812.212.21
VAMOMÉDOM
CH
CH
Art. 23 Ordinanza del 21 settembre 2018 sui medicamenti (OM) - Modifiche maggiori
OM; Capitolo 2: Procedura di omologazione
Art. 23 OM · Modifiche maggiori
Le modifiche del medicamento che possono avere conseguenze significative sulla sua qualità, sicurezza o efficacia e che non costituiscono un’estensione dell’omologazione devono essere approvate da Swissmedic prima della loro attuazione.
Decisioni giudiziarie che applicano questa disposizione (8)
C-546/2010 (Art. 23 VAM)
Swissmedic v. Aesthetics Company: Advertising Ban and Website Modifications
Cited to define the criteria for assigning human medicinal products to dispensing category A, indicating higher health risks.
30.2002.40 · ti (art. 23 OM)
Pharmacy Manager Appeal Against Fine for Illegal Prescription Drug Sales
This article was cited in the section preceding the final orders as part of the legal basis for the decision being upheld.
JAAC 61.87 (Art. 23 OM)
Military Damage Claim for Shelter Entry
This article establishes the Confederation's liability for damages caused by military exercises or troop service activities.
JAAC 59.6 (Art. 23 OM)
Hikers' Claim Against Confederation for Denied Access Dismissed Due to Third-Party Fault
This provision governs the Confederation's liability for damages caused by military personnel during exercises or service activities.
JAAC 52.41 (Art. 23 al. 1 OM)
Confederation v. Automobilist
Basis for the Confederation's liability for damage caused during military service.
JAAC 52.41 (Art. 23 al. 2 OM)
Confederation v. Automobilist
Basis for the Confederation's liability for damage to property caused during military service.
JAAC 52.41 (art. 23 al. 1 in fine OM)
Confederation v. Automobilist
Cited in conjunction with other articles to justify a reduction of damages due to the victim's fault.
30.2002.40 · ti (art. 23 OM)
Pharmacist Fine for Unprescribed Category A Medicine Sales
Cited among the provisions forming the legal basis for the final decision (referring to the relevant ordinance article).