Clinical Trials Ordinance (ClinO)
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 General Provisions
Art. 19 Categorisation of clinical trials of medicinal products
1 Clinical trials of medicinal products come under Category A if: a. the investigational medicinal product is a medicinal product authorised in Switzerland; b. the investigational medicinal product has not been modified; and c. the use of the investigational medicinal product: 1. is in accordance with the prescribing information, 2. is in an indication or dosage different from that specified in the prescribing information, but in accordance with the following criteria: – the indication is within the same disease group of the International Classification of Diseases (ICD), as specified in Annex 1 number 3, – the disease in question is self-limiting and the dosage of the medicinal product is lower than that specified in the prescribing information; or 3. is recognised as standard in guidelines prepared in accordance with internationally accepted quality criteria. 2 They come under Category B if the investigational medicinal product: a. is a medicinal product authorised in Switzerland, wh
Art. 19 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Art. 20 Categorisation of clinical trials of products under Article 2a paragraph 2 TPA
1 Clinical trials of products under Article 2a paragraph 2 TPA come under Category A if: a. the product that is under investigation has been notified under Article 6 paragraph 3 MedDO in its version of 1 January 2002 in application of Article 108 paragraph 1 letter b MedDO; and b. it is used in accordance with the instructions for use. 2 They come under Category C if: a. the product that is under investigation has not been notified under Article 6 paragraph 3 MedDO in its version of 1 January 2002 in application of Article 108 paragraph 1 letter b MedDO; b. the product that is under investigation is not used in accordance with the intended purposes specified in the instructions for use; or c. use of the product that is under investigation is prohibited in Switzerland.
Art. 20 — Amended by Annex 2 No 2 of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294). Para. 1 let. a — SR 812.213 Para. 1 let. a — AS 2001 3487
Art. 21 Clinical trials of transplant products
For clinical trials of transplant products, the provisions of this Ordinance concerning clinical trials of medicinal products apply mutatis mutandis.
Art. 22 Clinical trials of gene therapy and clinical trials of genetically modified or pathogenic organisms
1 For the purposes of this Ordinance, clinical trials of gene therapy are trials in which genetic information is introduced into somatic cells (somatic gene therapy). 2 For the purposes of this Ordinance, clinical trials of genetically modified organisms are trials of medicinal products containing genetically modified organisms as defined in the Release Ordinance of 10 September 2008, and in particular replication-competent viruses. 3 For the purposes of this Ordinance, clinical trials of pathogenic organisms are trials of medicinal products containing pathogenic organisms as defined in the Release Ordinance. 4 For clinical trials of gene therapy and for clinical trials of genetically modified or pathogenic organisms, the provisions of this Ordinance concerning clinical trials of medicinal products apply mutatis mutandis.
Para. 2 — SR 814.911
Art. 23 Coordination and information in approval procedures and deadline for submission of the application to the second authority responsible for approval
1 The investigator and the sponsor may simultaneously submit applications to the responsible ethics committee and to Swissmedic. 1bis For Category B and C clinical trials, the application must be submitted to the second authority within two years after approval has been granted by the first authority. 1ter At the request of the approval holder, the first authority may extend the deadline specified in paragraph 1bis. Such a request constitutes a substantial modification to the clinical trial. 1quater If the deadline specified in paragraph 1bis or the deadline extended in accordance with paragraph 1ter is exceeded, or if a request for a deadline extension in accordance with paragraph 1ter is rejected, then the approval granted shall lapse. 2 The responsible ethics committee and Swissmedic shall inform each other about matters relating to the review areas specified in Article 25 and in Article 32, and shall coordinate their assessments.
Art. 23 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 1 — Term amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). This amendment has been made throughout the Ordinance. Para. 1bis — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 1ter — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 1quater — Inserted by No I of the O of 7 June 2024, in
Art. 23a Deadline for enrolment of the first participant
1 The first participant must be enrolled in the clinical trial within two years after the last approval required has been granted. 2 In the case of clinical trials on rare diseases, the authorities may, in the course of the approval procedure, set a longer deadline at the request of the applicant. 3 The deadline in accordance with paragraph 1 or 2 may be extended at the request of the approval holder. The request must be made to all the authorities involved in the approval procedure and constitutes a substantial modification to the clinical trial. If the modification is not approved, then approvals already granted shall lapse. 4 If the first participant is not enrolled in the clinical trial within the deadline in accordance with paragraphs 1–3, then the clinical trial is considered to be interrupted as specified in Article 38 paragraph 2 third sentence. The clinical trial may only be commenced if a request for a deadline extension in accordance with paragraph 3 has been approved.
Art. 23a — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Section 2 Procedure before the Responsible Ethics
Art. 24 Application
1 The investigator shall submit to the responsible ethics committee the application documents specified in Annex 3 for review. 2 The ethics committee may request additional information. 3 The sponsor may submit the application instead of the investigator. In this case, the sponsor assumes the obligations of the investigator as specified in Articles 29 and 36a and also the notification and reporting obligations vis-à-vis the responsible ethics committee.
Para. 3 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Art. 25 Review areas
The responsible ethics committee shall review: a. the completeness of the application; b. the categorisation requested; c. the information intended for registration in accordance with Article 64; d. the protocol with regard to: 1. the scientific relevance of the topic (Art. 5 HRA), the suitability of the chosen scientific methodology and compliance with Good Clinical Practice, 2. the ratio between the likely risks and burdens and the expected benefits (Art. 12 para. 2 HRA), 3. the measures taken to minimise risks and burdens, and for the protection and follow-up of participants (Art. 15 HRA), including precautionary measures in the handling of personal data, 4. the need to involve persons, and in particular persons who are particularly vulnerable (Art. 11 HRA), 5. the criteria for the selection of participants, 6. the proposed procedure for providing information and obtaining consent, including the appropriateness of the period for reflection, 7. the appropriateness of the remuneration
let. dbis — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). let. ebis — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). let. j — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). let. k — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Art. 26 Procedure and deadlines
1 The ethics committee shall acknowledge receipt of the application within 7 days and notify the investigator of any formal deficiencies in the application documents. 2 It shall reach a decision within 30 days of acknowledgement of receipt of the formally correct application documents. 3 If the ethics committee requests additional information in accordance with Article 24 paragraph 2, the clock shall be stopped until this information has been received. 4 It shall inform Swissmedic of its decision in the case of Category B and C clinical trials.
Art. 27 Multicentre clinical trials
1 The coordinating investigator shall submit the application for multicentre clinical trials to the lead committee in accordance with Article 47 paragraph 2 HRA. The sponsor may submit the application instead of the coordinating investigator; Article 24 paragraph 3 applies mutatis mutandis. 2 The coordinating investigator is the person responsible in Switzerland for coordination of the investigators responsible at the individual trial sites. 3 The lead committee shall acknowledge receipt of the application within 7 days and at the same time notify the coordinating investigator whether the application documents are formally in order. 4 At the request of the lead committee, the coordinating investigator shall submit the required number of copies of the application documents specified in Annex 3 to the ethics committees responsible at the other trial sites (ethics committees concerned). These shall review the local conditions and inform the lead committee of their assessment within 15 day
Art. 28
Repealed by No I of the O of 7 June 2024, with effect from 1 Nov. 2024 (AS 2024 322).
Art. 29 Modifications
1 Substantial modifications to an approved clinical trial must be approved by the ethics committee before being implemented. Exempt from this requirement are measures which have to be taken immediately in order to protect the participants. 2 The investigator shall submit to the ethics committee any application documents specified in Annex 3 which are affected by the modification. At the same time, the investigator shall provide information on the reasons for the modification. 3 The following are considered to be substantial modifications: a. modifications affecting the participants’ safety and health, or their rights and obligations; b. modifications to the protocol, and in particular modifications based on new scientific knowledge which concern the trial design, the method of investigation, the endpoints or the form of statistical analysis; c. a change of trial site, or conducting the clinical trial at an additional site; d. a change of sponsor, coordinating investigator or investigat
Para. 3 let. e — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Section 3: Procedure before Swissmedic
Art. 30 Exemption from mandatory approval
Category A clinical trials are exempted from the requirement for approval by Swissmedic as specified in Article 54 paragraph 1 TPA.
Art. 30 — Amended by Annex No 2 of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).
Art. 31 Application
1 The sponsor shall submit to Swissmedic the application documents specified in Annex 4 for review. 1bis Swissmedic may prepare a list of specific documents in accordance with the content of Annex 4 that are required for submission of the application. 2 Swissmedic may request additional information.
Para. 1bis — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Art. 32 Review areas
1 For clinical trials of medicinal products, Swissmedic shall review: a. the completeness of the application; b. the safety of the medicinal product, and in particular the preclinical and clinical pharmacology, toxicology, formulation and pharmacokinetics, and the proposed dosage and indication; c. the risk assessment and risk management based on the medicinal product safety data; d. the quality of the medicinal product and compliance with Good Manufacturing Practice (GMP); e. other areas, where this is necessary to assess the safety or quality of the medicinal product. 2 For Category B clinical trials of medicinal products capable of emitting ionising radiation, it shall additionally review compliance with radiological protection legislation and the dose estimation. 3 For clinical trials of products under Article 2a paragraph 2 TPA, it shall review: a. the completeness of the application; b. the requirements specified in Article 54 paragraph 4 letter b TPA.
Art. 33 Procedure and deadlines
1 Swissmedic shall acknowledge receipt of the application within 7 days and notify the sponsor of any formal deficiencies in the application documents. 2 Swissmedic shall reach a decision within 30 days of acknowledgement of receipt of the formally correct application documents. 3 If a medicinal product or product under Article 2a paragraph 2 TPA is to be used in persons for the first time or manufactured in a new process, this deadline may be extended by a maximum of 30 days. Swissmedic shall inform the sponsor of the extended deadline. 4 If Swissmedic requests additional information in accordance with Article 31 paragraph 2, the clock shall be stopped until this information has been received. 5 Swissmedic shall inform the responsible ethics committee and other competent cantonal authorities of its decision.
Art. 34 Modifications
1 Substantial modifications to an approved clinical trial must be approved by Swissmedic before being implemented. Exempt from this requirement are measures which have to be taken immediately in order to protect the participants. 2 The sponsor must submit to Swissmedic any application documents specified in Annex 4 which are affected by the modification. At the same time, the sponsor shall provide information on the reasons for the modification. 3 The following are considered to be substantial modifications: a. modifications to the medicinal product or product under Article 2a paragraph 2 TPA, or to its administration or use; b. modifications based on new preclinical or clinical data which may affect product safety; c. modifications concerning the production of the medicinal product or product under Article 2a paragraph 2 TPA which may affect product safety; or d. the extension of a deadline in accordance with Articles 23 and 23a; in the application to Swissmedic, the sponsor shall ind
Para. 3 let. d — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Section 4 Special Provisions for Clinical Trials o
Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Art. 35 Clinical trials of gene therapy and clinical trials of genetically modified or pathogenic organisms
1 For Category B and C clinical trials of gene therapy and for clinical trials of genetically modified or pathogenic organisms as defined in Article 22, the documents specified in Annex 4 number 1 must be submitted to Swissmedic. 2 Before granting approval, Swissmedic shall seek opinions from the Swiss Expert Committee for Biosafety (SECB), the Federal Office for the Environment (FOEN) and the FOPH. 3 In addition to the areas specified in Article 32, Swissmedic shall review whether the quality and biological safety of the product are guaranteed with regard to the participants and to human beings and the environment. 4 It shall grant approval if: a. the SECB has confirmed the quality and biological safety of the product with regard to the participants and to human beings and the environment; and b. no objections to the clinical trial have been raised by the FOPH or by the FOEN, based on the assessment of the environmental data. 5 Swissmedic shall make a decision within 60 days of acknow
Para. 1 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 5 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 6 — Repealed by No I of the O of 7 June 2024, with effect from 1 Nov. 2024 (AS 2024 322).
Art. 36 Clinical trials of medicinal products capable of emitting ionising radiation
1 For Category B and C clinical trials of medicinal products capable of emitting ionising radiation, the documents specified in Annex 4 number 5 must additionally be submitted to Swissmedic. 2 In the case of Category C clinical trials, Swissmedic shall seek an opinion from the FOPH before granting approval. The FOPH shall review compliance with radiological protection legislation and the dose estimation. 3 Swissmedic shall grant approval if: a. the requirements covered by Article 32 are met; and b. the FOPH has raised no objections to the clinical trial. 4 Swissmedic shall reach a decision on Category C clinical trials within 60 days of acknowledgement of receipt of the formally correct application documents. Swissmedic shall inform the FOPH of its decision. 5 …
Art. 36 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 1 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 2 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 5 — Repealed by No I of the O of 7 June 2024, with effect from 1 Nov. 2024 (AS 2024 322).
Art. 36a Procedure for accompanying examinations involving ionising radiation
1 In the case of accompanying examinations involving ionising radiation, the investigator shall submit to the responsible ethics committee the additional application documents specified in Annex 3 number 5. Subject to the provisions of paragraphs 2–6, the approval procedure is governed by Articles 24–27 and 29. 2 The investigator shall additionally submit to the FOPH the application documents specified in Annex 3 number 6 if: a. a radiopharmaceutical employed is not used in accordance with the authorisation or is not authorised in Switzerland; b. a medical device employed which is capable of emitting ionising radiation: 1. is not used in accordance with the instructions for use, or 2. does not bear a conformity marking in accordance with Article 13 MedDO; or c. some other radioactive source is used. 3 If additional documentation has to be submitted in accordance with paragraph 2, the investigator shall inform the ethics committee accordingly. 4 The FOPH shall, within a reasonable perio
Art. 36a — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322, 582). Para. 2 let. b let. 2 — SR 812.213
Section 5 Documentation, Notifications and Reporti
Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Art. 37 For safety and protective measures
1 If immediate safety and protective measures have to be taken during the conduct of a clinical trial, the investigator shall notify the ethics committee of these measures, and of the circumstances necessitating them, within 7 days. 2 In the case of clinical trials of products under Article 2a paragraph 2 TPA, this notification shall be made within 2 days. 3 For Category B and C clinical trials, the notifications specified in paragraphs 1 and 2 shall additionally be made to Swissmedic. This obligation rests on the sponsor.
Art. 37 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 3 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Art. 38 For the first visit and for completion, premature termination, interruption and resumption of a clinical trial
1 The investigator shall notify the ethics committee, within 30 days, of: a. the first visit of the first participant in the clinical trial in Switzerland; and b. the completion of the clinical trial in Switzerland. 1bis The investigator shall notify the ethics committee, within 90 days, of the global completion of a multinational clinical trial. 1ter Completion of a clinical trial is marked by the last participant’s final follow-up visit, in the absence of provisions to the contrary in the protocol. 2 The investigator shall notify the ethics committee of the premature termination, interruption or resumption of the clinical trial within 15 days. In the notification, the reasons for the premature termination, interruption or resumption must be stated. An interruption lasting for more than two years is considered to be a premature termination. 3 The investigator shall submit a summary final report to the ethics committee within a year of the completion or premature termination of the cli
Art. 38 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Art. 39 For adverse events (AE) in clinical trials of medicinal products
1 If adverse events occur in the course of a Category C clinical trial, they must be documented by the investigator in a standardised manner. 1bis In the protocol for Category C clinical trials, the sponsor may, in justified exceptional cases, waive the documentation requirements for adverse events identified as not critical to the safety evaluation. 2 If adverse events occur in the course of a Category B clinical trial, they must be documented by the investigator in a standardised manner if: a. the adverse events are identified in the protocol as critical to the safety evaluation; or b. this was requested by the authorities responsible for approval. 3 For Category A clinical trials, there is no obligation to document adverse events. 4 The definition of adverse events is governed by the rules of Good Clinical Practice as specified in Annex 1 number 2.
Art. 39 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 1 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 1bis — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 2 let. b — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Art. 40 For serious adverse events (SAE) in clinical trials of medicinal products
1 If, in the course of a clinical trial, serious adverse events occur in participants, the investigator must document these in a standardised manner and report them to the sponsor within 24 hours after they become known. Events which are not to be reported according to the protocol are exempted. 2 and3 … 4 The definition of serious adverse events is governed by the rules of Good Clinical Practice as specified in Annex 1 number 2.
Art. 40 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 23 — Repealed by No I of the O of 7 June 2024, with effect from 1 Nov. 2024 (AS 2024 322).
Art. 41 For suspected unexpected serious adverse reactions (SUSAR) in clinical trials of medicinal products
1 If, in the course of a clinical trial, a suspected unexpected serious adverse reaction occurs in a participant, the investigator must document this in a standardised manner and report it to the sponsor within 24 hours after it becomes known. 2 The investigator shall report a suspected unexpected adverse reaction with life-threatening or fatal consequences occurring in Switzerland to the responsible ethics committee within 7 days, and any other suspected unexpected serious adverse reaction within 15 days. 3 If, in the case of a multicentre clinical trial, a suspected unexpected serious adverse reaction occurs at one of the trial sites in Switzerland, the coordinating investigator shall also report it to the ethics committee concerned in accordance with paragraph 2, within the same period. 4 For Category B and C clinical trials, the reports specified in paragraph 2 shall also be made to Swissmedic. This obligation rests on the sponsor. For Category A clinical trials, the sponsor is sub
Art. 41 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 1 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 2 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 3 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 4bis — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 5 — Amended by No I of th
Art. 42 For serious adverse events (SAE) and deficiencies in clinical trials of products under Article 2a paragraph 2 TPA
1 The investigator shall, within 7 days, report to the responsible ethics committee: a. serious adverse events which occur in participants in Switzerland in the course of a Category C clinical trial of products under Article 2a paragraph 2 TPA and where it cannot be excluded that the events are attributable: 1. to the product under investigation, or 2. to an intervention undertaken in the clinical trial; b. deficiencies in the product under Article 2a paragraph 2 TPA under investigation that might have led to serious adverse events if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate. 2 If in the case of a multicentre clinical trial, at one of the trial sites, serious adverse events or deficiencies in the product under Article 2a paragraph 2 TPA under investigation occur, the coordinating investigator shall also report them to the ethics committee concerned. 3 For a Category C clinical trial, the reports specified in paragrap
Art. 42 — Amended by Annex 2 No 2 of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294). Art. 42 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 2 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 3 — SR 812.213 Para. 3 — AS 2001 3487
Art. 43 Reporting on the safety of participants
1 Once a year, the investigator shall present to the responsible ethics committee a list of events and deficiencies in the product under Article 2a paragraph 2 TPA under investigation and adverse reactions as specified in Articles 40–42. On this basis, the investigator shall submit a report on their severity and causal relationship to the intervention, and on the safety of participants, and shall inform the ethics committee about the general progress of the clinical trial. 2 In the case of clinical trials also conducted abroad according to the same protocol, the events and deficiencies in the product under Article 2a paragraph 2 TPA under investigation and adverse reactions occurring abroad must also be included in the list and the report. 3 For Category B and C clinical trials, reports as specified in paragraphs 1 and 2 must also be submitted to Swissmedic. This obligation rests on the sponsor.
Para. 1 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 2 — Amended by Annex 2 No 2 of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294).
Art. 44 For the use of ionising radiation
1 In clinical trials involving any use of ionising radiation, the investigator shall assess compliance with the dose constraint specified in Article 45 of the Radiological Protection Ordinance of 26 April 2017. 2 If the permitted dose constraint is exceeded at any time, the investigator shall notify the responsible ethics committee within seven working days of it becoming known. 3 In the case of Category B and C clinical trials of medicinal products capable of emitting ionising radiation, notification in accordance with paragraph 2 must also be made to Swissmedic. This obligation rests on the sponsor. 4 The responsible ethics committee and Swissmedic may obtain expert advice from the FOPH in order to assess the dose calculation or the dose estimation and to decide what further measures are required. 5 If any use is made of ionising radiation, the investigator shall document in the summary final report in accordance with Article 38, all information of relevance for radiological protecti
Art. 44 — Amended by Annex 11 No 6 of the Radiological Protection Ordinance of 26 Apr. 2017, in force since 1 Jan. 2018 (AS 2017 4261). Art. 44 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 1 — SR 814.501 Para. 1 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 3 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 5 — Amended by No I of the O of 7 June 2024, in force sinc
Art. 44a Assumption of the investigator’s notification and reporting obligations by the sponsor
Instead of the investigator, the sponsor may assume the notification and reporting obligations listed in this Section vis-à-vis the ethics committee or ethics committees, if this is provided for in the application documents.
Art. 44a — Inserted by No I of the O of 7 June 2024, in force since 11 Nov. 2024 (AS 2024 322).
Art. 45 Data retention requirements
1 The sponsor must retain all data relating to the clinical trial until the expiry date of the last batch supplied of the medicinal product under investigation or of the last product under Article 2a paragraph 2 TPA manufactured, but at least for twenty years after the completion or premature termination of the clinical trial. 2 The investigator must retain all documents required for the identification and follow-up of participants, and all other original data, for at least twenty years after the completion or premature termination of the clinical trial. 3 For clinical trials of transplant products and for clinical trials of blood and blood products, the retention requirements are governed by Article 40 paragraph 1 TPA.
Para. 1 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 2 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Section 6 Inspections and Official Measures
Art. 46 Swissmedic inspections
1 Swissmedic is entitled to inspect all clinical trials of medicinal products, products under Article 2a paragraph 2 TPA or transplant products. 2 If Swissmedic carries out inspections, it shall inform in advance the responsible ethics committee and other competent cantonal and federal authorities. They may participate in the inspection. 3 Swissmedic’s powers are governed by Article 62 of the Medicinal Products Authorisation Ordinance of 14 November 2018. 4 Swissmedic may additionally carry out inspections abroad at the sponsor’s expense, if this is necessary to assess the clinical trial conducted in Switzerland. The sponsor must be informed in advance. 5 Swissmedic shall inform the responsible ethics committee and other competent cantonal and federal authorities of the results of the inspection.
Para. 3 — SR 812.212.1. The reference has been amended on 1 Jan. 2019 pursuant to Art. 12 para. 2 of the Publications Act of 18 June 2004 (SR 170.512).
Art. 47 Official measures of Swissmedic
Swissmedic may revoke or suspend the approval granted or make the continuation of the clinical trial subject to additional conditions, in particular if: a. the safety or health of participants is at risk, particularly as a result of inadequate product safety or manufacturing defects; b. the quality of the data collected is poor; c. the clinical trial is not conducted in accordance with the application documents approved by Swissmedic or by the ethics committee; d. the approval and reporting requirements have not been complied with.
Art. 48 Coordination and information
1 The responsible ethics committee, Swissmedic and the other competent cantonal authorities shall coordinate in advance the official measures to be taken. 2 The right is reserved to take measures which have to be ordered without delay in order to protect the safety or health of the persons concerned. The ethics committees and the other competent federal and cantonal authorities shall immediately inform each other about such measures.