812.21 HMGLPTHLATER

CH AI generated

Art. 18 Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Mandatory licence

TPA; Chapter 2 Medicinal Products

Open official source Full Act (141 Articles) Machine-readable Markdown (.md)

Legislator summary

AI generated

A licence granted by the Agency is required by any person who professionally: a. imports ready-to-use medicinal products intended for distribution or dispensing; b. exports ready-to-use medicinal products intended for distribution or dispensing; c. trades medicinal products in foreign countries from Switzerland, without their entering Switzerland; d. acts from Switzerland as a broker or agent for medicinal products. {note: Amended by Annex No 2 of the FD of 29 Sept. 2017 (Medicrime Convention), in force since 1 Jan. 2019 ( AS 2018 4771; BBl 2017 3135).} The Federal Council shall specify the requirements for activities under paragraph 1. {note: Amended by Annex No 2 of the FD of 29 Sept. 2017 (Medicrime Convention), in force since 1 Jan. 2019 ( AS 2018 4771; BBl 2017 3135).} It may issue exemptions from the requirement of licence for: a. medical professionals who work across borders; b. international organisations. Goods stored in a customs warehouse or a bonded warehouse shall be considered to be imported. {note: Inserted by Annex No 17 of the Customs Act of 18 March 2005, in force since 1 May 2007 ( AS 2007 1411; BBl 2004 567).} The Federal Council may issue special regulations for goods in transit. If another State requests export certificates and attestations for the importing of medicinal products, the Agency may issue such documents to persons holding an authorisation to export.

Art. 18 TPA · Mandatory licence

A licence granted by the Agency is required by any person who professionally: a. imports ready-to-use medicinal products intended for distribution or dispensing; b. exports ready-to-use medicinal products intended for distribution or dispensing; c. trades medicinal products in foreign countries from Switzerland, without their entering Switzerland; d. acts from Switzerland as a broker or agent for medicinal products.

The Federal Council shall specify the requirements for activities under paragraph 1.

It may issue exemptions from the requirement of licence for: a. medical professionals who work across borders; b. international organisations.

Goods stored in a customs warehouse or a bonded warehouse shall be considered to be imported.

The Federal Council may issue special regulations for goods in transit.

If another State requests export certificates and attestations for the importing of medicinal products, the Agency may issue such documents to persons holding an authorisation to export.

← Art. 17 TPA Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Purpose Art. 19 TPA →

Court Decisions Applying This Provision (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.