Traditional herbal medicinal products and simplified registrations for homeopathic medicinal product
The purpose of this document is to clarify pharmacovigilance requirements for traditional herbal medicinal products registered further to a simplified registration procedure (traditional use-registration) on the basis of Article 16a of Directive 2001/83/EC1 and homeopathic medicinal products registered further to the special, simplified registration procedure under Article 14(1) of Directive 2001/83/EC and the process for obtaining access to adverse reaction reports in EudraVigilance for traditional use herbal medicinal products.
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