Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Influence of the 2004/24/EC on the previously marketed Herbal medicinal products within the EU

Reinhold Schilling (Abschlußjahr: 2015)

Summary
Language: English
The THMP- Directive influences an existing market, which was regulated nationally and therefore was unharmonized. Herbal medicinal products have been used in the Union extensively even before the Directive 2004/24/EC entered into force.
The EMA published in the end of 2014 an article about the tenths birthday of the HMPC . It is important to evaluate the self-assessment of an agency. The THMP Directive has a direct influence on the pharmaceutical industry this is even enforced since the industry requests harmonization within the European Union since the beginning of the 1990s.
The goal of the THMPD was to

  • promote harmonization
  • keep existing products on the market
  • establish an acceptable level of safety
  • establish new criteria for herbal products to make the efficacy plausible
  • create monographs for herbal substances
  • create a legally binding list with herbal substances (Union List entries)

This goals have been verified in order to evaluate impact of the THMPD:
The legal requirements have been harmonized. This is of importance in an industrial sector which is currently underlying a defragmentation process: national companies are growing into international companies with one global regulatory affairs department. The same dossier can be submitted to all NCAs in the EEA. The levels of safety and plausibility of efficacy are harmonized as well.
However, several products are lost to the regulated medicinal market and are now present as food supplements. The toxicological risks of herbal products shall not be underestimated.
Lastly all applications made produced enormous financial costs for the pharmaceutical industry. The traditional statement had to be prepared. The pharmaceutical Dossier had to be updated and the national competed authority demanded fees.
Overall this directive brings the European ideals to the herbal medicinal products market by enhancing an acceptable level of safety and creating harmonization. The safety of the public health as well as the free movements of goods play a superordinate role in the European Union. The downside of harmonization is that nationally accepted herbal products vanished forever.
Pages: 57, Annexes: 1, Pages: 3

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