Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Applications for Marketing Authorization and for Registration of Herbal Medicinal Products in the Community - Different Views despite of European Harmonization ***

Dr. Katharina Veltmann (Abschlußjahr: 2015)

Summary
Language: English
With Directive 2004/24/EC the community code has been amended to introduce new legal provision for herbal medicinal products (HMPs) in the EU. Apart from the simplified procedure for traditional herbal medicinal products (THMPs), the establishment of a European Committee for HMPs (HMPC) and the preparation of community monographs and community list entries were codified. Typically, HMPs are either authorized based on a well-established use (WEU) of at least 10 years in the community, or are registered as THMPs based on the traditional use (TU) of 30 years – thereof at least 15 years in the community.
Community list entries and community monographs on TU or WEU of a herbal substance/preparation/or combinations thereof provide an effective tool in regulatory procedures. While community list entries for THMPs are adopted by the European Commission and have therefore a binding character to the member states, community monographs are prepared by the HMPC, thus having no legally binding force. Although the European procedures are open for HMPs, applications for registration/authorization are still typically submitted via the national procedure. This is due to the divergent assessment of HMPs by national competent authorities (NCAs) in the member states confronting applicants with unnecessary delays and hurdles in European procedures.
The regulatory differences between authorized and registered HMPs establish also commercial differences to the products. Although these differences are often not realized by the consumers, HMPs are usually authorized according to article 10a of the community code based on the WEU – on condition there is a sound basis for safety and efficacy for an authorization of the respective herbal product in question.
This thesis deals with the acceptance and relevance of TU and WEU monographs, and the considerable differences of the assessment of HMPs across the EU in the MSs. The examples presented reveal that the harmonization process in regulating HMPs in the EU is by far not yet completed. This is evident from the divergent concerns raised by individual NCAs of member states.
It remains to be seen whether the legal provisions currently in force and instruments are sufficient to drive the harmonization procedure forward or whether further measurements with more legally binding force need to be installed. The latter appears not to be the case as some of the NCAs have already fully implemented the existing regulatory framework into their regulatory practice. It is desirable other NCAs also follow these examples so that the existing regulatory framework provides a solid basis for successfully application procedures throughout the EU.
Pages: 77