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).

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 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.

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 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 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 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.

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.

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 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.

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.

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.

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.

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 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 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 3^bis 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 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 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 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 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.

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.

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.