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Art. 7 Verordnung vom 21. September 2018 über die Arzneimittel (VAM) - Beschleunigtes Zulassungsverfahren
VAM; 2. Kapitel: Zulassungsverfahren
Art. 7 VAM · Beschleunigtes Zulassungsverfahren
Eine Gesuchstellerin kann bei der Swissmedic für ein Humanarzneimittel oder für dessen Änderung die Durchführung eines beschleunigten Zulassungsverfahrens beantragen, wenn: a. es sich um eine erfolgversprechende Prävention oder Therapie gegen eine schwere, invalidisierende oder lebensbedrohliche Krankheit handelt; b. keine oder nur unbefriedigende Behandlungsmöglichkeiten mit zugelassenen Arzneimitteln vorhanden sind; und c. vom Einsatz des neuen Arzneimittels ein hoher therapeutischer Nutzen erwartet wird.
Gerichtsentscheide zu dieser Bestimmung (8)
VB.2024.00500 · zh (Art. 7 Abs. 2 VAM)
Appeal Against Denial of Definitive Admission to Gymnasium Following Probationary Period Failure
Cited as the provision allowing the class conference to deviate from promotion requirements under special circumstances, which the court found not to be met.
C-2532/2013 (Art. 7 Abs. 2 VAM)
Biowaiver Denial Upheld Due to Insufficient Data and Quality Control Deficiencies
This provision states that the institute must grant approval if the applicant proves the drug meets quality requirements, is relatively safe and effective.
C-4776/2010 (Art. 7 Abs. 2 VAM)
E.________-_______ Generic Drug Marketing Authorization Rejection Upheld
Cited as a basis for the decision-making authority of the regulatory body regarding drug approval, emphasizing the need for proof of meeting quality, safety, and efficacy standards.
C-7594/2008 (Art. 7 cpv. 3 OM)
Marketing Authorization Appeal for Carbon Dioxide Local Anesthetic
Cited to state that an application must be rejected if the requirements for quality, safety, and efficacy are not met.
36.2011.49 · ti (Art. 7 OM)
Health Insurance Reimbursement for Off-Label Psoriatic Arthritis Medication
Cited regarding the document accompanying a positive marketing authorization decision from Swissmedic.
JAAC 69.21 (Art. 7 Abs. 2 VAM)
Drug Quality Deficiencies Lead to Marketing Authorization Refusal
This provision relates to the authority's obligation to grant approval when prerequisites are met and refuse it when they are not, directly impacting the decision on the applicant's request.
JAAC 67.58 (Art. 7 Abs. 1 VAM)
Herbal Medicine Labeling: Drug-to-Extract Ratio Upheld
States that drug approval is granted for specific characteristics that are recorded in a summary.
36.2011.49 · ti (Art. 7 cpv. 4 OM)
Cantonal Insurance Court Upholds Denial of Humira Coverage for Psoriatic Arthritis Without Prior DMARD Failure
Cited in the reasoning regarding the decision document accompanying the marketing authorization (Summary of Product Characteristics).