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Art. 13 Legge federale del 15 dicembre 2000 sui medicamenti e i dispositivi medici (LATer) - Medicamenti e procedure omologati all’estero
LATer; Capitolo 2: Medicamenti
Art. 13 LATer · Medicamenti e procedure omologati all’estero
I risultati degli esami eseguiti su medicamenti o procedure già omologati in un altro Paese che prevede un controllo dei medicamenti equivalente sono presi in considerazione.
Decisioni giudiziarie che applicano questa disposizione (7)
VPB 08-1321-6731 (Art. 13 LPTh)
Swiss Approval of Foreign-Approved Products
This article is cited as the basis for developing implementing provisions to renounce scientific expertise for medicines already authorized abroad under equivalent regulations.
C-1664/2019 (Art. 13 LPTh)
Pharmaceutical Company Denied Market Authorization for Acne Gel
Legal basis for simplified marketing authorization for drugs already authorized abroad in countries with equivalent drug control systems.
A-3621/2014 (Art. 13 LPTh)
Pharmaceutical Product Approval Document Access Dispute
Cited in relation to the requirement of authorization for therapeutic products.
C-6513/2010 (Art. 13 HMG)
Insulin Manufacturing Process Change Requires New Approval and Higher Fee
Cited as the basis for the simplified review procedure which led to a reduction in fees.
C-7594/2008 (Art. 13 LATer)
Marketing Authorization Appeal for Carbon Dioxide Local Anesthetic
Cited again to emphasize that foreign approvals are not binding for Swissmedic, and the specific medicinal product must be identical.
C-7594/2008 (Art. 13 LATer)
Marketing Authorization Appeal for Carbon Dioxide Local Anesthetic
Cited to explain that foreign approvals are not directly recognized in Switzerland and require material examination by Swissmedic.
JAAC 68.31 (Art. 13 HMG)
Preservative-Free Eye Drops: Four-Week Expiry Upheld Amid Safety Concerns
Consideration of foreign approval results in Swiss approval procedures, but without binding Swiss authorities.