7. Special cases in marketing authorisations: Herbal medicines

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1. Herbal medicines

1.4. Committee for Herbal Medicinal Products (HMPC)

Given the particularities of herbal medicines, a Committee for Herbal Medicinal Products (HMPC) has been established at the EMA (Article 16h of Directive 2001/83/EC).

The HMPC issues scientific opinions on herbal substances and preparations, along with information on recommended uses and safe conditions of use and is responsible for various tasks concerning the simplified registration and authorisation of medicines as provided for in Directive 2001/83/EC and in Regulation (EC) No 726/2004).

Legal Basis:

Artl. 16a to i of Directive 2001/83/EC as amended

Directive 2004/24/EC (the Herbal Directive), which amends Directive 2001/83/EC.