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 countries or regions in which the coronavirus Sars-CoV-2 has been detected and in which:

a.

there is an increased risk of infection; or

b.

a variant of the virus is widespread that carries a higher risk of infection or causes a more severe form of the disease in comparison with the variant of the virus that is prevalent in the Schengen area.⁵

³ The lists of high-risk countries and regions is published in Annex 1.⁶

¹ The following persons 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 2005⁸ (FNIA):

a.

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 1999⁹ 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 of the Convention of 4 January 1960¹⁰ establishing the European Free Trade Association (EFTA Convention);

b. and c.¹¹

... .¹²

² The following persons are exempt from this ban on entry:

a.¹³ persons who prove that they have been vaccinated against Sars-CoV-2; the persons who are regarded as having been vaccinated, the period for which the vaccination is valid, and the accepted forms of proof are regulated in Annex 1a number 1;

a^bis.¹⁴

persons who prove that they have been infected with Sars-CoV-2 and have recovered; the period for which exemption is valid and the accepted forms of proof are regulated in Annex 1a number 2;

b.

persons who provide credible evidence that they are in a situation of special necessity;

c.¹⁵

persons under the age of 18.¹⁶

^2bis ...¹⁷

^2ter The exemptions under paragraph 2 letters a, a^bis and c do not apply to persons who wish to enter Switzerland from a country or region listed in Annex 1 number 2.¹⁸

^2quater The State Secretariat for Migration (SEM) shall issue the required directives on exceptions to the ban on entry.¹⁹

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.

The Federal Department of Justice and Police (FDJP) shall update Annexes 1 and 1a continuously in consultation with the Federal Department of Home Affairs (FDHA) and the Federal Department of Foreign Affairs (FDFA).

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 movements for certain flights, close individual airfields with international borders to passenger movements from high-risk countries or regions or prohibit movements of persons to Switzerland from high-risk countries or regions entirely.

³ Restrictions on cross-border movements of persons are set out in Annex 2.

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 AFMP²⁴ or the EFTA Convention²⁵ 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 Foreign nationals who have been prevented from acting within the deadlines laid down in Articles 47 or 61 FNIA²⁷ 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 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.²⁸

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 the Interdepartmental Working Group on Medical Goods.²⁹

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 CMS delegate shall chair the working group.³⁰

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 FOPH on their current stocks of such tests when requested to do so.³¹

³ The CMS may request details of stocks from companies that store 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 2005³² 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 The cantons shall submit requests for allocation to the ResMaB as required.³³

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 …³⁴

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.

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

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.

⁵ If the procured goods become freely available in the market again, the Confederation may sell its stocks at market prices.³⁵

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.

^1bis Medicinal products that are manufactured with active substances under Annex 5a in order to prevent the COVID-19 infection of immunosuppressed persons in whom sufficient immune protection cannot be built up despite vaccination or who cannot be vaccinated may be placed on the market without authorisation after submission of an application for the authorisation of a medicinal product containing any of these active substances until Swissmedic's decision on the authorisation has been taken.³⁷

² Amendments to the authorisation for a medicinal product authorised in Switzerland containing an active substance under Annex 4 number 1 on the basis of which the medicinal product can be used to treat COVID-19 patients in Switzerland may be made immediately after filing a corresponding amendment application and pending Swissmedic’s decision on authorisation. Swissmedic may, on the basis of a risk-benefit analysis, permit a relaxation of the relevant requirements under the law on therapeutic products for amendments to the authorisation of medicinal products containing an active substance listed in Annex 4 number 1.³⁸

³ The FDHA shall regularly update the lists in Annexes 5 and 5a.³⁹

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.

⁵ In derogation from Article 9a paragraph 1 letter c of the Therapeutic Products Act of 15 December 2000, temporary authorisations may be issued even if an authorised equivalent medicinal product that can be used as an alternative is available in Switzerland, provided the authorisations serve to guarantee the supply of medicinal products to prevent and combat the coronavirus in Switzerland.⁴⁰

¹ Following the submission of a authorisation application for a medicinal product containing active substances listed in Annex 5 for the treatment of Covid 19 patients, the applicant may import the medicinal product prior to its authorisation or entrust the import of the medicinal product to a company with a wholesale or import licence.⁴¹

^1bis 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.⁴²

² Notice of each import under paragraph 1^bis must be given to Swissmedic within 10 days of the arrival of goods.⁴³

^2bis After submitting an application for the authorisation of a medicinal product in accordance with Article 21 paragraph 1^bis, the applicant may import the medicinal product or instruct a company with a wholesale or import licence to import it before authorisation is granted.⁴⁴

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 2018⁴⁵.⁴⁶

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 23 the Medical Devices Ordinance of 1 July 2020⁴⁸,⁴⁹ (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 23 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 3^bis may not be used in hospitals or medical practices by persons in direct contact with patients.

^5bis The SwissCovid app as specified in the Ordinance of 24 June 2020⁵⁰ on the Proximity Tracing System for the Coronavirus Sars-CoV-2 and as specified in the Ordinance of 30 June 2021⁵¹ on a Notification System for possible Infection with the Coronavirus Sars-CoV-2 at Events is not subject to the provisions on the conformity assessment of medical devices.⁵²

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

¹ FFP masks that do not comply with the principles and procedures for conformity assessment under Article 3 paragraph 2 of the PPE Ordinance of 25 October 2017⁵⁵ (PPEO) and whose non-compliance with these principles and procedure has not been approved based on Article 24 paragraph 3 in its version of 22 June 2020⁵⁶ may not be placed on the market.

² FFP masks under paragraph 1 held in federal and cantonal stocks may be supplied to private hospitals, homes for the elderly and care homes and organisations that provide nursing services and other assistance at home as well as to federal and cantonal facilities such as the armed forces, civil defence units, hospitals and prisons provided the federal or cantonal authority responsible for the supply:

a.

guarantees by means of testing by a recognised European conformity assessment body for FFP masks that the masks provide a level of safety equivalent to that legally required under the PPEO; and

b.

guarantees their traceability.

³ Product information in at least one official language or in English must be available when the masks are supplied. It must be ensured that the user is able to use the product in accordance with the relevant provisions.

¹ Non-automated single-patient rapid tests for direct detection of Sars-CoV-2 (Sars-CoV-2 rapid tests) for specialist use may only be carried out in the following facilities:⁵⁹

a.⁶⁰

laboratories licensed under Article 16 of the Epidemics Act of 28 September 2012⁶¹ (EpidA);

b.⁶²

medical practices, pharmacies and hospitals, homes for the elderly and care homes and socio-medical institutions, and test centres operated by or on behalf of the canton.

^1bis They may also be carried out in and by organisations that provide nursing services and other assistance at home as well as by assistants as defined in the Federal Act of 19 June 1959⁶³ on Invalidity Insurance (InvIA).⁶⁴

² Sars-CoV-2 rapid tests may also be carried out at a location outside the facilities mentioned in paragraph 1 letter b provided a specialist with a CET qualification awarded by the Swiss «The Medical Laboratories of Switzerland» Federation (FAMH), a doctor or a pharmacist accepts responsibility for complying with the requirements of this article and Articles 24a and 24b.⁶⁵

³ If facilities under paragraph 1 letter a offer Sars-CoV-2 rapid tests at a location outside the licensed facilities, they require a licence from Swissmedic and must notify the canton at the location of their offer.⁶⁶

⁴ Facilities under paragraphs 1 letter b and 1^bis may carry out Sars-CoV-2 rapid tests for specialist use without a licence under Article 16 EpidA and outside closed systems provided they comply with the following conditions:⁶⁷

a.

Suitable safety measures and precautionary measures plans to protect persons, animals, the environment and biological diversity have been prepared and implemented.

b.⁶⁸

The tests are only carried out by persons 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.

^4bis Sars-CoV-2 rapid tests for self-testing by the public (Sars-CoV-2 self-tests) may be supplied and used if they are intended for self-testing by the manufacturer and certified accordingly.⁶⁹

⁵ Sars-CoV-2 rapid tests are direct detection methods that detect the antigens to 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.⁷⁰

¹ The only test systems that may be used for Sars-CoV-2 rapid tests for specialist use are those authorised in the EU for issuing the EU’s digital COVID certificate.

² In derogation from paragraph 1, other test systems may also be used provided the Sars-CoV-2 rapid tests are carried out by laboratories licensed under Article 16 EpidA.⁷²

If no confirmatory diagnosis is made following a positive result for a Sars-CoV-2 rapid test and if the FDHA has not required a report on the result of Sars-CoV-2 rapid tests on the basis of Article 19 of the Epidemics Ordinance of 29 April 2015⁷⁴, the facility or person responsible for conducting the tests must notify the cantonal authority or organisation responsible for contact tracing of the positive test result.

The FOPH shall maintain continuously updated lists of Sars-CoV-2 rapid tests for specialist use in accordance with Article 24a and the Sars-CoV-2 self-tests in accordance with Article 24 paragraph 4^bis and shall publish the lists on its website.

The cantons are responsible for monitoring and enforcing compliance with the conditions in Articles 24–24b for Sars-CoV-2 rapid tests that are not carried out at the facilities referred to in Article 24 paragraph 1 letter a.

¹ Samples for molecular-biological analyses for Sars-CoV-2 may be collected:

a.

in laboratories licensed under Article 16 EpidA and in sample collection stations that they operate;

b.

in facilities or by persons in accordance with Article 24 paragraphs 1 letter b, 1^bis and 2;

c.⁷⁸

…

² The sample collection station must verify the identity of the person being tested. The sample must be collected by a person trained for this purpose.

³ The sample may also be collected by the person being tested themselves:

a.

in the facility, provided the facility verifies the identity of the person being tested and supervises the collection of the sample as it is being done; or

b.

outside the facility, provided the facility verifies the identity of the person being tested and guarantees that the sample is correctly assigned to the person being tested by taking suitable precautions, in particular by the video monitoring of the process.

Swissmedic is responsible for monitoring compliance with the requirements set out in Article 24e by laboratories licensed under Article 16 EpidA and the cantons are responsible for monitoring in the facilities in accordance with Article 24e paragraph 1 letter b.

Only laboratories with a licence under Article 16 EpidA may commission a foreign laboratory to conduct molecular-biological analyses for Sars-CoV-2. They remain subject to the requirement to report under Article 12 EpidA.

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.