¹ In order to maintain Switzerland’s capacities to manage the COVID-19 epidemic and in particular to guarantee the conditions required to provide the population with adequate care and a sufficient supply of therapeutic products, the following measures in particular must be taken.

a.¹

measures to restrict the entry of persons from high-risk countries and areas and the import and export of goods;

b.

controls on exports of goods important to the provision of healthcare;

c.²

measures to guarantee the provision of essential medical goods.³

² High-risk countries or areas are in particular countries or areas in which the authorities have taken exceptional measures to prevent and combat the COVID-19-epidemic. A list of high-risk countries and areas is published in Annex 1 to this Ordinance. 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).⁴

¹ Persons coming from a high-risk country or from a high-risk area who wish to enter Switzerland must meet at least one of the following requirements:¹

a.

they are Swiss citizens;

b.²

they have a travel document; and

1.

a residence document, in particular a Swiss residence permit, a cross-border commuter permit, a visa issued by Switzerland for the purpose of attending professional consultations as a health sector specialist or for making an official visit of vital importance,

2.³

an entry permit with a visa issued by Switzerland or the assurance of a residence permit;

c.⁴

they have rights under the Agreement on the Free Movement of Persons, have a work-related reason for entering Switzerland and can provide a confirmation of notification (Meldebestätigung/ attestation d’annonce/ attestato di notifica);

d.

they are transporting goods for commercial purposes and can provide a bill of lading for the goods;

e.⁵

they are simply travelling in transit through Switzerland with the intention of going directly to another country that they are permitted to enter;

f.

they are in an emergency situation;

g.⁶

they are a specialist in the healthcare sector and need to enter Switzerland for important professional reasons.

^1bis Entry with a cross-border commuter permit in accordance with paragraph 1 letter b number 1 is only permitted for work-related purposes.⁷

^1ter Foreign nationals who do not come within the scope of the AFMP or the Convention of 4 January 1960⁸ establishing the European Free Trade Association (EFTA Convention) must also meet the entry requirements set out in Article 5 of the Foreign Nationals and Integration Act of 16 December 2005⁹ (FNIA).¹⁰

^1quater The competent authorities shall conduct risk-based checks.¹¹

² The persons concerned must provide credible evidence that they meet at least one of the above-mentioned requirements. The State Secretariat for Migration shall issue the required directives.¹²

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.¹³

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.

⁵ Foreign nationals at Schengen internal and external borders at airports may likewise be refused entry, unless at least one of the requirements in paragraph 1 is met. The FDJP in consultation with the FDHA and the FDFA shall decide on the high-risk countries or areas to which this measure applies. Paragraphs 2 and 4 apply mutatis mutandis in such a case.¹⁴

¹ In the case of foreign nationals covered by the AFMP or the EFTA Convention², concerns related to public health protection are not taken into consideration for the purposes of admission or the notification for short-term work provided:

a.

the admission or notification is in connection with work that is in the overriding public interest, in particular in relation to the national economic supply;

b.

the admission is for the purpose of family reunification;

c.

the application for admission for a stay in order to work or the notification of short-term work was submitted to the competent cantonal authority as part of the notification procedure before 25 March 2020, or obligations were entered into under an employment contract with a Swiss before this date; or

d.

notification of the short-term provision of a cross-border service under the notification procedure is based on a written contract for the provision of services entered into before 25 March 2020.

² The national economic supply in terms of paragraph 1 letter a supports activities that are in particular related to therapeutic products and care, foodstuffs, energy, logistics and information and communications technology. This also includes maintenance work on infrastructures in these sectors.

¹ In the case of foreign nationals who are not covered by the AFMP or the EFTA Convention² concerns related to public health protection are not taken into consideration for the purposes of admission for a stay in order to work provided:

a.

they meet the requirements of Article 3 paragraph 1 letter f or g and the admission requirements under the FNIA³;

b.

the application for admission was approved before 19 March 2020, but the entry permit, visa or assurance of a residence permit could not be issued because of measures taken under this Ordinance; or

c.

the application by the employer was filed before 19 March 2020.

² Admission for the purpose of work under paragraph 1 letter b or c in an establishment that is affected by measures in accordance with Chapter 3 and in particular that falls within the scope of Article 6 paragraph 2 is not permitted.

Concerns related to public health protection are not taken into consideration for admission for the purposes of family reunifications under Article 42 FNIA² where the family members resident in Switzerland are Swiss citizens.

The import of goods over land border crossings from a neighbouring state that is a high-risk country is prohibited if the goods have been acquired in the course of a journey that has served the exclusive purpose of going shopping.

¹ The FDHA, in consultation with the FDJP and the Federal Department of Finance (FDF), may order health-related measures at the border in accordance with Articles 35 and 41 paragraphs 2 and 4 EpidA for persons entering Switzerland from a high-risk country or area.

² The measures are listed in Annex 7.

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 road, rail, ship and air passenger services from high-risk countries or areas.

² It may in particular suspend specific forms of passenger transport for certain routes, lines or flights, close individual border crossings, ports or airports to passenger transport from high-risk countries or areas or simply prohibit passenger transport to Switzerland from high-risk countries or areas.

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

⁴ The Federal Customs Administration (FCA) may independently order and enforce the closure to passenger and goods transport of small subsidiary land border crossings provided and for as long as this is necessary because of the situation. It shall notify the FDJP, DETEC and the FDFA immediately of any closures that it orders. It shall indicate closed border crossings as such and publish the current list of open land border crossings on its website³.⁴

⁵ It shall decide on the border crossings at which priority lanes (green lanes) will be provided for road traffic bringing important goods to maintain the national economic supply and for persons in priority professional groups, in particular persons working in the health sector. It shall lay down the conditions for using the green lanes for important goods in consultation with the Logistics Division at the Federal Office for National Economic Supply. It shall consult the cantons with regard to the use of green lanes by persons in priority professional groups. It shall publish the current list of green lanes and the conditions for their use on its website⁵.⁶

The granting of Schengen visas and of national visas and entry permits to persons from high-risk countries or areas in accordance with Annex 1 shall be suspended. Exempted from the foregoing are applications from persons who are admitted in accordance with Article 3a paragraph 1 letter b, Article 3b paragraph 1 letters b and c or Article 3c or who meet the requirements of Article 3 paragraph 1 letter f or g.

¹ A licence from the State Secretariat for Economic Affairs (SECO) is required for the export from Swiss customs territory of the goods listed in Annex 3, if applicable in addition to the authorisation required under the law on therapeutic products and narcotics.²

² Paragraph 1 does not apply to the export of goods:³

a.

provided reciprocity is guaranteed, to EU member states, the overseas countries and territories listed in Annex II of the Treaty of 13 December 2007⁴ on the Functioning of the European Union (Consolidated Version), Norway, Iceland, the United Kingdom, the Faroe Islands, Andorra, San Marino and the Vatican City;

b.

by medical, disaster relief and civil protection personnel in order to carry out their professional duties or to provide first aid;

c.

by other persons for their own personal use;

d.

as equipment for providing first aid or for other emergency uses in buses, trains, aircraft or ships on international transport services;

e.

to supply:

1.

Swiss foreign representations, foreign missions and deployments for the European Border and Coast Guard Agency Frontex,

2.

Swiss public institutions abroad,

3.

Members of the Swiss armed forces deployed abroad,

4.

Swiss members of international police missions or civilian international peace-keeping missions.

¹ The application must be submitted via the ELIC electronic licensing system operated by SECO.

² SECO shall decide within five working days of receipt of the duly completed application. If particularly complex clarifications are required, this deadline may be extended by a further five working days.

³ SECO notifies the applicant of the decision in electronic form.

⁴ A licence shall be granted provided there are sufficient goods under Annex 3 for healthcare facilities, other medical personnel, patients, civil protection and civil defence and for rescue and security authorities and organisations in Switzerland.²

⁵ Before making its decision, SECO shall consult the Federal Office for National Economic Supply, the Federal Office of Public Health (FOPH), the Federal Office for Civil Protection and the Coordinated Medical Services (CMS). The competent bodies shall in particular declare the quantities of protective equipment or essential medical goods that have been reported in compliance with the duty to report under paragraphs 2–4.³

^5bis SECO may decide on applications for the export of up to 10 000 items of goods in accordance with Annex 3 list 1 (protective equipment) without consultations in accordance with paragraph 5.⁴

⁶ SECO may consult foreign authorities, provide them with relevant information and take account of information they have provided when reaching its decision.

⁷ The decision whether to grant a licence shall be based on all relevant considerations, including where applicable the question of whether the export will support:

a.

states or international organisations that have made a request to Switzerland;

b.

aid organisations abroad that are protected under the Geneva Convention on Refugees⁵;

c.

the Global Outbreak Alert and Response Network (GOARN) of the World Health Organization (WHO).

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 FOPH is responsible for the list, shall update the same regularly in consultation with the Armed Forces Pharmacy, the Spiez Laboratory and the Therapeutic Products Division of the Federal Office for National Economic Supply with regard to the goods to be procured, and shall decide on the quantities required in each case.

¹ The cantons are obliged to report regularly to the CMS on the current stocks of essential medical goods in their healthcare facilities, subject to paragraphs 2 and 3.

² The cantons, hospitals and manufacturers and distributors of medicinal products are obliged to report regularly to the Therapeutic Products Division of the Federal Office for National Economic Supply on their current stocks of specific medicinal products listed in Annex 4 number 1.

³ 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.

⁴ 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 4e.

³ The following bodies are responsible for procuring essential medical goods under paragraph 1 on behalf of the FOPH:

a.

for medical devices and protective equipment: the Armed Forces Pharmacy;

b.

for medicinal products: the FOPH in consultation with the Therapeutic Products Division of the Federal Office for National Economic Supply.

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, having obtained the approval of the Federal Finance Administration, 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.²

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 the FOPH and the Therapeutic Products Division of the Federal Office for National Economic Supply 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 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 4f 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 defined in Article 4d 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 4f 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 under Article 4f cannot be guaranteed, the FDHA 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 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 under Article 4f cannot otherwise be guaranteed, the Federal Council 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 the coronavirus 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 FOPH shall regularly update the list in Annex 5 after consulting Swissmedic.

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 the coronavirus 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 the coronavirus 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 the coronavirus 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.

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.

^3bis 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:

a.

they are placed on the market exclusively for non-medical use; and

b.

their effectiveness has been proven by a Swiss testing laboratory that has been accredited in accordance with European standard SN EN ISO/IEC 17025, 2005, «General Requirements for the competence of testing and calibration laboratories»².³

^3ter 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.⁴

⁴ The obligations in relation to product surveillance under the MedDO, in particular to collecting reports of incidents, continue to apply.

¹ In the case of protective equipment in accordance with Annex 4 number 3 that is manufactured and placed on the market in Switzerland or imported into Switzerland and placed on the market here, a derogation may made from the rules and procedures for the conformity assessment under Article 3 paragraph 2 of the PPE Ordinance of 25 October 2017¹ (PPEO) if the use of the equipment for preventing and combating the coronavirus in Switzerland is in the interests the public health or patient safety or health.

² Derogations under paragraph 1 are permitted provided an appropriate level of safety in view of the relevant legal requirements under the PPEO is guaranteed and the equipment is manufactured in accordance with:

a.

a harmonised European standard with a pending conformity assessment procedure;

b.

a standard mentioned in the WHO guidelines; or

c.

another, non-European standard or another technical solution.

³ The inspection bodies that are responsible for PPE under Annex 4 number 3 in accordance with Article 3 the EAER Ordinance of 18 June 2010² on Conducting Market Surveillance pursuant to Section 5 of the Ordinance on Product Safety shall examine and approve specific technical solutions in accordance with paragraph 2.