Herbal medicinal products in the European Union - AESGP

available in many countries, in some cases these combinations are regarded as
food or food supplements, in other cases a “full” application procedure is
required.
VII.2 Requirements for Marketing Authorisation
VII.2.1 Application of Council Directive 65/65/EEC to Herbal Medicinal
Products
Council Directive 65/65/EEC lays down that proof of quality, safety and efficacy is a precondition
for marketing authorisation of medicinal products. Article 39 Paragraph 2 of
Council Directive 75/319/EEC requires the Member States to progressively apply the
provisions of the Directive to all medicinal products placed on the market within fifteen
years. Member States have taken a variety of approaches to meeting these requirements. For
this reason, they were asked whether Council Directive 65/65/EEC is also applied to
medicinal products containing herbal ingredients. The results are shown in the following
table:
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