Herbal medicinal products in the European Union - AESGP

clarification, the European Commission issued a call for tender for a study on herbal
medicinal products in the pharmaceutical sector [6].
The main objectives of the study were described as follows:
• to clarify the current legal situation for herbal medicinal products in each Member
State with respect to the implementation of the requirements of Council Directives
65/65/EEC, 75/318/EEC and 75/319/EEC;
• to compare actual practices in the assessment of quality, safety and efficacy of herbal
medicinal products in the Member States, with particular emphasis on the application
of the derogation in Article 4.8 (a) (ii) of Council Directive 65/65/EEC;
• for the purpose of mutual recognition under Council Directive 75/319/EEC, to evaluate
the consequences of possible divergence in either the legal position or the assessment
of herbal medicinal products; and
• to make recommendations on how to best safeguard public health while allowing the
free movement of herbal medicinal products throughout the European Union.
AESGP was selected to carry out the study and started work on 1 January 1998. In
accordance with the contract for the study, an Interim Report was provided on 29 May 1998
and the Draft Final Report was submitted on 30 September 1998.
IV. CURRENT LEGAL SITUATION OF HERBAL MEDICINAL
PRODUCTS IN THE EUROPEAN UNION
IV.1 Definition of Medicinal Products
According to Council Directive 65/65/EEC of 26 January 19651, a medicinal product is
defined as “any substance or combination of substances presented for treating or preventing
disease in human beings or animals”. This Directive further states that “any substance o r
combination of substances which may be administered to human beings or animals with a view
to making a medical diagnosis or to restoring, correcting or modifying physiological functions
in human beings or in animals is likewise considered a medicinal product”. Article 3 clarifies
that no medicinal product may be marketed in a Member State unless an authorisation has
been issued by the competent authority of that Member State.
IV.2 Herbal Products Not Regarded as Medicinal Products
Applying the definition of a medicinal product laid down in Council Directive 65/65/EEC to
herbal preparations, has led to the conclusion that these preparations are not considered as
medicinal products if they are intended to be used as food, cosmetics, etc. and are not
intended or presented for treating, preventing or diagnosing diseases or restoring,
correcting or modifying physiological functions. Herbal preparations that are not medicinal
products do not require a marketing authorisation from the competent authority.
Homeopathic preparations, covered by Council Directive 92/73/EEC of 22 September 19922, are
likewise not considered as herbal medicinal products.
Although Council Directive 65/65/EEC defines the basic criteria for a medicinal product, it is
in many cases not so easy to draw the line distinguishing medicinal products from nonmedicinal
products. This dilemma is illustrated in the disparate definitions of herbal
medicinal products used by each Member State.
IV.3 Requirements for Marketing Authorisation
Council Directive 65/65/EEC establishes that proof of quality, safety and efficacy is a precondition
for delivering a marketing authorisation for a medicinal product. The specific
requirements for documentation and expert reports on quality, safety and efficacy are
1 Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down b y
law, regulation or administrative action relating to medicinal products (OJ 22 of 9.2.1965, p. 369).
2 Council Directive 92/73/EEC of 22 September 1992, widening the scope of Directives 65/65/EEC and
75/319/EEC on the approximation of provisions laid down by law, regulation or administrative
action relating to medicinal products and laying down additional provisions on homeopathic
medicinal products (OJ L 297 of 13.10.1992, p. 8).
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