title: [Special therapeutic guidelines from the viewpoint of BfArM (Federal Institute for Drug and Medical Products)].
abstract: Homeopathic, anthroposophic and phytotherapeutic drugs are subject to the German Medicines Act of 1976 (AMG). The relevant EU regulations also refer to this group of medicinal products. Definitions and requirements for proof of adequate quality, efficacy and safety are set out by regulations under national law, as well as EU and WHO regulations. Homeopathic products may be registered without statement of indication. It has become possible in the meantime that medicinal products belonging to these particular schools of therapy and groups of substances are critically reviewed and assessed without being blamed for bias in the sense of discrimination against one of these therapies or exaggerated criticism. The term of "particular schools of therapy and groups of substances" is different from what is understood by "traditional" products according to article 109a AMG. "Traditional" products are subject to reduced requirements and their documentation need not fulfil the assessment criteria established for particular schools of therapy.
authors.affiliation: Bundesinstitut für Arzneimittel und Medizinprodukte, Berlin.
authors.forename: K
authors.initials: K
authors.lastname: Keller
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence; D000887:Anthroposophy; D000529:Complementary Therapies / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005858:Germany; D006705:Homeopathy / Q000331:legislation & jurisprudence; D006801:Humans; D008517:Phytotherapy; D017410:Practice Guidelines as Topic; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence
vernacular_title: Besondere Therapierichtungen aus der Sicht des BfArM.