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Table 3 Marketing authorization vs. simplified registration for herbal medicinal products in the EU

From: Key quality factors for Chinese herbal medicines entering the EU market

Categories Market authorization for herbal medicinal products
(2001/83/EC)
Simplified registration for herbal medicinal products
(2004/24 /EC)
Indications No specific limitations Limited to self-medication and OTC
Traditional use evidence No requirement for stand-alone or mixed application
At least 10 years (medicinal use) for well-established use
30 years outside the EU including 15 years in the EU
Dosage form No specific limitations Limited to oral, external use and inhalation
Dossier requirements Pre-clinical (new tests) and clinical data (new trials), or combined with some bibliographic data,
Pharmacovigilance
Bibliographic documents,
or safety tests,
Pharmacovigilance
Quality control GACP, GMP and CMC GACP, GMP and CMC
  1. OTC Over-the-Counter, GACP Good Agricultural and Collection Practice, GMP Good Manufacturing Practice, CMC Chemistry Manufacturing and Controls