Masterarbeit

Challenges in the regulatory requirements for homeopathic medicinal products in Canada and the European Union with Germany and Belgium as examples under special consideration of recent developments ***

Frauke Wellhausen (2014)

Summary
This Master thesis inquires the current regulatory requirements for homeopathic medicinal products in Canada and the European Union.
Canada introduced new requirements in 2004, which resulted in a re-registration process for all products previously registered. Under consideration of the experiences with the processing of these applications, Health Canada’s Natural Health Products Department (NHPD) started an initiative to improve the licensing process. This includes a review of the current procedures and dossier requirements as well as implementation of a number of electronic tools. Two assessment procedures are currently available: compendial applications according to pre-cleared information from official NHPD product monographs or applications with full assessment of quality, safety and efficacy. The future procedure will classify applications into three categories according to the complexity of assessment. Evaluation criteria for homeopathic medicinal products remain basically the same. Canada presents a very pragmatic approach for the licensing of well-known substances under defined conditions of use. These may be processed within a very short time. Current and future processes are presented along with the requirements for the submitted evidence  and resulting challenges. Special consideration is given to labeling requirements, which include dosage recommendations and risk information for products with or without specific claim. Health Canada’s measures for post-licensing safety monitoring are presented. European Member States still struggle with harmonization of requirements. The thesis presents the current requirements with emphasis on the simplified registration. New developments regarding safety assessment are emphasized. HMPWG has published assessment reports for first safe dilutions for consultation. Examples for assessment are presented. In some cases, FSDs are presented in function of the possibility to label contraindications. A comprehensive labeling including dosage recommendations and risk information also in the simplified registration procedure, as currently practiced for example in Germany and Canada, is presented as one idea for a differentiated risk assessment.
Pages: 55, Annexes: 13