Herbal medicinal products in the European Union - AESGP

ibliographic registration dossier for a herbal medicinal product that meets the requirements
of Article 1 of Council Directive 75/318/EEC.
For bibliographic documentation on clinical efficacy of an extract, the MEB is of the opinion
that all extracts are not equivalent. Therefore there must be similarity between the extract
described in the supporting literature and the herbal medicinal product in the application.
Portugal
Reference to literature is in principle accepted.
Spain
According to Royal Decree 767/1993 [SP 3], pharmacological, toxicological and clinical
studies may in principle for non-prescription medicinal products be replaced by
bibliographic documentation. According to information from the Directorate General of
Pharmacy and Sanitary Products, it is sufficient in case of herbal medicinal products to
make reference to a monograph.
Sweden
According to the MPA’s Guidelines on marketing authorisation for natural remedies (LVFS
1995:18) [S 1], regarding safety consideration should primarily be given to experience with
the use of the product or its constituents, and it should be demonstrated that no harmful
effects have been reported or are being suspected. If satisfactory proof of safety is not
provided, this should be established by means of clinical trials and/or pharmacological and
toxicological studies. Even if the experience of long-term use of a natural remedy does not
indicate that it has any harmful effects, this cannot always be assumed to be proof of the
remedy’s safe use.
By definition, natural remedies may only be marketed with indications for diseases or
symptoms of diseases which are temporary or mild in nature, i.e. for diseases or conditions
that are suitable for self-medication. The fields that may be approved for natural remedies at
a later date depend on the supporting documentation provided in the application.
For well-documented ingredients or products for which there is adequate experience, reliable
bibliographic data may be sufficient to support statements about a natural remedy’s efficacy.
However, the precondition is that the product’s formulation, use and dosage, etc. do not
deviate from those traditionally described. In cases where the product’s properties deviate
from the traditional description, the application is to be supplemented by specific productrelated
documentation in accordance with the MPA’s Guidelines on the documentation of
natural remedies, Part IV, efficacy documentation.
A specific statement on traditional use should be included in the label.
United Kingdom
In principle, the MCA accepts bibliographic proof of efficacy under 4.8 (a) (ii) for all herbal
medicinal products, but this has to satisfy all the requirements of Council Directives
75/318/EEC and 75/319/EEC. For products well-established in the United Kingdom, the
applicant has to submit the actual documentation (i.e. provide the MCA with copies of the
documents, not only refer to it). Documents have to be in English, otherwise they have to be
translated. The full package should be provided, and there must be an expert report. For
products not already licensed in the United Kingdom, the application is treated as a New
Chemical Entity (NCE).
The problem of the bibliographic proof of efficacy under Article 4.8 (a) (ii) of Council
Directive 65/65/EEC is the concept of essential similarity.
Summary
The option of bibliographic application is available in the following Member States:
Country Option of bibliographic application
Austria Yes - only for safety documentation
Belgium Yes - in principle
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