7. Special cases in marketing authorisations: Herbal medicines

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Book:	7. Special cases in marketing authorisations: Herbal medicines

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1. Herbal medicines

1. Herbal medicines

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EU legislation on pharmaceutical products for human use also applies to herbal medicines.

1.1. Definitions

A herbal medicine is defined as any medicine, exclusively containing as active ingredients:

one or more herbal substance(s)* or
one or more herbal preparations**, or
a combination of the two.

*Herbal substances: All mainly whole, fragmented or cut plants, algae, fungi, or lichen in an unprocessed dried or fresh form, precisely defined by the plant part used and the botanical name

**Herbal preparations: preparations obtained from herbal substances after treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. Include powdered substances, tinctures, extracts, essential oils, juices and processed exudates.

Traditional herbal medicines form a specific group of herbal medicines, especially characterised by a long tradition of use and which do not fulfil the requirements for a marketing authorisation according to Directive 2001/83/EC, in particular because of a lack of sufficient scientific literature demonstrating a well-established medicinal use with recognised efficacy and an acceptable level of safety.

1.2. Simplified registration procedure for Traditional herbal medicines

A special, simplified registration procedure (‘traditional-use registration’) is established for herbal medicines which fulfil all of the following criteria:

indications exclusively appropriate to traditional herbal medicines for use without the supervision of a medical practitioner;
exclusively administered with a specified strength and posology;
preparation is oral, external and/or inhalation;
a long tradition of medicinal use;
sufficient safety data in the specified conditions of use and plausible efficacy;

The simplified procedure allows the registration of a Traditional herbal medicine:

without requiring documents on tests and trials on safety and efficacy, if the efficacy is plausible on the basis of its long-standing use and experience as testified by bibliographic or expert evidence;
if the safety is substantiated by a bibliographic review of safety data together with an expert report;
with bibliographical or expert evidence that the medicine, or a corresponding product has been in medicinal use for at least 30 years, including at least 15 years in the Union preceding the date of the application (Article 16c(1)(c) of Directive 2001/83/EC)
is intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment and therefore has to be a non-prescription medicine;
fulfils the same requirements as applications for a marketing authorisation with regards to the manufacturing and quality. Results of pharmaceutical (physico-chemical, biological or microbiological) tests must be submitted.

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.

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.