Herbal medicinal products in the European Union - AESGP

The descriptions of the analytical data must be so detailed that it is possible for the Danish
Medicines Agency to perform controls. Methods of analysis that do not come from
recognised pharmacopoeias must be validated, i.e. it must be shown that the method is
suitable for the purpose.
Modifications to the composition of a herbal medicinal product must be done in accordance
with Order No. 49 of 1987 on the quality of medicinal products. Such changes could concern
specifications for a medicinal product or a raw material which is not or only partly covered
by a monograph included in a valid pharmacopoeia. Modifications must be approved by the
Danish Medicines Agency.
Finland
Finland accepts applications which make use of Article 4.8 (a) (ii) of Council Directive
65/65/EEC as almost the only way to prove or support the safety and efficacy of herbal
medicinal products.
The requirements for the marketing authorisation of herbal medicinal products are as
follows:
— compliance with the definition of herbal medicinal products as laid down in the
Medicines Law (see point VII.1.1.);
— quality and manufacturing in accordance with the requirements for normal
medicinal products, taking into account the special characteristics of herbal medicinal
products;
— safety and efficacy in accordance with bibliographic data;
— adequate expert reports; and
— adequate labelling with the term “herbal remedy.”
In accordance with Council Directive 75/319/EEC, an expert report together with appendices
in tabular form and an optional written summary should be submitted on the
pharmaceutical and chemical particulars. With regard to pharmacological and toxicological
particulars, a summary should be submitted based on the application material and briefly
describing the main indications of the products as well as other facts that the manufacturer
considers to be of significance in the evaluation of the application. A critical evaluation of
the pharmacological and toxicological data should be included in the summary.
The documentation on pharmaceutical and chemical particulars should be presented i n
accordance with Council Directive 75/318/EEC, which is applicable to all medicinal products.
The particulars on the quality and manufacturing of herbal medicinal products should
further take into account the EC Guideline “Quality of Herbal Remedies”. The raw
materials must meet the requirements of the pharmacopoeia or, in the absence of such
specifications, detailed quality requirements should be drafted in accordance with the model
monographs of the European Pharmacopoeia. Quality requirements and analytical methods
for intermediate and finished products must be presented. Analytical methods must be
validated. If the product contains more than one herbal drug or herbal drug preparation,
these should be identified (e.g., by the thin layer chromatography fingerprint method). The
finished products should meet the requirements of the European Pharmacopoeia and the
Finnish and Swedish Standards for Medicinal Products. Shelf-life should be indicated for
the finished product based on appropriate stability tests. The tests should be conducted i n
specified circumstances in the package intended for sale.
If the herbal medicinal product or its active ingredient has been used for a long time i n
Europe or in countries close to Europe with regard to healthcare traditions, the safety and
proposed indication of the product can normally be explained by information available i n
the scientific literature. The application should also contain a bibliography listing of the
citations for the data that are appended or otherwise referred to in the application.
The proposals for the labelling and package leaflet as well as the summary of product
characteristics should be submitted to the National Agency for Medicines (NAM) together
with the application. The label of a herbal medicinal product must clearly state that it is a
herbal medicinal product [FIN 1].
Renewals of marketing authorisation can be granted for a period of five years at a time. The
application for renewal of a marketing authorisation with its appendices should be submitted
to the NAM at least three months before the expiry of the marketing authorisation, i n
accordance with Administrative Regulation 4/93.
39