Regulation of Herbal and Traditional Medicines in Germany BfArM in Dialogue – Free PDF download

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Herbal and Traditional Medicines in Germany Particular Environment
• phytotherapy, homeopathy, anthroposophy
• long history of usage
• science, research, education
• regulation in the pharmaceutical legal framework
• acceptance among citizens
• 25% of European market
• small- and medium-sized German enterprises

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marketing authorisations
– dossier-related inspections
– pharmacovigilance inspections
– pharmacovigilance management
– management of product defects
(Rapid Alert System)
– OMCL (PEI, vaccines)
– GMP/GCP inspections
– GMP/GDP certificates
– manufacturers/importers
– export certificates
– drug testing


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