812.21 HMGLPTHLATER

CH

Art. 18 Legge federale del 15 dicembre 2000 sui medicamenti e i dispositivi medici (LATer) - Obbligo di autorizzazione

LATer; Capitolo 2: Medicamenti

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Art. 18 LATer · Obbligo di autorizzazione

Necessita di un’autorizzazione rilasciata dall’Istituto chi, a titolo professionale: a. importa medicamenti allo scopo di smerciarli o di dispensarli; b. esporta medicamenti allo scopo di smerciarli o di dispensarli; c. commercia in medicamenti dalla Svizzera, senza che questi tocchino il territorio svizzero; d. esercita a partire dalla Svizzera l’attività di mediatore o agente in medicamenti.

Il Consiglio federale precisa i requisiti per le attività di cui al capoverso 1.

Può adottare eccezioni all’obbligo di autorizzazione per: a. il personale sanitario con attività transfrontaliera; b. le organizzazioni internazionali.

L’immagazzinamento in un deposito doganale o in un deposito franco doganale è considerato importazione.

Il Consiglio federale può emanare disposizioni speciali per il transito.

Se un altro Paese esige certificati d’esportazione e attestati per i medicamenti da importare, l’Istituto può rilasciarli alle persone autorizzate a esportare.

← Art. 17 LATer Legge federale del 15 dicembre 2000 sui medicamenti e i dispositivi medici (LATer) - Scopo Art. 19 LATer →

Decisioni giudiziarie che applicano questa disposizione (13)

BE.2024.13 (Art. 18 Abs. 1 lit. a HMG)

Unsealing of Documents in Unlawful Medicinal Product Importation Case

Cited in conjunction with Art. 86 Abs. 1 lit. a HMG to establish the suspicion of importing medicines without the required permit.

BV.2024.17 (Art. 86 Abs. 1 lit. a i.V.m. Abs. 2 lit. b und Art. 18 Abs. 1 lit. a HMG)

Bank Seizure Upheld in Unlawful Medication Importation Case

Cited as the legal basis for the suspicion of illicit professional importation of medicines for third parties, leading to the rejection of the appeal.

BV.2024.30 (art. 18 LPTh)

Swissmedic Seizure of Unapproved Medications Upheld

Cited as part of the authorization system for operations involving medicinal products, including importation.

C-1924/2019 (Art. 18 Abs. 1 lit. a HMG)

Pharmaceutical Import/Export Permit Fee Dispute

Cited to establish that distinct permits are required for importing medicinal products.

C-1924/2019 (Art. 18 Abs. 1 lit. b HMG)

Pharmaceutical Import/Export Permit Fee Dispute

Cited to establish that distinct permits are required for exporting medicinal products.

C-1924/2019 (Art. 18 Abs. 1 lit. c HMG)

Pharmaceutical Import/Export Permit Fee Dispute

Cited to establish that distinct permits are required for trading medicinal products abroad.

BV.2022.9 (art. 18 LPTh)

Swissmedic Property Seizure Upheld in Unapproved Product Sales Case

Relates to authorization for export, import, foreign trade, and brokerage of medicinal products.

C-2650/2014 (Art. 18 Abs. 1 lit. a und b HMG)

Physician's License Application Denied Due to Unsuitability

These provisions establish the general requirement for a license for importing, exporting, or wholesale trading of medicinal products.

C-3749/2011 (Art. 18 Abs. 1 Bst. c HMG)

Swiss Postal Address for Online Drug Sales Requires Medicine Trading License

This provision forms the legal basis for the prohibition of the appellant's activities, as he engaged in trading medicines from Switzerland without the required permit.

C-2005/2012 (Art. 18 Abs. 1 HMG)

Importation of Unapproved Testosterone Ampoules Justifies Destruction and Fee

This provision requires a permit from the institute for importing medicinal products for commercial distribution or dispensing.

C-6339/2010 (Art. 18 cpv. 1 lett. a LATer)

Itone Eye Drops: Unapproved Medicine Import Banned

Requires authorization for those professionally importing medicines for sale or dispensing.

C-227/2010 (Art. 18 al. 1 let. a LPTh)

Viagra Import Seizure Upheld

Cited regarding the requirement for a professional importer to possess an authorization from Swissmedic.

JAAC 67.93 (Art. 18 Abs. 1 Bst. a HMG)

Pharmaceutical Importation and Formula Magistralis Exemption

Requires an authorization from the Institute for the commercial import of ready-to-use medicinal products for distribution or dispensing in Switzerland.