Therapeutic Products Act (TPA)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Art. 86 Felonies and misdemeanours
1 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 42a 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 pursua
Art. 86 — Amended by No I of the FA of 18 March 2016 with the exception of paragraph 1 letter h in force since 1 Jan. 2020 (AS 2017 2745, 2018 3575, 2019 1393; BBl 2013 1). Para. 1 let. c — 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). Para. 1 let. d — Amended by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1). Para. 1 let. i — Inserted by No I of t
Art. 87 Other offences
1 A fine not exceeding 50,000 Swiss francs shall be imposed on any person who wilfully: a. manufactures, places on the market, imports or exports, or trades in a foreign country therapeutic products or excipients which do not conform to the requirements stated in the Pharmacopoeia; b. contravenes the regulations on the advertising of medicinal products; c. violates an obligation under this Act to notify, register or disclose; d. violates the obligations to label, keep records, to archive or to cooperate; e. violates the obligation of secrecy, unless there is a violation of Article 162, 320 or 321 of the Criminal Code; f. commits an offence referred to in Article 86 paragraph 1 letters a–g where the therapeutic product is intended exclusively for personal use or involves an over-the-counter medicinal product or a Class I medical device in accordance with Annex IX to Directive 93/42/EEC concerning medical devices; [tab] g.fails to comply with a ruling against him or her which refers to t
Art. 87 — 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). Para. 1 — 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). Para. 1 let. c — Amended by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1). Para. 1 let. e — SR 311.0 Para. 1 let. f — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl
Art. 88 Application of other criminal provisions
The criminal provisions of the Federal Act of 6 October 1995 on Technical Barriers to Trade apply to forgeries, to false certificates, to obtaining a false certificate by fraudulent means, to the use of false or inaccurate attestations, to the unauthorised issuing of declarations of conformity, to the unauthorised attachment and use of marks of conformity, and to securing unlawful financial advantages under Articles 23 to 29 of the aforementioned Act.
SR 946.51
Art. 89 Offences committed within a company
1 If a fine not exceeding 20,000 Swiss francs may be imposed and if the investigation of persons suspected of an offence under Article 6 of the Federal Act of 22 March 1974 on Administrative Criminal Law (ACLA) would result in investigative measures which would be disproportionate to the penalty imposed, the company (Art. 7 ACLA) may be ordered to pay the fine instead of prosecuting such persons. 2 Articles 6 and 7 of the ACLA apply to criminal proceedings carried out by cantonal authorities.
Art. 89 — 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). Para. 1 — SR 313.0
Art. 90 Prosecution
1 Prosecutions conducted at federal level shall be conducted by the Agency and by the FOPH in accordance with the ACLA. If the import, transit and export of therapeutic products also involves a violation of the Customs Act of 18 March 2005 or the Value Added Tax Act of 12 June 2009, the FOCBS shall prosecute and judge the offences. 2 If two or more federal authorities are competent to prosecute under this or another federal act, they may agree to bring the prosecution under one authority, provided the facts of the case are the same or are closely related. 3 Criminal proceedings in the sphere of enforcement of the cantons fall within their jurisdiction. The Agency may exercise the rights of a private claimant in the proceedings. The cantonal prosecutor shall inform the Agency of the initiation of preliminary proceedings. 4 If both the Confederation and the cantons have jurisdiction over a criminal matter that falls within the scope of application of this Act, the competent authorities m
Art. 90 — Amended by Annex No 2 of the FD of 29 Sept. 2017 (Medicrime Convention), in force since 1 Jan. 2019 (AS 2018 4771; BBl 2017 3135). Para. 1 — SR 313.0 Para. 1 — SR 631.0 Para. 1 — SR 641.20 Para. 1 — Name in accordance with No I 30 of the O of 12 June 2020 on the Amendment of Legislation as a consequence of the Change to the Name of the Federal Customs Administration as part of its further Development, in force since 1 Jan. 2022 (AS 2020 2743). This change has been made throughout the t
Art. 90a Covert surveillance measures
1 The Agency or the FOCBS may order covert surveillance measures pursuant to Articles 282 and 283 or 298a–298d CrimPC. 2 Where a measure under paragraph 1 lasts for more than 30 days, approval is required from the director of the ordering authority. 3 At the latest following conclusion of the investigation, the ordering authority shall notify the person concerned of the reason, form and duration of the covert surveillance. 4 Where covert surveillance measures pursuant to Articles 269–281 or 284–298 CrimPC are considered necessary, the Agency or the FOCBS shall notify the Office of the Attorney General of Switzerland (OAG) immediately. 5 In cases under paragraph 4, the Agency or the FOCBS with the agreement of the OAG shall apply to the compulsory measures court. If the court approves the measures, the OAG shall take over the proceedings in accordance with the CrimPC.
Art. 90a — Inserted by Annex No 2 of the FD of 29 Sept. 2017 (Medicrime Convention), in force since 1 Jan. 2019 (AS 2018 4771; BBl 2017 3135). Para. 1 — SR 312.0
Art. 90b Offences committed abroad and complex proceedings
Where proceedings conducted by the Agency or the FOCBS relate primarily to offences committed abroad or if the proceedings prove to be so complex or time-consuming that they cannot be concluded at all or within a reasonable time using the resources available to the Agency or the FOCBS, the Agency or the FOCBS may request the OAG to take over the proceedings. The OAG shall conduct the proceedings in accordance with the CrimPC.
Art. 90b — Inserted by Annex No 2 of the FD of 29 Sept. 2017 (Medicrime Convention), in force since 1 Jan. 2019 (AS 2018 4771; BBl 2017 3135). SR 312.0
Art. 90c Involvement of third parties
The Agency and the FOPH may instruct independent specialists to secure, save, analyse and retain data seized in the course of administrative criminal proceedings. When acting on behalf of the Agency or the FOPH, such specialists shall be subject to the obligations that apply to employees of the Agency or the Federal Administration. The compensation paid to the specialists is deemed to be cash outlays in terms of Article 94 paragraph 1 ACLA.
Art. 90c — Inserted by Annex No 2 of the FD of 29 Sept. 2017 (Medicrime Convention), in force since 1 Jan. 2019 (AS 2018 4771; BBl 2017 3135). SR 313.0