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812.21 HMGLPTHLATER CH AI generated

Art. 65 Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA)

TPA; Chapter 4 Common Provisions on Medicinal Products and Medical Devices
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The Agency and other authorities entrusted with enforcing this Act shall levy fees for the licences, controls and the services that they provide. Furthermore, the Agency may levy fees for the receipt of notifications. It shall levy a supervision fee on the marketing authorisation holders for the financing of costs it incurs in the field of medicinal products which are not covered by fees in accordance with paragraph 1 or by payments from the Confederation in accordance with Article 77 paragraph 2a. {note: Amended 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 supervision fee shall be levied on the ex-factory price of the authorised ready-to-use medicinal products sold in Switzerland. The maximum fee is 1.5 per cent of the ex-factory price. The income from the fee may not exceed a total of 1 per cent of the proceeds from all medicinal products sold in the respective levy year. {note: Amended 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 Federal Council shall regulate the details of the supervision fee, in particular the fee rate applicable to the individual price categories. {note: Amended 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 Council shall set its fees in accordance with paragraph 1 in the Agency’s Fees Ordinance. The Fees Ordinance shall be submitted to the Federal Council for approval. {note: Amended 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 Federal Council may, under the strategic objectives, request that the Agency relinquish all or part of the fees for certain licences, provisions of service or controls. {note: Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 ( AS 2017 2745, 2018 3575; BBl 2013 1).}

Art. 65 TPA

The Agency and other authorities entrusted with enforcing this Act shall levy fees for the licences, controls and the services that they provide. Furthermore, the Agency may levy fees for the receipt of notifications.

It shall levy a supervision fee on the marketing authorisation holders for the financing of costs it incurs in the field of medicinal products which are not covered by fees in accordance with paragraph 1 or by payments from the Confederation in accordance with Article 77 paragraph 2a.

The supervision fee shall be levied on the ex-factory price of the authorised ready-to-use medicinal products sold in Switzerland. The maximum fee is 1.5 per cent of the ex-factory price. The income from the fee may not exceed a total of 1 per cent of the proceeds from all medicinal products sold in the respective levy year.

The Federal Council shall regulate the details of the supervision fee, in particular the fee rate applicable to the individual price categories.

The Agency Council shall set its fees in accordance with paragraph 1 in the Agency’s Fees Ordinance. The Fees Ordinance shall be submitted to the Federal Council for approval.

The Federal Council may, under the strategic objectives, request that the Agency relinquish all or part of the fees for certain licences, provisions of service or controls.

← Art. 64g TPA Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Purpose Art. 66 TPA →

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Court Decisions Applying This Provision (43)

C-3201/2022 (Art. 65 al. 1 LPTH)
Imported Medications Destruction and Fees Upheld
Used to hold the appellant liable for procedural fees.
C-4944/2022 (Art. 65 Abs. 1 Satz 1 HMG)
Company's Advertising Case Deemed Partially Moot, Administrative Fee Upheld
Grants Swissmedic the authority to charge fees for its services, including controls and permits.
C-4738/2019 (Art. 65 Abs. 1 Satz 1 HMG)
Pharmaceutical Company v. Drug Authority: Reclassification and Fee Dispute
Cited as the legal basis for Swissmedic to charge fees for its services.
C-1924/2019 (Art. 65 Abs. 1 HMG)
Pharmaceutical Import/Export Permit Fee Dispute
Cited as the legal basis for levying fees for permits, controls, and services by Swissmedic.
C-1924/2019 (Art. 65 Abs. 5 HMG)
Pharmaceutical Import/Export Permit Fee Dispute
Cited as the legal basis for the delegation of fee determination to the ordinance level.
C-2652/2019 (art. 65 al. 1 LPTh)
Imported Medication Seizure and Fee Upheld Due to Excessive Quantity
Dispose que Swissmedic et les autres autorités perçoivent des émoluments pour les autorisations, contrôles et prestations de service.
C-5010/2019 (Art. 65 Abs. 1 Satz 1 HMG)
Medication Reclassification Upheld Due to Safety Concerns
This provision establishes the legal basis for Swissmedic to charge fees for its services.
C-5010/2019 (Art. 65 Abs. 5 HMG)
Medication Reclassification Upheld Due to Safety Concerns
This provision relates to the approval of Swissmedic's fee regulations by the Federal Council.
C-5710/2019 (Art. 65 Abs. 1 Satz 1 HMG)
Company Permit Suspension Upheld Due to Responsible Person's Criminal Charges
This provision establishes the legal basis for Swissmedic to charge fees for its services, including permits and controls.
C-5720/2019 (Art. 65 Abs. 1 Satz 1 HMG)
Pharmaceutical Company's Operating Permit Suspension Upheld Due to Personnel's Criminal Investigation
This provision is the legal basis for the levying of fees by the institute for its services.
C-5006/2019 (Art. 65 Abs. 1 Satz 1 HMG)
Medication Reclassification and Administrative Fees Upheld
The legal basis for Swissmedic to charge fees for its services, including the reclassification of medicinal products.
C-1168/2018 (Art. 65 al. 1 LPTh)
Recipient Liable for Fees on Illegal Drug Importation Despite Denial
States that Swissmedic and other authorities may charge fees for authorizations, controls, and services provided under the LPTh.
C-1748/2014 (Art. 65 cpv. 1 LATer)
Graviola Leaf Powder: Medicinal Product or Food Supplement
Basis for the imposition of fees by Swissmedic for its services.
C-3297/2014 (art. 65 al. 1 LPTh)
Imported Coffee Contains Banned Substance, Destined for Destruction
Cited as the basis for Swissmedic levying fees for authorizations, controls, and services.
C-5515/2011 (Art. 65 Abs. 1 HMG)
Swissmedic Fee for Domicile Change Upheld
Basis for the Swissmedic institute to levy fees for its services.