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812.21 HMGLPTHLATER CH AI generated

Art. 66 Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - In general

TPA; Chapter 4 Common Provisions on Medicinal Products and Medical Devices
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The Agency and the other authorities entrusted with the enforcement of this Act may within their jurisdiction take all administrative measures necessary to enforce this Act. {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).} In particular they may: {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).} a. raise objections and set an appropriate time period for restoring the state of law; b. suspend or revoke licences and marketing authorisations; c. close down establishments; d. seize, hold in official storage or destroy therapeutic products which endanger health or which do not conform to the regulations of this Act; e. prohibit the distribution, dispensing, import, export and foreign trade from Switzerland of therapeutic products, order their immediate recall from the market, or order the publication of recommendations of conduct to prevent damage; f. seize, hold in official storage, destroy or prohibit the use of illegal advertising media, and publish the prohibition at the expense of the responsible parties; g. temporarily or permanently prohibit the advertising of a specific therapeutic product in the event of serious or repeated infringements of the provisions of this Act, and publish the prohibition at the expense of the responsible parties. They may order therapeutic products from a person under a fictitious name if: a. they suspect that the person is manufacturing, importing or exporting therapeutic products illegally or placing them on the market illegally; and b. previous enquiries have been unsuccessful or further enquiries would otherwise be futile or would be disproportionately difficult. {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 customs authorities shall be entitled to hold back shipments of therapeutic products at the border, in a free port or in a customs warehouse if they suspect that the recipient or sender in Switzerland is in breach of the provisions governing the import, manufacture, placing on the market or export of therapeutic products with the contents of the shipment. {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).} They may call in the enforcement authorities. The latter shall make any further enquiries and take the necessary measures. In particular, they may ask postal service providers for the name and address of the holder of a post office box. In this case, the providers are obliged to provide information. {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 enforcement authorities shall inform the persons concerned at the latest after the completion of the procedure of: a. the order under a fictitious name; b. the request for information and the reason for it. {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).}

Art. 66 TPA · In general

The Agency and the other authorities entrusted with the enforcement of this Act may within their jurisdiction take all administrative measures necessary to enforce this Act.

In particular they may: a. raise objections and set an appropriate time period for restoring the state of law; b. suspend or revoke licences and marketing authorisations; c. close down establishments; d. seize, hold in official storage or destroy therapeutic products which endanger health or which do not conform to the regulations of this Act; e. prohibit the distribution, dispensing, import, export and foreign trade from Switzerland of therapeutic products, order their immediate recall from the market, or order the publication of recommendations of conduct to prevent damage; f. seize, hold in official storage, destroy or prohibit the use of illegal advertising media, and publish the prohibition at the expense of the responsible parties; g. temporarily or permanently prohibit the advertising of a specific therapeutic product in the event of serious or repeated infringements of the provisions of this Act, and publish the prohibition at the expense of the responsible parties.

They may order therapeutic products from a person under a fictitious name if: a. they suspect that the person is manufacturing, importing or exporting therapeutic products illegally or placing them on the market illegally; and b. previous enquiries have been unsuccessful or further enquiries would otherwise be futile or would be disproportionately difficult.

The customs authorities shall be entitled to hold back shipments of therapeutic products at the border, in a free port or in a customs warehouse if they suspect that the recipient or sender in Switzerland is in breach of the provisions governing the import, manufacture, placing on the market or export of therapeutic products with the contents of the shipment.

They may call in the enforcement authorities. The latter shall make any further enquiries and take the necessary measures. In particular, they may ask postal service providers for the name and address of the holder of a post office box. In this case, the providers are obliged to provide information.

The enforcement authorities shall inform the persons concerned at the latest after the completion of the procedure of: a. the order under a fictitious name; b. the request for information and the reason for it.

← Art. 65 TPA Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Purpose Art. 67 TPA →

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Court Decisions Applying This Provision (90)

C-3035/2022 (Art. 66 Abs. 2 Bst. a und f HMG)
Company fined for illegal advertising of migraine medication.
These provisions were cited as the legal basis for the administrative measures ordered by the authority, namely prohibiting further publication and ordering removal from the website.
C-2987/2021 (Art. 66 Abs. 1 und Abs. 2 Bst. a und f HMG)
Magazine's Pharmaceutical Advertising Violated Regulations
These provisions were cited as the legal basis for Swissmedic's authority in market surveillance and the imposition of sanctions.
C-3910/2020 (Art. 66 Abs. 1 HMG)
Spinal Implant Device Recall Upheld Due to Insufficient Clinical Data
Cited as the basis for the Institute's authority to take necessary measures when medical devices do not comply with legal provisions.
C-3910/2020 (Art. 66 Abs. 2 Bst. e HMG)
Spinal Implant Device Recall Upheld Due to Insufficient Clinical Data
Provides the legal basis for prohibiting the placing on the market and recalling products.
C-3201/2022 (Art. 66 al. 1 LPTh)
Imported Medications Destruction and Fees Upheld
Used to justify the destruction of the seized merchandise.
C-3057/2021 (Art. 66 Abs. 1 HMG)
Mootness of Drug Recall Appeal Due to Voluntary Recall
Cited as the legal basis for the authority of the respondent to take necessary administrative measures.
C-3057/2021 (Art. 66 Abs. 2 Bst. e HMG)
Mootness of Drug Recall Appeal Due to Voluntary Recall
Cited as the specific legal basis for the respondent's authority to order product recalls and prohibit distribution.
C-2652/2019 (art. 66 al. 1 LPTh)
Imported Medication Seizure and Fee Upheld Due to Excessive Quantity
Permet à Swissmedic de prendre toutes les mesures administratives nécessaires pour exécuter la loi, y compris la saisie et la destruction de produits thérapeutiques dangereux ou non conformes.
C-2652/2019 (art. 66 al. 2 let. d LPTh)
Imported Medication Seizure and Fee Upheld Due to Excessive Quantity
Spécifie que Swissmedic peut saisir, garder en dépôt ou détruire des produits thérapeutiques dangereux pour la santé ou non conformes aux prescriptions de la loi.
C-5710/2019 (Art. 66 Abs. 2 lit. b HMG)
Company Permit Suspension Upheld Due to Responsible Person's Criminal Charges
This provision grants the authority to suspend or revoke permits and was applied in conjunction with Art. 39 Abs. 3 AMBV for the suspension of the operating permit.
C-5720/2019 (Art. 66 Abs. 2 lit. b HMG)
Pharmaceutical Company's Operating Permit Suspension Upheld Due to Personnel's Criminal Investigation
This provision grants the institute the power to suspend permits, which was applied in conjunction with Art. 39 Abs. 3 AMBV.
C-1168/2018 (Art. 66 al. 1 LPTh)
Recipient Liable for Fees on Illegal Drug Importation Despite Denial
Cited as a legal basis for Swissmedic to take administrative measures, including seizure and destruction of non-compliant therapeutic products.
C-1168/2018 (Art. 66 al. 2 let. d LPTh)
Recipient Liable for Fees on Illegal Drug Importation Despite Denial
Cited as a legal basis for Swissmedic to seize, keep in deposit, or destroy therapeutic products that are dangerous for health or non-compliant.
C-6365/2018 (Art. 66 Abs. 2 lit. b HMG)
Company License Suspension Upheld for Pharmaceutical Trading Violations
Legal basis for suspending or revoking licenses.
BVGE-2019-V-8 (Art. 66 f. HMG)
Unlicensed Activity and Untrustworthiness Justify Wholesale License Denial
Cited in the context of administrative measures for violations of the Heilmittelgesetz.