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 Pharmacopoeia
Art. 52
1 The Agency shall publish the Pharmacopoeia. 2 It shall involve the interested parties in the drafting of the Pharmacopoeia. In particular, it shall call upon experts and working groups. 3 It shall participate in the development of the European Pharmacopoeia (Pharmacopoeia Europaea) in accordance with international conventions and transpose it into federal law. It may enact additional regulations valid for Switzerland (Pharmacopoeia Helvetica). 4 The Pharmacopoeia shall be published separately from the Official Compilation of Federal Legislation. The Federal Council shall regulate the details of publication and in particular shall stipulate the languages in which it shall be published.
Section 2 Clinical Trials
Art. 53 Principle
For clinical trials of therapeutic products in humans, the Human Research Act of 30 September 2011 applies in addition to the provisions of this Act.
Art. 53 — Amended by Annex No 6 of the Human Research Act of 30 Sept. 2011, in force since 1 Jan. 2014 (AS 2013 3215; BBl 2009 8045). SR 810.30
Art. 54 Mandatory authorisation
1 Clinical trials of therapeutic products require authorisation from the Agency in advance. 2 Exempted from mandatory authorisation are clinical trials involving authorised medicinal products used in accordance with the product information. 3 The Federal Council may: for other trials, grant an exemption from mandatory authorisation or specify mandatory notification; b. for clinical trials of veterinary therapeutic products, specify mandatory authorisation or notification; c. make modifications to clinical trials subject to mandatory authorisation. 4 As part of the authorisation procedure, the Agency shall verify: in the case of medicinal products, whether they comply with the rules of Good Manufacturing Practice and of medicinal product safety; in the case of medical devices, whether: 1. the medical devices meet the requirements specified in Article 45, insofar as compliance with these requirements is not the subject of the clinical trial, 2. the risks associated with a medical device
Art. 54 — Amended by Annex No 6 of the Human Research Act of 30 Sept. 2011, in force since 1 Jan. 2014 (AS 2013 3215; BBl 2009 8045). Para. 2 — Amended by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1). Para. 3 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. 4 let. 3 — Amended by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1). Para. 5 — Repealed by No
Art. 54a Paediatric investigation plan
1 For each medicinal product, a paediatric investigation plan shall be drawn up with a view to its marketing authorisation which sets out the requirements for the development of the medicinal product in paediatrics and which must be submitted to the Agency. 2 The Federal Council shall regulate: a. the procedure; b. the requirements for the paediatric investigation plan in accordance with the EU provisions. 3 It may waive the obligation to prepare a paediatric investigation plan, in particular for medicinal products for the treatment of diseases that occur only in adults. It may provide for a paediatric investigation plan assessed by a foreign authority to be taken into account.
Art. 54a — 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. 54b Supervision
1 The Agency may at any time carry out an inspection to determine whether the conduct of the clinical trial meets the requirements specified in this Act and in the Human Research Act of 30 September 2011. 2 The Federal Council may, having regard to recognised international regulations, specify notification and information requirements, concerning in particular: a. the completion or discontinuation of a clinical trial; b. adverse events observed in connection with a clinical trial; c. incidents occurring during the conduct of a clinical trial which may affect the safety or health of the participants or call into question the acquisition of reliable and robust data. 3 It shall regulate the notification procedure and the exchange of information. It may stipulate that notification and the exchange of information must be effected electronically.
Art. 54b — Inserted by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1). Para. 1 — SR 810.30
Section 2a Integrity and Transparency
Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2020 (AS 2017 2745, 2019 1393; BBl 2013 1).
Art. 55 Integrity
1 Persons who prescribe, dispense, use or purchase for this purpose prescription medicinal products, and organisations employing such persons shall not claim, be promised or accept any undue advantage for themselves or for the benefit of a third party. Similarly, it is forbidden to offer, promise or grant an undue advantage to any such person or organisation for their benefit or for the benefit of a third party. 2 The following are not regarded as undue advantages: a. advantages of modest value which are of relevance to medical or pharmaceutical practice; b. support for research, education and training, provided that certain criteria are met; c. compensation for equivalent services in return, in particular for those provided in connection with orders and deliveries of therapeutic products; d. price discounts or refunds granted on medical purchases, provided they have no influence on the choice of treatment. 3 The Federal Council shall regulate the details. It may extend the applicabili
Art. 55 — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2020 (AS 2017 2745, 2019 1393; BBl 2013 1).
Art. 56 Duty of transparency
1 All discounts and rebates granted on purchases of medicinal products shall be shown on the receipts and invoices and in the accounts of both the selling and the purchasing persons and organisations and shall be disclosed to the competent authorities on request. 2 The Federal Council shall regulate the details. 3 It may provide for exceptions to the requirement laid down in paragraph 1 in the case of therapeutic products with a low risk potential.
Art. 56 — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2020 (AS 2017 2745, 2019 1393; BBl 2013 1).
Art. 57
Repealed by Annex No 6 of the Human Research Act of 30 Sept. 2011, with effect from 1 Jan. 2014 (AS 2013 3215; BBl 2009 8045).
Section 3 Market Surveillance and Inspection Proce
Art. 58 Official market surveillance
1 The Agency and the other authorities entrusted with the enforcement of this Act shall monitor, within the limits of their powers, whether the manufacture, distribution, dispensing and maintenance of, and claims relating to therapeutic products are lawful. For this purpose, they may carry out announced and unannounced inspections. 2 The Agency shall verify the therapeutic products placed on the market. It shall verify that the medicinal products conform to the marketing authorisation and that the medical devices satisfy the legal requirements. 3 The Agency shall be responsible for monitoring the safety of therapeutic products. To this effect, it shall in particular collect the notifications referred to in Article 59, evaluate them, and take the necessary administrative measures. 4 The Agency and the other authorities entrusted with the implementation of this Act may take samples, request essential information and documents, and ask for any help necessary for this purpose. Neither the
Para. 1 — Amended by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1). Para. 4 — 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. 5 — 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. 59 Mandatory notification, notification system and the right to notify
1 Any person manufacturing or distributing ready-to-use therapeutic products must put in place a system of notification. He must notify the Agency of any adverse event or reaction which: a. is or may be attributable to the therapeutic product itself, its use or to incorrect labelling or instructions; b. may endanger or damage the health of the consumer, of the patient, of a third party or of the treated animals. 2 Any person manufacturing or distributing therapeutic products must furthermore notify the Agency of any quality defects and any further findings and assessments which could influence the basis of evaluation. 3 Any person who professionally dispenses therapeutic products or administers them to humans or animals or who is entitled to do so as medical personnel must notify the Agency of any serious or previously unknown adverse effects and incidents, observations of other serious or previously unknown facts or quality defects that are of significance for drug safety. 3bis Any pe
Para. 3 — 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 — 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. 5 — 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. 6 — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013
Art. 60 Competence for conducting inspections
1 The Agency is responsible for inspections carried out in Switzerland subject to the reservations of Articles 30 and 34 paragraph 4. 2 It is responsible for the inspections specified in Articles 6, 19 and 28 in the following sectors: a. immunological medicinal products; b. blood and blood products; c. rarely used procedures which require very specific and specialised knowledge. 3 It shall delegate the inspections referred to in Articles 6, 19 and 28 in all other sectors to the cantonal inspectorates insofar as they satisfy the requirements of federal legislation and international law applicable in Switzerland. 4 It may involve the cantonal inspectorates in, or ask them to carry out inspections within its area of competence. 5 The cantons may involve regional or other cantonal inspectorates or the Agency in, or ask them to carry out the inspections referred to in paragraph 3.
Section 4 Obligation of Secrecy and Data Processin
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. 61 Obligation of secrecy
Persons responsible for the execution of this Act are obliged to maintain professional secrecy.
Art. 62 Data confidentiality
1 If there is an overriding legitimate interest in preserving the secrecy of the data collected in accordance with this Act, the competent authority must treat such data as confidential. 2 The Federal Council may determine the data which are disclosed by the competent authority.
Art. 62a Processing of personal data
1 Federal and cantonal authorities, regional centres and third parties entrusted with enforcement tasks may, to the extent necessary to fulfil their duties under this Act, process the following sensitive personal data: a. data on health: 1. for official market surveillance, 2. to exercise vigilance in connection with incoming notifications on adverse effects and events and on quality defects, 3. to verify clinical trials on the basis of incoming notifications and inspections, or 4. in connection with applications for temporary authorisations as specified in Article 9b paragraph 1 and for exemptions for medical devices as specified in Article 46 paragraph 3 letter b; b. data on administrative or criminal prosecutions and sanctions: 1. within the framework of procedures for granting establishment licences, or 2. to assess whether an investigator is qualified for conducting clinical trials. 2 Sensitive personal data pursuant to paragraph 1 letter a shall be made anonymous wherever possibl
Art. 62a — 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. 1 — Amended by Annex 1 No II 74 of the Data Protection Act of 25 Sept. 2020, in force since 1 Sept. 2023 (AS 2022 491; BBl 2017 6941). Para. 1 let. a let. 1 — 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. a let. 4 — Inserted by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl
Art. 62b Cooperation with the private sector
1 The Agency and the Federal Office for Customs and Border Security (FOCBS), after weighing up the interests, are entitled on a case-by-case basis to disclose confidential data collected in accordance with this Act to the holder of an operating licence or of a marketing authorisation for medicinal products or to any person who places a medical device on the market, including sensitive personal data in accordance with Article 5 letter c number 5 of the Data Protection Act of 25 September 2020, provided this measure is regarded as necessary in order to uncover or combat suspected illegal trading in therapeutic products. 2 Personal data relating to patients may not be disclosed.
Art. 62b — 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 235.1 Para. 1 — Amended by Annex 1 No II 74 of the Data Protection Act of 25 Sept. 2020, in force since 1 Sept. 2023 (AS 2022 491; BBl 2017 6941).
Art. 62c Medical devices information system
1 The Agency, to fulfil its tasks, shall operate a medical devices information system; this shall serve in particular to ensure the safety of medical devices, as well as vigilance and surveillance. 2 The information system shall contain data as specified in Article 62a which is necessary for the surveillance of medical devices and the conduct of notification and authorisation procedures for clinical trials in accordance with this Act. 3 The data referred to in paragraph 2 may be automatically aligned with Eudamed. 4 Any data referred to in paragraph 2 which is not sensitive may be published with due protection of professional confidentiality and trade secrets. 5 The Federal Council shall regulate: a. the structure and data catalogue; b. the access rights; c. the organisational and technical measures necessary to ensure data protection and data security; d. the storage period.
Art. 62c — Inserted by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1).
Art. 63 Data disclosure between the enforcement authorities in Switzerland
1 The federal and cantonal authorities responsible for enforcing this Act shall ensure mutual disclosure of the data insofar as this is necessary for enforcing this Act. 2 The Federal Council may make provision for the disclosure of data to other authorities or organisations should this be necessary for the enforcement of this Act. 3 It may make provision for the Agency to disclose data to other federal authorities if this is necessary for the enforcement of federal legislation relating to health.
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).
Art. 64 Conditions for the disclosure of data and information abroad
1 The federal authorities responsible for the enforcement of this Act may disclose information which is not publicly accessible to the foreign authorities and institutions responsible for the enforcement of therapeutic product regulations and to international organisations, provided that it is ensured that: a. the requesting body is bound by official secrecy and uses the information received exclusively in an administrative procedure in connection with the enforcement of therapeutic product regulations and does not pass it on to third parties; b. only information required for the enforcement of therapeutic product regulations is transmitted; c. no manufacturing or trade secrets are disclosed, unless the transmission of such information is required to avert an immediate and serious risk to human life or health. 2 They may disclose personal data, including data on health and on administrative or criminal proceedings or sanctions, if legislation in the state concerned guarantees adequate
Art. 64 — Amended by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1).
Art. 64a Cross-border inspections
1 Competent foreign authorities shall, on notifying the Agency, be entitled to inspect Swiss establishments operating in the therapeutic products sector provided that: a. the inspection has the sole purpose of verifying compliance with regulations on therapeutic products; b. the results of the inspection are used solely in administrative proceedings in connection with the enforcement of regulations on therapeutic products; c. the establishment concerned consents to the inspection; and d. the foreign authority informs the Agency of the results by providing it with the inspection report in an official Swiss language or in English. 2 The Agency may accompany the foreign authority during its inspection. 3 It may in consultation with the competent authorities carry out inspections of establishments abroad that operate in the therapeutic products sector, if this is required to guarantee the protection of health. In addition, it may participate in inspections carried out by competent foreign
Art. 64a — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2018 (AS 2017 2745; BBl 2013 1). Para. 3 — Second sentence inserted by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1).
Section 4a Information System on Antibiotics in Ve
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. 64b Processing of personal data
The competent federal and cantonal authorities are entitled to process personal data as part of the implementation of their duties under this Act with regard to measures to reduce antibiotic resistance in veterinary medicine.
Art. 64c Operation and purpose of the Antibiotics Information System
1 The Federal Food Safety and Veterinary Office (FSVO) operates an information system to monitor antibiotic sales, antibiotic consumption and antibiotic resistance (Antibiotics Information System). 2 The Antibiotics Information System is part of the joint central information system along the food chain of the Federal Office for Agriculture (FOAG) and the FSVO. 3 The costs of setting up and operating the Antibiotics Information System are borne by the federal government.
Art. 64d Content of the Antibiotics Information System
1 The Antibiotics Information System contains personal data including: a. the quantity of medicinal products containing antimicrobial agents distributed to the persons entitled to dispense them; b. the data on prescription, dispensing and use of medicinal products containing antimicrobial agents in accordance with the instructions for use and the official prescription form; c. the name and address of the dispensing person or practice; d. the name of the livestock holder to whom the medicinal product is dispensed; e. the date of dispensing. 2 The Antibiotics Information System obtains: a. data from other applications of the joint central information system along the food chain as referred to in Article 64c paragraph 2; b. personal data from the Register of Medical Professions in accordance with Articles 51–54 of the Medical Professions Act of 23 June 2006.
Para. 2 let. b — SR 811.11
Art. 64e Access to the Antibiotics Information System
1 As part of their statutory duties, the following authorities may process data online in the Antibiotics Information System: a. the FSVO: to compile antibiotics sales and consumption statistics, to monitor the antibiotic resistance situation and to guarantee the enforcement of the legislation; b. the cantonal enforcement authorities: to fulfil their tasks in their respective areas of responsibility. 2 In order to fulfil their statutory duties, the following authorities or persons may retrieve data online from the Antibiotics Information System: a. the FSVO and the cantonal enforcement authorities: distribution, prescription, dispensing and application data; b. the FSVO: distribution, prescription, dispensing and application data to fulfil the tasks assigned to it in accordance with the Agriculture Act of 29 April 1998; c. livestock holders: data concerning themselves; d. veterinarians and other persons subject to the obligation to report under Article 64f letter h: data concerning the
Para. 2 let. b — SR 910.1
Art. 64f Implementing provisions
The Federal Council regulates the following for the Antibiotics Information System: a. the structure and data catalogue, including the part used by the cantons; b. the responsibilities for data processing; c. the access rights under Article 64e, in particular their scope; d. the organisational and technical measures necessary to ensure data protection and data security; e. the cooperation procedure with the cantons; f. storage and destruction periods; g. archiving; h. the reporting obligations of persons who market, prescribe, dispense and use antibiotics; livestock holders are exempt from the obligation to report; i. obtaining data on the veterinary profession from the Register of Medical Professions in accordance with Articles 51–54 of the Medical Professions Act of 23 June 2006.
let. i — SR 811.11
Art. 64g Use of the Antibiotics Information System by the cantons
The cantons that use the Antibiotics Information System for their own enforcement purposes are obliged to issue equivalent data protection provisions for their own areas and to designate a body to monitor compliance with these provisions.
Section 5 Fees and Supervision Fee
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
1 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. 2 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. 3 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. 4 The Federal Council shall regulate the details of the supervision fee, in particular the fee rate applicable to the individual price categories. 5 The Agency Cou
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 — 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 — 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. 5 — 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. 6 — Amended by
Section 6 Administrative Measures
Art. 66 In general
1 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. 2 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 thera
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. 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 let. b — 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 — 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. 5 — Ins
Art. 67 Informing the general public
1 The Agency shall ensure that the public is informed of occurrences specifically relating to therapeutic products which endanger health, and shall issue appropriate recommendations. It shall publish information of general interest about the therapeutic products sector, in particular regarding authorisation and revocation decisions as well as about findings within the framework of market surveillance. 1bis The professional information contains all the active substances and excipients of a medicinal product. 2 The competent federal offices may inform the public on the correct use of therapeutic products for the purpose of protecting health and combating the abuse of such products. 3 The marketing authorisation holders, representatives of the interested medical professions, persons with independent dispensing rights in accordance with Article 25 and patients or their associations shall jointly maintain an institution in the form of a foundation which operates an electronic register with
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. 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, 2018 3575; BBl 2013 1). Para. 5 — Inse
Art. 67a Provision of information about the use of medicinal products in certain population groups
1 In order to improve safety in the use of medicinal products in paediatrics, the Federal Council may allow for the collection, harmonisation, evaluation and publication of data relating to the prescription, supply and use of medicinal products. 2 The Confederation may arrange for a database to be established and operated by third parties for this purpose. This database may not contain personal data. 3 The Federal Council: a. shall specify the basic requirements for the content, operation and quality of the database and regulate the conditions for the access to and use of the data; b. determines the entity responsible for managing the database and may authorise the same to gather information in anonymised form from medical professionals. 4 The operators in accordance with paragraph 2 shall guarantee the interoperability of this database with the register in accordance with Article 67. 5 The Federal Council may extend the activities under paragraphs 1 and 2 to include further specific p
Art. 67a — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2018 (AS 2017 2745; BBl 2013 1).
Art. 67b Publication of clinical trial results
1 The Federal Council may, taking into account internationally recognised regulations, provide that the results of clinical trials carried out with a view to developing a medicinal product for human use shall be published after the authorisation decision. 2 For this purpose, the Confederation may operate a database or have it operated by third parties. This database may not contain any data that would allow any reference to persons participating in clinical trials. 3 The Federal Council: a. designates the authority responsible for maintaining the database; b. specifies the duties and procedure with regard to publication; c. determines the content and form of the results to be published; d. determines the requirements for the content and operation of the database; e. regulates the access to and use of the data.
Art. 67b — 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).