Key Benefits:
15 December 2000 (State 1 Er January 2014)
1 This Act, with a view to protecting the health of humans and animals, aims to ensure the placing on the market of quality, safe and effective therapeutic products.
2 It also aims to:
3 In the performance of this Act, including the development of the orders and their application in each case, it is necessary to ensure that:
1 This Act applies to:
2 The Federal Council may exempt from the scope of this Law all or part of the medical devices intended for animals or for veterinary diagnostic use.
Every person who carries out an operation in relation to therapeutic products shall take all the measures required by the state of science and technology in order not to endanger the health of human beings and animals.
1 For the purposes of this Law:
2 The Federal Council may, by order, delimit each other the other terms used in this Act and the definitions set out in para. 1, specify and provide for exceptions taking into account the latest scientific and technical knowledge and international developments.
1 Must have an authorization issued by the Swiss Institute for Therapeutic Products (Institut) whoever:
2 The Federal Council regulates the derogations from the authorisation scheme. It may include:
1 New content according to the c. I of the PMQ of 13 June 2008, in force since 1 Er Oct. 2010 ( RO 2008 4873 , 2010 4027; FF 2007 2245 ).
1 The authorization is issued:
2 The competent authority shall verify, through an inspection, that the conditions are fulfilled.
Drugs and excipients placed on the market must meet the requirements of the Pharmacopoeia, as long as it exists.
1 Ready-to-use drugs and veterinary drugs intended for the manufacture of medicated feeds (premixes for medicated feeds) must have been authorised by the Institute in order to be placed on the market. International agreements on the recognition of marketing authorisations are reserved.
2 The following are exempt from authorisation:
2bis An establishment with a manufacturing authorization may be responsible for the manufacture of drugs within the meaning of s. 2, let. A to c Bis . 5
2ter The Federal Council shall lay down the qualitative and quantitative criteria to be met by the medicinal products referred to in para. 2, let. A to c Bis And 2 Bis . 6
3 The Federal Council may provide for the marketing authorisation scheme for the process of obtaining or manufacturing medicinal products which cannot be standardised.
4 The Institute may authorise, for a limited period, the distribution or delivery of medicinal products against fatal diseases which are not authorised to be placed on the market if such authorisation is compatible with the protection of health, That a great therapeutic utility is expected from the administration of these drugs and that there is no equivalent drug.
1 New content according to the c. I of the PMQ of 13 June 2008, in force since 1 Er Oct. 2010 ( RO 2008 4873 , 2010 4027; FF 2007 2245 ).
2 New content according to the c. I of the PMQ of 13 June 2008, in force since 1 Er Oct. 2010 ( RO 2008 4873 , 2010 4027; FF 2007 2245 ).
3 New content according to the c. I of the PMQ of 13 June 2008, in force since 1 Er Oct. 2010 ( RO 2008 4873 , 2010 4027; FF 2007 2245 ).
4 Introduced by ch. I of the PMQ of 13 June 2008, in force since 1 Er Oct. 2010 ( RO 2008 4873 , 2010 4027; FF 2007 2245 ).
5 Introduced by ch. I of the PMQ of 13 June 2008, in force since 1 Er Oct. 2010 ( RO 2008 4873 , 2010 4027; FF 2007 2245 ).
6 Introduced by ch. I of the PMQ of 13 June 2008, in force since 1 Er Oct. 2010 ( RO 2008 4873 , 2010 4027; FF 2007 2245 ).
1 Anyone seeking authorization to market a drug or process must:
2 The Institute shall verify that the conditions attached to the marketing authorisation are fulfilled. For this purpose, it may carry out product-oriented inspections.
1 The application for a marketing authorisation shall contain the data and documents necessary for its assessment, in particular:
2 The Federal Council:
3 The Institute shall specify the data and documents referred to in para. 1. It can provide for others.
1 Anyone seeking authorisation to place on the market a medicinal product which is very close to an already authorised medicinal product (original preparation) and which is intended for the same job, may refer to the results of the pharmacological tests, Toxicological and clinical of previous applicant:
2 Protection is limited to ten years. The Federal Council may also grant appropriate protection to test results relating to original preparations referred to in para. 1 in case of new indications, new modes of administration, new galenical forms or new dosages.
If a medicinal product or a process has already been authorised for placing on the market in a country which has instituted control of equivalent medicinal products, the results of the tests carried out for the granting of the authorisation shall be taken into account.
1 The Institute shall provide for simplified marketing authorisation procedures for certain medicinal products, where this is compatible with the requirements of quality, safety and efficacy, and that no interest from Switzerland or any International engagement is not opposed. This rule applies in particular to:
2 The Institute shall provide for a simplified marketing authorisation procedure for any request from another person responsible for marketing a medicinal product already authorised in Switzerland and imported from a country which has established an equivalent system Market authorization:
1 New content according to the c. I of the PMQ of 13 June 2008, in force since 1 Er Oct. 2010 ( RO 2008 4873 , 2010 4027; FF 2007 2245 ).
2 Repealed by c. II of the LF of 19 Dec. 2008, with effect from 1 Er July 2009 ( RO 2009 2615 ; FF 2008 257 ).
Where certain medicinal products or categories of medicinal products fulfil the conditions for the granting of a simplified authorisation for placing on the market and it is not appropriate to initiate such a procedure, the Institute may provide for a simple An obligation to announce, in particular for medicinal products intended for hospital purposes.
1 New content according to the c. I of the PMQ of 13 June 2008, in force since 1 Er Oct. 2010 ( RO 2008 4873 , 2010 4027; FF 2007 2245 ).
1 The Institute shall authorise the placing of a medicinal product on the market if the conditions are met. It may link the authorisation to charges and conditions.
2 The authorisation shall be valid for five years. During this period, the Institute may, on its own initiative or upon request, adapt the decision to grant self-assessment to changes in situation or revoke it.
3 The Institute may, regardless of the period of validity of the authorisation, review the medicinal products by groups and if necessary adapt or revoke the award decision.
4 It shall, on request, renew the authorisation if the conditions are met.
1 The Institute shall revoke the marketing authorization if:
2 The Federal Council may provide for derogations from para. 1.
3 It may provide for drugs for serious illnesses, injuries and disabilities that the authorization is revoked even before the expiry of the period prescribed in para. 1. It sets the deadlines and defines the criteria for the revocation.
1 Introduced by ch. I of the PMQ of 13 June 2008, in force since 1 Er Oct. 2010 ( RO 2008 4873 , 2010 4027; FF 2007 2245 ).
1 If the manufacture of a drug requires specific measures, including safety, an application for release must be submitted to the Institute for each lot prior to its distribution. International agreements on the recognition of the release of consignments are reserved.
2 The Institute shall determine the categories of drugs for which the release of lots is required, as well as the requirements to be met and the procedure.
3 It publishes a list of drugs for the distribution of which release of batches is required.
1 Must have an authorization issued by the Institute, anyone, on a professional basis:
2 The Federal Council may also provide for the authorisation scheme for the import and export of non-ready-to-use medicines.
3 It may introduce derogations from the authorisation scheme for:
4 Storage in a customs warehouse or in a customs deposit is treated as an import. 1
5 The Federal Council may issue special provisions on transit.
6 If another State requires export certificates and certificates for the medicinal products to be imported, the Institute may issue these documents to the persons authorised to export.
1 New content according to the c. 17 of the Annex to the PMQ of 18 March 2005 on customs, in force since 1 Er May 2007 ( RO 2007 1411 ; FF 2004 517 ).
1 The authorization is issued:
2 It is also issued to the applicant who already has the authorisation to manufacture medicinal products. The authorization referred to in s. 18, para. 1, let. B and c, is also issued to the applicant who already has the authorization to import or trade bulk of the drugs.
3 The competent authority shall verify, through an inspection, that the conditions are fulfilled.
1 Drugs that are allowed to be placed on the market or are not subject to market authorization may be imported.
2 The Federal Council may authorise the import, in small quantities, of ready-to-use medicinal products and not authorised to be placed on the market by:
3 It can:
4 The Institute shall draw up a list of medicinal products whose import is restricted or prohibited.
1 The export of medicines and their trade abroad from Switzerland are prohibited:
2 The Federal Council may prescribe that the export of medicinal products whose placing on the market is not authorised in Switzerland or in the country of destination is, in the case of a species, prohibited by the institute or subject to restrictions.
3 The Institute shall draw up a list of medicinal products for which export is restricted or prohibited.
4 In such cases, it may authorise derogations from restrictions or prohibitions on exports, in particular if the authority of the country of destination consents.
1 Any person who exports ready-to-use drugs, whether packaged or not, must provide the recipient with appropriate basic medical and pharmaceutical information, without making the request.
2 Anyone who exports drugs for clinical trials must require proof that the rules of Good Clinical Trial Practice will be applied.
1 Drugs are classified according to whether they are subject to prescription or not.
2 A category of non-prescription drugs is created. Art. 24 to 27 and 30 are not applicable to him.
3 The Federal Council sets the classification criteria. The Institute shall place in a category any medicinal product for which it has authorised the placing on the market.
1 The following are entitled to submit prescription drugs:
2 Animal medicated feeds that are subject to prescription may also be dispensable by prescription from a veterinary surgeon by persons who have authorization to add drugs to feed.
3 The cantons may authorise the persons referred to in Art. 25, para. 1, let. C, administer certain prescription drugs.
1 Are authorized to deliver non-prescription drugs:
2 The Federal Council shall determine the categories of duly trained persons referred to in para. 1, let. C.
3 The Institute shall determine the classes of drugs that may be given by the persons referred to in para. 1, let. B and c.
4 The cantons may grant to the right holders of the federal diploma the right to surrender all non-prescription medicines to the extent that the supply of such medicines is not guaranteed throughout the territory Cantonal. The Federal Council determines the conditions under which this right is granted.
5 Subject to reservations of paras. 2 and 3, the cantons may grant to persons with recognised training at the cantonal level the right to surrender certain groups of medicines, such as medicines of complementary medicine. The Institute must be informed of this.
1 Recognized pharmaceutical and medical science rules must be respected when prescribing and dispensing drugs.
2 A drug should only be prescribed if the health of the consumer or patient is known.
1 The sale by mail order is in principle prohibited.
2 An authorisation shall, however, be issued under the following conditions:
3 The Federal Council regulates the modalities.
4 The cantons shall issue the authorisation.
1 Anyone who trades large drugs must have an authorization issued by the institute.
2 The authorization is issued:
3 The authorization is also issued to the applicant who already has the authorization to manufacture or import drugs.
4 The competent authority shall verify, through an inspection, that the conditions are fulfilled.
1 Anyone who trades large drugs must comply with the accepted rules of Good Wholesale Trade Practices.
2 The Federal Council specifies the recognized rules of Good Wholesale Trade Practices. In doing so, it takes into account internationally recognized standards and guidelines.
1 Is lawful:
2 The Federal Council sets out the conditions under which price comparisons of prescription drugs may be published.
3 It may, in order to protect health and prevent deception, restrict or prohibit the advertising of certain medicinal products or groups of medicines and issue prescriptions concerning cross-border advertising.
1 Is illegal:
2 Illegal advertising to the public for medicinal products:
1 It is prohibited to grant, offer or promise material benefits to persons who prescribe or remit drugs and to organizations that employ such persons.
2 Individuals who prescribe or provide drugs and organizations that employ such persons are prohibited from soliciting or accepting material benefits.
3 Are allowed:
1 Any person who collects blood from persons for the purpose of transferring or manufacturing therapeutic products or remitting it to third parties for these purposes must have an operating authorization issued by the Institute.
2 The authorization is issued:
3 The Institute shall verify, through an inspection, that the conditions are fulfilled.
4 Establishments such as hospitals that only store blood or blood products must have a Cantonal Operating Authorization. The cantons shall lay down the conditions and procedure for granting this authorisation. They carry out periodic checks.
1 Any importation of blood and blood products is subject to authorization. Storage in a customs warehouse is considered to be an import.
2 The Federal Council may provide for derogations from the requirement to possess an authorisation to import if any danger to persons is excluded.
1 The holder of the authorization referred to in s. 34, para. 1, must check the person's ability to give blood.
2 Must be excluded from donors:
3 The Federal Council shall lay down the requirements for the ability to give blood, the competence to establish this aptitude and the data to be recorded during the donation of blood.
1 Any operation in relation to blood and blood components, including the collection, manufacture, processing, storage and placing on the market, shall be carried out in accordance with the principles of quality management and Good Manufacturing Practices rules for blood and blood products.
2 Blood and blood components, as well as related samples, must be labelled so that they can be permanently identified.
3 The Federal Council specifies the recognized rules of Good Manufacturing Practices. In doing so, it takes into account internationally recognized standards and guidelines.
1 The blood collected must be tested for the presence of pathogens or indices thereof and tested for compatibility.
2 The Federal Council fixes:
3 It may provide for exemptions from the requirement to test for autologous transfusions.
1 Every person who performs an operation in relation to blood or blood products shall be required to:
2 For each levy, the following will be recorded:
3 People who are excluded from the blood donor circle will be registered:
4 People who have been administered blood or blood products will register:
5 The Federal Council regulates the modalities. In particular, it may provide for derogations from the obligation to register for autologous transfusions.
1 The recorded data referred to in Art. 39 and all important documents must be archived for 20 years.
2 The Federal Council regulates the modalities. It may include:
The Federal Council may prescribe additional security measures; in particular, it may provide that processes for the removal or inactivation of potential pathogens may be used only after the Institute has authorised their release. On the market.
1 A medicinal product may be prescribed or given for an animal only if the prescriber knows the animal or the animal.
2 If the drug is intended for use in an animal, the prescriber must also know the health status of the animals.
3 The Federal Council may prohibit the prescription and dispensing of medicines for animals which are prepared on the basis of a formal formula (Art. 9, para. 2, let. (a).
Any person who imports or exports, distributes or delivers veterinary drugs, administers or administers veterinary drugs, shall maintain records of entries and exits, and shall archive the supporting documents.
The Federal Council may prescribe to the cantons measures to ensure uniformity of enforcement and to oblige them to inform the competent federal departments of the implementing measures taken and the results of analyses.
1 No medical device used in accordance with its intended use shall endanger the health of the user, the consumer, the patient or third parties. Claims about performance or efficacy should be demonstrable.
2 Anyone who puts a medical device on the market must be able to prove that the device meets the essential requirements.
3 The Federal Council sets out the requirements to be met by medical devices. It sets out in particular:
4 The Institute refers to the technical standards that enable essential requirements to be met. It shall designate as far as possible internationally harmonized standards. Any derogation must be approved by the competent authority 1 .
5 The Federal Council shall lay down the requirements for medical devices intended for testing.
1 State Secretariat for the Economy
1 Anyone who puts a medical device on the market must be able to prove that it has been subject to the prescribed conformity assessment procedures.
2 The Federal Council regulates conformity assessment procedures. It sets out in particular:
3 It can:
1 Anyone who puts medical devices on the market is required to put in place and manage a system of observation of products to collect and analyse the experiments done with them, and to provide that the data thus Acquired are taken into account in their manufacture or further development.
2 The Federal Council may:
In order to protect health, the Federal Council may, for certain medical devices:
1 Every person who uses a medical device on a professional basis or applies it to another person shall take all the maintenance measures necessary to maintain the performance and safety of the medical device.
2 The Federal Council may:
1 If required by health protection, the Federal Council may restrict or prohibit the import and export of certain medical devices.
2 If another State requires export certificates and certificates for medical devices to be imported, the Institute may issue these documents to the exporters.
The Federal Council may, in order to protect health and prevent deception, restrict or prohibit advertising for certain medical devices and lay down requirements for cross-border advertising.
1 The institute makes the Pharmacopoeia.
2 It partners interested circles in the development of the Pharmacopoeia. This includes the use of experts and working groups.
3 It participates in the development of the European Pharmacopoeia (Pharmacopoea Europaea) in accordance with international conventions and transposes it into federal law. It may make additional requirements valid for Switzerland (Pharmacopoea Helvetica) .
4 The Pharmacopoeia is published outside the Official Collection of Federal Statutes. The Federal Council regulates the terms of publication and in particular determines the languages in which it is published.
The conduct of clinical trials of therapeutic products on human beings is based on this Law and on the Law of 30 September 2011 on Human Research 1 .
1 Before being carried out, clinical trials of therapeutic products require the authorization of the Institute.
2 Clinical trials for the following therapeutic products are excluded from the authorization regime:
3 The Federal Council may:
4 As part of the authorisation procedure, the Institute shall verify:
5 The Institute may at any time carry out an inspection to verify that the clinical trial complies with the requirements of this Law and of the Law of 30 September 2011 on Human Research 1 .
6 The Federal Council shall issue procedural provisions. Amendments related to clinical trials may be subject to authorization.
7 It may provide for an obligation to advertise and inform, in particular in the following cases:
8 The Federal Council shall issue the provisions required under paras. 4 and 5 taking into account recognized international regulations.
Repealed
1 The Institute and the cantons shall monitor, within the limits of their powers, whether the manufacture, distribution and delivery of therapeutic products and the presentation of their effects are in conformity with the law. They verify, through periodic inspections, that the conditions attached to the authorisations are met.
2 The institute checks for therapeutic products placed on the market. It verifies that the medicinal products comply with the marketing authorisation and that the medical devices meet the legal requirements.
3 The Institute is responsible for monitoring the safety of therapeutic products. For this purpose, it shall, inter alia, collect the announcements referred to in Art. 59 1 And to their assessment, and takes the necessary administrative measures.
4 The Institute and the cantons may take the necessary samples free of charge, require the necessary information and documents and request any other support.
5 The Townships shall report to the Institute any event, finding or dispute arising out of the application of para. 1. The Institute shall take the necessary administrative measures. The cantons may also take the necessary administrative measures in the event of a serious and immediate threat to health.
1 Rectified by the Ass CoR. Fed. (art. 33 LREC; 1974 1051).
1 Anyone who makes therapeutic products or distributes them who are ready for use must put in place an announcement system. It is required to notify the Institute of any adverse effects or incidents:
2 Any person who manufactures or distributes therapeutic products is also required to announce to the Institute any defect or fact or assessment which may affect the basis of the assessment.
3 It is also required to announce any serious or previously unknown adverse reactions and any incidents or defects, whether in a professional capacity, administer or deliver therapeutic products to humans or animals.
4 Consumers, patients and their organisations, as well as interested third parties, may announce to the Institute the adverse effects of therapeutic products and the incidents attributable to them.
1 The Institute shall be responsible for inspections carried out in Switzerland subject to Art. 30 and 34, para. 4.
2 It is competent for the inspections referred to in Art. 6, 19 and 28 in the following areas:
3 It delegates to Cantonal Services the inspections referred to in s. 6, 19 and 28 in other areas, provided that they meet the requirements of federal law and applicable international law in Switzerland.
4 It may associate the cantonal services with inspections within its competence or entrust them with such inspections.
5 The cantons may associate regional inspection services or other cantonal inspection services or the institute with inspections referred to in para. 3, or carry out such inspections.
Persons responsible for the execution of this Law shall have the obligation to keep the secret.
1 The competent authority shall be obliged to treat in confidence the data collected under this Law and for the maintenance of the secrecy of which there is a paramount interest worthy of protection.
2 The Federal Council may determine the data published by the competent authority.
1 The services of the Confederation and the cantons responsible for the implementation of this Law shall ensure that the data necessary for the execution of this Law are communicated to each other.
2 The Federal Council may provide for the provision of data to other authorities or organisations, provided that this is necessary in order to comply with this Law.
1 The services of the Confederation responsible for the implementation of this Law may seek information from competent foreign authorities or international organisations.
2 They shall be authorised to communicate to competent foreign authorities or to international organisations non-confidential data collected under this Law.
3 They shall be authorised to communicate to foreign competent authorities or to international organisations confidential data collected under this Law if this measure avoids serious health risks or To date illegal traffic or other serious offences under this Act.
4 They shall be authorised to communicate to the competent foreign authorities, at their request, confidential data collected under this Law, provided that:
5 The Federal Council may conclude international agreements on the communication of confidential data to foreign authorities or to international organisations, provided that the execution of this Law requires it.
6 The provisions on mutual assistance in criminal matters are reserved.
1 The Institute and other authorities responsible for the performance of this Law shall receive emoluments for the authorisations they issue, the checks carried out and the services provided by them. In addition, the Institute may collect emoluments for the reception of announcements.
2 The Institute may receive a fee on ready-to-use medicines sold in Switzerland to monitor their trade.
3 The Federal Council may authorise the Institute to receive an annual fee for the maintenance of authorisations.
4 The Institute shall determine the amount of the emoluments referred to in paras. 2 and 3 in such a way that they also cover the costs of developing drug quality standards, market surveillance, informing the public about them, and taking action against their abuse Or incorrect.
5 It fixes the amount of its emoluments in such a way that they meet the terms of the benefit mandate relating to cost coverage.
6 The Federal Council may, within the framework of the benefit mandate, request the Institute to waive the collection of all or part of the fees for certain authorisations or services or certain controls.
1 The Institute may take all necessary administrative measures to implement this Act.
2 It may include:
3 The cantons shall take, within the limits of their powers, the administrative measures necessary for the implementation of this Law which are referred to in para. 2.
4 Customs organs shall be empowered, if they suspect an infringement of the provisions of this Law, to detain consignments of therapeutic products at the border or in a customs warehouse and to appeal to the implementing authorities. They shall conduct the investigation and take the necessary measures.
1 The Institute shall ensure that the public is informed of specific events in relation to therapeutic products posing a health hazard, and that recommendations on the behaviour to be adopted are issued. It publishes information of general interest in relation to therapeutic products, in particular decisions on market authorisation and revocation, as well as changes in information for professionals and professionals. Patients.
2 The competent services of the Confederation may inform the public about the correct use of therapeutic products for the purpose of protecting health and combating their abuse.
1 The Confederation manages the institute with the assistance of the cantons.
2 The Institute is a public law institution with legal personality.
3 It is autonomous in its organisation and management; it is self-financing and maintains its own accounts.
4 It can use individuals to perform certain tasks.
5 It may establish advisory committees and mandate experts.
1 The Institute performs the tasks:
2 It may, for remuneration, provide services to authorities or individuals.
3 The Federal Council may give it the mandate to participate in the preparation of legislative acts in the area of therapeutic products.
1 The organs of the Institute shall be:
2 The Federal Council appoints the members of the Board of the Institute and its President. The cantons may propose the appointment of at most three members. Art. 6 A , para. 1 to 5, of the Act of 24 March 2000 on the personnel of the Confederation 1 Shall apply mutatis mutandis to the fees and other contractual conditions agreed with the members of the Board of the Institute. 2
3 The Federal Council shall appoint the Director after hearing the advice of the Institute and designating the review body.
1 RS 172.220.1
2 Phrase introduced by ch. I 4 of the LF of 20 June 2003 on remuneration and on other contractual terms agreed with the officials of the highest hierarchical level and the members of the governing bodies of the companies and establishments of the Confederation, in force From 1 Er Feb 2004 ( RO 2004 297 ; FF 2002 6972 6990).
The Board of the Institute:
The Director:
The review body shall report to the Federal Council and the Board of the Institute. To this end, it checks:
1 The Institute engages its staff as an employer of public law. In justified cases, it may conclude contracts according to the code of obligations 1 .
2 The Federal Council shall issue the necessary provisions. In so doing, it takes into account the autonomy necessary for the institute to carry out its tasks. Art. 6 A , para. 1 to 5, of the Act of 24 March 2000 on the personnel of the Confederation 2 Shall apply mutatis mutandis to salary and other contractual terms and conditions agreed with the directors of the Institute and other staff members who are remunerated in a comparable manner. 3
1 RS 220
2 RS 172.220.1
3 Phrase introduced by ch. I 4 of the LF of 20 June 2003 on remuneration and on other contractual terms agreed with the officials of the highest hierarchical level and the members of the governing bodies of the companies and establishments of the Confederation, in force From 1 Er Feb 2004 ( RO 2004 297 ; FF 2002 6972 6990).
The staff of the Institute shall be insured in the Federal Pension Fund.
1 New content according to the c. 3 of the Annex to the PMQ of 14 Dec. 2012, effective from 1 Er Jul. 2013 ( RO 2013 1493 ; FF 2011 6171 ).
1 The Confederation and the cantons may allocate endowment capital to the Institute.
2 The Institute's Board may decide that the endowment capital will be productive of interest.
3 The Institute shall finance its expenditure in particular:
The Institute shall draw up its budget and hold its accounts independently of those of the Confederation.
1 If the Institute makes a profit, it shall allocate it to the establishment of appropriate reserves.
2 The reserves are intended to finance future investments of the institute and to cover possible losses. If the reserves exceed a reasonable amount, the amount of the emoluments will be reduced.
3 Any loss is deferred to the following year. Where appropriate, the Institute shall report the amount of the emoluments.
The Institute is meeting its commitments. For the remainder, s. 19 of the Act of 14 March 1958 on Liability 1 Is applicable.
1 The Federal Council and the Institute shall carry out the tasks assigned by this Law to the Confederation. The Federal Council may delegate to other authorities certain tasks of the Institute.
2 The Federal Council shall issue the implementing provisions in so far as this Law does not declare the competent institute or has not entrusted it with the competence to issue technical and minor requirements.
1 Unless this Act provides otherwise, the administrative procedure and the legal remedies shall be governed by the Federal Act of 20 December 1968 on the administrative procedure 2 , by the Act of 17 June 2005 on the Federal Administrative Tribunal 3 And by the Act of 17 June 2005 on the Federal Court 4 . 5
2 The Institute shall be entitled to use the remedies of cantonal law and federal law against decisions of the cantonal authorities and the Federal Administrative Tribunal in accordance with this Law and its provisions To execute. 6
3 It also has the power to appeal against the decisions of the last cantonal authorities pursuant to the Human Research Act of 30 September 2011 7 (art. 89, para. 2, let. A, of the Act of 17 June 2005 on the Federal Court 8 ). 9
1 Repealed by c. 89 of the Annex to the PMQ of 17 June 2005 on the TAF, with effect from 1 Er Jan 2007 ( RO 2006 2197 1069; FF 2001 4000 ).
2 RS 172.021
3 RS 173.32
4 RS 173.110
5 New content according to the c. 89 of the Annex to the PMQ of 17 June 2005 on the TAF, in force since 1 Er Jan 2007 ( RO 2006 2197 1069; FF 2001 4000 ).
6 New content according to the c. I 12 of the Ass O. Fed. 20 Dec. 2006 on the adaptation of legislative acts to disp. Of the PMQ on the TF and the PMQ on the TAF, in force since 1 Er Jan 2007 ( RO 2006 5599 ; FF 2006 7351 ).
7 RS 810.30
8 RS 173.110
9 Introduced by ch. 6 of the schedule to the PMQ of Sept. 2011 on human research, in force since 1 Er Jan 2014 ( RO 2013 3215 ; FF 2009 7259 ).
1 Repealed by c. 89 of the Annex to the PMQ of 17 June 2005 on the TAF, with effect from 1 Er Jan 2007 ( RO 2006 2197 1069; FF 2001 4000 ).
1 The person shall be liable to imprisonment or a fine of up to 200 000 francs, unless he has committed a more serious offence within the meaning of the Penal Code 1 Or the Act of 3 October 1951 on Narcotic Drugs 2 , who intentionally endangers human health by the fact that:
2 If the author acts by profession, the penalty of imprisonment shall be no more than five years and the fine of up to 500 000 francs.
3 If the perpetrator acts by negligence, the penalty of imprisonment shall be no more than six months or a fine of up to 100 000 francs.
1 Every person shall be liable to a judgment or a fine of not more than 50 000 francs, wilfully:
2 If the author acts by profession, in the cases provided for in para. 1, let. A, b, e or f, the penalty shall be imprisonment for not more than six months and a fine of up to 100 000 francs.
3 If the perpetrator is negligent, the penalty is a fine of not more than 10 000 francs.
4 Attempt and complicity are punishable.
5 The contravention and sentence are prescribed by five years.
6 In cases of very minor gravity, criminal prosecution and conviction may be waived.
The criminal provisions of the Federal Act of 6 October 1995 on Technical Barriers to Trade 1 Apply to forgery, false findings, fraudulent obtaining of false findings, use of false or inaccurate certifications, unauthorized establishment of declarations of conformity, apposition and non-compliance Authorized signs of conformity, as well as the economic benefits acquired unlawfully within the meaning of s. 23 to 29 of the said Act.
Art. 6 and 7 (offences committed in a company) of the Federal Act of 22 March 1974 on administrative criminal law 1 Also apply to cantonal criminal prosecution.
1 The criminal prosecution in the field of the execution of the Confederation shall be carried out by the Institute, in accordance with the provisions of the Federal Act of 22 March 1974 on administrative criminal law 1 .
2 The criminal prosecution in the area of the execution of the cantons is the responsibility of the cantons.
1 The Federal Council may require services which, prior to the entry into force of this Act, were responsible for the registration of therapeutic products or for monitoring the contract to be submitted to the Institute.
2 For the remainder, the Federal Council concludes with the Inter-cantonal Drug Control Union a convention on the resumption of the Inter-cantonal Office for the Control of Medicinal Products by the Institute.
1 The Federal Council appoints the first director of the institute on a proposal from the Federal Department of the Interior.
2 The Federal Department of the Interior makes the first appointment of the other members of the Directorate. Their appointment will be confirmed by the Board of the Institute in accordance with Art. 72, let. H, within 18 months at most after the Institute has begun its activity.
3 Staff reports from the Federal Office of Public Health and the Inter-cantonal Office for the Control of Medicinal Products transferred to the Institute shall be subject to the Staff Regulations of the Institute as soon as the Institute has started its Activity.
Upon the establishment of the Institute, the Confederation resumed the deficit of the Federal Pension Fund for the insured persons transferred from the Federal Office of Public Health to the Institute.
1 Proceedings which, upon entry into force of this Law, are pending before the Federal Office of Public Health, the Federal Office for Food Safety and Veterinary Affairs 1 , the Intercantonal Office for the Control of Medicinal Products, the bodies of the Inter-cantonal Drug Control Union and the administrative cantonal authorities of the first instance shall be conducted in accordance with this Law and by The authorities it designates.
2 The acts of procedure of the authorities which were competent before the entry into force of this Law shall remain valid insofar as they are not contrary to the substantive provisions of this Law.
1 Drug registrations by the Federal Office of Public Health, the Federal Office for Food Safety and Veterinary Affairs and the Inter-cantonal Office for Drug Control are valid for five years As from the date of entry into force of this Act.
2 Cantonal authorisations for medicinal products are valid until 31 December 2017; medicinal products may be authorised by the Institute within two years of the expiry of the transitional period. 1 Are reserved:
3 Applications for marketing authorisations for medicinal products which were not subject to such authorization, either by the cantonal law or by federal law, but which must be made under this Act, must be submitted in the Within one year from the date of entry into force of this Act. These drugs may continue to be placed on the market until the Institute has made a decision.
4 In vitro diagnostics may be placed on the market in accordance with the old law until 7 December 2003. Authorisations and registrations of in vitro diagnostics established in accordance with the former right shall be valid until the expiry of their term of validity or for at most three years from the date of entry into force of this Law.
5 Authorisations issued by the Confederation and the cantons in accordance with the former right shall be valid until the expiry of the term of their validity or for no more than five years from the date of entry into force of this Law.
6 Persons who do not comply with the provisions for the remission of medicinal products (art. 24 and 25) shall cease to submit within seven years from the date of entry into force of this Act. The Federal Council may, however, provide for derogations for those who provide evidence that they have adequate training.
7 Administrative measures taken by the Institute and referred to in Art. 66 are reserved.
1 New content according to the c. I of the PMQ of June 21, 2013, in force since 1 Er Jan 2014 ( RO 2013 4137 ; FF 2013 2885 2893).
In the case of drugs that are already authorized upon entry into force of the June 13, 2008 amendment, the prescribed time limits under s. 16 A , para. 1, begin to run as of the date of entry into force of this amendment.
1 Introduced by ch. I of the PMQ of 13 June 2008, in force since 1 Er Oct. 2010 ( RO 2008 4873 , 2010 4027; FF 2007 2245 ).
I
The Pharmacopoeia Act of 6 October 1989 1 Is repealed.
II
The current law is amended as follows:
... 2
1 [RO 1990 570]
2 The mod. Can be viewed at RO 2001 2790 .