Criteria for registration and requirements for marketing authorizations for herbal remedies are as set out by European Directives and guidelines, such as the Note for Guidance on Quality of Herbal Remedies, the European Pharmacopoeia, and national guidelines and directives such as the guidelines for testing of drugs following section 26 of the Medicines Act. While bibliographic data on well-established use of herbal medicines is accepted, the criteria developed by Commission E and positive monographs are widely used to document safety and efficacy of herbal remedies. Monographs can to a large extent replace pharmacological, toxicological and clinical documentation as can bibliographic data. Medicines or groups of medicines which do not pose a direct or indirect risk to the health of man or animal can be exempted from the requirement of individual marketing authorization according to section 6 of Medicines Act. To ensure their quality, safety and efficacy, each such medicinal product referring to this procedure must comply exactly with a monograph of a standardized marketing authorization published by the Ministry of Health.

The fifth amendment of the German Medicines Act, which became effective in August 1994, widened the scope of existing legislation for herbal medicinal and other products already on the market. Traditional medicine usage instead of reasonable proof of efficacy is accepted for a certain category of products, mostly sold outside pharmacies. These products have to be labelled as ‘traditionally used’ and in accordance to section 109a of the Medicines Act, the BfArM has compiled lists stating which preparations are allowed to refer to this regulation and which traditional indications can be claimed. This new system offers a legal possibility for a large number of preparations without sufficient documentation as proof of efficacy to be re-registered under such a simplified procedure.

On a ‘higher level’, ‘non-traditional’ are admissible, provided that these are based on monographs or on individual clinical studies with defined preparations. In contrast to herbal medicines, the quality dossiers of ‘traditional’ products are not checked by the health authority. The regulation contrasts with EU requirements for the marketing of medicinal products. Hence the new regulation offers a legal possibility for herbal and non-herbal preparations to stay on a strictly national market without sufficient documentation as proof of efficacy and safety and without thorough control of pharmaceutical quality. In Germany three possibilities for marketing herbal drugs exist:

1. Temporary marketing authorization for old herbal drugs until they are evaluated for safety and efficacy;
2. Monographs of standardized marketing authorization;
3. Individual marketing authorization.