812.21 HMGLPTHLATER

CH

Art. 20 Legge federale del 15 dicembre 2000 sui medicamenti e i dispositivi medici (LATer) - Disposizioni speciali relative all’importazione

LATer; Capitolo 2: Medicamenti

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Art. 20 LATer · Disposizioni speciali relative all’importazione

Possono essere importati i medicamenti omologati e quelli non soggetti all’obbligo di omologazione.

Il Consiglio federale può autorizzare l’importazione, in piccole quantità, di medicamenti non omologati, pronti per l’uso, da parte di: a. persone singole per il consumo proprio; b. operatori sanitari.

Il Consiglio federale può autorizzare le persone di cui all’articolo 25 capoverso 1 lettere b e c a importare, in piccole quantità e nei limiti della loro competenza in materia di dispensazione di medicamenti, medicamenti non omologati, pronti per l’uso e non soggetti a prescrizione se è fornita la prova che non è omologato alcun medicamento alternativo equivalente.

Può: a. prescrivere che l’importazione di medicamenti che necessitano di un particolare controllo per la protezione della salute deve essere autorizzata singolarmente dall’Istituto; b. limitare o vietare l’importazione di determinati medicamenti se risulta dalle circostanze che essi possono essere destinati a scopi illegali o a un uso abusivo.

L’Istituto allestisce un elenco dei medicamenti soggetti a una limitazione o a un divieto di importazione.

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Decisioni giudiziarie che applicano questa disposizione (34)

UE230315 · zh (Art. 20 Abs. 2 lit. a HMG)

Importation of Controlled Substance for Medical Use as "Particularly Light Case"

Cited in the reasoning to determine that the quantity imported exceeded the limit for the exception regarding the introduction of non-approved medicines for private use.

C-2652/2019 (art. 20 al. 2 let. a LPTh)

Imported Medication Seizure and Fee Upheld Due to Excessive Quantity

Autorise le Conseil fédéral à permettre l'importation, en petites quantités, de médicaments prêts à l'emploi et non autorisés à être mis sur le marché par les particuliers pour leur consommation personnelle.

C-1168/2018 (Art. 20 al. 2 let. a LPTh)

Recipient Liable for Fees on Illegal Drug Importation Despite Denial

Mentions the possibility for the Federal Council to authorize the import of small quantities of unauthorized ready-to-use medicinal products for personal use, which is also reflected in Art. 36 al. 1 aOAMéd.

C-1748/2014 (Art. 20 cpv. 1 LATer)

Graviola Leaf Powder: Medicinal Product or Food Supplement

Rule stating that only authorized or non-authorized medicines are allowed to be imported, which is the basis for prohibiting the import of the product in question.

C-1351/2013 (art. 20 al. 2 LPTh)

Confiscation of Imported Growth Hormones Upheld

Cited in relation to the import of non-authorized medicines for personal use, but deemed secondary to the LESp when a product is listed as a doping product.

C-5098/2013 (Art. 20 Abs. 1 HMG)

United States v. Shi

Used to establish that the import of the medicinal products was prohibited.

C-3182/2011 (Art. 20 Abs. 1 HMG)

Destruction of Excessive Unapproved Erectile Dysfunction Medication Upheld

This provision establishes a general prohibition on importing medicinal products that are subject to approval but not yet approved, forming the basis for the illegality of the attempted import.

C-2005/2012 (Art. 20 Abs. 1 HMG)

Importation of Unapproved Testosterone Ampoules Justifies Destruction and Fee

This provision stipulates that medicines can only be imported if they are approved in Switzerland or are not subject to approval.

C-5189/2012 (Art. 20 Abs. 1 HMG)

Imported Medication Destruction Upheld

Cited to establish that medicinal products may only be imported if they are approved in Switzerland.

C-5189/2012 (Art. 20 Abs. 2 HMG)

Imported Medication Destruction Upheld

Cited in conjunction with Art. 6 Abs. 1 AMBV to allow the import of non-approved medicinal products in small quantities for personal use.

C-6679/2011 (Art. 20 Abs. 1 HMG)

Imported Steroids and Administrative Fees

The court cited this provision to establish that medicinal products may only be imported if they are approved or not subject to approval in Switzerland, and to note that the attempted import was unlawful.

C-6679/2011 (Art. 20 Abs. 2 HMG)

Imported Steroids and Administrative Fees

The court cited this provision to refer to the exception for the import of medicinal products by individuals in small quantities for personal use.

C-8707/2010 (Art. 20 Abs. 1 HMG)

Importation of Non-Approved Medication Prohibited in Switzerland

Prohibits the import of medicinal products.

C-8707/2010 (Art. 20 Abs. 2 HMG in Verbindung mit Art. 36 Abs. 1 der Verordnung vom 17. Oktober 2001 über die Bewilligungen im Arzneimittelbereich (AMBV, SR 812.212.1))

Importation of Non-Approved Medication Prohibited in Switzerland

Provides an exception to the import ban for small quantities of medicinal products for personal use.

C-2163/2011 (art. 20 al. 1 LPTh)

Recipient Liable for Fees After Court Upholds Medication Destruction Due to Prior Unauthorized Orders

Cited as the general rule for importing authorized medications.