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812.21 HMGLPTHLATER CH

Art. 68 Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA)

TPA; Chapter 5 Swiss Agency for Therapeutic Products
Open official source Full Act (141 Articles) Machine-readable Markdown (.md)

Art. 68 TPA

The Confederation shall run the Agency with the cooperation of the cantons.

The Agency is an institution under public law with its own legal personality.

It is autonomous in its organisation and management; it may use its funding as it sees fit and shall keep its own accounts.

It may call upon private individuals to perform certain tasks.

It may appoint advisory committees and experts.

← Art. 67b TPA Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Purpose Art. 69 TPA →

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Court Decisions Applying This Provision (5)

C-4944/2022 (Art. 31, 32 und 33 Bst. e VGG; Art. 68 Abs. 2 des Bundesgesetzes über Arzneimittel und Medizinprodukte (Heilmittelgesetz, HMG))
Company's Advertising Case Deemed Partially Moot, Administrative Fee Upheld
Establishes the jurisdiction of the Federal Administrative Court for appeals concerning medicinal products.
C-2532/2013 (Art. 68 Abs. 2 HMG)
Biowaiver Denial Upheld Due to Insufficient Data and Quality Control Deficiencies
This provision classifies Swissmedic as a public law institution of the Confederation, establishing its status as a federal authority.
C-6679/2011 (Art. 68 Abs. 2 HMG)
Imported Steroids and Administrative Fees
The court cited this provision to classify the Institute as a public law institution of the Confederation.
C-7594/2008 (Art. 68 cpv. 5 LATer)
Marketing Authorization Appeal for Carbon Dioxide Local Anesthetic
Cited to explain that the MEC is an advisory commission appointed by Swissmedic.
JAAC 68.169 (Art. 68 al. 5 LPTh)
Access to External Expert Reports vs. Anonymity of Experts in Drug Approval
This provision allows the Swiss Agency for Therapeutic Products to obtain external expertise, which, when submitted as expert reports, falls under the right of inspection.