type: legislation

jurisdiction: Switzerland

text: 812.214.31 English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.Ordinance on Integrity and Transparency in relation to Therapeutic Products(TPITO)of 10 April 2019 (Status as of 1 January 2020)The Swiss Federal Council,on the basis of Articles 4 paragraph 2, 55 paragraph 3 and 56 paragraphs 2 and 3 of the Therapeutic Products Act of 15 December 20001 (TPA),ordains:1 SR 812.21Section 1 General Provisions  Art. 1 Subject matter  This Ordinance regulates the details on the requirement for integrity and the duty of transparency in Articles 55 and 56 TPA.Art. 2 Definitions  In this Ordinance:a. professionals means persons who prescribe prescription-only medicinal products, dispense the same, use them independently on professional basis, or purchase them or jointly decide on their purchase for these purposes;b. organisations means private or public legal entities and companies and sole proprietorships that employ professionals.Section 2 Integrity  Art. 3 Advantages of modest value  1 Advantages of modest value under Article 55 paragraph 2 letter a TPA that are permitted are advantages given to professionals that have a maximum total value of 300 francs per professional per year that are of relevance to medical or pharmaceutical practice.2 An advantage is of relevance to medical or pharmaceutical practice if it is directly connected with the practice of the profession by the professional or of direct benefit to the professional’s customers.3 Competition winnings and prizes are only permitted if:a. they constitute an advantage of modest value and of relevance to medical or pharmaceutical practice;b. the competition is directed exclusively towards the addressees of specialist advertising as defined in Article 3 of the Medicinal Products Advertising Ordinance of 17 October 20012 (MPAO); andc. participation in the competition is not conditional on purchasing prescription-only medicinal products.2 SR 812.212.5Art. 4 Support for research, teaching and infrastructure  Contributions that are permitted as support given to organisations for research, teaching and infrastructure in accordance with Article 55 paragraph 2 letter b TPA are contributions that:a. are not offered, promised or given to professional in person but to the organisation that employs the professional;b.  are based on a written agreement which clearly states their intended purpose;c. are used exclusively for that intended purpose;d. are not subject to conditions or requirements that relate to the prescription, dispensing, use or purchase of certain prescription-only medicinal products;e. are credited to a specific account held by the organisation to which professionals do not have sole access; andf. are shown in the organisation’s accounts.Art. 5 Support for the continuing education and training and continuing professional development of professionals  1 Contributions that are permitted as support for the continuing education and training and continuing professional development of professionals in accordance with Article 55 paragraph 2 letter b TPA are contributions that meet the requirements of Article 4 letters a–f.2 The organisation must decide independently on the form and choice of the continuing education and training and continuing professional development events and on the professionals who participate.Art. 6 Support for participating in events for the continuing education and training and continuing professional development of professionals  1 Contributions are permitted as support for participating in events for the continuing education and training and continuing professional development of professionals in accordance with Article 55 paragraph 2 letter b TPA provided they are agreed in writing and the professionals participating or the organisations that employ them make an appropriate contribution to the costs of the event (the personal contribution to the costs).2 The personal contribution per person attending a continuing professional development event amounts to at least one third, and per person attending a continuing education and training event to at least one fifth of the following costs:a. registration fees;b. travel costs to and from the event;c. accommodation and meals; andd. costs of activities that are not required in order to participate in the event (fringe events) and that are clearly of subordinate importance.3 A personal contribution to the costs is not required if:a. the participating professional provides a service in return of equivalent value in accordance with Article 7 at the event;b.  the participating professional is not required to make an overnight stay at the location of the event and the event lasts for no more than half a working day, not including any meal served following the professional part of the event.4 The following are not permitted:a. the full or partial refund of the personal contribution to the costs;b. any payment in respect of indirect participation costs such as lost working hours or lost income;c. any payment of the costs of fringe events that are not clearly of subordinate importance to the professional part of the event;d. any payment of the costs of travelling, accommodation, meals or fringe events for persons accompanying the participating professional, even if the accompanying persons are themselves professionals.Art. 7 Compensation for services of equivalent value  1 Compensation for services of equivalent value provided by a professional or organisation in accordance with Article 55 paragraph 2 letter c TPA is compensation that:a. is based on a written agreement which sets out the nature and extent of the service and the compensation; andb. is commensurate with the service provided.2 In the context of a specialist discussion, the requirement in paragraph 1 letter a does not apply to the payment of the cost of meals up to a maximum of 100 francs.3 No compensation shall be due for services that a professional or organisation:a. provides for themselves;b. provides in fulfilment of statutory obligations; orc. is otherwise remunerated for.4 Compensation under paragraph 1 is in particular permitted for:a. costs assumed in connection with the purchase of prescription-only medicinal products, such as the payment of transport costs, storage costs or the assumption of storage risks;b. teaching, expert and advisory activities or the conduct of scientific studies and clinical trials;c. reports on practical experiences that are published in a scientifically recognised specialist medium;d. participation in advisory bodies, workshops or market research projects, provided they have no promotional purpose.Art. 8 Discounts  1 A discount corresponds to the difference between the standard price of a product and the price effectively paid in a transaction. For medicinal products on the list of pharmaceutical specialities, a discount is deemed to have been granted in particular where the price effectively paid is less than the ex factory price.2 The delivery of a larger quantity than ordered and invoiced is not permitted.Art. 9 Free samples  Free samples as defined in Article 10 MPAO3 may not be sold by professionals who receive them.3 SR 812.212.5Section 3 Transparency  Art. 10 1 All discounts and refunds that are given on the purchase of therapeutic products to persons or organisations that prescribe, dispense or use medicinal products or purchase the same for that purpose must be disclosed to the Federal Office of Public Health on request.2 The duty of transparency in accordance with Article 56 TPA does not apply to the purchase of over-the-counter medicinal products (Distribution Category E) and conventional medicinal products falling within Class I in accordance with Annex IX of Council Directive 93/42/EEC4 concerning medical devices.4 Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ L 169 of 12.7.1993, S. 1; last amended by Directive 2007/47/EC, OJ L 247 of 21.9.2007, p. 21.Section 4 Controls  Art. 11 Any person who produces or sells medicines subject to the provisions on integrity and transparency must:a. designate a person to deliver all the required documents and information to the Federal Office of Public Health on request;b. retain all the agreements entered into with professionals and organisations in terms of this Ordinance for ten years after their final use;c. maintain a list of all professionals and organisations that have received due advantages in accordance with this Ordinance.Section 5 Final Provisions  Art. 12 Amendment of other legislation  The amendment of other legislation is regulated in the Annex.Art. 13 Commencement  This Ordinance comes into force on 1 January 2020.Annex (Art. 12)Amendment of other legislation The ordinances below are amended as follows:...55 The amendments can be consulted under AS 2019 1395.


text: 813.1 English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.Federal Act on Protection against Dangerous Substances and Preparations(Chemicals Act, ChemA)of 15 December 2000 (Status as of 1 January 2017)The Federal Assembly of the Swiss Confederation,based on Articles 95 paragraph 1, 110 paragraph 1 letter a and 118 paragraph 2 letter a of the Federal Constitution1,and having considered the Dispatch of the Federal Council dated 24 November 19992,ordains:1 SR 1012 BBl 2000 687Chapter 1 General Provisions and Principles  Section 1 General Provisions  Art. 1 Purpose  This Act is intended to protect the lives and health of human beings against harmful effects arising from substances and preparations.Art. 2 Scope  1 This Act applies to the handling of substances and preparations.2 The handling of microorganisms is deemed equivalent to the handling of substances and preparations in so far as they are used in biocidal products or plant protection products.3 The Federal Assembly may by means of an ordinance extend the scope of this Act or of individual provisions to include:a.organisms that have, or may have, dangerous properties within the meaning of this Act;b.the protection of the lives and health of farm and household animals.4 The Federal Council shall provide for exemptions from the scope or from individual provisions of this Act in cases where:a.lives and health are adequately protected by other federal legislation against harmful effects arising from substances and preparations;b.substances and preparations are intended solely for through transit or export;c.general defence or the tasks of the police and customs authorities necessitate such exemptions.Art. 3 Dangerous substances and preparations  1 Substances and preparations are deemed dangerous if they are capable of presenting a hazard to life or health as a result of physico-chemical or toxic effects.2 The Federal Council shall specify the properties deemed dangerous and define categories of danger.Art. 4 Definitions  1 In this Act:a.substances means chemical elements and their compounds in the natural state or obtained by any production process. A distinction is drawn between existing and new substances:1.substances shall be deemed to be existing substances if they are designated as such by the Federal Council,2.all other substances shall be deemed new;b.active substances means substances and microorganisms including viruses which on account of their action are designed to be used as biocidal products or plant protection products;c.preparations means mixtures or solutions composed of two or more substances;d.biocidal products means active substances and preparations that are not plant protection products and which are designed to:1.deter, render harmless, destroy or otherwise control harmful organisms, or 2.prevent damage from being caused by harmful organisms;e.plant protection products means active substances and preparations that are designed to:1.protect plants and plant products against harmful organisms or prevent the action of such organisms,2.influence the life processes of plants other than as a nutrient,3.preserve plant products,4.destroy unwanted plants or parts of plants, or5.control the undesired growth of plants;f.manufacturer means any natural or legal person who, by way of profession or trade, produces or extracts substances or preparations, or imports them for professional or commercial purposes;g.notifier means any natural or legal person who notifies new substances to the notification authority, submits documentation on existing substances under review, or requests authorisation for active substances or preparations;h.notification authority means the federal authority that receives in particular notifications of new substances, documentation on existing substances under review, or requests for authorisation for active substances and preparations, as well as other submissions, coordinates the procedures and issues the necessary rulings;i.placing on the market means providing for or supplying to third parties and importing for professional or commercial purposes;j.handling means any activity in connection with substances or preparations, in particular, production, import, export, placing on the market, storage, keeping, transport, use or disposal.2 The Federal Council may define more precisely the terms specified in paragraph 1, as well as other terms used in this Act, draw further distinctions, and, in the light of new scientific and technological knowledge and in line with international developments, make adjustments and grant exemptions.Section 2 Principles for the Handling of Substances and Preparations Art. 5 Self-regulation  1 Any manufacturer who places substances or preparations on the market shall be responsible for ensuring that they do not endanger life or health. In particular, the manufacturer shall:a.assess and classify substances and preparations according to their properties;b.package and label them in accordance with the type of hazard concerned.2 The Federal Council shall issue regulations on the nature, extent and review of self-regulation. In particular, it shall specify:a.test methods, the principles of Good Laboratory Practice (GLP) and the criteria for assessment and classification;b.packaging and labelling requirements.Art. 6 Placing on the market  Having completed the appropriate self-regulation procedures, the manufacturer shall be entitled to place substances and preparations on the market without the prior consent of the authorities. The following exceptions apply:a.notification is required for placing new substances on the market as such or as a constituent of a preparation (Art. 9);b.authorisation is required for placing biocidal products or plant protection products on the market (Art. 10 and 11).Art. 7 Obligation to inform purchasers  1 Any person who places substances or preparations on the market must inform purchasers about properties and hazards relevant to health, and about the appropriate precautions and protective measures.2 The Federal Council shall issue regulations concerning the nature, content and scope of such information, in particular the distribution and content of a safety data sheet.Art. 8 Duty of care  Any person involved in the handling of substances or preparations must pay due regard to their dangerous properties and take any measures necessary to protect life and health. In particular, due consideration must be given to the relevant information provided by the manufacturer.Chapter 2 Notification of and Authorisation for Specific Substances and Preparations Art. 9 Notification of new substances  1 The notification authority shall review and assess the documents submitted in conjunction with the federal authorities responsible for the technical matters in question (assessment authorities) and shall inform the notifier of the outcome within a period specified by the Federal Council.2 A substance for which notification has been submitted may be placed on the market if the notification authority has accepted the notification or if it has not requested any further documents or information concerning the notification within the above-mentioned period.3 The Federal Council shall issue regulations on the requirements and the procedure for the notification of new substances. It shall specify any exemptions from mandatory notification, taking into account in particular the intended use, the type of substance or preparation and the quantities that are to be produced or placed on the market.Art. 10 Authorisation for biocidal products  1 The notification authority shall review and assess the documents submitted in conjunction with the assessment authorities and shall issue its decision – taking the risk assessment into consideration (Art. 16) – within a period specified by the Federal Council.2 Authorisation shall be granted for a biocidal product in particular if, when used as intended:a.it is sufficiently effective;b.it does not have any unacceptable adverse effects on the health of humans or of farm or household animals.3 Authorisation may be withheld or revoked if the health risks give rise to concern and if another active substance is available for which authorisation has been granted for biocidal products of the same type, which is associated with a considerably lower health risk and which does not entail any significant economic or practical disadvantages for users.4 The Federal Council shall specify the types of authorisation and the authorisation procedures, as well as any exemptions from mandatory authorisation for biocidal products. Authorisation shall be granted for limited periods.Art. 11 Authorisation for plant protection products  1 Authorisation shall be granted for a plant protection product in particular if, when used as intended, it does not have any unacceptable adverse effects on the health of humans or of farm or household animals.2 In other respects, the types of authorisation and the authorisation procedures, as well as any exemptions from mandatory authorisation for plant protection products, shall be determined by the relevant agricultural legislation. When issuing the appropriate implementing regulations, the Federal Council shall give due consideration to the protection of health within the meaning of this Act.Art. 12 Obligation to request information in advance  Before notifiers conduct the animal experiments required for notification or authorisation, they must enquire at the notification authority as to whether the substance or preparation concerned has already been notified or authorisation has already been granted.Art. 13 Second notification and second authorisation  1 Notification or authorisation in accordance with Articles 9–11 shall also be required in cases where substances or preparations subject to mandatory notification or authorisation have already been notified by another notifier or authorisation has already been granted to another notifier.2 The Federal Council shall establish a special procedure for second notification or authorisation and, giving due consideration to the interests of the original notifier, shall specify the conditions under which:a.the second notifier may refer to notification documents already submitted;b.the original notifier, in the interests of animal welfare, has to accept the use of its notification documents.Art. 14 Use of documents  Subject to the provisions of Article 13 paragraph 2, the federal authorities involved in the notification or authorisation procedure shall not be entitled to use information or documents provided by a notifier for the benefit of a different notifier without the former’s consent. The Federal Council shall specify the period of protection and determine any exemptions, giving due consideration to the confidentiality of the information concerned.Art. 15 Review of existing substances  1 The Federal Council shall issue regulations concerning the review and assessment of individual existing substances.2 The notification authority may request manufacturers to carry out investigations or tests or to provide documents relating to existing substances that:a.in view of the quantities produced or placed on the market or in view of their dangerous character may pose a particular risk to life or health; or b.are being reviewed in connection with international efforts and programmes.Art. 16 Risk assessment  1 The notification authority, in conjunction with the assessment authorities, shall identify possible hazards presented by substances or preparations (risk assessment). For this purpose, the notifier may be requested to provide additional information and, if necessary, to carry out further tests.2 A risk assessment shall be required for:a.new substances (Art. 9);b.substances and preparations subject to mandatory authorisation (Art. 10 and 11);c.existing substances under review in accordance with Article 15 paragraph 2 letter b.3 On the basis of the risk assessment, having first consulted the notifier, the notification authority may recommend or order that the notifier should take measures to reduce the risks.4 If no measures can be taken to reduce the risks or if the risks cannot be adequately reduced by such measures, the authorities responsible shall take appropriate steps to amend the relevant legal regulations.5 Risk assessments shall be reviewed and, if necessary, revised in the light of new findings. In addition, reviews shall be carried out periodically in the case of biocidal products and plant protection products.Art. 17 Supplementary information  The notifier must inform the notification authority without delay and if necessary submit new documents if new findings emerge relating to the substance or preparation concerned or if significant changes occur with regard to essential points such as properties, intended use, or the quantities produced or placed on the market.Chapter 3 Special Provisions concerning the Handling of Substances and Preparations Art. 18 Reporting the details of substances and preparations  1 In cases where dangerous substances or preparations not subject to a mandatory notification or authorisation procedure are placed on the market, the manufacturer shall inform the notification authority of the following:a.the name and address of the manufacturer;b.the essential details concerning the identity of the product;c.the classification and labelling;d.the substances relevant to the classification.2 In the case of certain substances and preparations, the Federal Council may waive, in part or in full, the requirement to provide such information, particularly if:a.on account of their properties or the intended use, information on the substances or preparations concerned is of little importance for the identification of risks or for prevention;b.they are supplied exclusively to professional or commercial users; orc.they are supplied in small amounts to a restricted circle of users.3 It may, if this is important for the identification of risks or for prevention:a.stipulate that additional details be reported for certain substances and preparations, specifically concerning their composition;b.extend the scope of mandatory reporting to include preparations that are not dangerous but contain dangerous substances.Art. 19 Regulations concerning substances  1 The Federal Council may issue special regulations:a.for certain substances and preparations that may endanger life or health;b.for articles containing substances or preparations as specified under letter a that may endanger life or health when they are used as intended or in a foreseeable way.2 It may:a.impose restrictions on the way in which they are handled, and in particular produced, placed on the market and used;b.impose restrictions on the intended use for which a substance or preparation is placed on the market, and on the quality and form thereof;c.prohibit any handling if life and health cannot otherwise be protected;d.attach special conditions to exports;e.require articles to be labelled if certain substances are contained in or may be released from them;f.require certain poisonous plants and animals to be labelled as such if they are placed on the market;g.specify the classification and labelling of individual dangerous substances and set threshold concentrations for the classification and labelling of preparations that contain these substances.Art. 20 Advertising  1 The promotion and offering for sale of dangerous substances and preparations, and of preparations containing dangerous substances, must not give rise to misapprehensions regarding the hazards or encourage inappropriate handling. In the case of biocidal products, no misleading claims may be made regarding efficacy.2 The Federal Council shall issue regulations on how reference is to be made to the hazards in such promotion and offering for sale.Art. 21 Keeping, storage  Dangerous substances and preparations shall be kept and stored securely according to the type of hazard involved. In particular, they must:a.be protected against hazardous external influences;b.be inaccessible to unauthorised parties;c.be kept or stored in such a way as to prevent any risk of confusion, specifically with foodstuffs, or of their being used by mistake.Art. 22 Obligation to return and to accept returns  1 Any person who supplies dangerous substances or preparations shall be obliged to accept them when returned by non-commercial users for appropriate disposal. Small quantities shall be returnable free of charge.2 In the case of particularly dangerous substances and preparations, the Federal Council may stipulate that they are to be returned by the owner for disposal.Art. 23 Theft, loss, inadvertent placing on the market  The Federal Council shall issue regulations concerning the measures that are to be taken when dangerous substances or preparations have been stolen, lost, or placed on the market by mistake.Art. 24 Regulations concerning personal and technical qualifications  1 The Federal Council shall specify the personal and technical qualifications required by persons wishing to handle substances and preparations with particularly dangerous properties or in specific categories of danger or carrying special risks. It shall establish a licensing requirement if this is necessary to protect life and health.2 It shall specify how the necessary expertise may be acquired.Art. 25 Measures required in commercial and educational establishments  1 Any person who is involved in the handling of substances and preparations by way of profession or trade shall be obliged to take such measures to protect the life and health of employees as are necessary in the light of experience, practicable according to the state of technological development and appropriate to the circumstances of the establishment concerned. Subject to the provisions of Articles 42 and 45, the present provision shall be implemented in accordance with the Labour Law of 13 March 19643 and the Federal Law of 20 March 19814 on Accident Insurance.2 In commercial and educational establishments where dangerous substances or preparations are handled by way of profession or trade, a person is to be designated who is responsible for questions of appropriate handling and who can provide the enforcement authorities with the necessary information (Art. 42 Para. 2). This person shall be required to have the necessary technical qualifications and operational authority. The cantonal authority responsible for enforcement shall be notified of the name of the person designated.3 SR 822.114 SR 832.20Chapter 4 Documentation and Information  Art. 26 Documentation  1 The notification authority shall be responsible for the management of cross-sectoral documentation on substances and preparations. To this end, it shall maintain a product register.2 The assessment authorities shall be responsible for obtaining the documentation required to fulfil their tasks.Art. 27 Product register  1 The product register shall contain the information on substances and preparations that:a.has been acquired or compiled by the notification authority and the assessment authorities in the course of the notification or authorisation procedure as specified in Chapter 2;b.has been reported by the manufacturer in accordance with Article 18.2 The Federal Council shall regulate the processing of data contained in the product register, particularly its use and disclosure, giving due consideration to the interests of the manufacturer; it shall specify the type of information that may be disclosed to enforcement authorities implementing regulations on substances and preparations on the basis of other legal instruments.Art. 28 Information  1 The federal government shall inform the public and authorities about the risks and hazards involved in handling substances and preparations and shall recommend measures to reduce the risks.2 It shall issue technical guidelines and publish the lists of substances and preparations that are required for the application of this Act.3 The cantons shall provide information within their areas of responsibility.Art. 29 Information on indoor air  The federal government shall provide information on hazards arising from indoor pollutants. It may in particular issue recommendations on the limitation or prevention of exposures hazardous to health and on the improvement of indoor air quality.Art. 30 Poisons information centre  1 The Federal Council shall establish a poisons information centre and ensure that it is financially compensated for carrying out the tasks assigned to it.2 The information centre shall provide information on the prevention and treatment of poisoning and shall recommend appropriate measures; to this end, it shall collect and process the necessary information, including details of cases of poisoning.3 It shall have unrestricted access to the data in the product register (Art. 27) and shall be entitled to request the manufacturer directly to provide any additional information on substances and preparations that may be required for the fulfilment of its tasks.4 The Federal Council shall take appropriate measures to ensure that the data made available in accordance with paragraph 3 is treated confidentially and that commercial and industrial secrets are protected. It shall specify in particular the conditions under which and the extent to which the information centre may, for medical purposes of a preventive or curative nature, disclose details of the composition and properties of substances and preparations.Chapter 5 Enforcement  Section 1 Cantons  Art. 31 Enforcement  1 In so far as the federal government is not responsible, this Act shall be enforced by the cantons. They shall ensure that the authorities responsible for enforcing this Act coordinate their activities with the enforcement authorities responsible for workplace safety and for environmental protection.2 They shall implement decisions issued by the federal authorities, when requested to do so by the latter.Art. 32 Cantonal regulations  The cantons shall issue the organisational regulations for enforcement and shall notify the federal government thereof.Section 2 Federal Government  Art. 33 Supervision  1 The federal government shall supervise the enforcement of this Act.2 It shall coordinate cantonal enforcement measures in so far as uniform enforcement is deemed desirable. To this end, it may in particular:a.impose a duty on the cantons to inform the federal government about enforcement measures;b.prescribe measures to ensure uniform enforcement by the cantons;c.in exceptional circumstances, order the cantons to take specific enforcement measures;d.5support continuing education and training for the enforcement authorities. 5 The amendment in accordance with the Federal Act of 20 June 2014 on Continuing Education and Training, in force since 1 Jan. 2017 relates only to the French and Italian texts (AS 2016 689; BBl 2013 3729).Art. 34 Enforcement powers of federal government  1 The federal government shall enforce:a.Article 5 paragraph 1 letter a (assessment and classification of substances and preparations) and the requirements based on Article 5 paragraph 2 letter a;b.Article 7 (manufacturer’s obligation to inform purchasers);c.Articles 9–17 (notification of and authorisation for specific substances and preparations);d.Article 18 (reporting of details of substances and preparations);e.Article 19 paragraph 2 letter d (exports);f.Articles 26–30 (documentation and information), with the exception of Article 28 paragraph 3.2 It may delegate responsibility to the cantons for individual parts of the tasks specified in paragraph 1 or request their participation in specific parts of tasks.3 The federal government is responsible for enforcement with regard to the following matters:a.installations, activities, substances and preparations required for the purposes of national defence;b.imports, through transit or exports.Art. 35 Coordination  1 The Federal Council shall determine which assessment authorities are to be involved in the procedures and reviews specified in Chapter 2.2 If under different items of legislation substances or preparations must be notified to or authorisation granted by more than one federal authority, it shall designate a joint notification authority.3 The Federal Council shall regulate the cooperation between the federal authorities involved.Art. 36 Delegation of enforcement tasks  The Federal Council may delegate enforcement tasks to public or private organisations and persons.Art. 37 Scientific requirements, research  1 The federal government shall ensure that the scientific requirements necessary for the application of this Act are fulfilled.2 It may carry out surveys itself or in cooperation with the cantons, or with appropriate institutions or experts.3 Within the framework of international cooperation, it may finance investigations of substances and preparations in whole or in part.4 It shall promote scientific teaching and research in the field of dangerous properties of substances and preparations.Art. 38 Federal Council implementing provisions  The Federal Council shall issue the implementing provisions. Where possible, it shall combine these with the implementing provisions for other federal acts if the latter include provisions relating to substances and preparations.Art. 39 Adoption of internationally harmonised regulations and standards  1 When issuing its provisions, the Federal Council shall give due consideration to internationally harmonised guidelines and recommendations, and internationally harmonised technical regulations and standards.2 It may declare certain internationally harmonised technical regulations and standards to be applicable in connection with this Act. It may authorise the relevant federal office to make subsequent adjustments to technical details of minor importance in the regulations and standards that have been declared applicable.3 In exceptional cases, it may decide that the regulations and standards declared applicable are to be published in a special form and that translation into the official languages is not required.Art. 40 International cooperation  1 By way of amendment to the provisions of Article 18 of the Federal Act of 6 October 19956 on Technical Barriers to Trade (TBA), the Federal Council may approve the recognition in particular of tests, inspections or assessments carried out abroad and of foreign reports or certificates.2 Within the scope of the authority granted by this Act, it may conclude international agreements over and above the provisions of Article 14 paragraph 1 TBA.3 The federal authorities shall cooperate with foreign authorities and institutions, and with international organisations.6 SR 946.51Art. 41 Safeguard clause  If the notification authority has good reason to believe that substances or preparations represent a health hazard, although they comply with the requirements of this Act, in particular if their classification, packaging or labelling is no longer appropriate, it may, having first consulted the manufacturer, provisionally reclassify the substances or preparations, prohibit their placing on the market or make them subject to special conditions. In such cases, the measures required to amend the regulations concerned shall be taken without delay.Section 3 Special Regulations on Enforcement  Art. 42 Powers of enforcement authorities  1 In order to monitor compliance with the provisions of this Act, the enforcement authorities shall be authorised to test substances, preparations and articles as specified in Article 19 Paragraph 1 letter b and to examine procedures for the handling thereof.2 For this purpose, they shall be authorised to request that any persons involved in the handling of such substances, preparations or articles should, free of charge:a.provide the necessary information;b.carry out or submit to investigations;c.grant access to production and storage facilities;d.permit sampling or provide samples on request.3 They shall be authorised, at the expense of the person responsible, to take any measures necessary to remedy irregularities with regard to such substances, preparations or articles. In particular, they shall be authorised to:a.prohibit any further handling of such substances, preparations or articles;b.order them to be recalled or returned;c.order them to be rendered harmless or destroyed;d.order their seizure.Art. 43 Secrecy  Any person carrying out tasks in accordance with this Act is bound to maintain secrecy.Art. 44 Confidentiality of information  1 Information shall be treated as confidential if its disclosure would be detrimental to an interest deemed worthy of protection. In particular, one such interest is that of manufacturers in the preservation of their commercial and industrial secrets.2 The Federal Council shall define the types of information for which preservation of secrecy cannot be asserted to be an interest deemed worthy of protection.Art. 45 Data exchange among enforcement authorities  1 If several different federal authorities are involved in enforcement, they shall be responsible for ensuring that data is exchanged in so far as this is necessary for the fulfilment of their tasks.2 The Federal Council may approve the exchange of data with additional authorities or with public or private organisations and persons if this is necessary for the enforcement of this Act.3 The federal authorities shall disclose to the relevant cantonal enforcement authorities any data required for the fulfilment of their enforcement tasks.4 The cantonal enforcement authorities shall communicate to the relevant federal authorities any data that they have collected in accordance with this Act.5 For the purposes of data exchange, automated recall procedures may be established. In this case, the Federal Council, giving due consideration to the interests of the parties concerned deemed worthy of protection, shall determine who is permitted to call up data, what data may be called up, and for what purposes.Art. 46 Data exchange with foreign countries and with international organisations  1 The Federal Council shall establish responsibilities and procedures for the exchange of data with foreign authorities and institutions and with international organisations.2 Confidential information may only be disclosed to foreign authorities and institutions or to international organisations if:a.this is required by international agreements or the resolutions of international organisations; orb.it is imperative in order to avert an imminent hazard to life or health.Art. 47 Fees  The Federal Council shall set the Fees to be levied for enforcement by the federal authorities. It may grant exemptions from the liability to pay fees.Chapter 67  … 7 Repealed by Annex No. 90 of the Federal Administrative Court Act of 17 June 2005, with effect from 1 Jan. 2007 (AS 2006 2197 1069; BBl 2004 4202). Art. 48 Chapter 7 Criminal Provisions8 8 From 1 Jan. 2007, the penalties and prescriptive periods below must be interpreted or recalculated in application of Art. 333 para. 2–6 of the Criminal Code (SR 311.0) in the version of the Federal Act of 13 Dec. 2002 (AS 2006 3459). Art. 49 Misdemeanours  1 A penalty of imprisonment or a fine of up to 200,000 Swiss francs shall be imposed on manufacturers who wilfully:a.place substances or preparations on the market for a use that poses an immediate threat to life or health, if they are aware or should be aware of this fact (Art. 5 para. 1);b.fail to correctly classify, package or label substances or preparations (Art. 5 para. 1), fail to produce a safety data sheet, or include inaccurate or incomplete information in such a sheet (Art. 7);c.place substances or preparations on the market:1.without having notified them (Art. 6 and Art. 13 para. 1),2.before the notification has been accepted or the specified period has elapsed (Art. 9 para. 2),3.without authorisation having been granted (Art. 6 and Art. 13 para. 1);d.withhold information on substances or preparations from, or give false information to, the authorities responsible (Art. 9 para. 3, Art. 10 para. 4, Art. 11 para. 2, Art. 15 para. 2, Art. 16 para. 1, Art. 17, Art. 30 para. 3 and Art. 42 para. 2);e.infringe regulations concerning substances (Art. 19 para. 2 let. a–c, e and g);f.contravene measures ordered pursuant to the safeguard clause (Art. 41).2 The penalty shall be imprisonment of up to five years or a fine of up to 500,000 Swiss francs if human life is severely endangered as a result of the offences specified in paragraph 1.3 A penalty of imprisonment or a fine shall be imposed on anyone who wilfully:a.places dangerous substances or preparations on the market without duly informing the purchaser about the properties thereof or the appropriate precautions and protective measures, or without supplying the purchaser with a safety data sheet (Art. 7);b.breaches the duty of care in the handling of dangerous substances and thereby knowingly endangers human life or health (Art. 8, Art. 21, Art. 23 and Art. 25 para. 1);c.contravenes the obligation to request information in advance (Art. 12);d.infringes regulations concerning substances (Art. 19 para. 2 let. a and c);e.infringes regulations concerning exports (Art. 19 para. 2 let. d);f.handles substances or preparations without due authorisation (Art. 24 para. 1);g.supplies dangerous substances or preparations to unauthorised parties (Art. 19 para. 2 let. a and Art. 24 para. 1);h.breaches the duty of secrecy (Art. 30 para. 4, Art. 43 and Art. 44);i.contravenes measures ordered pursuant to the safeguard clause (Art. 41).4 The penalty shall be imprisonment of up to five years or a fine of up to 100,000 Swiss francs if human life is severely endangered as a result of the offences specified in paragraph 3.5 In cases of negligence, the penalty shall be imprisonment of up to one year or a fine of up to 100,000 Swiss francs for offences specified in Paragraph 1 and imprisonment of up to six months or a fine for offences specified in Paragraph 3.Art. 50 Contraventions  1 A penalty of detention or a fine of up to 20,000 Swiss francs shall be imposed to any person who wilfully:a.infringes the provisions concerning self-regulation (Art. 5);b.breaches the duty of care in the handling of substances or preparations (Art. 8, Art. 21, Art. 23 and Art. 25 para. 1);c.fails to report details of substances or preparations or gives false information (Art. 18);d.contravenes the labelling requirements for poisonous plants and animals (Art. 19 para. 2 let. f);e.infringes the regulations concerning advertising (Art. 20);f.refuses to accept the return of dangerous substances or preparations (Art. 22 para. 1);g.breaches the duty to provide information to the cantonal enforcement authorities (Art. 25 para. 2);h.breaches the duty to provide information or misinforms the enforcement authorities (Art. 42 para. 2);i. contravenes an injunction issued with specific reference to the sanctions of the present article.2 In cases of negligence, the penalty shall be a fine.3 In cases where infringements of implementing regulations do not constitute an offence under paragraph 1 or Article 49, the Federal Council may impose sanctions of detention or a fine of up to 20,000 Swiss francs for wilful acts, or a fine in cases of negligence.4 Attempt and aiding and abetting are also offences.5 In particularly minor cases, prosecution and penalties may be waived.6 The right to prosecute contraventions prescribes after two years, and penalties for contraventions after five years.Art. 51 Offences in commercial establishments  Articles 6 and 7 of the Federal Act of 22 March 19749 on Administrative Criminal Law apply to offences under this Act.9 SR 313.0Art. 52 Criminal prosecution and complaints  1 The cantons shall be responsible for the prosecution and adjudication of offences.2 If there are adequate grounds to suspect that an offence has been committed within the area of federal enforcement, the federal agency responsible shall report this to the cantonal authority. In particularly minor cases, a complaint may be dispensed with.Chapter 8 Final Provisions  Art. 53 Repeal and amendment of existing legislation  The repeal and amendment of existing legislation is regulated in the Annex.Art. 54 Transitional provisions  1 Data collected under existing legislation by the Toxicology Documentation Office (Art. 18 of the Toxic Substances Act of 21 March 196910), in particular that included in the list of toxic substances (Art. 4 of the Toxic Substances Act), may be included in the product register (Art. 27) and continue to be used, in so far as it is relevant to the enforcement of this Act.2 After the commencement of this Act, substances and preparations that are packaged and labelled in accordance with existing legislation may still be placed on the domestic market by the manufacturer for one year and may be supplied to final users for two years. For these substances and preparations, the preparation and supply of safety data sheets shall be governed by existing law.3 For substances and preparations subject to mandatory notification or authorisation that are already on the market when this Act comes into force, the Federal Council shall specify a facilitated notification or authorisation procedure. At the same time, for such cases, it shall grant an appropriate extension of the periods specified in paragraph 2.4 Authorisation procedures for substances and preparations which are pending when this Act comes into force shall be pursued and concluded by the federal authority that is responsible under this Act in accordance with the provisions of this Act.5 The Federal Council shall determine to what extent and for how long persons licensed to deal with toxic substances under existing law are entitled to handle dangerous substances and preparations.10 [AS 1972 430 1977 2249 No. I 541, 1982 1676 Annex No. 10, 1984 1122 Art. 66 No. 4, 1985 660 No. I 41, 1991 362 No. II 403, 1997 1155 Annex No. 4, 1998 3033 Annex No. 7.]Art. 55 Referendum and commencement  1 This Act shall be subject to an optional referendum.2 The Federal Council shall set the commencement date.Commencement date: 1 August 200511Art. 19 para. 2 let. a and d, 34 para. 1 let. e, 38, 49 para. 3 let. e and Annex No. II 2 (Art. 39 para. 1bis of the Environmental Protection Act): 1 January 20051211 Ordinance of 18 May 2005 (AS 2005 2293).12 Federal Council Decree of 10 Nov. 2004Annex Repeal and Amendment of Current Legislation IThe Toxic Substances Act of 21 March 196913 is repealed.IIThe Federal Acts listed below are amended as follows:…1413 [AS 1972 430, 1977 2249 No. I 541, 1982 1676 Annex No. 10, 1984 1122 Art. 66 No. 4, 1985 660 No. I 41, 1991 362 No. II 403, 1997 1155 Annex No. 4, 1998 3033 Annex No. 7]14 The amendments may be consulted under AS 2004 4763.


text: 813.112.1 English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.Ordinance on Good Laboratory Practice (OGLP)of 18 May 2005 (Status as of 1 December 2012)The Federal Councilbased on Article 5 paragraph 2 letter a of the Chemicals Act of 15 December 2000 (ChemA)1,Article 26 paragraph 3, Article 38 paragraph 3 and Article 39 paragraph 1 of the Environmental Protection Act of 7 October 19832 (EPA) and Article 11 paragraph 2 letter a of the Federal Act of 15 December 20003 on Therapeutic Products (TPA) decrees:1 SR 813.12 SR 814.013 SR 812.21Section 1  General Provisions  Art. 1 Objective and purpose  1 This Ordinance lays down the Principles of Good Laboratory Practice (GLP) as the quality standard for studies, and regulates compliance monitoring.2 The Ordinance aims to:a.ensure that test data are reproducible;b.promote international acceptance of tests conducted in Switzerland in order to avoid duplicate testing.Art. 2 Scope  The Ordinance applies to non-clinical studies of substances, preparations and articles (test items) that:a.serve to obtain data on the properties of a test item and its safety with respect to human health and the environment; andb.provide data to be submitted to the authorities in view of a registering or licensing procedure.Art. 3 Definitions  1 In this Ordinance:a.Good Laboratory Practice (GLP) means a quality system concerned with the organisational process and the conditions under which studies are planned, performed, monitored, recorded, archived and reported.b.4areas of expertise means studies conducted in the following categories: 1.physical-chemical testing,2.toxicity studies, 3.mutagenicity studies, 4.environmental toxicity studies on aquatic and terrestrial organisms, 5.studies on behaviour in water, soil and air; bioaccumulation6.residue studies, 7.studies on effects on mesocosms and natural ecosystems, 8.analytical and clinical chemistry testing, 9.other studies, specify;c.study audit means an audit of a study to verify that its data, records, reports and other elements comply with GLP Principles;d.test facility means the persons, premises and operational unit(s) that are necessary for conducting studies; for multi-site studies conducted at more than one site, the test facility comprises the site at which the study director is located and all individual test sites that individually or collectively may be considered as such. 2 Further terms relevant to GLP are defined in Annex 1.4  Amended by Annex No 2 of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).Section 2 GLP Principles and Compliance Monitoring  Art. 4 GLP Principles  1 The principles of GLP are listed in Annex 2.2 The Federal Office of Public Health (FOPH)5, the Federal Office for the Environment (FOEN) and Swissmedic (Swiss Agency for Therapeutic Products) may issue joint guidelines on the interpretation of GLP Principles. In doing so they must take account of internationally recognised regulations.5 The name of the administrative unit was amended in application of Art. 16 para 3 of the Publications Ordinance of 17 Nov. 2004 (SR 170.512.1). This amendment has been applied throughout the text.Art. 5 Application  1 Establishments that wish to have their test facilities listed in the register (Art. 14) must apply to the notification authority (Art. 8).2 For each test facility, the application must include the following information:a.name and address of the test facility;b.site plans documenting the use of the individual premises;c.organisation charts documenting the name and position of the test facility management, the personnel in charge of quality assurance and the study directors;d.name and address of a contact person;e.standard operating procedures for quality assurance;f.a list of all standard operating procedures;g.the relevant areas of expertise; h.a list of all studies planned over the next six months with the relevant schedules;i.a list of all studies conducted over the last six months, or still being carried out, in the relevant areas of expertise.3 On request from the competent authority, the establishments must submit other information.4 If conditions in a test facility are substantially modified, the establishment must submit a new application without delay. In this case the list pursuant to paragraph 2 letter i must include all studies since the last inspection. In the event of any doubt, the establishment must refer without delay to the notification authority to determine whether the modification is substantial. The notification authority gives its decision in agreement with the competent authorities concerned.Art. 6 Inspections  1 After receiving an application, the competent authority shall inspect the test facilities on site. During this inspection, the authority checks in particular whether the procedures, operating procedures and data obtained respect the principles of GLP.2 Thereafter, the authority shall inspect the test facilities again every two to three years. Prior to each inspection the authority shall request information pursuant to Article 5 paragraph 2. The list pursuant to Article 5 paragraph 2 letter i must include all studies conducted since the last inspection. The competent authority may request further data.3 If there is sufficient reason to assume that a test facility does not comply with the GLP Principles, the competent authority may conduct an inspection without delay.4 The competent authority shall produce a report on each inspection.Art. 7 Study audits  1 The competent authority shall conduct a study audit on its own initiative or at the request of another competent Swiss or foreign authority if:a.there is sufficient reason to assume that a test facility did not comply with GLP Principles when conducting certain studies;b.the results of a particular study are of vital importance for assessing human or environmental safety.2 If after completion of the study audit the competent authority concludes that the audited study did not comply with GLP Principles, it may carry out an inspection.3 The competent authority may also carry out a study audit as part of an inspection.4 The competent authority shall produce a report on each inspection.Art. 8 Competent authorities  1 The notification authority in accordance with Article 4 paragraph 1 letter h of the ChemA shall coordinate the conduct of inspections and of study audits and, in agreement with the competent authorities, produce decisions on conformity with the principles of GLP.2 The following authorities are competent to carry out inspections and study audits:a.the FOPH and Swissmedic for studies of toxicological properties;b.the FOEN for studies of ecotoxological properties or of environmental behaviour of the test items;c.the FOPH, the FOEN or Swissmedic after mutual agreement for studies of all other properties.3 Where necessary the authorities may delegate tasks to each other, or call in specialists. They may delegate all or part of the tasks and competences with which they are entrusted by virtue of this Ordinance to appropriate public corporations or individuals. The FOPH and Swissmedic may only delegate the conduct of inspections and study audits.Art. 9 Duties and powers of the authority  1 The authority shall carry out inspections and study audits according to the guidelines in Sections A and B of Annex I of European Directive 2004/9/EC of the Parliament and of the Council of 11 February 20046.2 On request, the establishment must submit to the authorities all documents and all other evidence required to assess its compliance with GLP Principles.3 The authorities must be allowed to access the test facilities at all times.4 If an establishment with test facilities has been accredited by the Swiss Accreditation Service pursuant to Article 14 of the Ordinance of 17 June 19967 on Accreditation and Identification, the authority shall take these results into account.6  Directive 2004/9/EC of the European Parliament and of the Council of 11 Feb. 2004 on the inspection and verification of good laboratory practice (GLP); OJ No. L 050 of  20 Feb. 2004, pp. 28-43. The European Community legislation mentioned in this Ordinance can be ordered for a fee or consulted free of charge at the notification authority for chemical products, 3003 Bern; it can also be consulted at www.cheminfo.ch.7 SR 946.512Art. 10 Reports on inspections and study audits  1 The competent authority shall provide the establishment with the draft of the inspection report and allow it an appropriate period in which to state its position thereon. On receipt of a response from the establishment or on expiry of the period, the authority shall pass the inspection report to the notification authority.2 The competent authority shall pass the report on the study audit to the notification authority.3 The notification authority shall decide:a.on the basis of the inspection report, whether the test facility is operating according to the GLP Principles;b.on the basis of the study audit report, whether the study was carried out according to the GLP Principles;4 The provisions on study audits also apply to studies audited during an inspection.Art. 11 Information   The notification authority shall inform the competent authorities of planned inspections and study audits, and of decisions pursuant to Article 10.Art. 12 Obligation to notify  1 An establishment must immediately notify the notification authority if:a.it changes its name or address;b.one of its test facilities changes its name or address;c.one of its test facilities is no longer willing to comply with GLP Principles.d.there are changes in responsibilities at the level of the management of the test facility or of the quality assurance unit.e.it intends to extend the area of expertise.Section 3 Documentation and Conformity with GLP Principles  Art. 13 1 For any study that must be carried out according to the principles of GLP, it is necessary in the procedure of notification or authorisation: to show that the study was carried out in a test facility registered, at the time when the study was carried out, in the Swiss register of test facilities that comply with the principles of GLP;to present a study report in which the study director confirms, in one of the Swiss national languages or in English, that the study was carried out in compliance with the principles of GLP.2 If the study was carried out in a country other than Switzerland, in addition to the study report, an extract from the foreign register or a confirmation from the foreign authority must be submitted proving that the test facility was included in the official monitoring programme at the time the study was carried out. In the case of countries that are not members of the Organisation for Economic Co-operation and Development (OECD), the notification authority may request other documents that it considers necessary to evaluate compliance with the principles of GLP.3 If justified by the circumstances, and in particular if the results of the study are very important, or if there is doubt whether the principles of GLP have been respected, a federal executive authority may ask the notification authority to have a study audit carried out.Section 4 Other Regulations  Art. 14 Register and GLP list  1 The notification authority shall maintain a register of all establishments with their inspected test facilities and their audited studies. 2 The notification authority shall enter the data in the register as soon as the formal decision has been made confirming conformity of the test facility with the principles of GLP. 3 The notification authority shall provide the establishment with a confirmation stating, in one of the official Swiss languages or in English, that its test facilities are listed in the register.4 The notification authority shall regularly publish, in an appropriate way, a list of the test facilities that work according to the principles of GLP.5 If the principles of GLP are no longer respected, the test facility shall be removed from the list mentioned in paragraph 4.Art. 15 Content of the register  The register shall specify:a.the name and address of the establishment and of its test facilities;b.the type and date of inspection and the relevant areas of expertise;c.the date of the study audit and identification of the study;d.the decision relative to compliance with GLP Principles;e.the date of the decision or of the notification that the relevant test facility no longer complies with GLP Principles.Art. 16 Notification in cases of serious non-compliance with GLP Principles  1 If in the course of an inspection, the competent authority ascertains that a test facility fails to comply with GLP Principles to the extent that the reliability of study results is no longer guaranteed, and that in consequence these results may generate erroneous conclusions relating to human and environmental safety, it must immediately inform the notification authority.2 The notification authority must inform the federal executive authorities responsible for evaluating notifications or authorisations for substances and preparations.Art. 17 Confidentiality of data  1 The competent authorities may transmit confidential data only to:a.each other;b.the federal executive authorities pursuant to Article 16 paragraph 2;c.foreign GLP authorities, if this is provided for by agreements under international law or by federal legislation.2 Under no circumstances are the entries in the register pursuant to Article 15 confidential.Art. 18 Dealings with foreign authorities  1 Depending on the area of competence (Art. 8), the FOPH, the FOEN and Swissmedic shall represent Switzerland on GLP-related issues in dealings with authorities and institutions abroad, and with international organisations.2 The FOEN shall co-ordinate dealings with the Organisation for Economic Co-operation and Development (OECD) at national level. Each year it shall supply the OECD and the OECD member states with a list of inspected establishments with their test facilities and conducted study audits, and notify them of establishments that are guilty of serious non-compliance with GLP Principles.Section 5  Final Provisions  Art. 19 Transitional provisions  1 Decisions made and confirmations delivered before this Ordinance comes into force remain valid until they are replaced by documents after the next inspection.2 Requests made according to the previous legislation and still being processed by the GLP authorities shall be passed on to the notification authority when this Ordinance comes into force.Art. 20 Commencement  This Ordinance comes into force on 1 August 2005. Annex 1 (Art.3, para 2)Terms relating to GLP  1 Terms concerning the Organisation of a Test Facility  1.1 Test site means the location(s) at which one or more phases of a study is conducted.1.2 Test facility management means the person(s) who has the authority and formal responsibility for the organisation and functioning of the test facility according to these Principles of Good Laboratory Practice.1.3 Test site management (if appointed) means the person(s) responsible for ensuring that the phase(s) of the study, for which he is responsible, are conducted according to these Principles of Good Laboratory Practice.1.4 Study Director means the individual responsible for the overall conduct of the non-clinical health and environmental safety study.1.5 Principal Investigator means an individual who, for a multi-site study, acts on behalf of the Study Director and has defined responsibility for delegated phases of the study. The Study Director’s responsibility for the overall conduct of the study cannot be delegated to the Principal Investigator(s); this includes approval of the study plan and its amendments, approval of the final report, and ensuring that all applicable Principles of Good Laboratory Practice are followed.1.6 Quality Assurance Programme means a defined system, including personnel, which is independent of study conduct and is designed to assure test facility management of compliance with these Principles of Good Laboratory Practice.1.7 Standard Operating Procedures (SOPs) means documented procedures which describe how to perform tests or activities normally not specified in detail in study plans or test guidelines.1.8 Master schedule means a compilation of information to assist in the assessment of workload and for the tracking of studies at a test facility.2 Terms concerning Studies  2.1 Short-term study means a study of short duration with widely used, routine techniques.2.2 Study plan means a document which defines the objectives and experimental design for the conduct of the study, and includes any amendments.2.3 Study plan amendment means an intended change to the study plan after the study initiation date.2.4 Study plan deviation means an unintended departure from the study plan after the study initiation date.2.5 Test system means any biological, chemical or physical system or a combination thereof used in a study.2.6 Raw data means all original test facility records and documentation, or verified copies thereof, which are the result of the original observations and activities in a study. Raw data also may include, for example, photographs, microfilm or microfiche copies, computer readable media, dictated observations, recorded data from automated instruments, or any other data storage medium that has been recognised as capable of providing secure storage of information for a time period as stated in Annex 2, number 10.2.7 Specimen means any material derived from a test system for examination, analysis, or retention.2.8 Experimental starting date means the date on which the first study specific data are collected.2.9 Experimental completion date means the last date on which data are collected from the study.2.10 Study initiation date means the date the Study Director signs the study plan.2.11 Study completion date means the date the Study Director signs the final report.3 Terms concerning the Test Item  3.1 Test item means an article that is the subject of a study.3.2 Reference item (control item) means any article used to provide a basis for comparison with the test item.3.3 Batch means a specific quantity or lot of a test item or reference item produced during a defined cycle of manufacture in such a way that it could be expected to be of a uniform character and should be designated as such.3.4 Vehicle means any agent which serves as a carrier used to mix, disperse, or solubilise the test item or reference item to facilitate the administration/application to the test system.Annex 28 8 Revised in accordance with Annex No 2 of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).(Art. 4, para 1)GLP Principles 1 Test Facility Organisation and Personnel  1.1 Test Facility Management’s Responsibilities  1 Each test facility management should ensure that these Principles of Good Laboratory Practice are complied with, in its test facility.2 As a minimum it should:a.ensure that a statement exists which identifies the individual(s) within a test facility who fulfil the responsibilities of management as defined by these Principles of Good Laboratory Practice;b.ensure that a sufficient number of qualified personnel, appropriate facilities, equipment, and materials are available for the timely and proper conduct of the study;c.ensure the maintenance of a record of the qualifications, training, experience and job description for each professional and technical individual;d.ensure that personnel clearly understand the functions they are to perform and, where necessary, provide training for these functions;e.ensure that appropriate and technically valid Standard Operating Procedures are established and followed, and approve all original and revised Standard Operating Procedures;f.ensure that there is a Quality Assurance Programme with designated personnel and assure that the quality assurance responsibility is being performed in accordance with these Principles of Good Laboratory Practice;g.ensure that for each study an individual with the appropriate qualifications, training, and experience is designated by the management as the Study Director before the study is initiated. Replacement of a Study Director should be done according to established procedures, and should be documented.h.ensure, in the event of a multi-site study, that, if needed, a Principal Investigator is designated, who is appropriately trained, qualified and experienced to supervise the delegated phase(s) of the study. Replacement of a Principal Investigator should be done according to established procedures, and should be documented.i.ensure documented approval of the study plan by the Study Director;j.ensure that the Study Director has made the approved study plan available to the Quality Assurance personnel;k.ensure the maintenance of an historical file of all Standard Operating Procedures;l.ensure that an individual is identified as responsible for the management of the archive(s);m.ensure the maintenance of a master schedule;n.ensure that test facility supplies meet requirements appropriate to their use in a study;o.ensure for a multi-site study that clear lines of communication exist between the Study Director, Principal Investigator(s), the Quality Assurance Programme(s) and study personnel;p.ensure that test and reference items are appropriately characterised;q.establish procedures to ensure that computerised systems are suitable for their intended purpose, and are validated, operated and maintained in accordance with these Principles of Good Laboratory Practice.3 When a phase(s) of a study is conducted at a test site, test site management (if appointed) will have the responsibilities as defined above with the following exceptions: point 1.1, paragraph 2, letters g., i., j. and o.1.2 Study Director’s Responsibilities  1 The Study Director is the single point of study control and has the responsibility for the overall conduct of the study and for its final report.2 These responsibilities should include, but not be limited to, the following functions. The Study Director should:a.approve the study plan and any amendments to the study plan by dated signature;b.ensure that the Quality Assurance personnel have a copy of the study plan and any amendments in a timely manner and communicate effectively with the Quality Assurance personnel as required during the conduct of the study;c.ensure that study plans and amendments and Standard Operating Procedures are available to study personnel;d.ensure that the study plan and the final report for a multi-site study identify and define the role of any Principal Investigator(s) and any test facilities and test sites involved in the conduct of the study;e.ensure that the procedures specified in the study plan are followed, and assess and document the impact of any deviations from the study plan on the quality and integrity of the study, and take appropriate corrective action if necessary; acknowledge deviations from Standard Operating Procedures during the conduct of the study;f.ensure that all raw data generated are fully documented and recorded;g.ensure that computerised systems used in the study have been validated;h.sign and date the final report to indicate acceptance of responsibility for the validity of the data and to indicate the extent to which the study complies with these Principles of Good Laboratory Practice;i.ensure that after completion (including termination) of the study, the study plan, the final report, raw data and supporting material are archived.1.3 Principal Investigator’s Responsibilities  The Principal Investigator will ensure that the delegated phases of the study are conducted in accordance with the applicable Principles of Good Laboratory Practice.1.4 Study Personnel’s Responsibilities  1 All personnel involved in the conduct of the study must be knowledgeable in those parts of the Principles of Good Laboratory Practice which are applicable to their involvement in the study.2 Study personnel will have access to the study plan and appropriate Standard Operating Procedures applicable to their involvement in the study. It is their responsibility to comply with the instructions given in these documents. Any deviation from these instructions should be documented and communicated directly to the Study Director, and/or if appropriate, the Principal Investigator(s).3 All study personnel are responsible for recording raw data promptly and accurately and in compliance with these Principles of Good Laboratory Practice, and are responsible for the quality of their data.4 Study personnel should exercise health precautions to minimise risk to themselves and to ensure the integrity of the study. They should communicate to the appropriate person any relevant known health or medical condition in order that they can be excluded from operations that may affect the study.2 Quality Assurance Programme  2.1 General  1 The test facility should have a documented Quality Assurance Programme to assure that studies performed are in compliance with these Principles of Good Laboratory Practice.2 The Quality Assurance Programme should be carried out by an individual or by individuals designated by and directly responsible to management and who are familiar with the test procedures.3 This/these individual/s should not be involved in the conduct of the study being assured.2.2 Responsibilities of the Quality Assurance Personnel  The responsibilities of the Quality Assurance personnel include, but are not limited to, the following functions. They should:a.maintain copies of all approved study plans and Standard Operating Procedures in use in the test facility and have access to an up-to-date copy of the master schedule;b.verify that the study plan contains the information required for compliance with these Principles of Good Laboratory Practice. This verification should be documented;c.conduct inspections to determine if all studies are conducted in accordance with these Principles of Good Laboratory Practice. Inspections should also determine that study plans and Standard Operating Procedures have been made available to study personnel and are being followed. Inspections can be of three types as specified by Quality Assurance Programme Standard Operating Procedures:1.Study-based inspections,2.Facility-based inspections,3.Process-based inspections.Records of such inspections should be retained.d.inspect the final reports to confirm that the methods, procedures, and observations are accurately and completely described, and that the reported results accurately and completely reflect the raw data of the studies;e.promptly report any inspection results in writing to management and to the Study Director, and to the Principal Investigator(s) and the respective management, when applicable;f.prepare and sign a statement, to be included with the final report, which specifies types of inspections and their dates, including the phase(s) of the study inspected, and the dates inspection results were reported to management and the Study Director and Principal Investigator(s), if applicable. This statement would also serve to confirm that the final report reflects the raw data.3 Facilities  3.1 General  1 The test facility should be of suitable size, construction and location to meet the requirements of the study and to minimise disturbance that would interfere with the validity of the study.2 The design of the test facility should provide an adequate degree of separation of the different activities to assure the proper conduct of each study.3.2 Test System Facilities  1 The test facility should have a sufficient number of rooms or areas to assure the isolation of test systems and the isolation of individual projects, involving substances or organisms known to be or suspected of being biohazardous.2 Suitable rooms or areas should be available for the diagnosis, treatment and control of diseases, in order to ensure that there is no unacceptable degree of deterioration of test systems.3 There should be storage rooms or areas as needed for supplies and equipment. Storage rooms or areas should be separated from rooms or areas housing the test systems and should provide adequate protection against infestation, contamination, and/or deterioration.3.3 Facilities for Handling Test and Reference Items  1 To prevent contamination or mix-ups, there should be separate rooms or areas for receipt and storage of the test and reference items, and mixing of the test items with a vehicle.2 Storage rooms or areas for the test items should be separate from rooms or areas containing the test systems. They should be adequate to preserve identity, concentration, purity, and stability, and ensure safe storage for hazardous substances.3.4 Archive Facilities  Archive facilities should be provided for the secure storage and retrieval of study plans, raw data, final reports, samples of test items and specimens. Archive design and archive conditions should protect contents from untimely deterioration.3.5 Waste Disposal  Handling and disposal of wastes should be carried out in such a way as not to jeopardise the integrity of studies. This includes provision for appropriate collection, storage and disposal facilities, and decontamination and transportation procedures.4 Apparatus, Material, and Reagents  1 Apparatus, including validated computerised systems, used for the generation, storage and retrieval of data, and for controlling environmental factors relevant to the study should be suitably located and of appropriate design and adequate capacity.2 Apparatus used in a study should be periodically inspected, cleaned, maintained, and calibrated according to Standard Operating Procedures. Records of these activities should be maintained. Calibration should, where appropriate, be traceable to national or international standards of measurement.3 Apparatus and materials used in a study should not interfere adversely with the test systems.4 Chemicals, reagents, and solutions should be labelled to indicate identity (with concentration if appropriate), expiry date and specific storage instructions. Information concerning source, preparation date and stability should be available. The expiry date may be extended on the basis of documented evaluation or analysis.5 Test Systems  5.1 Physical/Chemical  1 Apparatus used for the generation of physical/chemical data should be suitably located and of appropriate design and adequate capacity.2 The integrity of the physical/chemical test systems should be ensured.5.2 Biological  1 Proper conditions should be established and maintained for the storage, housing, handling and care of biological test systems, in order to ensure the quality of the data.2 Newly received animal and plant test systems should be isolated until their health status has been evaluated. If any unusual mortality or morbidity occurs, this lot should not be used in studies and, when appropriate, should be humanely destroyed. At the experimental starting date of a study, test systems should be free of any disease or condition that might interfere with the purpose or conduct of the study. Test systems that become diseased or injured during the course of a study should be isolated and treated, if necessary to maintain the integrity of the study. Any diagnosis and treatment of any disease before or during a study should be recorded.3 Records of source, date of arrival, and arrival condition of test systems should be maintained.4 Biological test systems should be acclimatised to the test environment for an adequate period before the first administration/application of the test or reference item.5 All information needed to properly identify the test systems should appear on their housing or containers. Individual test systems that are to be removed from their housing or containers during the conduct of the study should bear appropriate identification, wherever possible.6 During use, housing or containers for test systems should be cleaned and sanitised at appropriate intervals. Any material that comes into contact with the test system should be free of contaminants at levels that would interfere with the study. Bedding for animals should be changed as required by sound husbandry practice. Use of pest control agents should be documented.7 Test systems used in field studies should be located so as to avoid interference in the study from spray drift and from past usage of pesticides.6 Test and Reference Items  6.1 Receipt, Handling, Sampling and Storage  1 Records including test item and reference item characterisation, date of receipt, expiry date, quantities received and used in studies should be maintained.2 Handling, sampling, and storage procedures should be identified in order that the homogeneity and stability are assured to the degree possible and contamination or mix-up are precluded.3 Storage container(s) should carry identification information, expiry date, and specific storage instructions.6.2 Characterisation  1 Each test and reference item should be appropriately identified (e.g. code, Chemical Abstracts Service Registry Number [CAS number], name, biological parameters).2 For each study, the identity, including batch number, purity, composition, concentrations, or other characteristics to appropriately define each batch of the test or reference items should be known.3 In cases where the test item is supplied by the sponsor, there should be a mechanism, developed in co-operation between the sponsor and the test facility, to verify the identity of the test item subject to the study.4 The stability of test and reference items under storage and test conditions should be known for all studies.5 If the test item is administered or applied in a vehicle, the homogeneity, concentration and stability of the test item in that vehicle should be determined. For test items used in field studies (e.g. tank mixes) these may be determined through separate laboratory experiments.6 A sample for analytical purposes from each batch of test item should be retained for all studies except short-term studies.7 Standard Operating Procedures  1 A test facility should have written Standard Operating Procedures approved by test facility management that are intended to ensure the quality and integrity of the data generated by that test facility. Revisions to Standard Operating Procedures should be approved by test facility management.2 Each separate test facility unit or area should have immediately available current Standard Operating Procedures relevant to the activities being performed therein. Published text, books, analytical methods, articles and manuals may be used as supplements to these Standard Operating Procedures.3 Deviations from Standard Operating Procedures related to the study should be documented and should be acknowledged by the Study Director and the Principal Investigator(s), as applicable.4 Standard Operating Procedures should be available for, but not be limited to, the following categories of test facility activities. The details given under each heading are to be considered as illustrative examples.a.Test and reference items: receipt, identification, labelling, handling, sampling and storage.b.Apparatus, materials and reagents1.Apparatus: use, maintenance, cleaning and calibration,2.Computerised systems: validation, operation, maintenance, security, change control and back-up.3.Materials, reagents and solutions: preparation and labelling.c.Record keeping, reporting, storage, and retrieval: coding of studies, data collection, preparation of reports, indexing systems, handling of data, including the use of computerised systems.d.Test System (where appropriate):1.Room preparation and environmental room conditions for the test system.2.Procedures for receipt, transfer, proper placement, characterisation, identification and care of the test system.3.Test system preparation, observations and examinations, before, during and at the conclusion of the study.4.Handling of test system individuals found moribund or dead during the study.5.Collection, identification and handling of specimens including necropsy and histopathology.6.Siting and placement of test systems in test plots.e.Quality Assurance Procedures: operation of Quality Assurance personnel in planning, scheduling, performing, documenting and reporting inspections.8 Performance of the Study  8.1 Study Plan  1 For each study, a written plan should exist prior to the initiation of the study. The study plan should be approved by dated signature of the Study Director and verified for GLP compliance by Quality Assurance personnel as specified at point 2.2 letter b. The study plan should also be approved by the test facility management.2  Study plan amendments and deviations should be treated as follows:a.Amendments to the study plan should be justified and approved by dated signature of the Study Director and maintained with the study plan.b.Deviations from the study plan should be described, explained, acknowledged and dated in a timely fashion by the Study Director and/or Principal Investigator(s) and maintained with the study raw data.3 For short-term studies, a general study plan accompanied by a study specific supplement may be used.8.2 Content of the Study Plan  The study plan should contain, but not be limited to the following information:a.Identification of the study, the test item and reference item1.A descriptive title;2.A statement which reveals the nature and purpose of the study;3.Identification of the test item by code or name (IUPAC; CAS number, biological parameters, etc.);4.The reference item to be used.b.Information concerning the sponsor and the test facility1.Name and address of the sponsor;2.Name and address of any test facilities and test sites involved;3.Name and address of the Study Director;4.Name and address of the Principal Investigator(s), and the phase(s) of the study delegated by the Study Director and under the responsibility of the Principal Investigator(s).c.Dates1.The date of approval of the study plan by signature of the Study Director. The date of approval of the study plan by signature of the test facility management.2.The proposed experimental starting and completion dates.d.Test methods: reference to the OECD Test Guideline or other test guideline or method to be used.e.Issues (where applicable):1.Justification for selection of the test system;2.Characterisation of the test system, such as the species, strain, substrain, source of supply, number, body weight range, sex, age and other pertinent information;3.Method of administration and the reason for its choice;4.Dose levels and/or concentration(s), frequency, and duration of administration/application;5.Detailed information on the experimental design, including a description of the chronological procedure of the study, all methods, materials and conditions, type and frequency of analysis, measurements, observations and examinations to be performed, and statistical methods to be used (if any).f.Records: a list of records to be retained.8.3 Conduct of the Study  1 A unique identification should be given to each study. All items concerning this study should carry this identification. Specimens from the study should be identified to confirm their origin. Such identification should enable traceability, as appropriate for the specimen and study.2 The study should be conducted in accordance with the study plan.3 All data generated during the conduct of the study should be recorded directly, promptly, accurately, and legibly by the individual entering the data. These entries should be signed or initialled and dated.4 Any change in the raw data should be made so as not to obscure the previous entry, should indicate the reason for change and should be dated and signed or initialled by the individual making the change.5Data generated as a direct computer input should be identified at the time of data input by the individual(s) responsible for direct data entries. Computerised system design should always provide for the retention of full audit trails to show all changes to the data without obscuring the original data. It should be possible to associate all changes to data with the persons having made those changes, for example, by use of timed and dated (electronic) signatures. Reason for changes should be given.9 Reporting of Study Results  9.1 General  1 A final report should be prepared for each study. In the case of short term studies, a standardised final report accompanied by a study specific extension may be prepared.2 Reports of Principal Investigators or scientists involved in the study should be signed and dated by them.3 The final report should be signed and dated by the Study Director to indicate acceptance of responsibility for the validity of the data. The extent of compliance with these Principles of Good Laboratory Practice should be indicated.4 Corrections and additions to a final report should be in the form of amendments. Amendments should clearly specify the reason for the corrections or additions and should be signed and dated by the Study Director.5 Reformatting of the final report to comply with the submission requirements of a national registration or regulatory authority does not constitute a correction, addition or amendment to the final report.9.2 Content of the Final Report  The final report should include, but not be limited to, the following information:a.Identification of the study, the test item and reference item1.A descriptive title;2.Identification of the test item by code or name (e.g., IUPAC, CAS number, biological parameters, etc.);3.Identification of the reference item by name;4.Characterisation of the test item including purity, stability and homogeneity.b.Information concerning the sponsor and the test facility1.Name and address of the sponsor;2.Name and address of any test facilities and test sites involved;3.Name and address of the Study Director;4.Name and address of the Principal Investigator(s) and the phase(s) of the study delegated, if applicable5.Name and address of scientists having contributed reports to the final report; c.Dates: experimental starting and completion dates.d.Statement: a Quality Assurance statement listing the types of inspections made and their dates, including the phase(s) inspected, and the dates any inspection results were reported to management and to the Study Director and Principal Investigator(s), if applicable. This statement would also serve to confirm that the final report reflects the raw data.e.Description of materials and test methods:1.Description of methods and materials used;2.Reference to OECD Test Guideline or other test guideline or method.f.Results:1.A summary of results;2.All information and data required by the study plan;3.A presentation of the results, including calculations and determinations of statistical significance; 4.An evaluation and discussion of the results and, where appropriate, conclusions.g.Storage: the location(s) where the study plan, samples of test and reference items, specimens, raw data and the final report are to be stored.10 Storage and Retention of Records and Materials  1 The following should be retained in the archives for at least ten years after study completion:a.The study plan, raw data, samples of test and reference items, specimens, and the final report of each study;b.Records of all inspections performed by the Quality Assurance Programme, as well as master schedules;c.Records of qualifications, training, experience and job descriptions of personnel;d.Records and reports of the maintenance and calibration of apparatus;e.Validation documentation for computerised systems;f.The historical file of all Standard Operating Procedures;g.Environmental monitoring records.2 In the absence of a required retention period, the final disposal of any study materials should be documented. When samples of test and reference items and specimens are disposed of before the expiry of the required retention period for any reason, this should be justified and documented. Samples of test and reference items and specimens should be retained only as long as the quality of the preparation permits evaluation.3 Material retained in the archives should be indexed so as to facilitate orderly storage and retrieval.4 Only personnel authorised by management should have access to the archives. Movement of material in and out of the archives should be properly recorded.5 If a test facility or an archive contracting facility goes out of business and has no legal successor, the archive should be transferred to the archives of the sponsor(s) of the study(s).