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812.212.21 VAMOMÉDOM CH

Art. 10 Verordnung vom 21. September 2018 über die Arzneimittel (VAM) - Übertragbarkeit

VAM; 2. Kapitel: Zulassungsverfahren
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Art. 10 VAM · Übertragbarkeit

Die Zulassung ist übertragbar.

← Art. 9 VAM Verordnung vom 21. September 2018 über die Arzneimittel (VAM) Art. 11 VAM →

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Gerichtsentscheide zu dieser Bestimmung (7)

C-5515/2011 (Art. 10 VAM)
Swissmedic Fee for Domicile Change Upheld
Defines which changes to medicinal products require approval.
C-5515/2011 (Art. 65 Abs. 1 HMG i.V.m. Art. 10 VAM, Art. 22a AMZV und Anhang 7 Ziff. 3 AMZV)
Swissmedic Fee for Domicile Change Upheld
Establishes the legal basis for charging a fee for the approval and amendment of medicinal product licenses.
C-6513/2010 (Art. 10 VAM)
Insulin Manufacturing Process Change Requires New Approval and Higher Fee
Defines 'genehmigungspflichtige Änderungen' (changes requiring approval) and is used to contrast with 'wesentliche Änderungen'.
36.2011.49 · ti (Art. 10 OM)
Health Insurance Reimbursement for Off-Label Psoriatic Arthritis Medication
Cited regarding the requirement to seek authorization for modifications to professional information or indications.
JAAC 67.58 (Art. 10 VAM)
Herbal Medicine Labeling: Drug-to-Extract Ratio Upheld
Governs the approval or notification requirements for changes to drug information, indicating that the change in this case required approval.
VPB 1990-03-08 (Art. 10 OM)
Military Organization Act Revisions Case
This provision is discussed and voted upon in the dispositive, concerning the possibility of obliging recruits and soldiers to undergo further training for non-commissioned officer positions.
36.2011.49 · ti (Art. 10 OM)
Cantonal Insurance Court Upholds Denial of Humira Coverage for Psoriatic Arthritis Without Prior DMARD Failure
Cited in the reasoning regarding the requirement for authorization if the authorization holder intends to modify professional information or indications.