities;
- OoC,, overview of comments;
- THMP,, traditional herbal medicinal product(s);
- TU,, traditional use;
- WEU,, well-established use
Keywords
- Herbal medicinal products;
- List entries;
- Community monographs;
- Public statements;
- TU-WEU HMPs
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