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Art. 84 Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - ...

TPA; Chapter 7 Administrative Procedure and Rights of Appeal
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Unless this Act provides otherwise, the administrative procedure and rights of appeal are regulated by the Federal Act of 20 December 1968 {note: SR 172.021} on Administrative Procedure and by the Federal Administrative Court Act of 17 June 2005 {note: SR 173.32} , and the Federal Supreme Court Act of 17 June 2005 {note: SR 173.110} . {note: Amended by Annex No 89 of the Federal Administrative Court Act of 17 June 2005, in force since 1 Jan. 2007 ( AS 2006 2197 1069; BBl 2001 4202).} In administrative proceedings involving the Agency, the consent of assessors and scientific advisors is required before their names may be disclosed to the parties. {note: Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 ( AS 2017 2745, 2018 3575; BBl 2013 1).} The Agency is entitled to exercise the rights of appeal under cantonal and federal law against rulings of the cantonal authorities and the Federal Administrative Court in application of this Act and its implementing provisions. {note: Amended by No 1 12 of the Federal Assembly O of 20 Dec. 2006 on the Amendment of Legislation in accordance with the provisions of the Federal Supreme Court Act and the Federal Administrative Court Act, in force since 1 Jan. 2007 ( AS 2006 5599; BBl 2006 7759).} It is also entitled to appeal against decisions made by the highest cantonal authorities in application of the Human Research Act of 30 September 2011 {note: SR 810.30} (Art. 89 para. 2 let. a of the Federal Supreme Court Act of 17 June 2005). {note: Inserted by Annex No 6 of the Human Research Act of 30 Sept. 2011, in force since 1 Jan. 2014 ( AS 2013 3215; BBl 2009 8045).}

Art. 84 TPA · ...

Unless this Act provides otherwise, the administrative procedure and rights of appeal are regulated by the Federal Act of 20 December 1968 on Administrative Procedure and by the Federal Administrative Court Act of 17 June 2005 , and the Federal Supreme Court Act of 17 June 2005 .

In administrative proceedings involving the Agency, the consent of assessors and scientific advisors is required before their names may be disclosed to the parties.

The Agency is entitled to exercise the rights of appeal under cantonal and federal law against rulings of the cantonal authorities and the Federal Administrative Court in application of this Act and its implementing provisions.

It is also entitled to appeal against decisions made by the highest cantonal authorities in application of the Human Research Act of 30 September 2011 (Art. 89 para. 2 let. a of the Federal Supreme Court Act of 17 June 2005).

← Art. 83 TPA Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Purpose Art. 85 TPA →

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Court Decisions Applying This Provision (11)

C-2650/2014 (Art. 84 Abs. 1 HMG)
Physician's License Application Denied Due to Unsuitability
This provision, in conjunction with another, establishes the appeal route to the Federal Administrative Court.
C-6960/2013 (Art. 84 Abs. 1 HMG)
Regulatory Agency Reclassifies Plant-Derived Drugs
Cited as the legal basis for appealing decisions from Swissmedic to the Federal Administrative Court.
C-2532/2013 (Art. 84 Abs. 1 HMG)
Biowaiver Denial Upheld Due to Insufficient Data and Quality Control Deficiencies
This provision, in conjunction with Art. 49 VwVG, defines the grounds for appeal in drug approval matters.
C-4776/2010 (Art. 84 Abs. 1 HMG)
E.________-_______ Generic Drug Marketing Authorization Rejection Upheld
Cited in conjunction with Art. 49 VwVG, outlining the grounds on which an appealed decision can be challenged, including violations of federal law or incorrect factual findings.
C-2005/2012 (Art. 84 Abs. 1 HMG)
Importation of Unapproved Testosterone Ampoules Justifies Destruction and Fee
This provision specifies the grounds for appealing decisions related to medicinal products.
C-6679/2011 (Art. 84 Abs. 1 HMG in Verbindung mit Art. 49 VwVG)
Imported Steroids and Administrative Fees
The court cited these provisions to outline the grounds for appeal against a decision of the Institute.
C-6339/2010 (Art. 84 LATer)
Itone Eye Drops: Unapproved Medicine Import Banned
Allows appeals against decisions of Swissmedic to be brought before the Federal Administrative Court.
C-227/2010 (Art. 84 al. 1 LPTh)
Viagra Import Seizure Upheld
Cited to confirm the Federal Administrative Court's jurisdiction over decisions made by Swissmedic.
C-7701/2007 (art. 84 LPTh)
Pharmaceutical Laboratory v. Swissmedic
States that administrative procedure and legal remedies are governed by specific federal laws, including the PA and LTAF.
C-2266/2006 (Art. 84 Abs. 1 HMG)
Medicinal Product Sales Fee Applies to All Distributors and Product Types
This provision outlines the grounds for appeal against a decision of the Institute.
JAAC 66.102 (Art. 84 Abs. 1 HMG)
Pharmaceutical Advertising Restrictions: Balancing Public Health and Economic Freedom
This provision is cited in conjunction with Art. 55 VwVG to establish the general suspensive effect of appeals in matters regulated by the HMG.