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Art. 86 Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Felonies and misdemeanours

TPA; Chapter 8 Criminal Provisions
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Any person who wilfully: a. manufactures, places on the market, uses, prescribes, imports or exports, or trades in a foreign country medicinal products without the required marketing authorisation or licence, or contrary to the due diligence requirements stipulated in Articles 3, 7, 21, 22, 26, 29 and 42; b. uses antibiotic substances contrary to the restrictions or prohibitions laid down in Article 42 a paragraph 2; c. {note: Amended by No I of the FA of 29 Sept. 2023 (Amendments to the Provisions on Blood Donation), in force since 1 Jan. 2025 ( AS 2024 534; BBl 2022 2348, 3169).} violates, when handling blood or blood products, the ban on payment for blood donations, on the fitness of the donor to give blood, on the obligation to test, on the obligation to record or archive or due diligence requirements in accordance with Article 37, or fails to take the necessary protections and safeguards; d. {note: Amended by No I of the FA of 22 March 2019, in force since 26 May 2021 ( AS 2020 2961; BBl 2019 1).} places on the market, exports or uses medical devices which do not satisfy the requirements of this Act, or uses medical devices without the necessary technical or operational requirements being fulfilled; e. violates the due diligence requirement pursuant to Article 48 or the obligation to maintain medical devices; f. performs a clinical trial on a human being which does not satisfy the requirements of this Act, or allows the same to be performed; g. unlawfully copies, falsifies or incorrectly names medicinal products or medical devices, or places on the market, uses, imports or exports, or trades in a foreign country, unlawfully copied, falsified or incorrectly named medicinal products or medical devices; h. violates a prohibition under Article 55. i. {note: Inserted by No I of the FA of 22 March 2019, in force since 26 May 2021 ( AS 2020 2961; BBl 2019 1).} places on the market products which do not meet the requirements specified by the Federal Council in accordance with Article 2 a; j. {note: Inserted by No I of the FA of 22 March 2019, in force since 26 May 2021 ( AS 2020 2961; BBl 2019 1).} offers, grants, demands or accepts a financial gain or other advantage for human tissue or human cells or uses such tissues or cells for the manufacture of products as specified in Article 2 a; k. {note: Inserted by No I of the FA of 22 March 2019, in force since 26 May 2021 ( AS 2020 2961; BBl 2019 1).} removes or uses human tissue or human cells for the manufacture of products as specified in Article 2 a in the absence of consent for removal. [tab] shall be liable to a custodial sentence not exceeding three years or to a monetary penalty. A ny person who, in the cases referred to in paragraph 1 letters a–g and i– k : a. knows or must assume that the violation specifically endangers human health; b. achieves a high turnover or makes substantial profits through commercial activity. shall be liable to a custodial sentence not exceeding ten years or a monetary penalty. {note: Amended by No I 30 of the FA of 17. Dec. 2021 on the Harmonisation of Sentencing Policy, in force since 1 July 2023 ( AS 2023 259; BBl 2018 2827).} Any person acting as a member of a gang involved in the illicit trade in therapeutic products in the cases referred to in paragraph 1 letters a, c, d, f, g and i–k shall be liable to a custodial sentence not exceeding ten years or to a monetary penalty. {note: Amended by No I 30 of the FA of 17. Dec. 2021 on the Harmonisation of Sentencing Policy, in force since 1 July 2023 ( AS 2023 259; BBl 2018 2827).} If the person concerned acts through negligence, he or she shall be liable to a monetary penalty. In minor cases, a fine may be imposed. {note: Amended by No I of the FA of 22 March 2019, in force since 26 May 2021 ( AS 2020 2961; BBl 2019 1).}

Art. 86 TPA · Felonies and misdemeanours

Any person who wilfully: a. manufactures, places on the market, uses, prescribes, imports or exports, or trades in a foreign country medicinal products without the required marketing authorisation or licence, or contrary to the due diligence requirements stipulated in Articles 3, 7, 21, 22, 26, 29 and 42; b. uses antibiotic substances contrary to the restrictions or prohibitions laid down in Article 42 a paragraph 2; c. violates, when handling blood or blood products, the ban on payment for blood donations, on the fitness of the donor to give blood, on the obligation to test, on the obligation to record or archive or due diligence requirements in accordance with Article 37, or fails to take the necessary protections and safeguards; d. places on the market, exports or uses medical devices which do not satisfy the requirements of this Act, or uses medical devices without the necessary technical or operational requirements being fulfilled; e. violates the due diligence requirement pursuant to Article 48 or the obligation to maintain medical devices; f. performs a clinical trial on a human being which does not satisfy the requirements of this Act, or allows the same to be performed; g. unlawfully copies, falsifies or incorrectly names medicinal products or medical devices, or places on the market, uses, imports or exports, or trades in a foreign country, unlawfully copied, falsified or incorrectly named medicinal products or medical devices; h. violates a prohibition under Article 55. i. places on the market products which do not meet the requirements specified by the Federal Council in accordance with Article 2 a; j. offers, grants, demands or accepts a financial gain or other advantage for human tissue or human cells or uses such tissues or cells for the manufacture of products as specified in Article 2 a; k. removes or uses human tissue or human cells for the manufacture of products as specified in Article 2 a in the absence of consent for removal. [tab] shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.

A ny person who, in the cases referred to in paragraph 1 letters a–g and i– k : a. knows or must assume that the violation specifically endangers human health; b. achieves a high turnover or makes substantial profits through commercial activity. shall be liable to a custodial sentence not exceeding ten years or a monetary penalty.

Any person acting as a member of a gang involved in the illicit trade in therapeutic products in the cases referred to in paragraph 1 letters a, c, d, f, g and i–k shall be liable to a custodial sentence not exceeding ten years or to a monetary penalty.

If the person concerned acts through negligence, he or she shall be liable to a monetary penalty. In minor cases, a fine may be imposed.

← Art. 85 TPA Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Purpose Art. 87 TPA →

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Court Decisions Applying This Provision (67)

BE.2024.13 (Art. 86 Abs. 1 lit. a HMG)
Unsealing of Documents in Unlawful Medicinal Product Importation Case
Used as the legal basis for the suspicion of unauthorized professional import of medicines for third parties.
BV.2024.17 (Art. 86 Abs. 1 lit. a i.V.m. Abs. 2 lit. b und Art. 18 Abs. 1 lit. a HMG)
Bank Seizure Upheld in Unlawful Medication Importation Case
Cited as the legal basis for the suspicion of illicit professional importation of medicines for third parties, leading to the rejection of the appeal.
BV.2024.30 (art. 86 al. 1 let. a LPTh)
Swissmedic Seizure of Unapproved Medications Upheld
Cited as the suspected offense leading to the administrative criminal proceeding and the sequestration.
P/9262/2021 · ge (art. 86 al. 1 let. a LPTh)
Prosecutor v. Defendants (Encouraging Prostitution Appeal)
Cited in the dispositive (within the confirmed first instance judgment) for the conviction/acquittal concerning infraction to the Federal Act on Therapeutic Products (aLPTH) for different periods.
SB240314 · zh (Art. 87 Abs. 1 lit. f HMG in Verbindung mit Art. 86 Abs. 1 lit. a HMG)
Appeal Regarding Drug Trafficking Conviction, Sentencing, and Fines
The court confirmed the conviction for violating the Medicinal Products Act (though it waived punishment for this offense in the final order).
501 2023 25 · fr (art. 86 al. 1 let. a LPTh)
Medical Secretary Acquitted of Swindling Doctor, Upheld on Attempted Fraud and Forgery
Used in order 2 to confirm the appellant's conviction for infringement of the Federal Act on Therapeutic Products.
SK 2024 98 · be (art. 86 al. 1 let. a LPTh)
Reclassification of Narcotics Offense in Sentence Review
Cited as the legal basis for the conviction under the Therapeutic Products Act in the previously confirmed judgment (B.III.4).
SB230204 · zh (Art. 86 Abs. 1 lit. a HMG)
Drug Violations, Unlawful Residency, and Sentence Execution Appeal
The court used this article to find the defendant guilty of violating the Medicinal Products Act (HMG).
2023.12.19.sr.1 · bl (Art. 86 Abs. 1 lit. b HMG)
Narcotics Act Case Discontinued Due to Procedural Limitations
Cited in the first instance judgment regarding the conviction for violation of the HMG.
P/18780/2021 · ge (art. 86 al. 1 let. a LPTh)
Appellant Overturned on Narcotics Conviction Due to Insufficient Evidence, Compensation Denied
The court acquitted the appellant of the charge under this provision, which was the main ground for the verdict.
SK 2022 432 · be (art. 86 al. 1 let. a LPTh)
Criminal Conviction Appeal Involving Sexual Offense, Robbery, and Drug Law Violations with Procedural Mitigation and Expulsion Order
Cited in section III.3 concerning the conviction for Infraction à l’art. 86 al. 1 let. a LPTh for sales after Jan 1, 2019.
P/5431/2021 · ge (art. 86 al. 1 let. a LPTh)
International Drug Trafficking and Associated Offenses
Basis for the conviction of X. and Y. for violation of the Federal Act on Medicines and Medical Devices.
SK 2021 303 · be (Art. 86 Abs. 1 Bst. a HMG)
Natural Health Practitioner Convicted for Document Forgery and Unlicensed Practice under Therapeutic Products Act
The accused was convicted for illegal manufacturing and distribution of medicinal products (Widerhandlung gegen das Heilmittelgesetz).
BV.2022.9 (art. 86 al. 1 let. a LPTh)
Swissmedic Property Seizure Upheld in Unapproved Product Sales Case
The suspected violation of this article is the basis for the administrative criminal procedure and the sequestration.
Jug.2022.408 · vd (art. 86 al. 1 let. a LPTh)
Regulatory Body v. Veterinarians (Unauthorized Drug Mixture)
This provision is the main ground for declaring the defendants guilty of a felony under the Law on Therapeutic Products, as applied in the operative part (II. I and II.).