Safety, Pharmacovigilance and Appropriate Information for Patients of Homeopathic Medicinal Products

Rubrik: Arzneimittelwesen

(Treffer aus pharmind, Nr. 11, Seite 1473 (2018))

Michels H | Mohr C | Orth H | Thurisch B | Sickmüller B | Criswell M

Safety, Pharmacovigilance and Appropriate Information for Patients of Homeopathic Medicinal Products / Michels et al. • Information for Patients · Michels H, Mohr C, Orth H, Thurisch B, Sickmüller B, Criswell M · ¹Pascoe pharmazeutische Präparate GmbH, Gie und DHU-Arzneimittel GmbH & Co. KG, ß und Bundesverband der Pharmazeutischen Industrie e. V., en und Neustadt und an der Weinstraße und Karlsruhe und Berlin
Patients’ demand for homeopathic medicinal products is continuously high [ 1 , 2 ]. In Germany and generally in the EU, the current legal and regulatory requirements ensure that the available homeopathic medicinal products are safe and of high quality. They contain appropriate information and pharmacovigilance requirements are established. These regulatory requirements and their legal genesis are outlined in a wider context below. 1) For the entire EU, the term homeopathic medicinal product is defined by Article 1 (5) of Directive 2001/83/EC. This definition is implemented in Germany through the Medicinal Products Act (Arzneimittelgesetz, AMG). Pursuant to Section 4 (26) Sentence 1 AMG, ...