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Art. 25 Ordinanza del 21 settembre 2018 sui medicamenti (OM) - Classificazione delle modifiche e procedura
OM; Capitolo 2: Procedura di omologazione
Art. 25 OM · Classificazione delle modifiche e procedura
Swissmedic attribuisce le singole modifiche alle diverse categorie e definisce in dettaglio le procedure di cui agli articoli 21–24 nonché la documentazione necessaria. A tal fine tiene conto delle norme e delle direttive riconosciute sul piano internazionale, segnatamente del regolamento (CE) n. 1234/2008 nonché delle linee guida della Commissione europea fondate su questo regolamento.
Stabilisce le modalità affinché in un’unica domanda possano essere richieste più modifiche.
Decisioni giudiziarie che applicano questa disposizione (6)
VPB JAAC-59-7B (Art. 25 et 26 OM)
Confederation v. Service Member: Indemnity for Gross Negligence and Traffic Accident Damages
These articles establish the military member's liability for damages caused.
VB.2014.00340 · zh (Art. 25 VAM)
Mail-Order Pharmacy Prescription Requirement Affirmation
This provision, concerning the dispatch of medicinal products, is implicitly applied as a basis for the ruling regarding the ordering system for all categories of medicines.
VPB JAAC-61-88B (Art. 25 OM)
Military Member Liable for Gross Negligence in Trailer Accident
This provision establishes the military member's responsibility for entrusted material and liability for damage caused through intentional or grossly negligent violation of service duties.
VPB JAAC-61-88A (Art. 25 et 26 OM)
Military Driver Grossly Negligent in Truck Collision
These articles define gross negligence, which is the condition for the Confederation to seek recourse against a military member after a traffic accident.
VPB JAAC-52-43A (Art. 25 OM)
Military Member's Gross Negligence in Backing Accident Leads to Liability
This provision allows the Confederation to seek recourse against a military member who caused damage intentionally or through gross negligence.
VB.2014.00340 · zh (Art. 25 VAM)
Mail-Order Pharmacy Online Prescription Requirement Upheld
This provision is cited as part of the legal basis concerning the sale of medicinal products, supporting the final decision to reject the appeal.