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CC 818.101.24 Ordinance 3 of 19 June 2020 on Measures to Combat the Coronavirus (COVID-19) (COVID-19 Ordinance 3)

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818.101.24

English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.

Ordinance 3 on Measures to Combat the Coronavirus (COVID-19)

(COVID-19 Ordinance 3)

of 19 June 2020 (Status as of 21 December 2020)

The Swiss Federal Council,

based on Articles 3 and 8 of the COVID-19 Act of 25 September 20201 and on Article 63 paragraph 3 of the Therapeutic Products Act of 15 December 20002,3

ordains:

  Chapter 1 General Provisions

  Art. 1 Subject matter and purpose

1 This Ordinance orders measures applicable to the population, organisations and institutions and the cantons to combat the coronavirus (COVID-19).

2 The measures serve to ensure Switzerland’s capacities to manage the epidemic, in particular to maintain the provision of the population with adequate care and a sufficient supply of essential medical goods.

  Art. 2 Responsibility of the cantons

Unless this Ordinance provides otherwise, the cantons shall retain their responsibilities.


  Chapter 2 Maintenance of Capacities to provide Healthcare

  Section 1 Principle

  Art. 3

1 In order to maintain Switzerland’s capacities to manage the COVID-19 epidemic and in particular to guarantee the provision of the population with adequate care and a sufficient supply of essential medical products, the following measures in particular must be taken:

a.
measures to restrict the entry of persons from high-risk countries and regions and the import and export of goods;
b.
measures to guarantee the provision of essential medical goods.

2 High-risk countries or regions are in particular countries or regions in which the authorities have taken exceptional measures to prevent and combat the COVID-19 epidemic. A list of high-risk countries and regions is published in Annex 1. The Federal Department of Justice and Police (FDJP) shall compile and regularly update the list in consultation with the Federal Department of Home Affairs (FDHA) and the Federal Department of Foreign Affairs (FDFA).


  Section 2 Restrictions on Border Crossings and the Admission of Foreign Nationals

  Art. 41Border crossings and controls

1 Foreign nationals who wish to enter Switzerland from a high-risk country or from a high-risk region and who do not fall within the scope of the Agreement of 21 June 19992 between the European Community and its Member States, of the one part, and the Swiss Confederation, of the other part, on the Free Movement of Persons (AFMP) or the Convention of 4 January 19603 establishing the European Free Trade Association (EFTA Convention) shall be refused entry for a period of stay of up to three months that does not require a permit and does not involve gainful employment (Art. 10 of the Foreign Nationals and Integration Act of 16 December 20054 (FNIA)).

2 Persons who provide credible evidence that they are in a situation of special necessity are exempted from this ban on entry. The State Secretariat for Migration (SEM) shall issue the required directives.

3 Decisions taken by the competent authorities may be enforced immediately. Article 65 of the FNIA applies mutatis mutandis. An appeal may be filed against the SEM decision within 30 days of notification. The appeal does not have suspensive effect.

4 The criminal provisions of Article 115 FNIA apply mutatis mutandis. In the event of any violation of the provision on entry, a ban on entry may also be imposed.


1 Amended by No I of the O of 24 June 2020 (Relaxation of Measures relating to Borders, Entry and Admission for Residence and Employment), in force since 6 July 2020 (AS 2020 2611).
2 SR 0.142.112.681
3 SR 0.632.31
4 SR 142.20

  Art. 5–71

1 Repealed by No I of the O of 24 June 2020 (Relaxation of Measures relating to Borders, Entry and Admission for Residence and Employment), with effect from 6 July 2020 (AS 2020 2611).

  Art. 81

1 Repealed by Art. 6 No 1 of the COVID-19 Ordinance on International Passenger Transport Measures of 2 July 2020, with effect from 6 July 2020 (AS 2020 2737).

  Art. 9 Provisions on cross-border passenger and goods transport

1 The FDJP in consultation with the FDHA, the Federal Department of the Environment, Transport, Energy and Communications (DETEC), the FDF and the FDFA shall decide on restrictions on air passenger services from high-risk countries or regions.

2 It may in particular suspend passenger transport for certain flights, close individual airfields with international borders to passenger transport from high-risk countries or regions or simply prohibit passenger transport to Switzerland from high-risk countries or regions.

3 Restrictions on cross-border passenger transport are set out in Annex 2.

  Art. 101Granting of visas

Foreign nationals who wish to enter Switzerland from a high-risk country or from a high-risk region and who do not fall within the scope of the AFMP2 or the EFTA Convention3 shall not be granted a Schengen visa for periods of stay of up to three months that do not require a permit and do not involve gainful employment. Exempted from the foregoing are applications from persons under Article 4 paragraph 2.


1 Amended by No I of the O of 24 June 2020 (Relaxation of Measures relating to Borders, Entry and Admission for Residence and Employment), in force since 6 July 2020 (AS 2020 2611).
2 SR 0.142.112.681
3 SR 0.632.31

  Art. 10a1Extension of deadlines

1 Foreign nationals who have been prevented from acting within the deadlines laid down in Articles 47 or 61 FNIA2 because of measures in connection with the coronavirus may carry out the act required at any time while this Ordinance remains in force.

2 By carrying out the required act, they shall achieve the position that would have been achieved had they acted within the prescribed deadline.

3 If the deadlines under Articles 59b or 102a FNIA for updating biometric data in order to obtain or extend a permit cannot be met because of the coronavirus, the permit may still be issued or extended at any time while this Ordinance remains in force.


1 Inserted by No I of the O of 24 June 2020 (Relaxation of Measures relating to Borders, Entry and Admission for Residence and Employment), in force since 6 July 2020 (AS 2020 2611).
2 SR 142.20


  Section 3 Provision of Essential Medical Goods

  Art. 11 Definition

1 Medicinal products, medical devices and protective equipment (essential medical goods) that are important and urgently needed to prevent and combat the coronavirus (COVID-19) are the goods listed in Annex 4.

2 The Federal Department of Home Affairs (FDHA) is responsible for the list and shall update the same regularly in consultation with the Interdepartmental Working Group on Medical Goods in accordance with Article 12 and the Spiez Laboratory.1

3 The Federal Office of Public Health (FOPH) shall define the goods that need to be procured and how they should be used. Based on these terms of reference, the FOPH shall determine the quantities required in consultation with:2

a.
the Interdepartmental Working Group on Medical Goods: for active substances and drugs, medical devices, personal protective equipment and other equipment;
b.
the Spiez Laboratory: for COVID-19 tests and associated reagents.

1 Amended by No I of the O of 18 Dec. 2020 (Sars-CoV-2 Rapid Tests), in force since 21 Dec. 2020 (AS 2020 5801).
2 Amended by No I of the O of 18 Dec. 2020 (Sars-CoV-2 Rapid Tests), in force since 21 Dec. 2020 (AS 2020 5801).

  Art. 12 Interdepartmental Working Group on Medical Goods

1 The Interdepartmental Working Group on Medical Goods shall comprise as a minimum representatives from the following federal agencies:

a.
the FOPH;
b.
the Therapeutic Products Division of the Federal Office for National Economic Supply;
c.
the Swiss Agency for Therapeutic Products (Swissmedic);
d.
the National Emergency Operations Centre (NEOC);
e.
the Medical Services Coordination Committee (SANKO) for Resources Management at Federal Level (ResMaB);
f.
the Armed Forces Pharmacy;
g.
the Coordinated Medical Services (CMS).

2 The Federal Council CMS delegate chairs the working group.

  Art. 13 Duty to report

1 The cantons are obliged on request to report to the CMS on the current stocks of essential medical goods in their healthcare facilities.

2 Laboratories and manufacturers and distributors of in vitro diagnostics (COVID-19 tests) are obliged to report regularly to the Spiez Laboratory on their current stocks of such tests.

3 The CMS may request details of stocks from companies that store essential medical goods.

  Art. 14 Procurement of essential medical goods

1 In order to support the provision of essential medical goods to the cantons and their healthcare facilities, charitable organisations (for example Swiss Red Cross) and third parties (for example laboratories, pharmacies), essential medical goods may be procured if requirements cannot be covered through the normal procurement channels.

2 The essential medical goods that are required shall be determined on the basis of the data transmitted in accordance with Article 13.

3 The Armed Forces Pharmacy is responsible for procuring essential medical goods under paragraph 1 on behalf of the FOPH.

4 The responsible authorities may delegate the procurement of essential medical goods to third parties.

5 When procuring essential medical goods, the Armed Forces Pharmacy may take calculated risks and diverge from the provisions of existing directives and the Financial Budget Act of 7 October 20051 in relation to risks, such as prepayment without security or currency hedging.

6 The Armed Forces Pharmacy manages the procured essential medical goods as instructed by the Interdepartmental Working Group on Medical Goods.


1 SR 611.0

  Art. 15 Allocation of essential medical goods

1 The cantons shall submit requests for allocation to the CMS as required.

2 Allocation shall be made continuously based on the supply situation and the current number of cases in each canton.

3 The CMS in consultation with Interdepartmental Working Group on Medical Goods may allocate essential medical goods to the cantons, to charitable organisations and to third parties.

4 The Spiez Laboratory in consultation with the FOPH is responsible for allocating in vitro diagnostics (COVID-19 tests). Allocation when required applies to all tests available in Switzerland.

  Art. 16 Delivery and distribution of essential medical goods

1 The Confederation or the third parties that it instructs shall ensure the delivery of the essential medical goods procured under Article 14 to a distribution centre for each canton. In exceptional cases, the Confederation in consultation with the cantons may supply eligible facilities and organisations directly.

2 The cantons shall designate cantonal distribution centres for goods that are not supplied directly to the recipient, and shall give notice of these to the responsible federal authorities.

3 They shall ensure that essential medical goods that have been delivered are distributed as required and in good time on their territory.

  Art. 17 Direct sales by the Confederation

The Confederation may sell the essential medical goods on the market in return for payment, either itself or through third parties.

  Art. 18 Costs

1 The costs of procuring essential medical goods shall be funded in advance by the Confederation in the cases where it procures the goods.

2 The cantons, charitable organisations and third parties shall notify the Confederation as quickly as possible of the purchasing costs of the essential medical goods supplied to them where the Confederation has assumed responsibility for their procurement in accordance with Article 14 paragraph 1.

3 The Confederation shall bear the costs of delivering the procured essential medical goods to the cantons.

4 The cantons shall bear the costs of distributing these essential medical goods within the canton.

  Art. 19 Requisitioning

1 If the provision of essential medical goods cannot be guaranteed, the FDHA at the request of the Interdepartmental Working Group on Medical Goods may require individual cantons or public healthcare facilities that have adequate stocks of medicinal products under Annex 4 number 1 to deliver part of their stocks to other cantons or healthcare facilities. The cantons or healthcare facilities shall charge the recipient directly for the costs of the goods and their delivery at the sale price.

2 Subject to the requirement of paragraph 1, the FDHA at the request of the Interdepartmental Working Group on Medical Goods may order the requisitioning of essential medical goods held by companies. The Confederation shall pay compensation at the sale price.

  Art. 20 Manufacture

1 If the provision of essential medical goods cannot otherwise be guaranteed, the Federal Council at the request of the Interdepartmental Working Group on Medical Goods may require manufacturers to produce essential medical goods, to prioritise the production of such goods or to increase production volumes.

2 The Confederation may contribute to the cost of production under paragraph 1 where manufacturers suffer financial disadvantages as a result of the changeover in production or the cancellation of private orders.

  Art. 21 Exceptions to the requirement of authorisation for medicinal products

1 Medicinal products that are manufactured with active substances under Annex 5 for the treatment of COVID-19 patients may, provided an application for authorisation of a medicinal product containing one of these active substances has been filed, be placed on the market without authorisation pending Swissmedic’s decision on authorisation. When examining applications for authorisation, Swissmedic may permit a relaxation of the relevant requirements for such medicinal products under the law on therapeutic products on the basis of a risk-benefit analysis.

2 Amendments to the authorisation for a medicinal product authorised in Switzerland containing an active substance under Annex 4 number 1 that is used to prevent and treat COVID-19 in Switzerland may be made immediately after filing a corresponding amendment application. Swissmedic may permit a relaxation of the relevant requirements for such amendments under the law on therapeutic products on the basis of a risk-benefit analysis.

3 The FDHA shall regularly update the list in Annex 5.1

4 Swissmedic may on the basis of a risk-benefit analysis permit changes to the manufacturing process approved within the framework of the authorisation of medicinal products used to prevent and treat COVID-19 in Switzerland. It shall specify criteria according to which the person responsible for technical matters may grant an early market release for medicinal products used to prevent and treat COVID-19 in Switzerland.


1 Amended by No I of the O of 18 Dec. 2020 (Sars-CoV-2 Rapid Tests), in force since 21 Dec. 2020 (AS 2020 5801).

  Art. 22 Exceptions to the provisions on the import of medicinal products

1 Pharmacists that have pharmaceutical responsibility in a hospital pharmacy may import non-authorised medicinal products with active substances under Annex 5 for the treatment of COVID-19 patients. A company with a wholesale or import licence may be instructed to import such medicinal products.

2 Notice of the import must be given to Swissmedic within 10 days of the arrival of goods.

3 In order to prevent and treat COVID-19 in Switzerland, Swissmedic may allow the temporary placing on the market of a medicinal product as a short-term solution for the temporary non-availability of an identical medicinal product authorised in Switzerland, provided no essentially identical medicinal product is authorised and available in Switzerland.

4 After submitting its application for authorisation for a COVID-19 vaccine and for an operating licence under Article 10 paragraph 1 letter b of the Therapeutic Products Act of 15 December 2000, the applicant may instruct a company with a wholesale or import licence to import the COVID-19 vaccine before its authorisation and to store the vaccine until authorisation is granted. The company instructed must comply with the international rules on good distribution practice in accordance with Annex 4 of the Medicinal Products Licensing Ordinance of 14 November 20181.2


1 SR 812.212.1
2 Inserted by No I of the O of 18 Dec. 2020 (Sars-CoV-2 Rapid Tests), in force since 21 Dec. 2020 (AS 2020 5801).

  Art. 23 Exceptions for medical devices

1 In response to an application, Swissmedic may authorise the placing on the market and use of medical devices that have not undergone a conformity assessment procedure in accordance with Article 10 the Medical Devices Ordinance of 17 October 20011 (MedDO), provided their use for preventing and combating the coronavirus in Switzerland is in the interests of public health or patient safety or health and provided, taking account of their intended purpose, their fulfilment of the essential requirements and their effectiveness and performance are adequately proven.

2 When assessing the risks under paragraph 1, Swissmedic shall in particular take account of the procurement needs identified by the FOPH for preventing and combating the coronavirus in Switzerland.

3 Authorisation shall be granted to the Swiss distributor or the applicant institution or healthcare facility. It may be made subject to a time limit and other conditions and requirements.

4 Facemasks which have not undergone a conformity assessment procedure under Article 10 MedDO may be placed on the market without authorisation under paragraph 1 provided they:

a.
are placed on the market exclusively for non-medical use; and
b.
are expressly labelled as being for non-medical use.

5 Facemasks placed on the market in accordance with paragraph 3bis may not be used in hospitals or medical practices by persons in direct contact with patients.

6 The obligations in relation to product surveillance under the MedDO, in particular to collecting reports of incidents, continue to apply.


1 SR 812.213

  Art. 241Facilities that may carry out non-automated single-patient rapid tests for direct detection of Sars-CoV-2

1 Non-automated single-patient rapid tests for direct detection of Sars-CoV-2 (Sars-CoV-2 rapid tests) may only in be carried out in the following facilities:

a.
laboratories licensed under Article 16 of the Epidemics Act of 28 September 20122 (EpidA) and sample collection stations that they operate;
b.
medical practices, pharmacies and hospitals and in test centres operated by or on behalf of the canton.

2 Sars-CoV-2 rapid tests may be carried out outside the facilities mentioned in paragraph 1, provided a laboratory manager, a doctor or a pharmacist accepts responsibility for complying with the requirements of Articles 24–24b.

3 Sars-CoV-2 rapid tests based on molecular-biological detection procedures may only be carried out:

a.
in facilities under paragraph 1 letter a;
b.
outside such facilities if a laboratory manager for such a facility accepts responsibility for carrying out the tests.

4 Facilities under paragraph 1 letter b may conduct Sars-CoV-2 rapid tests without a licence under Article 16 EpidA and outside closed systems provided they comply with the following conditions:

a.
Suitable safety measures and precautionary measures plans to protect persons, animals, the environment and biological diversity have been prepared and implemented.
b.
The tests are only carried out by staff specifically trained for this purpose according to the instructions provided by the test manufacturer.
c.
The test results are interpreted under the supervision of persons with the required expertise; external experts may also be consulted.
d.
The facilities keep records that permit the traceability and prove the quality of the test systems used. The records must be preserved.
e.
The facilities are authorised by the canton to carry out such tests.

5 Sars-CoV-2 rapid tests are direct detection methods that detect the antigens to or the ribonucleic acids of Sars-CoV-2. The tests are not automated and are carried out with the minimum of instruments; only the reading of the test result may be automated.


1 Amended by No I of the O of 18 Dec. 2020 (Sars-CoV-2 Rapid Tests), in force since 21 Dec. 2020 (AS 2020 5801).
2 SR 818.101

  Art. 24a1Sars-CoV-2 rapid tests to be used in facilities under Article 24 paragraph 1 letter b

1 In facilities under Article 24 paragraph 1 letter b, the only test systems that may be used are those whose reliability and performance have been proven to meet the minimum criteria under Annex 5a by independent validation carried out by a laboratory licensed under Article 16 EpidA2.

2 Instead of the test systems under paragraph 1, in specific cases test systems may also be used that have been validated by a laboratory or facility with European recognition, provided the FOPH, with the assistance of the Swiss Society for Microbiology (SGM) or the National Reference Centre for Emerging Viral Infections (NAVI), recognises this validation.

3 The test systems referred to in paragraphs 1 and 2 may only are used insofar as this does not jeopardise an adequate supply of test materials to the laboratories under Article 24 paragraph 1 letter a.

4 The FDHA may amend Annex 5a to take account of technical and scientific developments.


1 Inserted by No I of the O of 18 Dec. 2020 (Sars-CoV-2 Rapid Tests), in force since 21 Dec. 2020 (AS 2020 5801).
2 SR 818.101

  Art. 24b1Persons eligible for Sars-CoV-2 rapid tests

1 Sars-CoV-2 rapid tests may only be carried out on persons who meet the FOPH criteria for suspicion, sampling and reporting of 18 December 20202.

2 They may also be carried out in facilities in accordance with Article 24 paragraph 1 or outside such facilities in compliance with Article 24 paragraph 2 on persons who do not meet the criteria referred to in paragraph 1 provided:

a.
the requirements of Articles 24 paragraph 4 and 24a are met;
b.
the facility or the person that carries out the Sars-CoV-2 rapid test:
1.
allows a sample to be taken with a view to molecular-biological analysis for Sars-CoV-2 as a confirmatory diagnosis,
2.
informs the cantonal authority or organisation responsible for contact tracing if there is no confirmatory diagnosis.

3 The FOPH shall publish information on the use of Sars-CoV-2 rapid tests by persons who do not meet the criteria in paragraph 1.


1 Inserted by No I of the O of 18 Dec. 2020 (Sars-CoV-2 Rapid Tests), in force since 21 Dec. 2020 (AS 2020 5801).
2 Abrufbar unter www.bag.admin.ch > Krankheiten > Infektionskrankheiten bekämpfen > Meldesysteme für Infektionskrankheiten > Meldepflichtige Infektionskrankheiten > Meldeformulare.

  Art. 24c1List of Sars-CoV-2 rapid tests

1 The FOPH shall maintain a list of the Sars-CoV-2 rapid tests that may be used.

2 It shall publish the list on its website and keep it up to date.


1 Inserted by No I of the O of 18 Dec. 2020 (Sars-CoV-2 Rapid Tests), in force since 21 Dec. 2020 (AS 2020 5801).

  Art. 24d1Responsibility of the cantons for carrying out Sars-CoV-2 rapid tests

The cantons are responsible for monitoring and enforcing compliance with the conditions in Articles 24–24b at the facilities referred to in Article 24 paragraph 1 letter b.


1 Inserted by No I of the O of 18 Dec. 2020 (Sars-CoV-2 Rapid Tests), in force since 21 Dec. 2020 (AS 2020 5801).

  Art. 24e1Disclosure of data

Swissmedic may disclose data on essential medical goods to the federal offices and organisations mentioned in Article 12 paragraph 1, provided this is required in order to implement this Ordinance. The data must not include sensitive personal data.


1 Inserted by No I of the O of 18 Dec. 2020 (Sars-CoV-2 Rapid Tests), in force since 21 Dec. 2020 (AS 2020 5801).


  Chapter 3 Healthcare Provision

  Art. 25 Hospitals and clinics

1 The cantons shall ensure that sufficient capacities (in particular beds and specialist staff) are available in the inpatient departments of hospitals and clinics for COVID-19 patients and for other urgently required medical examinations and treatments, in particular in the intensive care units and the general internal medicine departments.

2 For this purpose, they may require hospitals and clinics:

a.
to make their inpatient capacities available immediately or on demand; and
b.
to restrict or suspend non-urgent medical procedures and treatments.

3 The hospitals and clinics must ensure that supplies of medicinal products for COVID-19 patients and for other urgently required medical examinations and treatments is guaranteed in their outpatient and inpatient departments.

  Art. 261Payment of costs for analyses for Sars-CoV-2

1 The Confederation shall pay the costs of microbiological analyses for Sars-CoV-2, analyses for Sars-CoV-2 antibodies, immunological analyses for Sars-CoV-2 antigens and Sars-CoV-2 rapid tests (analyses for Sars-CoV-2) carried out in an outpatient setting on persons who fulfil the FOPH criteria for suspicion, sampling and reporting of 18 December 20202. The services for which payment is made and the maximum amounts paid per service are set out in Annex 6. The FDHA may adjust the maximum amounts paid in line with the effective costs.3

2 The Confederation shall pay the costs only if the services specified in Annex 6 are provided by:

a.
the following service providers under the Federal Act of 18 March 19944 on Health Insurance (HIA):
1.
doctors,
2.
pharmacists,
3.
hospitals,
4.
laboratories in accordance with Article 54 paragraph 3 of the Ordinance of 27 June 19955 on Health Insurance (HIO) and hospital laboratories in accordance with Article 54 paragraph 2 HIO that hold a licence under Article 16 paragraph 1 EpidA6;
b.
test centres that are operated by or on behalf of the canton.

3 Health insurance companies under Article 2 of the Health Insurance Oversight Act of 26 September 20147 and the military insurance are liable to pay the service providers under paragraph 2 for the services in accordance with the system of tiers payant as defined in Article 42 paragraph 2 of the Health Insurance Act.

4 Persons tested as specified in Annex 6 shall not be required to pay a share of the costs in accordance with Article 64 of the Health Insurance Act.

5 Service providers under paragraph 2 shall not charge persons tested as specified in Annex 6 any additional costs. They must pass on any sums that directly or indirectly cover any part of the cost shares in accordance with Annex 6 numbers 1–3 to the reimbursement debtor.

6 The Confederation does not pay the cost of analyses for Sars-CoV-2 carried out in relation to persons who do not meet the FOPH criteria for suspicion, sampling and reporting of 18 December 2020.8


1 Amended by No I of the O of 28 Oct. 2020 (Sars-CoV-2 Rapid Antigen Tests), in force since 2 Nov. 2020 (AS 2020 4495).
2 Available at www.bag.admin.ch > Diseases > Combating infectious diseases > Reporting systems for infectious diseases > Infectious diseases requiring notification > Declaration forms.
3 Amended by No I of the O of 18 Dec. 2020 (Sars-CoV-2 Rapid Tests), in force since 21 Dec. 2020 (AS 2020 5801).
4 SR 832.10
5 SR 832.102
6 SR 818.101
7 SR 832.12
8 Inserted by No I of the O of 18 Dec. 2020 (Sars-CoV-2 Rapid Tests), in force since 21 Dec. 2020 (AS 2020 5801).

  Art. 26a1Procedure for paying the costs of analyses for Sars-CoV-2

1 Service providers under Article 26 paragraph 2 shall send their invoice for services under Annex 6 to the insurer within six months of providing the service at the latest. The invoice may cover only the services in accordance with Annex 6. It shall preferably be sent electronically.2

2 Service providers under Article 26 paragraph 5 shall not charge for services under Annex 6 numbers 1–4 as Position 3186.00 of Annex 3 to the Health Insurance Benefits Ordinance of 29 September 19953.

3 The insurer with which the person tested is insured against illness is liable under Article 26 paragraph 3. In the case of persons who are not insured in Switzerland, the Joint Institution under Article 18 of the Health Insurance Act4 is liable.

4 The insurers shall check the invoices and ascertain whether the service provider in accordance with Article 26 paragraphs 2–5 has charged correctly for the services under Annex 6. They shall comply with Articles 84–84b of the Health Insurance Act in processing the data.

5 At the start of January, April, July and October, they shall notify the FOPH of the number of analyses for which they have paid the service providers under Article 26 paragraph 2, and of the amount paid in each case. The external auditors for the insurers and for the Joint Institution shall each year review the figures and the conduct of suitable checks in accordance with paragraph 4 and submit a report to the FOPH. The FOPH may request additional information from the insurers and the Joint Institution on the amounts paid to each service provider under Article 26 paragraph 2.5

6 The Confederation shall reimburse the insurers every quarter for the services that they have paid for.

7 In the event of any violation by the service provider of the duties to report under Article 12 EpidA6, the Confederation may require the service provider to refund the payment.

8 The invoice for analyses for Sars-CoV-2 carried out in relation to persons who do not meet the FOPH criteria for suspicion, sampling and reporting of 18 December 20207 must be marked «Analysis for Sars-CoV-2 without meeting the testing criteria ».8


1 Inserted by No I of the O of 24 June 2020 (AS 2020 2549). Amended by No I of the O of 28 Oct. 2020 (Sars-CoV-2 Rapid Antigen Tests), in force since 2 Nov. 2020 (AS 2020 4495).
2 Amended by No I of the O of 18 Dec. 2020 (Sars-CoV-2 Rapid Tests), in force since 21 Dec. 2020 (AS 2020 5801).
3 SR 832.112.31
4 SR 832.10
5 Amended by No I of the O of 18 Dec. 2020 (Sars-CoV-2 Rapid Tests), in force since 21 Dec. 2020 (AS 2020 5801).
6 SR 818.101
7 Abrufbar unter www.bag.admin.ch > Krankheiten > Infektionskrankheiten bekämpfen > Meldesysteme für Infektionskrankheiten > Meldepflichtige Infektionskrankheiten > Meldeformulare.
8 Inserted by No I of the O of 18 Dec. 2020 (Sars-CoV-2 Rapid Tests), in force since 21 Dec. 2020 (AS 2020 5801).


  Chapter 4 Company Meetings

  Art. 27

1 In the case of company meetings, the organiser may, regardless of the probable number of participants and without complying with the period of notice for convening meetings, order the participants to exercise their rights exclusively:

a.
in writing or online; or
b.
through an independent proxy appointed by the organiser.

2 The organiser shall decide within the period specified in Article 29 paragraph 4. Notification of the order must be given in writing or published online no later than four days before the event.1


1 Amended by No I of the O of 11 Sept. 2020 (Extension; Test Costs), in force since 14 Sept. 2020 (AS 2020 3695).


  Chapter 5 Final Provisions

  Art. 28 Repeal of another enactment

The COVID-19 Ordinance 2 of 13 March 20201 is repealed.


1 [AS 2020 773 783 841 863 867 1059 1065 1101 1131 1137 1155 1199 1245 1249 1333 1401 1501 1505 1585 1751 1815 1823 1835 2097 2099 2213]

  Art. 28a1Transitional provision to the Amendment of 11 September 2020

Personal protective equipment that was permitted under Article 24 of the previous law may continue to be placed on the market until 30 June 2021.


1 Inserted by No I of the O of 11 Sept. 2020 (Extension; Test Costs), in force since 18 Sept. 2020 (AS 2020 3695).

  Art. 29 Commencement and term

1 This Ordinance comes into force on 22 June 2020 at 00.00.

2 It applies until 13 September 2020.1

3 ...2

4 The term of application of this Ordinance shall be extended to 31 December 2021.3


1 Amended by No II of the O of 12 Aug. 2020 (Requirement to wear Masks in Aircraft; Large-scale Events), in force since 15 Aug. 2020 (AS 2020 3547).
2 Repealed by No II of the O of 12 Aug. 2020 (Requirement to wear Masks in Aircraft; Large-scale Events), with effect from 15 Aug. 2020 (AS 2020 3547).
3 Inserted by No I of the O of 11 Sept. 2020 (Extension; Test Costs), in force since 14 Sept. 2020 (AS 2020 3695).


  Annex 11 

(Art. 3 para. 2)

  List of high-risk countries and regions

All states outside the Schengen area, with the exception of:

–
Andorra
–
Australia
–
Bulgaria
–
Croatia
–
Cyprus
–
Holy See
–
Ireland
–
Japan
–
Monaco
–
New Zealand
–
Romania
–
Rwanda
–
San Marino
–
South Korea
–
Singapore
–
Thailand
–
Uruguay

1 Amended by No I of the FDJP O of 29 Oct. 2020, in force since 3 Nov. 2020 (AS 2020 4521).

  Annex 21 


1 Rendered obsolete by the repeal of Art. 8 (see Art. 6 No 1 of the COVID-19 Ordinance on International Passenger Transport Measures of 2 July 2020; AS 2020 2737).

  Annex 3

(Art. 9 para. 3)

  Restrictions on cross-border passenger transport

  Annex 41 

(Art. 11 para. 1, 19 para. 1 and 21 para. 2)

  List of important medicinal products, medical devices and protective equipment (Essential Medical Goods)

  1. Active substances or medicinal products with the listed active substances

  1. Tocilizumab

  2. Remdesivir

  3. Propofol

  4. Midazolam

  5. Ketamine

  6. Dexmedetomidine

  7. Dobutamine

  8. Sufentanil

  9. Remifentanyl

10. Rocuronium

11. Atracurium

12. Suxamethonium

13. Noradrenalin

14. Adrenalin

15. Insulin

16. Fentanyl

17. Heparin

18. Argatroban

19. Morphine

20. Paracetamol (parenteral)

21. Metamizol (parenteral)

22. Lorazepam

23. Dexamethasone

24. Co-Amoxicillin

25. Piperacillin/Tazobactam

26. Meropenem

27. Imipenem/Cilastatin

28. Cefuroxime

29. Ceftriaxone

30. Amikacin

31. Posaconazole

32. Fluconazole

33. Voriconazole

34. Caspofungin

35. Esmolol (parenteral)

36. Metoprolol (parenteral)

37. Labetalol (parenteral)

38. Clonidine

39. Amiodarone

40. Furosemide

41. Vaccines against COVID-19

42. Vaccines against influenza

43. Vaccines against bacterial pneumonia (Prevnar 13)

44. COVID-19 immunotherapeutics

45. Medical gases

  2. Medical devices within the meaning of the Medical Devices Ordinance of 17 October 20012 

1. Ventilators

2. Monitoring equipment for intensive care

3. In vitro diagnostics (COVID-19 tests), including pre-analytical components and instruments

4. Surgical masks / OP masks (hygiene masks)

5. Surgical gloves / examination gloves

6. Medical oxygen

7. Infusion solutions

8. Test kits (tubes and swabs)

  3. Personal protective equipment and other equipment

  3.1 Personal protective equipment within the meaning of the PPE Ordinance of 25 October 20173 

1. Respirators (FFP2 and FFP3)

2. Aprons

3. Protective overalls

4. Protective eyewear

5. Disposable caps

  3.2 Further equipment

1. Hand disinfectants

2. Surface disinfectants

3. Ethanol

4. Hygiene products for intensive care (such as absorbent pads, diapers, faecal collectors, oral hygiene items)


1 Amended by No I of the FOPH O of 6 Oct. 2020 (List of important medical products and List of active substances for the treatment of COVID-19), in force since 19 Oct. 2020 (AS 2020 4129).
2 SR 812.213
3 SR 930.115

  Annex 51 

(Art. 21 para.s 1 and 3, as well as 22 para. 1)

  List of active substances for the treatment of COVID-19

1. Remdesivir

2. Tocilizumab


1 Amended by No I of the FOPH O of 6 Oct. 2020 (List of important medical products and List of active substances for the treatment of COVID-19), in force since 19 Oct. 2020 (AS 2020 4129).

  Annex 5a1 

(Art. 24a para. 1)

  Minimum criteria for the reliability and performance of Sars-CoV-2 rapid tests

  1 General Remarks

1.1
All tests to be validated must be compared with a real-time reverse transcription polymerase chain reaction (RT-PCR) from a nasopharyngeal swab.
1.2
Independent validation is required for the use of such Sars-CoV-2 rapid tests. The Sars-CoV-2 rapid tests are in principle validated on the basis of the clinical validation criteria set out in Number 2. An exception applies to Sars-CoV-2 rapid antigen tests from a nasopharyngeal swab; for these tests, technical validation in accordance with Number 3 is permitted.

  2 Criteria for clinical validation

2.1
The investigation of sensitivity and specificity in the clinical validation must be based on a minimum of 100 Sars-CoV-2-positive and 300 Sars-CoV-2-negative samples. The samples used must come from patients with symptoms in accordance with the FOPH clinical criteria who have been tested within 0–4 days of becoming symptomatic.
2.2
The sensitivity of the tests must be at least 85 % and the specificity at least 99 %.

  3 Criteria for the technical validation of Sars-CoV-2-rapid antigen tests from a nasopharyngeal swab

3.1
The sensitivity and specificity in the technical validation must be determined on the basis of a minimum of 100 Sars-CoV-2 positive and 300 Sars-CoV-2 negative samples, including at least 50 samples with a viral load of at least 10e5 virus copies/ml.
3.2
The rapid antigen tests to be validated must meet the following minimum requirements relating to sensitivity based on the number of copies of the starting material:
–
for 10e7 copies/ml: 95 %
–
for 10e6 copies/ml: 90 %
–
for 10e5 copies/ml: 80 %
3.3
The requirement for specificity is at least 99 %.

1 Inserted by No III para. 1 of the O of 18. Dec. 2020 (Sars-CoV-2 Rapid Tests), in force since 21 Dec. 2020 (AS 2020 5801).

  Annex 61 

(Arts 26 para. 1 and 26a para. 1)

  Services and maximum amounts paid for Sars-CoV-2 analyses

  1 Molecular-biological analyses for Sars-CoV-2

1.1
The Confederation shall pay a maximum of 156 francs of the cost of molecular-biological analyses for Sars-CoV-2.
1.2.
The amount in number 1.1 covers the following services and cost components:
a.
for taking a sample:

Service

Maximum amount

patient consultation and taking sample, including protective materials, by a doctor, in a laboratory, in a hospital, on the premises of a pharmacist or in a test centre:

25 Fr.

communicating the test result to the person tested and to the responsible authorities under Article 12 paragraph 1 EpidA2, by the doctor, the laboratory, the hospital, the pharmacist or the test centre

  2.50 Fr.

detailed doctor-patient consultation by the doctor on the indications, where such is carried out

22.50 Fr.

b.
for the molecular-biological analysis:

Service

Maximum amount

If carried out by laboratories on behalf of another authorised service provider: analysis and report to the authorities under Article 12 paragraph 2 EpidA order processing, overheads and sampling materials

106 Fr.

82 Fr.

24 Fr.

If carried out by laboratories for their own needs: analysis and report to the authorities under Article 12 paragraph 2 EpidA order processing, overheads and sampling materials

87 Fr.

82 Fr.

  5 Fr.

  2 Analyses for Sars-CoV-2 antibodies

2.1
The Confederation shall pay a maximum of 99 francs for the analysis for Sars-CoV-2 antibodies.
2.2
The amount in number 2.1 covers the following services and cost components:
a.
for taking a sample:

Service

Maximum amount

detailed doctor-patient consultation, by the doctor, on the indications

22.50 Fr.

taking a sample, including protective materials, by the doctor, the laboratory or the hospital

25 Fr.

communicating the test result to the person tested and to the responsible authorities under Article 12 paragraph 1 EpidA

  2.50 Fr.

b.
for the analysis for Sars-CoV-2 antibodies:

Service

Maximum amount

If carried out by laboratories on behalf of another authorised service provider: analysis and report to the authorities under Article 12 paragraph 2 EpidA order processing, overheads and sampling materials

49 Fr.

25 Fr.

24 Fr.

If carried out by hospital laboratories for the hospital’s own needs: analysis and report to the authorities under Article 12 paragraph 2 EpidA order processing, overheads and sampling materials

30 Fr.

25 Fr.

  5 Fr.

  3 Immunological analyses for Sars-CoV-2 antigens and and Sars- CoV-2 rapid tests

3.1
The Confederation shall pay a maximum of 99 francs for an immunological analysis for Sars-CoV-2 antigens and for a Sars-CoV-2 rapid test.
3.2
The amount in number 3.1 includes the following services and cost components:
a.
for taking a sample:

Service

Maximum amount

patient consultation and taking sample, including protective materials, by a doctor, in a laboratory, in a hospital, on the premises of a pharmacist or in a test centre,

25 Fr.

communicating the test result to the person tested and to the responsible authorities under Article 12 paragraph 1 EpidA, by the doctor, the laboratory, the hospital, the pharmacist or the test centre

2.50 Fr.

detailed doctor-patient consultation by the doctor on the indications, where such is carried out

22.50 Fr.

b.
for the immunological analysis for Sars-CoV-2 antigens and for a Sars-CoV-2 rapid test:

Service

Maximum amount

If carried out by laboratories for their own needs, and in the medical practice laboratory, on the premises of a pharmacist or in a test centre: analysis and report to the authorities under Article 12 paragraph 2 EpidA order processing

30 Fr.

25 Fr.

  5 Fr.

If carried out by laboratories on behalf of another authorised service provider: analysis and report to the authorities under Article 12 paragraph 2 EpidA order processing, overheads and sampling materials

49 Fr.

25 Fr.

24 Fr.

  4 Costs paid in the case of several analyses involving one person on the same day

4.1
If both a molecular-biological analysis for Sars-CoV-2 in accordance with number 1 and an analysis for Sars-CoV-2 antibodies in accordance with number 2 are carried out for the same person on the same day, the Confederation shall make only one payment of the amount due for taking a sample in accordance with number 1.2 letter a and 2.2 letter a and the amount due for the order processing, overheads and sampling materials in accordance with the number 1.2 letter b and 2.2 letter b.
4.2
If both a molecular-biological analysis for Sars-CoV-2 in accordance with number 1 and an immunological analysis for Sars-CoV-2 antigens in accordance with number 3 or a Sars-CoV-2 rapid test in accordance with number 3 are carried out for the same person on the same day, the Confederation shall make only one payment of the amount due for taking a sample in accordance with in accordance with number 1.2 letter a and 3.2 letter a and the amount due for the order processing, overheads and sampling materials or for the order processing in accordance with the number 1.2 letter b and 3.2 letter b.

1 Inserted by No II of the O of 28 Oct. 2020 (Sars-CoV-2 Rapid Antigen Tests) (AS 2020 4495). Amended by No III para. 2 of the O of 18. Dec. 2020 (Sars-CoV-2 Rapid Tests), in force since 21 Dec. 2020 (AS 2020 5801).
2 SR 818.101


 AS 2020 1295


1 SR 818.1022 SR 812.213 Amended by No I of the O of 18 Dec. 2020 (Sars-CoV-2 Rapid Tests), in force since 21 Dec. 2020 (AS 2020 5801).

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This text is in force.
Decision 19 June 2020
In force 22 June 2020
Expiration 31 December 2021

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All editions of this law

22.06.2020 - 01.01.2022
Ordinance 3 of 19 June 2020 on Measures to Combat the Coronavirus (COVID-19) (COVID-19 Ordinance 3)
 
13.03.2020 - 22.06.2020
Ordinance 3 of 19 June 2020 on Measures to Combat the Coronavirus (COVID-19) (COVID-19 Ordinance 3)
 

For comments and observations: Official Publications Centre
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