7. Special cases in marketing authorisations: 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 |
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 |
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) |
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.