The legislation governing the Herbal medicines area in the EU consists of two sets of legislation: National legislation and Community legislation. In this section relevant Community legislation is referred to: Directive 2001/83/EC on the Community code relating to medicinal products for human use and as amended. Below furthermore some of the other directives which only apply in part are mentioned: 2010/84/EC ( Community code) ,2001/20/EC (GCP), directive 2004/9/EC (GLP) and directive 2004/10/EC (implementation and validation of GLP). Please note that there are quite a number of other regulating laws (directives and regulations) applying in this area.
In the EU herbal medicine is in most ways comparable with normal medicine in terms of requirements to the production facility and the ingredient(s) used etc.
This often leaves one big problem: The API-requirements as listed in the legislation.
From January 2013, all imported active substances must have been manufactured in compliance with standards of good manufacturing practices (GMP) at least equivalent to the GMP requirements of the EU. The manufacturing standards in the EU for active substances are those of the ‘International Conference for Harmonization’ – ICH Q7.
In July 2013, this compliance must be confirmed in writing by the competent authority of the exporting country. This document must also confirm that the plant where the active substance was manufactured is subject to control and enforcement of good manufacturing practices at least equivalent to that in the EU.
For some herbal ingredients it is very difficult to meet API requirements.
Another approach here could be to look for accept as a “Food for Special Medical Purposes” (FSMP) hyperlink til regulatory affairs advice-> FSMP, where API criteria do not apply instead EU food law is applicable.
Provided the ingredient is non-novel or holds a novel food approval such an ingredient could be a fine candidate for a “FSMP”