Homeopathics

Application dossiers - Safety assessment

With the implementation of Directive 2001/83/EC as amended all Member States of the European Union (EU) have a system for registration under the simplified procedure (Article 14) as well as for authorization of homeopathic medicinal products (Article 16), if implemented in national legislation. Homeopathic medicinal products of botanical, mineral and chemical origin must be regulated according to the same non-clinical principles that are applied to other medicinal products. Specifically homeopathic medicinal products must demonstrate adequate safety. The proof of the first safe dilution (FSD), which includes information on pharmacodynamics, pharmacokinetics and toxicology, should be provided to guarantee the safety of the homeopathic medicinal products.

The establishment of a first safe dilution (FSD) for homeopathic medicinal products of botanical, mineral and chemical origin marks the threshold for the submission of a detailed non-clinical safety assessment. For homeopathic medicinal products for which neither analytical nor toxicological data are available, a justification for a given dilution will be provided within Module 4 on the basis of existing data. For compounds at a final dilution equal to or higher than the one mentioned in the list of first safe dilutions, a reference to the list of first safe dilutions in Module 4 will suffice. For compounds at a final dilution lower than the one mentioned in the list of first safe dilutions and for compounds not included in the list of first safe dilutions, a detailed Module 4 should be compiled. Any missing data should be justified; e.g. justification must be given why demonstration of an acceptable level of safety can be supported although some studies are lacking.

In the absence of a specific EU dossier template, the EU-Notice To Applicants (NTA) is mandatory for homeopathic medicinal products. The structure of the application dossiers for homeopathic medicinal products has to be in accordance with the Common Technical Document (CTD) format.

We take over the preparation of the pharmacological/toxicological expert reports and clinical expert reports in CTD format for the registration or authorization of homeopathic medicinal products. We compile the non-clinical assessment of your homeopathic medicinal products with a calculation of the first safe dilution (FSD) in accordance with the guidelines and recommendations of the Homeopathic Medicinal Product Working Group (HMPWG).

Decades of experience in the field of „Regulatory Affairs“ and „Pharmacovigilance“ of homeopathics, herbal medicinal products and chemically-synthesised medicinal products guarantee a comprehensive and competent preparation of the dossiers on schedule.