¹ Must have an authorization issued by the Swiss Institute for Therapeutic Products (Institut) whoever:

A.

Manufactures drugs;

B.

Adds drugs to feed.

² The Federal Council regulates the derogations from the authorisation scheme. It may include:

A. ¹

Submit the manufacture of drugs within the meaning of s. 9, para. 2, let. A to c ^Bis And 14, para. 1, let. C, a cantonal authorization or the obligation to announce;

B.

Dispensing with the authorization of the holders of animals that add drugs to food for their own livestock.

¹ The authorization is issued:

A.

Whether the conditions relating to professional qualifications and exploitation are met;

B.

If there is an appropriate quality assurance system.

² The competent authority shall verify, through an inspection, that the conditions are fulfilled.

¹ Drugs must be manufactured in accordance with the recognized Good Manufacturing Practices rules.

² The Federal Council specifies the recognized rules of Good Manufacturing Practices. In doing so, it takes into account internationally recognized guidelines and standards.

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:

A. ¹

Drugs that are manufactured pursuant to a medical prescription in a public office or hospital pharmacy that are intended for a specified person or circle of persons or an animal or a specified animal or herd (formula Compounding); on the basis of this order, the drug may be manufactured Ad hoc Or by lot in the public office or hospital pharmacy but may only be given on a medical prescription;

B. ²

The drugs that are manufactured Ad hoc Or by lot in a public office, hospital pharmacy, drugstore or other establishment with a manufacturing authorization, in accordance with a special monograph of the Pharmacopoeia or other pharmacopoeia or pharmacopoeia Formulariums recognized by the Institute and intended for delivery to the clients of the institution (compendial formula);

C. ³

Non-prescription drugs that are manufactured Ad hoc Or by lot in a public office, hospital pharmacy, drugstore or other establishment with a manufacturing authorization based on a formula specific to the establishment or a formula published in the specialized literature, in The limits of the right of the person responsible for making medicines (s. 25) to the establishment's clients;

C ^Bis . ⁴

Medicinal products for which there is evidence that no substitute or equivalent medicinal products are authorised or available, which are manufactured by lot in a hospital pharmacy according to a list of medicinal products internal to the hospital and which are intended to Be delivered to the institution's clients;

D.

Drugs intended for use in clinical trials;

E.

Drugs that cannot be standardized.

^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 Anyone seeking authorization to market a drug or process must:

A.

Proof that the drug or process is of high quality, safe and effective;

B.

Be the holder of an authorization to manufacture, import or conduct wholesale trade issued by the competent authority;

C.

Have a domicile or head office in Switzerland, or have established a subsidiary there.

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:

A.

Designation of the drug;

B.

The name of the manufacturer and the distribution company;

C.

The manufacturing process, composition, quality and stability of the drug;

D.

Residues and waiting times in the case of medicines for animals intended for the production of foodstuffs;

E.

Therapeutic effects and adverse reactions;

F.

Labelling, information, method of delivery and mode of administration;

G.

Results of physical, chemical, galenical and biological or microbiological and pharmacological and toxicological testing;

H.

The results of clinical trials.

² The Federal Council:

A.

Set, in accordance with internationally accepted guidelines and standards, the requirements to be met by the organization, conduct and registration of the pharmacological and toxicological testing referred to in para. 1, let. G, and lays down provisions on the control procedure;

B.

Determines the languages in which labelling and information are to be drafted.

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:

A.

If the latter authorizes it in writing;

B.

If the protection of the original preparation has expired.

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:

A.

Drugs whose active ingredients are known;

B.

Medicines of complementary medicine;

C.

Drugs that are prepared for inventory by a public office, drugery, or other establishment with a manufacturing authorization, based on a formula specific to the establishment (counter specialities), in accordance with Pharmacopoeia or other pharmacopoeia or formulariums recognized by the Institute and delivered to the institution's clients;

D. ¹

Drugs that are manufactured in a hospital pharmacy or hospital radiopharmaceutical and are intended for hospital purposes;

E.

Drugs that are manufactured by the military and used as part of the coordinated health service;

F.

Major drugs for rare diseases;

G.

Veterinary medicinal products intended exclusively for animals which are not intended for the production of foodstuffs.

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:

A.

Whether this medicinal product meets the requirements of the medicinal product which is already the subject of a marketing authorisation in Switzerland, in particular those relating to the labelling and information referred to in Art. 11;

B.

If that other person responsible for placing a medicinal product on the market is able to guarantee in a sustainable manner that all the medicinal products for which it is distributed and for which it has obtained a marketing authorisation fulfil the same The safety and quality requirements of the first applicant.

³ ... ²

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 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:

A.

The medicinal product has not actually been placed on the market within three years of the granting of the authorisation;

B.

The medicinal product placed on the market is no longer in the market for three consecutive years.

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 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:

A.

Any ready-to-use drugs for distribution or delivery;

B.

Exports, for distribution or remission, drugs that are ready for employment;

C.

International trade in medicines from Switzerland, without these drugs entering Switzerland.

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:

A.

Persons engaged in medical practice across the border;

B.

International organizations.

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 The authorization is issued:

A.

Whether the conditions relating to professional qualifications and exploitation are met;

B.

If there is an appropriate quality assurance system.

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:

A.

Individuals for personal consumption;

B.

Persons engaged in a medical profession.

³ It can:

A.

Prescribe that the importation of medicinal products requiring special control for the protection of health be authorised in the cases of the species by the Institute;

B.

To restrict or prohibit the importation of medicinal products if it is apparent from the circumstances that they could be used for illegal or improper purposes.

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:

A.

They are prohibited in the country of destination;

B.

Whether it is apparent from the circumstances that they could be intended for illicit purposes.

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:

A.

Pharmacists, on medical prescription and, in exceptional cases justified, without a medical prescription;

B.

Any other person in a medical profession, in accordance with the provisions of the pro-pharmacist;

C.

Any duly trained professional, under the control of a person referred to in the let. A and b.

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:

A.

Persons entitled to submit prescription drugs;

B.

The right-holders of the federal degree, within the limits of their right to deliver drugs;

C.

Any other person duly trained, within the limits of his or her right to provide medication;

D.

Any duly trained professional, under the control of persons referred to in the let. A and b.

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:

A.

The drug is the subject of a medical prescription;

B.

There is no security requirement;

C.

Advice is provided in the rules of the art;

D.

Adequate medical supervision of the action of the drug is guaranteed.

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:

A.

Whether the conditions relating to professional qualifications and exploitation are met;

B.

If there is an appropriate quality assurance system.

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 Any person in a pharmacy, drugstore or other retail establishment must have a Cantonal Authorization.

² The cantons shall lay down the conditions and procedure for the granting of authorisation to conduct retail trade. They carry out periodic checks.

¹ Is lawful:

A.

Advertising for all types of drugs, provided that it is intended exclusively for those who prescribe or remit them;

B.

Advertising to the public for non-prescription drugs.

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:

A.

Misleading advertising or contrary to public order and morality;

B.

Advertising that may lead to excessive, abusive or inappropriate use of drugs;

C.

Advertising for medicines that cannot be placed on the market in Switzerland.

² Illegal advertising to the public for medicinal products:

A.

May be given only by prescription;

B.

Containing narcotic drugs or psychotropic substances covered by the Narcotic Control Act of 3 October 1951 ¹ ;

C.

Which, because of their composition and intended use, cannot be used for the diagnosis, the prescription or the corresponding treatment without the intervention of a doctor;

D.

Are frequently the subject of abuse or may result in addiction or addiction.

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:

A.

Material benefits of modest value that relate to the practice of medicine or pharmacy;

B.

The usual trade and economic incentives that have a direct impact on the price.

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:

A.

Whether the conditions relating to professional qualifications and exploitation are met;

B.

If there is an appropriate quality assurance system.

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:

A.

Whose health may be impaired by blood collection;

B.

Whose blood could transmit pathogens.

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:

A.

Pathogens or evidence of their presence to be found in the blood;

B.

The procedure to be followed when the test result is reactive;

C.

The examinations to be carried out to ensure compatibility;

D.

The requirements for carrying out the tests.

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:

A.

Record all operations of interest to security;

B.

Keep these records in such a way as to ensure the traceability of the data to the person who gave blood or who received it.

² For each levy, the following will be recorded:

A.

The name, first name and date of birth of the person who donated blood;

B.

The date of collection;

C.

Test results and their interpretation.

³ People who are excluded from the blood donor circle will be registered:

A.

The name, first name and date of birth;

B.

The date and reason for the exclusion.

⁴ People who have been administered blood or blood products will register:

A.

The name, first name and date of birth;

B.

The date on which blood or blood products were administered;

C.

The labelling and provenance of blood or blood products.

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:

A.

Provide for the transfer to the Institute or the archiving of the data referred to in Art. 39 and important documents if an establishment ceases to be active prior to the expiry of the archival period;

B.

Provide for exemptions from the obligation to archive for autologous transfusions.

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 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:

A.

Drugs authorized and administered in accordance with authorized conditions of use;

B.

Medical devices that are compliant and used on a job-by-job basis as part of their conformity assessment.

³ The Federal Council may:

A.

Subtract other tests from the authorization regime or subject them to an obligation to advertise;

B.

Submit clinical trials of veterinary therapeutic products to the licensing regime or to the obligation to advertise.

⁴ As part of the authorisation procedure, the Institute shall verify:

A.

That the drugs meet the Good Manufacturing Practices and Drug Safety requirements;

B.

Medical devices meet the requirements of s. 45, the clinical trial takes into account the risks associated with the products and the data relating to the products correspond to the state of the science and are correctly reflected in the protocol.

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:

A.

The clinical trial is completed or discontinued;

B.

Adverse events occur during the clinical trial;

C.

Events that occur during the clinical trial may affect the safety or health of the individuals involved.

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 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:

A.

Which is or may be attributable to the therapeutic product itself, to its administration or to incorrect labelling or instructions;

B.

That could jeopardize or alter the health of the consumer, patient, third party, or treated animals.

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:

A.

Immunological drugs;

B.

Blood and blood products;

C.

Rarely used processes that require very specific knowledge.

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:

A.

That the requesting foreign authorities guarantee confidentiality;

B.

They use the data exclusively in the context of an administrative procedure in relation to the enforcement of provisions relating to therapeutic products;

C.

That only data necessary for the enforcement of provisions relating to therapeutic products be provided;

D.

No trade secrets or trade secrets are disclosed, unless the communication of data is required to deal with direct health threats.

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:

A.

Intervening in the event of non-compliance and setting an appropriate period for the restoration of the rule of law;

B.

Suspend or revoke authorizations;

C.

Closing facilities;

D.

Seize, store or destroy therapeutic products that are hazardous to health or that do not comply with the requirements of this Act;

E.

Prohibit the distribution and delivery of therapeutic products, their import and export as well as the trade abroad of these products from Switzerland and order the immediate withdrawal of the market for therapeutic products or Issuing recommendations on how to prevent damage;

F.

Seize illicit advertising material, keep them in custody, destroy them and prohibit their use and publish, at the expense of those responsible, the decision to intervene;

G.

In the case of a serious or repeated infringement of the provisions of this Law, provisionally or definitively prohibit the advertising of a particular therapeutic product and publish, at the expense of those responsible, the prohibition decision.

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:

A.

Are legally assigned to it;

B.

The Federal Council assigns it within the framework of the benefit mandate.

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 Federal Council assigns a mandate for benefits to the Institute.

² The competent department enters into an annual benefit contract with the Institute as part of its benefit mandate.

¹ The organs of the Institute shall be:

A.

The Board of the Institute, consisting of not more than seven members;

B.

The Director;

C.

The review body.

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.

The Board of the Institute:

A.

Defends, before the Federal Council and the relevant department, the interests of the Institute in the development of the benefit mandate and the benefit contract;

B.

Approves the management plan and budget, taking into account the benefit mandate and the benefit contract;

C.

Monitors the performance of the benefit mandate and the benefit contract;

D.

Proposes to the Federal Council the amount of compensation paid by the Confederation to the Institute for its services of general interest;

E.

Approves the Organizational Rules of the Institute;

F.

Establishes the rates of emoluments for the benefits of the institute;

G.

Approves the activity report and the annual accounts;

H.

Appoint the other members of the Directorate on a proposal from the Director;

I.

Approves reports to the principal;

J.

Performs other duties assigned to it by the Federal Council.

The Director:

A.

Presides over management;

B.

Manages the Institute in accordance with the principles of delegation and the agreed definition of objectives;

C.

Responds to its management before the Board of the Institute;

D.

Represents the institute outside.

The review body shall report to the Federal Council and the Board of the Institute. To this end, it checks:

A.

Accounting;

B.

The report on the performance of the benefit mandate and the benefit contract;

C.

The proper functioning of the Institute's planning, management, management and reporting systems.

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

The staff of the Institute shall be insured in the Federal Pension Fund.

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:

A.

By the remuneration of the tasks assigned to it by the benefit mandate;

B.

By revenue derived from the collection of the fees;

C.

By the remuneration of its services of general interest;

D.

Revenue from the provision of services provided to authorities and individuals.

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 Institute is exempt from the taxes of the Confederation, the cantons and the municipalities.

² The federal law governing:

A.

Value added tax on remuneration;

B.

Pre-tax and stamp duty.

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:

A.

The revocation of an authorization by the township;

B.

The replacement, on request, of a cantonal authorisation by a marketing authorisation issued by the Institute.

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.

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 This Act is subject to an optional referendum.

² The Federal Council shall fix the date of entry into force.