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.
Section 1 Legal Form and Position
Art. 68
1 The Confederation shall run the Agency with the cooperation of the cantons. 2 The Agency is an institution under public law with its own legal personality. 3 It is autonomous in its organisation and management; it may use its funding as it sees fit and shall keep its own accounts. 4 It may call upon private individuals to perform certain tasks. 5 It may appoint advisory committees and experts.
Section 2 Tasks and Strategic Objectives
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. 69 Tasks
1 The Agency shall accomplish the tasks assigned to it under this Act and other federal acts. 1bis The Federal Council may, against payment, delegate other tasks to the Agency which are closely related to the tasks assigned to it by law and which do not impair its performance. 2 The Agency may, in return for payment, provide services to other authorities and international organisations within the scope of its tasks under this Act, provided that such services do not jeopardise the independence of the Agency. 3 The Federal Council may ask the Agency to participate in the drafting of legislation in the therapeutic products sector. 4 The Agency is the national central and contact point pursuant to Articles 17 paragraph 3 and 22 paragraph 2 of the Council of Europe Convention of 28 October 2011 on the counterfeiting of medical products and similar crimes involving threats to public health. It shall maintain contacts with the designated contact points in other countries.
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. 1bis — 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). Para. 2 — 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. 4 — SR 0.812.41 Para. 4 — Inserted by Annex No 2 of the FD of 29 Sept. 2017 (Medicrime Convention), in force since 1 Jan. 2019 (AS
Art. 70 Strategic objectives
1 The Federal Council shall approve the Agency’s strategic objectives for a period of four years at the recommendation of the Agency Council. 2 Adjustments which become necessary on the basis of the annual review by the Agency Council shall be submitted to the Federal Council for review.
Art. 70 — 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).
Section 3 Governing Bodies and Responsibilities
Art. 71 Governing bodies
1 The governing bodies of the Agency are: a. the Agency Council; b. the Management Board; c. the auditor. 2 No person may belong to more than one of these bodies. 3 The Federal Council may remove one or more members of the Agency Council for good cause.
Art. 71 — 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. 71a Disclosure of the vested interests of the members of the Agency Council
1 The members of the Agency Council shall disclose their vested interests to the Federal Council prior to their election. 2 Any person who refuses to disclose their vested interests shall not be eligible for election as a member. 3 The members of the Agency Council shall immediately notify the Federal Department of Home Affairs of any change in their vested interests during their term of office. 4 The Agency shall update the register and publish the vested interests. 5 Professional secrecy within the meaning of the Criminal Code shall remain reserved. 6 A member of the Agency Council may be removed if they have not fully disclosed their vested interested at the time of the election or if they have not reported changes in their vested interests during their term of office, and if they fail to do so even after being requested to do so by the Federal Office of Home Affairs.
Art. 71a — 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). Para. 5 — SR 311.0
Art. 72 Composition and election of the Agency Council
1 The Agency Council shall comprise a maximum of seven members. 2 On the basis of a profile of requirements, the Federal Council shall elect the members of the Agency Council and appoint one of these members as chairperson. The cantons have the right to propose three members. 3 The election shall be for a term of four years. Re-election is possible for two further terms of office.
Art. 72 — 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. 72a Function and duties of the Agency Council
1 The Agency Council is the strategic body of the Agency and safeguards its interests. It has the following duties: a. It draws up the Agency’s strategic objectives, submits them to the Federal Council for approval and reviews them annually. b. It submits an annual report to the Federal Council on the achievement of the strategic objectives. It submits to the Federal Council the report of the Swiss Federal Audit Office on an audit of the Agency as part of financial supervision. c. It proposes to the Federal Council the amount of compensation to be paid by the Confederation for services rendered pursuant to Article 69. d. It issues the regulations of the organisation of the Agency. e. It issues is own rules of procedure and shall in particular lay down the rules on recusal. f. It prepares and approves a business report for each financial year and submits it to the Federal Council for approval. At the same time, it submits a request to the Federal Council for discharge and for the approp
Art. 72a — 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. 73 Management Board
1 The Management Board is the operative body of the Agency. It is headed by an executive director. 2 The Management Board has the following duties: a. to conduct business; b. to issue administrative orders as provided for in the regulations of the organisation; c. to prepare the basis for the decisions of the Agency Council and report to it regularly and without delay in the event of special incidents; d. to represent the Agency in contacts with the outside world; e. to issue the business plan and the budget and submit the same to the Agency Council for approval; f. to decide on establishment, amendment and termination of the employment relationship of Agency staff; the foregoing is without prejudice to Article 72a paragraph 1 letter h; g. to carry out the tasks not assigned to any other Agency body.
Art. 73 — 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. 74 Review body
1 The Federal Council appoints the review body for a period of four years. It may be re-appointed for a further term of office. 2 The provisions of the Swiss Code of Obligations concerning the review body of companies limited by shares apply by analogy to the auditor. 3 The review body shall conduct a statutory audit and submit comprehensive reports to the Federal Council and the Agency Council on the results of their audit. 4 The Federal Council may ask the review body to clarify certain matters. 5 It may remove the review body.
Art. 74 — 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. 2 — SR 220
Section 4 Staff
Art. 75 Compensation of the Agency Council and employment conditions
1 The Agency shall employ its staff under public law. In justified cases, contracts may be concluded in accordance with the Code of Obligations. 2 The Agency Council issues the Agency’s staff regulations subject to approval by the Federal Council. 3 With regard to the salaries of the members of the Management Board and other persons who are remunerated in a comparable way, and with regard to the other contractual conditions agreed with these persons, Article 6a paragraphs 1–5 of the Federal Personnel Act of 24 March 2000 apply by analogy. 4 The Federal Council shall determine the compensation of the members of the Agency Council. Article 6a paragraphs 1–5 of the Federal Personnel Act apply to the remuneration of the members of the Agency Council and to the other contractual conditions agreed with these persons.
Art. 75 — 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 220 Para. 2 — 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. 3 — SR 172.220.1 Para. 3 — 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). Para. 4 — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 20
Art. 75a Obligation to notify, right to report and protection
1 Employees shall notify the prosecution authorities, their superiors, the Agency Council or the Swiss Federal Audit Office of any felony or misdemeanour which they have discovered or has been reported to them in the course of their official duties. 2 The obligations to notify arising from other federal acts are reserved. 3 The obligation to notify does not apply to persons entitled to refuse to testify or give evidence under Articles 113 paragraph 1, 168 and 169 of the Criminal Procedure Code. 4 Employees are entitled to report to their superiors, the Agency Council or the Swiss Federal Audit Office any other irregularities discovered or reported to them in the course of their official duties. 5 Any person who has submitted a notification or a report in good faith or who has testified as a witness may not be disadvantaged in their professional status as a consequence.
Art. 75a — 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. 3 — SR 312.0
Art. 75b Data processing
1 The Agency shall process, on paper and in one or more information systems, employee data for the fulfilment of its tasks in accordance with this Act, in particular for: a. determining personnel requirements; b. meeting personnel requirements through staff recruitment; c. wage and salary accounting, preparation of personnel records, social insurance notifications; d. development and long-term retention of staff; e. maintenance and improvement of staff qualifications; f. planning, management and control through data analysis, benchmarking, reporting and planning of measures. 2 It may process the following personnel data necessary for the fulfilment of its tasks as specified in paragraph 1, including sensitive personal data: a. personal details; b. information on the health situation in relation to fitness for work; c. information on performance and potential, and on personal and professional development; d. data required for participation in the enforcement of social insurance law; e.
Art. 75b — Inserted by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1).
Art. 76 Pension fund
The staff of the Agency are insured by the Federal Pension Fund.
Art. 76 — Amended by Annex No 3 of the FA of 14 Dec. 2012, in force since 1 July 2013 (AS 2013 1493; BBl 2011 6703).
Section 5 Budget and Annual Report
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. 77 Financial resources
1 The Confederation and the cantons may allocate an interest-free endowment fund to the Agency. 2 The Agency shall finance its expenditure, in particular, from: a. federal remuneration for tasks referred to in Article 69 paragraph 1, where these are not covered by charges and fees; b. charges and fees referred to in Article 65; c. charges for services provided to other authorities and international organisations referred to in Article 69 paragraph 2. 2bis The following tasks and activities of the Agency shall be fully financed from federal remuneration: a. legislation; b. enforcement of criminal provisions; c. surveillance of medical devices. 3 The task-specific use of the funds referred to in paragraph 2 letters a and b and the adjustments to be made in the event of over- or underfinancing of the tasks and activities referred to in paragraph 2bis shall be determined within the framework of the approval of strategic objectives. 4 The fines and income from sanctions shall go to the Conf
Art. 77 — 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. 2 let. a — Amended by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1). Para. 2bis let. c — Inserted by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1). Para. 3 — Amended by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1).
Art. 78 Accounting
1 The financial statements of the Agency shall present its financial position and performance in accordance with the actual circumstances. 2 The accounting follows the general principles of materiality, completeness, comprehensibility, consistency and gross presentation, and is based on generally accepted standards. 3 The accounting and valuation rules derived from the accounting principles must be disclosed in the annex. 4 The Federal Council may issue accounting regulations for the Agency.
Art. 78 — 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. 78a Annual report
1 The annual report contains the annual accounts, the confirmation of audit of the annual accounts and the financial report. 2 The annual accounts consist of the balance sheet, the income statement and the annex. 3 The annual accounts shall be audited by the auditor.
Art. 78a — 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. 79 Reserves
1 If reserves are formed, they shall serve to finance future investments by the Agency and cover any losses. 2 Should the reserves exceed the amount of an annual budget, the charges and fees shall be reduced.
Art. 79 — 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. 79a Treasury
1 At the request of the Agency, the Federal Finance Administration may manage its liquid assets as part of its central treasury. 2 The Federal Finance Administration may grant the Agency loans at market interest rates to ensure that it is able to pay. 3 The Federal Finance Administration and the Agency shall agree on the details of this cooperation.
Art. 79a — 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. 80 Liability
1 The responsibilities of the Agency, its governing bodies, staff and agents are governed, subject to paragraph 2, by the Government Liability Act of 14 March 1958. 2 The Agency and its agents shall be liable only if: a. they breach important official obligations; b. damage is not attributable to a breach of duty by an agent.
Art. 80 — 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 170.32
Art. 81 Tax exemption
1 The Agency shall be exempt from all federal, cantonal and communal taxes. 2 This shall be without prejudice to the federal law governing: a. value added tax on remunerations; b. withholding tax and stamp duties.
Section 6 Independence and Oversight
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. 81a
1 The Agency shall conduct its supervisory activities autonomously and independently. 2 It is subject to the supervision of the Federal Council. 3 The Federal Council shall carry out its supervisory and control functions in particular by: a. electing and removing the members and the president of the Agency Council; b. approving the establishment and termination of the employment relationship with the director; c. electing and removing the auditor; d. approving the Agency’s staff and Fees Ordinance and affiliation agreement with PUBLICA (the federal pension fund); e. approving the annual report and the decision on the appropriation of any profit; f. approving the strategic objectives and the annual review of the achievement of the strategic objectives; g. granting discharge to the Agency Council. 4 The Federal Council may inspect the business records of the Agency in order to check whether the strategic objectives have been achieved and, for this purpose, obtain information on its busin