Herbal medicinal products in the European Union - AESGP

Products referred to in Section 68, Paragraphs 1 and 3 of the Medicines Act (1987/395) which,
upon the entry into force of the Administrative Regulation 9/93 have an authorisation
referred to in Section 69, Paragraph 1 of the Medicines Law or a license for sale or other
consumption granted under Section 10 (f) of the Pharmaceutical Preparations Law or which
have been granted a license for a semi-medicinal purpose under the Decree on licenses for
labelling the purpose of a semi-medicinal product (1993/1046), should, under the transitional
provisions of the law amending the Medicines Law (1993/1046), have been taken to the
register as herbal remedies with a marketing authorisation upon the entry into force of the
latter Act. Registration as herbal remedies also applies to homeopathic and anthroposophical
products which, upon the entry into force of the Administrative Regulation 9/93, have a
license referred to above and which do not meet the requirements of registration laid down
in Section 21a, Paragraphs 1 and 2 of the Medicines Law (1993/1046). The labelling of these
preparations should have been made to comply with the above provisions and those contained
in the Administrative Regulation 5/93 of NAM not later than 31 December 1995.
Holders of the marketing authorisations should submit their applications for renewal of the
marketing authorisations in accordance with the following groupings:
40
Corresponding licence
Authorisation should be (have been)
or approval granted in
submitted by
1983 – 1985 31 December 1995
1986 – 1987 31 December 1996
1988 – 1989 31 December 1997
1990 – 1991 31 December 1998
1992 – 1993 31 December 1999
Table 7: Renewal of marketing authorisations in Finland
The applications for renewal need to comply with the existing rules for applications for
marketing authorisations.
France
Bibliographic applications are accepted. However, none of them has up to now led to a
marketing authorisation as the dossiers were insufficient.
Germany
According to Section 5 of the Guidelines for Medicines Testing (“Arzneimittel-
Prüfrichtlinien”) [D 3], bibliographic data may be used as a reference for well-known
substances. Acceptable data include pharmacological, toxicological and clinical studies,
observational field studies, scientifically evaluated case reports and scientifically
documented medical experience.
During the review process between 1978 and 1994, monographs on active ingredients were as
a first step compiled by Expert Commissions according to Section 25 Paragraph 7 of the
German Medicines Law. The objective of the procedure was to establish clear, a priori
criteria for active ingredients and to make it clear to industry which products had a chance
of being authorised. The review of herbal remedies was conducted by a multidisciplinary
commission of experts, the so-called Commission E, consisting of pharmacists,
pharmacologists, toxicologists, clinical pharmacologists, biostatisticians, medical doctors
from hospitals and general medical practitioners [D 2]. This Commission was responsible
for the evaluation of more than 300 medicinal plants, and the results (i.e., the monographs)
have been published in the Federal Gazette (“Bundesanzeiger”), beginning in 1984. These
monographs cover most of the ingredients of industrially prepared herbal medicinal
products on the market.
The work of all review commissions, including Commission E, regarding the evaluation of
bibliographic data and the preparation of monographs was ended with the publication of the
5th Amendment of the Medicines Law in August 1994. The main reason was that the most
relevant active principles were covered by monographs and the remaining products could be
more economically assessed on a case-by-case basis. The commissions now serve as
advisory boards to the Federal Institute for Drugs and Medical Devices (BfArM) in making
decisions on the registration of new medicines and in the individual assessment of old
medicinal products, as the second step of the review process.