Art. 1 Subject matter
This Act regulates protecting people against communicable diseases and provides for the measures required to do so.
818.101
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
of 28 September 2012 (Status as of 1 July 2024)
The Federal Assembly of the Swiss Confederation,
on the basis of Articles 40 paragraph 2, 118 paragraph 2 letter b, 119 paragraph 2 and 120 paragraph 2 of the Federal Constitution1,
and having considered the Federal Council Dispatch dated 3 December 20102,
decrees:
This Act regulates protecting people against communicable diseases and provides for the measures required to do so.
1 This Act has the aim of preventing and controlling the outbreak and spread of communicable diseases.
2 The measures under this Act are intended to enable:
In this Act:
1 The Federal Council shall in consultation with the cantons determine the goals and strategies for detecting, monitoring, preventing and controlling communicable diseases.
2 The following in particular must be taken into consideration in determining the goals and strategies:
3 The Confederation and the cantons shall, based on the reports, review whether the goals have been achieved, and take the relevant measures as required.
1 The Federal Office of Public Health (FOPH) shall, in consultation with the cantons, develop topic-specific national programmes for detecting, monitoring, preventing and controlling communicable diseases, in particular relation to:
2 The Confederation and the cantons shall implement the national programmes within the scope of their powers.
1 A special situation arises if:
2 The Federal Council may, after consulting the cantons, order the following measures:
If an extraordinary situation so requires, the Federal Council may order the measures required for the entire country or for individual parts of the country.
1 The Confederation and the cantons shall take preparatory measures to limit the risks to and negative effects on public health at an early stage.
2 The FOPH may instruct the cantons to take specific measures in view of a special risk to public health, in particular:
1 The FOPH shall inform the public, specific groups of persons, authorities and experts about the dangers of communicable diseases and about the options for preventing and controlling such diseases.
2 It shall regularly publish compilations and analyses about the nature, incidence, causes and spread of communicable diseases.
3 It shall publish recommendations on measures against communicable diseases and on handling pathogens and shall adapt them regularly in line with the current state of scientific knowledge. If other federal offices are affected, the FOPH shall act in consultation with them.
4 The FOPH and the competent cantonal authorities shall coordinate their information activities.
1 The FOPH shall ensure that the cantons receive the information pertaining to preventing and combating communicable diseases.
2 The competent federal and cantonal bodies shall share research results, specialist knowledge and information on training and monitoring programmes with each other.
The FOPH shall in cooperation with other federal agencies and the competent cantonal bodies operate systems for the early detection and monitoring of communicable diseases. It shall ensure coordination with international systems.
1 Doctors, hospitals and other public or private healthcare institutions shall report observations on communicable diseases, including the information required to identify the persons who are ill, infected or have been exposed and to establish the route of transmission:
2 Laboratories shall report laboratory analysis findings on communicable diseases including the information required to identify the persons who are ill or infected to the competent cantonal authority and the FOPH.
3 The Federal Council may require that measures taken to prevent and control the disease as well as their effect are reported and that samples and test results are sent to the laboratories designated by the responsible authorities.
5 Any person piloting a ship or an aircraft shall report observations that indicate a risk to public health to the port or airport operator.
6 Observations must be reported if they relate to communicable diseases that:
1 The Federal Council shall stipulate the observations on communicable diseases that must be reported, together with the methods, criteria and time limits for reporting.
2 In the case of specific report content, it may restrict the duty to report to selected doctors, to hospitals and other public or private healthcare institutions and to laboratories.
1 The FOPH may agree for the purpose of epidemiological monitoring and for research purposes with doctors, laboratories, hospitals and other public or private healthcare institutions that they report observations that are not subject to the duty to report to a body designated by the FOPH.
2 The report must be made in anonymised form.
1 The competent cantonal authorities shall ensure the required epidemiological investigations, in particular on the nature, cause, source of infection and spread of a detected or suspected disease. They shall coordinate their activities and inform the FOPH about the results.
2 The competent federal authority shall provide the cantonal authorities with professional support with the epidemiological investigations. It may conduct such investigations itself, particularly if the canton concerned requests it to do so.
1 Laboratories that conduct microbiological tests for detecting communicable diseases require a licence from the competent federal authority.
2 The Federal Council shall carry out the following tasks:
3 Laboratories in doctors' practices, hospital laboratories, pharmacy dispensaries and other laboratories that conduct analyses as part of the universal provision of services under the Federal Act of 18 March 19943 on Health Insurance (Health Insurance Act) are exempted from the licence requirement.
The FOPH may designate individual laboratories as national reference centres or as confirmation laboratories and entrust the same with special tests and other special tasks.
The cantons shall operate a network of regional laboratories and ensure cooperation with the competent federal authorities and the high security laboratories.
1 The Confederation and the cantons shall take measures to control, reduce and eliminate the risks of disease transmission.
2 The Federal Council may issue the following regulations:
1 The FOPH, in cooperation with the Federal Commission for Vaccination, shall draw up and publish vaccination recommendations in the form of a national vaccination plan.
2 Doctors and other healthcare specialists shall assist in implementing the national vaccination plan as part of their activities.
3 They shall inform the persons addressed by the vaccination recommendations about the national vaccination plan.
1 The cantons shall encourage people to be vaccinated by:
2 They may in particular:
The cantons may declare vaccinations to be mandatory for population groups at high risk, persons who are particularly exposed to infection and persons that carry out certain activities, provided there is a significant risk.
1 The Federal Council may introduce a registration or licensing obligation for vaccinations for which an international certificate of vaccination or other prophylaxis under Article 36 of the International Health Regulations (2005) of 23 May 20054 is required.
2 The Federal Council shall carry out the following tasks:
1 The competent federal authorities shall in consultation with the cantons regularly review the appropriateness and effectiveness of the vaccination measures.
2 The competent cantonal authorities shall collect data on the numbers of persons who have been vaccinated and inform the FOPH regularly about the vaccination rate and about the measures taken to increase the rate.
3 The FOPH shall regularly draw up reports on monitoring and evaluation and publish these in a suitable form.
Any person who handles pathogens or their toxic products must take all the measures required to ensure that no one can come to any harm.
1 In the case of activities with pathogens in contained systems, all the containment measures that are required to prevent a risk to the population must be taken.
2 The Federal Council shall introduce a registration or licensing obligation; it shall regulate the requirements and the procedure.
3 It may simplify the registration or licensing obligation or provide for exceptions in the case of specific pathogens and activities if current scientific knowledge and experience indicate that there is no risk to health.
1 Any person who wishes to release or market pathogens for experimental purposes shall require a licence from the Confederation.
2 The Federal Council shall regulate the requirements and the procedure for granting the licence as well as the provision of information to the public on experimental releases.
3 It may provide for exceptions from the licensing obligation for specific pathogens if current scientific knowledge and experience indicate that there is no risk to health.
Any person who markets pathogens must inform customers about their health-related properties and risks and about the required precautionary and preventive measures.
The Federal Council may issue the following regulations:
5 Amended by Annex No 34 of the FA of 20 June 2014 on Continuing Education and Training, in force since 1 Jan. 2017 (AS 2016 689; BBl 2013 3729).
1 A measure in accordance with Articles 33-38 may only be ordered if:
2 The measure must be necessary and reasonable.
1 The competent cantonal authorities shall order the measures in accordance with Articles 33-38.
2 The competent federal authorities shall support the cantons in identifying and notifying persons, in particular persons travelling on international transport services.
3 When ordering measures, the persons concerned must be given an explanation of why the measures are being ordered and how long they are expected to apply.
4 The measures may only apply for as long as is necessary to prevent the spread of a communicable disease and to avert a serious risk to the health of other persons. They must be regularly reviewed.
The competent cantonal authorities may compulsorily enforce their orders relating to medical monitoring, quarantine, isolation or medical testing.
Any person who is ill, suspected of being ill, infected or suspected of being infected or who is spreading pathogens may be identified and notified.
1 Any person who is ill, suspected of being ill, infected or suspected of being infected or who is spreading pathogens may be made subject to medical monitoring.
2 The person concerned is required to inform the doctor responsible about their state of health and their contacts with other persons.
1 If medical monitoring is insufficient, the following measures may be taken:
2 The person concerned may if necessary be admitted to a hospital or another suitable institution.
3 The hospital or the institution must ensure that its staff and other persons at risk are protected against infection.
Any person who is ill, suspected of being ill, infected or suspected of being infected or who is spreading pathogens may be required to undergo a medical examination and to allow samples to be taken.
Any person who is ill, suspected of being ill, infected or suspected of being infected or who is spreading pathogens may be required to undergo medical treatment.
1 Any person who is ill, suspected of being ill, infected or suspected of being infected or who is spreading pathogens may be wholly or partly prohibited from carrying out certain activities or practising their profession. They may be required to give notice of any change in their canton of residence, their activity or profession to the competent cantonal authority without delay.
2 If a person is wholly or partly prohibited from carrying out certain activities or from practising their profession and if they have been required to give notice of a change in their canton of residence, their activity or profession, the competent cantonal authority shall notify the competent authority in the canton concerned about the prohibition or restriction.
Doctors who are treating or monitoring a person who is ill, suspected of being ill, infected or suspected of being infected or who is spreading pathogens shall take all the measures available to them to prevent the spread of a communicable disease. If official measures are required, this must be reported to the competent cantonal authority.
1 The competent cantonal authorities shall order measures to prevent the spread of communicable diseases among the population or within specific groups of persons. They shall coordinate their measures.
2 They may in particular take the following measures:
3 The measures may only apply for as long as is necessary to prevent the spread of a communicable disease. They must be regularly reviewed.
1 The Federal Council shall issue regulations on international travel to prevent communicable diseases spreading from one country to another.
2 If required to prevent the spread of a communicable disease, the FOPH may require persons entering or leaving Switzerland:
3 The FOPH may require persons entering Switzerland to submit to a measure in accordance with Articles 34, 35, 37 and 38; Articles 30-32 apply in an analogous manner. If required, the Federal Council may extend these measures temporarily to all persons entering Switzerland from regions considered to pose a risk.
4 The FOPH may temporarily deny any person who is ill, suspected of being ill, infected or suspected of being infected or who is spreading pathogens the right to leave Switzerland if this is required to prevent the spread of a communicable disease.
1 Operators of ports and airports shall make the required operational preparations for implementing the measures under Article 41. They shall have their own emergency plans.
2 The Federal Council shall designate the operators of ports and airports that must provide the required capacities in accordance with Annex 1 B of the International Health Regulations (2005) of 23 May 20056.
1 Companies that transport persons by rail, bus, ship or air internationally, airport operators, port operators, railway and bus stations and travel businesses are required to cooperate in carrying out the measures under Article 41. They may within the limits of their operational and technical capacities be required:
2 They must provide the operational and staff capacities necessary to carry out the measures under paragraph 1.
1 The Federal Council shall ensure that the population is supplied with the most important therapeutic products that are suitable for controlling communicable diseases, insofar as it is unable to guarantee supply by means of measures under the National Economic Supply Act of 8 October 19827.
2 It may issue regulations on:
3 It may provide for measures to supply Swiss citizens living abroad with therapeutic products.
1 The Federal Council may issue regulations on the transport and on the import, export and transit of goods that may be carriers of pathogens. It may in particular:
2 It may instruct the cantons to take individual measures.
1 The Federal Council shall issue the required regulations on the transport and the burial of dead bodies.
2 It shall regulate the transport of dead bodies through Switzerland, from another country to Switzerland and from Switzerland to another country.
1 If organisms occur that can transmit pathogens to human beings, the competent federal and cantonal bodies shall coordinate any measures required to control such organisms or to prevent their occurrence.
2 Companies that transport persons by rail, bus, ship or air, airport operators, port operators, railway and bus stations and travel businesses are required to cooperate in carrying out these measures.
1 The competent cantonal authorities shall ensure that disinfection and disinfestation, in particular of means of transport and goods, are carried out to prevent the spread of communicable diseases.
2 Companies that transport persons by rail, bus, ship or air, airport operators, port operators, railway and bus stations and travel businesses are required to cooperate in carrying out disinfection and disinfestation measures.
The competent cantonal authorities shall issue the required health certificates for international shipping.
The FOPH may within the limits of the authorised budget grant financial assistance to public and private organisations for measures in the national public interest for detecting, monitoring, preventing and controlling communicable diseases.
1 The Confederation may provide financial assistance for manufacturing therapeutic products under Article 44 in Switzerland if supplies to the population in special or extraordinary situations cannot otherwise be guaranteed.
2 It may provide the financial assistance within the limits of the authorised budget in the form of basic contributions, investment contributions or project-related contributions.
3 It may make the contributions provided the manufacturer:
The FOPH shall make compensatory payments to the laboratories designated as national reference centres or as confirmation laboratories for the expenses that they incur in carrying out their special tasks.
1 Each canton shall appoint a chief medical officer. Cantons may appoint a joint chief medical officer.
2 Chief medical officers shall coordinate their activities with other authorities and institutions involved in controlling communicable diseases. If a communicable disease arises in connection with a foodstuff, the chief medical officer shall notify the cantonal chemist.
3 The Federal Council shall specify the required qualifications for chief medical officers.
1 The Confederation and the cantons shall establish a body to promote cooperation (coordination body). Subsidiary bodies may be established to deal with specific fields, in particular detecting and monitoring, preventing and combating zoonoses.
2 The coordination body and its subsidiary bodies shall be made up of federal and cantonal representatives. They may also include other specialists, as required.
3 Their tasks shall include the following:
4 The Federal Council shall regulate the establishment and management of the coordination body and its subsidiary bodies.
1 The Federal Council shall have a task force at its disposal for events that may pose a special risk to public health, in particular to manage a special or extraordinary situation.
2 The Task Force shall have the following tasks:
1 Federal Commission for Vaccination shall advise the Federal Council on issuing regulations and the authorities on implementing this Act.
2 The Commission's tasks shall include the following:
3 It shall comprise specialists from outside the administration who have scientific or practical knowledge of vaccination matters.
4 It shall work with other federal and cantonal bodies that deal with vaccination matters.
The Swiss Expert Committee for Biosafety shall advise the Federal Council on issuing regulations and the authorities on implementing this Act.
1 Insofar as is required in order to identify persons who are ill, suspected of being ill, infected, suspected of being infected and persons suspected of spreading pathogens, the FOPH, the competent cantonal authorities and the public and private institutions entrusted with tasks under this Act may process or arrange for the processing of personal data, including health data, with a view to taking measures to protect public health, in particular to detect, monitor and control communicable diseases.
2 They shall be responsible for complying with the data protection regulations.
3 The data may be retained for a maximum of ten years, unless the specifics of the disease require a longer retention period. Thereafter they shall be destroyed or anonymised.
1 The federal and cantonal bodies responsible for implementing this Act may disclose to each other personal data, including data on health, which they require in order to carry out the tasks assigned to them under this Act.
2 In particular the following data may be disclosed:
3 The FOPH and the cantonal authorities responsible for implementing this Act may disclose personal data, including data on health, which are required to prevent the spread of a communicable disease to the following persons and authorities:
1 The FOPH shall operate an information system for storing data relating to persons who are ill, suspected of being ill, infected or suspected of being infected or who are spreading pathogens.
2 The information system shall contain the following data:
3 The information system shall be used to:
4 It shall also assist with the uniform processing of data by the responsible authorities, the production of statistics and checks on implementation.
5 The FOPH is responsible for the security of the information system and the legality of the processing of personal data. The cantons shall take appropriate organisational and technical measures to secure personal data in their area of responsibility.
6 The FOPH shall check whether the data it receives are accurate. It shall correct inaccurate data and destroy unnecessary data and notify the data providers concerned.
7 The information system shall be made available online to the FOPH, the cantonal bodies responsible for implementing this Act and the Coordinated Medical Services for tasks within their area of responsibility.
8 The Federal Council shall stipulate the requirements for safeguarding and deleting data and regulate the access rights.
9 The right to receive information on the data in the information system and the right to have the data corrected are governed by Articles 25 and 41 of the Data Protection Act of 25 September 20208.9 Requests for information on personal data and for corrections to be made to the data must be sent to the FOPH.
9 Amended by Annex 1 No II 75 of the Data Protection Act of 25 Sept. 2020, in force since 1 Sept. 2023 (AS 2022 491; BBl 2017 6941).
10 Inserted by No I of the FA of 19 June 2020 (AS 2020 2191, 2727; 2021 878 No III 3; BBl 2020 4461; 2021 2515). Amended by Annex No 2 of the FA of 16 Dec. 2022, in force from 1 Jan. 2023 to 30 June 2024 (AS 2022 817; BBl 2022 1549).
The Swiss Federal Statistical Office shall, for statistical purposes, provide the FOPH each year with data from the statistics on causes of death and the medical statistics from hospitals.
1 In order to implement this Act, the FOPH and the competent cantonal authorities may provide foreign authorities that have corresponding tasks and supranational and international organisations with personal data, including data on health, provided the state concerned and in particular its legislation or the supranational or international organisation guarantees an appropriate level of privacy protection for the person concerned:
2 In particular the following data may be disclosed:
3 In derogation from paragraph 1, personal data may only be disclosed abroad if:13
12 Amended by Annex 1 No II 75 of the Data Protection Act of 25 Sept. 2020, in force since 1 Sept. 2023 (AS 2022 491; BBl 2017 6941).
13 Amended by Annex 1 No II 75 of the Data Protection Act of 25 Sept. 2020, in force since 1 Sept. 2023 (AS 2022 491; BBl 2017 6941).
14 Repealed by Annex 1 No II 75 of the Data Protection Act of 25 Sept. 2020, with effect from 1 Sept. 2023 (AS 2022 491; BBl 2017 6941).
15 Amended by Annex 1 No II 75 of the Data Protection Act of 25 Sept. 2020, in force since 1 Sept. 2023 (AS 2022 491; BBl 2017 6941).
16 Inserted by No I of the FA of 19 June 2020 (AS 2020 2191, 2727; 2021 878 No III 3; BBl 2020 4461; 2021 2515). Amended by Annex No 2 of the FA of 16 Dec. 2022, in force from 1 Jan. 2023 to 30 June 2024 (AS 2022 817; BBl 2022 1549).
The ordering authority may compensate persons who suffer loss or damage as a result of official measures in accordance with Articles 33-38 and 41 paragraph 3, taking account of the financial circumstances of the persons concerned, insofar as the loss or damage is not otherwise covered.
1 Any person who is harmed by an officially ordered or officially recommended vaccination has the right to compensation.
2 Compensation shall only be awarded if the loss or damage cannot otherwise be covered through reasonable effort.
1 Any person who is harmed by an officially ordered or officially recommended vaccination has the right to satisfaction if the harm is sufficiently serious to justify this; Articles 47 and 49 of the Code of Obligations17 apply by analogy.
2 The satisfaction is determined by the seriousness of the harm.
3 It may not exceed 70,000 francs.
4 Satisfaction shall only be awarded if no payment or an insufficient payment is made by other persons. The satisfaction shall be reduced by the amount of any satisfaction payments made by other persons.
1 Any person who wishes to claim compensation or satisfaction must file a claim with the FDHA.
2 Any person who has been harmed by a vaccination must file the claim for compensation or satisfaction before reaching the age of 21 or within five years of the vaccination.
3 No interest shall be payable on the compensation or the satisfaction.
The FDHA may reduce the compensation or satisfaction or forego making any payment if the person suffering harm was substantially to blame for the harm suffered.
1 In the case of recommended vaccinations, the Confederation and the canton in which the vaccination takes places shall each pay one half of the costs of the compensation or satisfaction.
2 In the case of compulsory vaccinations, the entire costs of the compensation or satisfaction shall be paid by:
1 The FDHA decides after consulting the Federal Commission for Vaccination and the canton concerned whether compensation or satisfaction is to be paid.
2 Any person who claims compensation or satisfaction must credibly demonstrate that other persons have not made any payments or that the payments made by other persons are inadequate.
3 Appeal proceedings are governed by the general provisions on the administration of federal justice.
1 The Confederation may undertake to cover any loss or damage for which the manufacturer of a therapeutic product under Article 44 may be held liable as the consequence of the product being used as recommended or ordered by the Confederation in a special or extraordinary situation.
2 The extent and the modalities of the cover shall be set out in an agreement between the Confederation and the manufacturer.
The cantons shall bear the cost of:
The proprietor of a mode of transport, an installation or a product shall bear the costs of disinfection or disinfestation.
1 The Confederation shall bear the cost of supplying the population with therapeutic products pursuant to Article 44.
2 If therapeutic products are supplied, the costs shall be borne according to the requirements:
3 If the costs are not or not completely assumed in accordance with paragraph 2, they shall be borne by the Confederation.
1 The Confederation shall bear the cost of testing, monitoring, quarantine, isolation and treatment ordered by its bodies for passengers on international transport services, as well as the costs incurred as a result of the duty to cooperate under Article 43 paragraph 1 letters b, d and e.
2 Companies that transport persons internationally by rail, bus, ship or air, airport operators, port operators, railway stations and bus stations and travel businesses shall bear the costs incurred for preparations made under Article 42 and as a result of the duty to cooperate under Article 43 paragraph 1 letters a and c. The Confederation may contribute to exceptional outlays and expenditures if these place the companies concerned under an unreasonable financial burden.
The cantons shall implement this Act, unless the Confederation is responsible.
1 The cantons shall report to the FDHA on the implementation of the Act.
2 The Federal Council shall regulate the frequency, form and content of the reports.
1 The Confederation shall supervise the implementation of this Act by the cantons.
2 It shall coordinate the implementing measures taken by the cantons, insofar as there is an interest in uniform implementation.
3 It may for this purpose:
1 The Federal Council shall issue the implementing provisions.
2 It may delegate the issuing of implementing provisions to the responsible federal office, taking account of their scope.
1 The Federal Council may delegate implementation tasks to public or private organisations.
2 It shall supervise the organisations and persons entrusted with implementation tasks.
3 Public or private organisations that carry out implementation tasks under paragraph 1 are entitled to compensation. The Federal Council shall regulate the extent and modalities of compensation.
1 The Federal Council may enter into international agreements on:
2 The competent federal agencies shall work with foreign authorities and institutions and with international organisations.
3 The FOPH shall carry out the tasks of the National IHR Focal Point in accordance with the International Health Regulations (2005) of 23 May 200522. In particular, it shall report events to the WHO that could lead to a public health emergency of international concern.
21 Inserted by No I of the FA of 19 June 2020 (AS 2020 2191, 2727; 2021 878 No III 3; BBl 2020 4461; 2021 2515). Amended by Annex No 2 of the FA of 16 Dec. 2022, in force from 1 Jan. 2023 to 30 June 2024 (AS 2022 817; BBl 2022 1549).
The Federal Council shall periodically review the effectiveness, appropriateness and financial viability of the measures under this Act.
1 Unless a more serious offence under the Swiss Criminal Code23 has been committed, any person who wilfully commits any of the following acts shall be liable to a custodial sentence not exceeding three years or to a monetary penalty:
2 A person acting through negligence shall be liable to a monetary penalty for misdemeanours under paragraph 1.
1 Any person who wilfully commits any of the following acts shall be liable to a fine:
2 A person acting through negligence shall be liable to a fine not exceeding 5,000 francs for contraventions under paragraph 1.
24 Inserted by No I of the FA of 19 June 2020 (AS 2020 2191, 2727; 2021 878 No III 3; BBl 2020 4461; 2021 2515). Amended by Annex No 2 of the FA of 16 Dec. 2022, in force from 1 Jan. 2023 to 30 June 2024 (AS 2022 817; BBl 2022 1549).
1 The prosecution and adjudication of offences is a matter for the cantons.
2 Articles 6, 7 (offences by businesses) and 15 (forgery of documents, obtaining a false certificate by fraud) of the Federal Act of 22 March 197425 on Administrative Criminal Law also apply to the cantonal authorities.
The following Federal Acts are repealed:
26 [AS 1974 1071; 1985 1992 No I 2; 1991 362 No II 405; 1997 1155 Annex No 5; 2000 1891 No III 2; 2001 2790 Annex No 6; 2003 4803 Annex No 7; 2004 4763 Annex No II 3; 2005 2293; 2006 2197 Annex No 95 4137; 2008 3437 No II 34; 2012 7281]
27 [BS 4 363; AS 1964 965 No IV let a; 1974 1071 Art. 37; 1985 1992 No I 3; 1991 362 No II 406; 2006 2197 Annex No 96]
The following federal acts are amended as follows:
...28
28 The amendments may be consulted under AS 2015 1435.
1 Licences under Articles 5 paragraph 1bis, 29a paragraph 1 and 29c paragraph 2 of the Epidemics Act of 18 December 197029 remain valid until their expiry date or for for five years after this Act comes into force, whichever is earlier.
2 Recognitions under Article 5 paragraph 1 of the Epidemics Act of 18 December 1970 remain valid until their expiry date or for five years after this Act comes into force, whichever is earlier.
3 Laboratories that did not require a licence and did not have valid recognition before this Act came into force, but which require a licence after this Act comes into force, must apply for the licence within one year after this Act comes into force. They may continue to conduct tests until the competent federal authority issues its decision on the licence.