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Authorisation Procedure II • Procedure „New active pharmaceutical ingredients (New API)“ • Neither Dronabinol nor Cannabis-extracts have been included to date in any medicinal product that is or has been authorised by Swissmedic. • Evaluation of • information for healthcare professionals and patient information as well as packaging • applied supply category (indication, dosage, etc. are also taken into account) • Fees • according to the Ordinance on Fees for Therapeutic Products (HGebV) • Time • Swissmedic Processing Time: approx. 330 days. • Applicant Time for submitting answers, additional documentation 14
Authorisation Procedure - Overview • Documentation (Quality, Preclinical, Clinical) • Establishment licences, esp. for narcotics, granted by Swissmedic Application Total Applicant Time: 300 days Total Swissmedic Time: 330 days 15
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: Herbal medicinal products: Document
Page 17: Swissmedic / Swiss Agency for Thera

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