7. Special cases in marketing authorisations: Herbal medicines: Overview regulatory pathways for herbal medicines

1. Herbal medicines

1.3. Overview regulatory pathways for herbal medicines

Herbal medicines can be authorised via one of three options as shown in Table 2.

Table 2: Overview of regulatory pathways for herbal medicines

Pathway (classification)	Main Requirements	Procedure
product is classified under traditional use (Article 16a(1) of Directive 2001/83/EC	sufficient safety data and plausible efficacy, assessment of mostly bibliographic safety and efficacy data, used for at least 30 years, including at least 15 years within the EU, non-prescription medicine	traditional use registration (simplified registration procedure) granted by a National Competent Authority (NCA) (national, MRP or DCP procedure).
product is classified under well-established use (Article 10a of Directive 2001/83/EC)	scientific literature establishing its active substances medicinal use within the EU for at least ten years, recognised efficacy and an acceptable level of safety; assessment of mostly bibliographic safety and efficacy data	product is granted a MA by a NCA (national, MRP or DCP procedure) or by the EMA (if centralised procedure applies).
product is authorised via (stand-alone application) or (mixed application) (Article 8(3) of Directive 2001/83/EC)	stand-alone: only safety and efficacy data from the company’s own development mixed: combination of own studies and bibliographic data	product is granted a MA by a NCA (national, MRP or DCP procedure) or by the EMA (if centralised procedure applies).

Regardless of partially simplified requirements on safety and efficacy data, a full quality dossier is required for all herbal medicinal products as well as other fundamental principles that are applicable to all medicinal products including good manufacturing practice, pharmacovigilance and requirements on packaging and labelling.