Herbal medicinal products in the European Union - AESGP

system, documentation is required safeguarding the quality (both manufacturing and
product quality) at the same level as is required for chemically manufactured medicinal
products. Complete documentation of quality is to be submitted. It includes chemical,
microbiological and pharmaco-technical data, and its purpose is to describe and ensure
satisfactory product quality. In order to achieve this, the raw materials need to be of a high
and uniform quality. Furthermore, the documentation should adequately describe that the
manufacturing process is conducted in compliance with the EC Guidelines on Good
Manufacturing Practice (GMP). Control of these factors helps to ensure that the product has
reproducible composition and other characteristics which in turn means that the final
consumer receives a product of uniform quality. With regard to safety and efficacy,
bibliographic applications are in principle possible (see point VII.2.3.).
United Kingdom
The requirements of the marketing authorisation system are set out principally in the
Marketing Authorisations Regulations [UK 2]. No distinction is made between
manufactured medicinal products based on plant ingredients or other ingredients. However,
exemptions from licensing for certain herbal remedies are contained in Section 12 of the
Medicines Act [UK 1]. There is no simplified procedure and the only alternative would be a
full application.
Summary
A “normal” registration procedure for herbal medicinal products with full proof
of safety and efficacy is possible in all Member States except Denmark, Finland
and Luxembourg. In Denmark and Finland, only bibliographic applications are
used. Luxembourg grants marketing authorisations based on the assessment o f
other countries.
VII.2.3 Bibliographic Applications
According to Article 4.8 (a) (ii) of Council Directive 65/65/EEC, “the applicant shall not be
required to provide the results of pharmacological and toxicological tests or the results of
clinical trials if he can demonstrate … by detailed references to published scientific
literature presented in accordance with the second paragraph of Article 1 of Council
Directive 75/318/EEC that the constituent or the constituents of the medicinal product have a
well established medicinal use, with recognised efficacy and an acceptable level of safety.”
Therefore, in principle, data from published literature may be used to substantiate safety and
efficacy in expert reports and dossiers. In this study Member States were asked whether they
accept applications which make use of Article 4.8 (a) (ii) of Council Directive 65/65/EEC to
prove or support the safety and efficacy of herbal medicinal products.
Austria
A full marketing authorisation (according to Section 13 of the Austrian Medicines Law
[AT 1]) solely based on bibliographic material in terms of the clinical documentation is not
permitted. According to Section 15 Paragraph 13 of the same law, however, scientific
knowledge or practical experience can be used for safety documentation instead of the
relevant studies.
According to Section 17a, submission of studies on efficacy and safety is not required if the
application is in line with this regulation.
Belgium
There have been no examples of bibliographic applications in Belgium.
The Ministry of Public Health does not consider that all extracts of a similar plant are
equivalent. However, they support the idea of having monographs of families of plants i n
order to introduce three or four different extracts on such a scale that they become a European
standard, in order to protect those companies that conducted the clinical research.
The Ministerial Circular (“Circulaire ministérielle”) of 30 November 1994 [B 2] lays down that
pharmaco-toxicological data may be replaced with references to published literature. This
provision is not specific to herbal medicinal products but also applies to other medicinal
products when the active principle(s) already exist(s) on the market.
37