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Conclusion • Medicinal Product with a Cannabis-extract as active substance • Herbal Medicinal Product • Evaluation according to „Instruction for Herbal Medicines“ • Fee: CHF 6‘000.- • Medicinal Product with Dronabinol ([-]-trans-∆ 9 -THC) as active substance • Synthetic Medicinal Product • Evaluation according to „Instructions for new active pharmaceutical ingredients” • Fee: CHF 60’000.- • Indication, supply category, etc. will be decided on after evaluation of the submitted documentation Competent Authority for Reimbursement: Federal Office of Public Health (FOPH) (BAG) („List of pharmaceutical specialties “) 16
Swissmedic / Swiss Agency for Therapeutic Products Thank you for your attention Heidi Tschümperlin Case Manager Division Complementary and Herbal Medicines Sector Authorisation Hallerstrasse 7 CH-3000 Bern 9 Switzerland phone: +41 31 322 05 92 email: Heidi.Tschuemperlin@swissmedic.ch web: www.swissmedic.ch/kpa.asp 17
Page 1 and 2: The Way to the Cannabis Medication
Page 3 and 4: authorised medicines abroad e.g. Ma
Page 5 and 6: Switzerland: Legal Situation I enac
Page 7 and 8: Switzerland: Legal Situation III Or
Page 9 and 10: Switzerland: Legal Situation V Admi
Page 11 and 12: Documentation I • about analytica
Page 13 and 14: Herbal medicinal products: Document
Page 15: Authorisation Procedure - Overview

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