Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Pharmacovigilance Obligations in the Pharmaceutical Company for Homeopathic- and Traditional Herbal Medicinal Products - Transposition of Directive 2001/83/EC into the German Medicinal Product Act - AMG

Britta Dauber (Abschlußjahr: 2020)

Summary
Language: English
The aim of this Master thesis is to elaborate Pharmacovigilance (PV) obligations in Germany for authorised and registered Homeopathic- and Traditional Herbal Medicinal Products (HMPs and THMPs).
The framework for PV obligations in the European Economic Area (EEA) is defined by a host of legal documents: Regulation European Commission (EC) No 726/2004, Directive 2001/83/EC, Commission Implementation Regulation European Union (EU) No 520/2012, Good Pharmacovigilance Practices Modules and its annexed ICH Guidelines, and the German Medicinal Product Act (Arzneimittelgesetz, AMG). However, not all stipulations of all European legal documents are completely implemented into the AMG.
This Master thesis describes the regulatory requirements for HMPs and THMPs, evaluates their legal basis and shows its implementation into the AMG. Until today, there is no full review or detailed clarification of the applicable rules by the competent authorities, leading to uncertainties for pharmaceutical companies. With regard to PV obligations, the different requirements for HMPs and THMPs raise major questions, like the applicability of PV obligations for HMPs and THMPs. For HMPs, regulatory requirements differ depending on their degree of dilution or type of active ingredients contained (synthetic, herbal or animal).
It is further illustrated that the obligations for PV and Risk Management are partially less extensive for registered medicinal products than for authorised medicinal products. Still, registered medicinal products must be compliant with PV obligations. Disparities in PV stipulations are rather confusing within the working environment of the pharmaceutical company, causing factual and practical problems - particularly if the company operates in more than one EU Member State.
Common, concordant implementation rules would eliminate existing national conditions like enhanced drug safety regulations for pharmaceutical companies entering the German market as set forth during the transposition of Directive 2001/83/EC into national law. In order to achieve this, fortified efforts on harmonisation are indispensable. Pharmaceutical companies holding Registrations and Marketing Authorisations for HMPs and THMPs in Germany stand to gain a lot more clarity and certainty of law, as well as a more level playing field inside the EEA. Companies from other Member States can cite enhanced standards when marketing their products on a global scale. Patients across the world would be better protected by implementing the strictest regulations available to ensure their medicinal products are of highest quality, safe and efficient.
Pages: 60