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Art. 28 Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Licence for wholesale trade
TPA; Chapter 2 Medicinal Products
Art. 28 TPA · Licence for wholesale trade
Any person engaged in the wholesale trade of medicinal products must possess a licence issued by the Agency.
The licence shall be issued if: a. the necessary technical and operational conditions are fulfilled; b. an appropriate system of quality assurance exists.
The licence shall also be issued if the applicant already possesses a manufacturing or import licence for medicinal products.
The competent authority shall verify by inspection that the conditions are fulfilled.
Court Decisions Applying This Provision (4)
C-1924/2019 (Art. 28 Abs. 1 HMG)
Pharmaceutical Import/Export Permit Fee Dispute
Cited to establish that distinct permits are required for wholesale trade of medicinal products.
BVGE-2019-V-8 (Art. 28 Abs. 3 HMG)
Unlicensed Activity and Untrustworthiness Justify Wholesale License Denial
Cited to state that there is no entitlement to a permit-free issuance of a wholesale permit if an import/export permit already exists.
C-2650/2014 (Art. 28 HMG)
Physician's License Application Denied Due to Unsuitability
This provision defines wholesale trade of medicinal products, which is central to the court's determination that the applicant engaged in such trade without a license.
C-1880/2010 (Art. 28 HMG)
Company denied pharmaceutical license due to persistent non-compliance
Cited as the basis for requiring a permit for importing, wholesaling, exporting, and trading pharmaceuticals abroad, contingent on meeting specific requirements.