EUR-Lex - 31998L0058 - EN Avis juridique important | 31998L0058 Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes Official Journal L 221 , 08/08/1998 P. 0023 - 0027 COUNCIL DIRECTIVE 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposesTHE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof,Having regard to the proposal from the Commission (1),Having regard to the opinion of the European Parliament (2),Having regard to the opinion of the Economic and Social Committee (3),Whereas all Member States have ratified the European Convention for the Protection of Animals Kept for Farming Purposes (hereinafter called 'the Convention`); whereas the Community has also approved this Convention by Decision 78/923/EEC (4) and has deposited its instrument of approval;Whereas the Community, as a contracting party, must give effect to the principles laid down in the Convention;Whereas those principles include the provision of housing, food, water and care appropriate to the physiological and ethological needs of the animals, in accordance with established experience and scientific knowledge;Whereas it is also necessary for the Community to make further provision for the uniform application of the Convention and its recommendations and for specific rules concerning the application of this Directive;Whereas the European Parliament, in its resolution of 20 February 1987 on animal welfare policy (5) called on the Commission to make proposals for Community rules covering general aspects of the rearing of livestock;Whereas Declaration No 24 annexed to the Final Act of the Treaty on European Union calls on the European institutions and the Member States, when drafting and implementing Community legislation, in particular on the common agricultural policy, to pay full regard to the welfare requirements of animals;Whereas differences which may distort conditions of competition interfere with the smooth running of the organisation of the market in animals;Whereas there is therefore a need to establish common minimum standards for the protection of animals kept for farming purposes in order to ensure rational development of production and to facilitate the organisation of the market in animals; whereas to that end it is appropriate to take account of animal welfare provisions already laid down in Community rules;Whereas a comparative examination of animal welfare provisions applicable in the Community and in certain non-member countries together with an appraisal thereof should be undertaken with a view to determining the nature of future Community initiatives aimed at eliminating distortions of competition,HAS ADOPTED THIS DIRECTIVE:Article 1 1. This Directive lays down minimum standards for the protection of animals bred or kept for farming purposes.2. It shall not apply to:(a) animals living in the wild;(b) animals intended for use in competitions, shows, cultural or sporting events or activities;(c) experimental or laboratory animals;(d) any invertebrate animal.3. This Directive shall apply without prejudice to specific Community rules laid down elsewhere, and in particular to Directives 88/166/EEC (6), 91/629/EEC (7) and 91/630/EEC (8), which shall continue to apply.Article 2 For the purposes of this Directive the following definitions shall apply:1. 'animal`: any animal (including fish, reptiles or amphibians) bred or kept for the production of food, wool, skin or fur or for other farming purposes;2. 'owner` or 'keeper`: any natural or legal person or persons responsible for or in charge of animals whether on a permanent or temporary basis;3. 'competent authority`: the competent authority within the meaning of Article 2(6) of Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market (9).Article 3 Member States shall make provision to ensure that the owners or keepers take all reasonable steps to ensure the welfare of animals under their care and to ensure that those animals are not caused any unnecessary pain, suffering or injury.Article 4 Members States shall ensure that the conditions under which animals (other than fish, reptiles or amphibians) are bred or kept, having regard to their species and to their degree of development, adaptation and domestication, and to their physiological and ethological needs in accordance with established experience and scientific knowledge, comply with the provisions set out in the Annex.Article 5 1. The Commission shall submit to the Council any proposals which may be necessary for the uniform application of the European Convention for the Protection of Animals Kept for Farming Purposes and, on the basis of a scientific evaluation, any recommendations made under this Convention and any other appropriate specific rules.2. In addition, every five years and for the first time five years after the date of entry into force of this Directive, the Commission, on the basis of experience acquired since the implementation of this Directive, in particular concerning the measures referred to in paragraph 1 and technical and scientific developments, shall submit to the Council a report, accompanied by any appropriate proposals taking into account the report's conclusions.3. The Council shall act by qualified majority on these proposals.Article 6 1. Member States shall ensure that inspections are carried out by the competent authority to check compliance with the provisions of this Directive. Such inspections may be carried out at the same time as checks for other purposes.2. From a date to be determined in accordance with the procedure laid down in paragraph 3, Member States shall submit to the Commission reports on the inspections required under paragraph 1. The Commission shall submit summaries of those reports to the Standing Veterinary Committee.3. The Commission shall before 1 July 1999, in accordance with the procedure laid down in Article 9 submit proposals with a view to harmonising:(a) the inspections required under paragraph 1;(b) the format, content and frequency of submission of the reports referred to in paragraph 2.Article 7 1. Whenever uniform application of the requirements of this Directive renders it necessary, veterinary experts from the Commission may, in conjunction with the competent authorities;(a) verify that the Member States are complying with the said requirements;(b) make on-the-spot checks to ensure that the checks are carried out in accordance with this Directive.2. A Member State in whose territory an inspection is made shall provide the veterinary experts from the Commission with any assistance they may require in the performance of their tasks. The outcome of the checks made must be discussed with the competent authority of the Member State concerned before a final report is drawn up and circulated.3. The competent authority of the Member State concerned shall take any measures which may be necessary to take account of the results of the check.4. Detailed rules for the application of this Article shall be adopted, where necessary, in accordance with the procedure laid down in Article 9.Article 8 1. Before 30 June 1999 the Commission shall submit to the Council a report on:- the comparison between animal welfare provisions in the Community and in non-member countries which supply the Community,- the scope for obtaining wider international acceptance of the welfare principles laid down in this Directive, and- the extent to which Community objectives in relation to animal welfare may be liable to be undermined as a result of competition from non-member countries which do not apply equivalent standards.2. The report referred to in paragraph 1 shall be accompanied by any necessary proposals with the aim of eliminating distortions of competition.Article 9 1. Where the procedure laid down in this Article is to be followed, the matter shall be referred without delay to the Standing Veterinary Committee set up by Directive 68/361/EEC (10), hereinafter referred to as 'the Committee`, by its chairman acting either on his own initiative or at the request of a Member State.2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote.3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.(b) If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall without delay submit to the Council a proposal relating to the measures to be taken. The Council shall act by qualified majority.If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the Commission shall adopt the proposed measures and implement them immediately, save where the Council has decided against the said measures by a simple majority.Article 10 1. Member States shall bring into force the laws, regulations and administrative provisions, including any sanctions, necessary to comply with this Directive not later than 31 December 1999, subject to any different decision taken by the Council in the light of the report referred to in Article 8. They shall forthwith inform the Commission thereof.When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.2. However, after 31 December 1999, Member States may, in compliance with the general rules of the Treaty, maintain or apply within their territories stricter provisions for the protection of animals kept for farming purposes than those laid down in this Directive. They shall inform the Commission of any such measures.3. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive.Article 11 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article 12 This Directive is addressed to the Member States.Done at Brussels, 20 July 1998.For the CouncilThe PresidentW. MOLTERER(1) OJ C 156, 23. 6. 1992, p. 11.(2) OJ C 337, 21. 12. 1992, p. 225.(3) OJ C 332, 16. 12. 1992, p. 22.(4) OJ L 323, 17. 11. 1978, p. 12.(5) OJ C 76, 23. 3. 1987, p. 185.(6) Council Directive 88/166/EEC of 7 March 1998 complying with the judgment of the Court of Justice in Case 131-86, (annulment of Council Directive 86/113/EEC of 25 March 1986 laying down minimum standards for the protection of laying hens kept in battery cages) (OJ L 74 19. 3. 1988, p. 83).(7) Council Directive 91/629/EEC of 19 November 1991 laying down minimum standards for the protection of calves (OJ L 340, 11. 12. 1991, p. 28). Directive as last amended by Directive 97/2/EC (OJ L 25, 28. 1. 1997, p. 24).(8) Council Directive 91/630/EEC of 19 November 1991 laying down minimum standards for the protection of pigs (OJ L 340, 11. 12. 1991, p. 33).(9) OJ L 224, 18. 8. 1990, p. 29. Directive as last amended by Directive 92/118/EEC (OJ L 62, 15. 3. 1993, p. 49).(10) OJ L 255, 18. 10. 1968, p. 23.ANNEX Staffing 1. Animals shall be cared for by a sufficient number of staff who possess the appropriate ability, knowledge and professional competence.Inspection 2. All animals kept in husbandry systems in which their welfare depends on frequent human attention shall be inspected at least once a day. Animals in other systems shall be inspected at intervals sufficient to avoid any suffering.3. Adequate lighting (fixed or portable) shall be available to enable the animals to be thoroughly inspected at any time.4. Any animal which appears to be ill or injured must be cared for appropriately without delay and, where an animal does not respond to such care, veterinary advice must be obtained as soon as possible. Where necessary sick or injured animals shall be isolated in suitable accomodation with, where appropriate, dry comfortable bedding.Record keeping 5. The owner or keeper of the animals shall maintain a record of any medicinal treatment given and of the number of mortalities found to each inspection.Where equivalent information is required to be kept for other purposes, this shall also suffice for the purposes of this Directive.6. These records shall be retained for a period of at least three years and shall be made available to the competent authority when carrying out an inspection or when otherwise requested.Freedom of movement 7. The freedom of movement of an animal, having regard to its species and in accordance with established experience and scientific knowledge, must not be restricted in such a way as to cause it unnecessary suffering or injury.Where an animal is continuously or regularly tethered or confined, it must be given the space appropriate to its physiological and ethological needs in accordance with established experience and scientific knowledge.Buildings and accommodation 8. Materials to be used for the construction of accommodation, and in particular for the construction of pens an equipment with which the animals may come into contact, must not be harmful to the animals and must be capable of being throughly cleaned and disinfected.9. Accommodation and fittings for securing animals shall be constructed and maintained so that there are no sharp edges or protrusions likely to cause injury to the animals.10. Air circulation, dust levels, temperature, relative air humidity and gas concentrations must be kept within limits which are not harmful to the animals.11. Animals kept in buildings must not be kept either in permanent darkness or without an appropriate period of rest from artificial lighting. Where the natural light available is insufficient to meet the physiological and ethological needs of the animals, appropriate artificial lighting must be provided.Animals not kept in buildings 12. Animals not kept in buildings shall where necessary and possible be given protection from adverse weather conditions, predators and risks to their health.Automatic or mechanical equipment 13. All automated or mechanical equipment essential for the health and well-being of the animals must be inspected at least once daily. Where defects are discovered, these must be rectified immediately, or if this is impossible, appropriate steps must be taken to safeguard the health and well-being of the animals.Where the health and well-being of the animals is dependent on an artificial ventilation system, provision must be made for an appropriate backup system to guarantee sufficient air renewal to preserve the health and well-being of the animals in the event of failure of the system, and an alarm system must be provided to give warning of breakdown. The alarm system must be tested regularly.Feed, water and other substances 14. Animals must be fed a wholesome diet which is appropriate to their age and species and which is fed to them in sufficient quantity to maintain them in good health and satisfy their nutritional needs. No animal shall be provided with food or liquid in a manner, nor shall such food or liquid contain any substance, which may cause unnecessary suffering or injury.15. All animals must have access to feed at intervals appropriate to their physiological needs.16. All animals must have access to a suitable water supply or be able to satisfy their fluid intake needs by other means.17. Feeding and watering equipment must be designed, constructed and placed so that contamination of food and water and the harmful effects of competition between the animals are minimised.18. No other substance, with the exception of those given for therapeutic, or prophylactic purposes or for the purposes of zootechnical treatment as defined in Article 1(2)(c) of Directive 96/22/EEC (1), must be administered to an animal unless it has been demonstrated by scientific studies of animal welfare or established experience that the effect of that substance is not detrimental to the health or welfare of the animal.Mutilations 19. Pending the adoption of specific provisions concerning mutilations in accordance with the procedure laid down in Article 5, and without prejudice to Directive 91/630/EEC, relevant national provisions shall apply in accordance with the general rules of the Treaty.Breeding procedures 20. Natural or artificial breeding or breeding procedures which case or are likely to cause suffering or injury to any of the animals concerned must not be practised.This provision shall not preclude the use of certain procedures likely to cause minimal or momentary suffering or injury, or which might necessitate interventions which would not cause lasting injury, where these are allowed by national provisions.21. No animal shall be kept for farming purposes unless it can reasonably be expected, on the basis of its genotype or phenotype, that it can be kept without detrimental effect on its health or welfare.(1) Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists (OJ L 125, 23. 5. 1996, p. 3).

Summary: Protection of farmed animals Protection of farmed animals SUMMARY OF: Directive 98/58/EC — protection of animals kept for farming purposes WHAT IS THE AIM OF THE DIRECTIVE? It lays down general rules concerning the protection of farmed animals, irrespective of the species. These apply to farmed animals destined for the production of foodstuffs, wool, skin or fur, or for other farming purposes, including fish, reptiles and amphibians. KEY POINTS All EU countries have ratified the European Convention for the Protection of Animals Kept for Farming Purposes. The main articles of this relate to the provision of housing, feed and care appropriate to the needs of these animals. EU countries must take account of these animal welfare requirements when drawing up and implementing EU legislation, especially in the area of agricultural policy. Animals This directive applies to animals (including fish, reptiles and amphibians) reared or kept for the production of food, wool, skin or fur or for other farming purposes. It does not apply to: wild animals animals intended for use in sporting or cultural events (shows) experimental or laboratory animals invertebrate animals. To learn more details about specific categories of animals, see also: Protection of laying hens Protection of calves Protection of pigs. Rearing conditions EU countries must adopt rules to ensure that the owners or keepers of animals look after the welfare of their animals and see that those animals are not caused any unnecessary pain, suffering or injury. Based on past experience and current scientific knowledge, the rearing conditions relate to the following. Staff: animals must be looked after by a sufficient number of staff who have the appropriate professional skills, knowledge and competence. Inspections: all animals kept in husbandry systems must be inspected at least once a day. Injured or ill animals must be treated immediately and isolated if necessary in suitable premises. Maintaining records: the owner or keeper of the animals must keep a record of any medical treatment for at least three years. Freedom of movement: all animals, even if tethered, chained or confined, must be given enough space to move without unnecessary suffering or injury. Buildings and accommodation: materials used in the construction of buildings must be capable of being cleaned and disinfected. Air circulation, dust levels, temperature and relative humidity should be kept within acceptable limits. Animals kept in buildings must not be kept in permanent darkness or constantly exposed to artificial lighting. Automatic or mechanical equipment: automatic or mechanical equipment essential for the health and well-being of the animals must be inspected at least once a day. Where an artificial ventilation system is in use, an appropriate backup system must be in place to guarantee sufficient air renewal. Feed, water and other substances: the animals must be given a wholesome and appropriate diet, fed to them in sufficient quantities and at regular intervals. All other substances are prohibited, unless given for therapeutic or prophylactic reasons or for the purposes of zootechnical treatment. In addition, the feeding and watering equipment must minimise the risks of contamination. Mutilations: national rules on mutilation apply. Rearing methods: rearing methods that cause suffering or injury must not be used unless their impact is minimal, brief or expressly allowed by the national authorities. No animal should be kept on a farm if it is harmful to its health or welfare. Inspections EU countries must take the necessary steps to ensure that the competent national authorities carry out inspections. They must report on these inspections to the European Commission, which will use the reports to formulate proposals on harmonising inspections. Evaluation and implementation Every 5 years, the Commission must report to the Council on the implementation of this directive, with proposals for improvement, if appropriate. The Council adopts this report by qualified majority vote. EU countries are allowed to keep or introduce stricter provisions. Official controls regulation Regulation (EU) 2017/625, the EU’s new legislation on the official controls of human food and animal feed, amends certain minor technical details of the directive. These changes will apply from 14 December 2019. FROM WHEN DOES THE DIRECTIVE APPLY? It has applied since 8 August 1998. EU countries had to incorporate it into national law by 31 December 1999. BACKGROUND For more information, see: Animal welfare on the farm (European Commission). MAIN DOCUMENT Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes (OJ L 221, 8.8.1998, pp. 23–27) Successive amendments to Directive 98/58/EC have been incorporated into the original document. This consolidated version is of documentary value only. RELATED DOCUMENTS Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, pp. 1–142) See consolidated version. Commission Decision 2006/778/EC of 14 November 2006 concerning minimum requirements for the collection of information during the inspections of production sites on which certain animals are kept for farming purposes (OJ L 314, 15.11.2006, pp. 39–47) See consolidated version. last update 13.11.2017


EUR-Lex - 21999A1009(01) - EN Avis juridique important | 21999A1009(01) Agreement on mutual recognition of OECD principles of good laboratory practice (GLP) and compliance monitoring programmes between the European Community and the State of Israel - Agreed Minutes Official Journal L 263 , 09/10/1999 P. 0007 - 0018 AGREEMENTon mutual recognition of OECD principles of good laboratory practice (GLP) and compliance monitoring programmes between the European Community and the State of IsraelTHE EUROPEAN COMMUNITY (hereinafter referred to as "the Community"),on the one hand, andTHE STATE OF ISRAEL (hereinafter referred to as "Israel")on the other hand,THE TWO PARTIES subsequently referred to as the "Contracting Parties",HAVING REGARD TO their obligations under the World Trade Organisation (WTO) and the WTO Agreement on technical barriers to trade, and especially to Annex I-C thereof, concerning the protection of intellectual property,HAVING REGARD TO the OECD Council Decision of 12 May 1981 on mutual acceptance of data for the evalutation of chemicals,HAVING REGARD TO the OECD Council Decision-Recommendation of 2 October 1989 on compliance with principles of good laboratory practice (C(89)87(final)),HAVING REGARD to the Agreement on the European Economic Area of 2 May 1992 that establishes a zone of free circulation of goods, services, people and capital between the European Community and Iceland, Liechtenstein and Norway and especially to its 12th Protocol,AFFIRMING the need to ensure the high quality, validity and reliability of health and environmental data generated during the testing of cosmetics, industrial chemicals, pharmaceuticals, food additives, animal feed additives, pesticides (hereinafter referred to as chemicals),NOTING that in the absence of a national GLP monitoring authority in Israel, there is a need for transitional arrangements during an initial period during which Israel will set up this authority,HAVE AGREED AS FOLLOWS:Article 1Definitions1. Unless specific definitions are given, the definition of terms in the "OECD principles of good laboratory practice" (Annex II to OECD Council Decision (C(81)30(final)), the "Guides for compliance monitoring procedures for good laboratory practice" (Annex I to Council Decision-Recommendation (C(89)87(final)), the "Application of the good laboratory practice principles to field studies" (GLP consensus document, OECD series on principles of good laboratory practice and compliance monitoring), and all amendments made thereto shall apply.2. "Accept" means that the receiving authorities will be obliged to recognise studies and data generated therefrom, from the other party on products subject to this Agreement under the same conditions as data generated on their own territory, provided that:- the study was conducted by a test facility located on the territory of the Contracting Parties,- the study is performed by a test facility that has been judged to operate in compliance with the good laboratory practice principles by the relevant national good laboraory practice monitoring Authorities.3. "Monitoring authority": a management body with responsibility for monitoring the good laboratory practice compliance of test facilities within the territory of its administration and for discharging other such functions related to good laboratory practice as may be nationally determined.Article 2Scope1. The Contracting Parties shall ensure the high quality, validity and reliability of safety evaluation data obtained during non-clinical testing on all chemicals as identified in Annex I before they are placed on the market.2. The Contracting Parties shall recognise the equivalence of each others' compliance monitoring programmes on GLP that are in accordance with the principles referred to in Article 3(1).3. Each Contracting Party shall accept studies and data generated therefrom, on the entirety of their territory as defined in Article 15, produced by the test facilities located on the territory of the other Contracting Party provided they participate in the GLP compliance monitoring programme of that Party in accordance with the principles referred to in Article 3(1).4. Under the terms of this Agreement, the studies and the data generated therefrom, shall be used by the Contracting Parties for consideration in any administrative action to allow placing on the market of all chemicals as defined in Annex I.Article 3Basis of reference1. For the purposes of this Agreement, the following conditions shall be fulfilled:- the principles of good laboratory practice shall be in conformity with those adopted by the OECD in its Decision of 12 may 1981 on mutual acceptance of data for the evaluation of chemicals (C(81)30(final)) and all amendments made thereto,- the provisions regarding test facility inspection and study audits shall be in conformity with those adopted by the Council of the OECD in Annexes I to III to the 1989 Decision-Recommendation (C(89)87(final)), that has been modified by its Decision-Recommendation of 9 March 1995 (C(95)8(final)), and all amendments made thereto,- the test facilities shall be recognised to be in conformity with good laboratory practice in accordance with the principles applicable respectively in the EC and Israel.2. The Contracting Parties shall inform each other in a timely manner of changes to their legislation that may affect good laboratory practice compliance standards or programmes.Article 4AmbitThis Agreement applies to studies conducted by test facilities on all chemicals either substances or preparations, as identified in Annex I, and to data generated therefrom. Modifications to that Annex shall be decided by the Joint Committee referred to in Article 10.Article 5Monitoring authorities1. The authorities empowered or designated in their respective territories to verify the conformity of the test facilities with the principles of good laboratory practice are listed in Annex II to this Agreement.2. The Contracting Parties shall inform and consult each other with regard to any further authorities which they wish to be included in this Agreement. Modifications to Annex II, by either adding or withdrawing authorities, shall be decided by the Joint Committee referred to in Article 10.Article 6Information about GLP-recognised test facilities1. The Contracting Parties shall provide each other at least annually with a list of the test facilities on their territory, which in the light of the results of the inspections and study audits conform to good laboratory practice, as well as of the dates of inspection or audit and their compliance status.2. The Contracting Parties shall inform each other promptly when a test facility coming under the terms of paragraph 1, which states that it applies good laboratory practice, fails to conform to such practice to an extent which may jeopardise the integrity or authenticity of any studies it conducts.3. The Contracting Parties shall provide each other promptly with the information referred to in paragraph 1 about test facilities that in the light of the results of the inspections and study audits conform to good laboratory practice but have yet not been included in the list referred to in that paragraph.Article 7Additional actions1. The Contracting Parties shall supply each other with any necessary additional information on a test facility inspection or study audit in response to a reasonable request from the other party.2. Each Contracting Party may request further test facility inspection or study audits on the other party's territory if there is a documented doubt as to wheter a test was conducted in accordance with good laboratory practice.3. If in exceptional cases doubts persist and the requesting party can justify a special concern, and with the consent of the test facility concerned, it may designate one or more expets of its authorities to participate in a test facility inspection or the audit of a study conducted by the authorities of the other party.Article 8Confidentiality1. The Contracting Parties shall make provision for the maintenance of confidentiality, not only by inspectors but also by any other persons who gain access to confidential information as a result of GLP compliance monitoring activities.2. The Contracting Parties shall ensure that, unless all commercially sensitive and confidential information has been excised, reports of test facility inspections and study audits are made available only to regulatory authorities and, where appropriate, to the test facilities inspected or concerned with study audits and/or to study sponsors. Test facilities can freely dispose of the reports of test facility inspection and study audits that concern them.Article 9Participation as observerEach Contracting Party may, on request, participate as an observer in an inspection of a test facility conducted by the autorities of the other party with the consent of the test facility concerned in order to maintain a continuing understanding of the other party's inspection procedures.Article 10Joint Committee1. A Joint Committee composed of representatives of both parties shall be established.2. The Joint Committee shall meet in order to resolve problems resulting from possible differences of view and practice within the two parties, to ensure proper implementation of this Agreement and to seek opportunities for further cooperation.TRANSITIONAL PROVISIONSArticle 11For an initial period, as a transitional arrangement, of a maximum of two years starting after the entry into force of this Agreement, the following provisions shall apply.1. Israel shall establish during this period a ntional GLP monitoring system.2. If there is no agreement between the parties that the above requirement has been met satisfactorily during the initial period, and if the two parties do not decide after a joint review to prolong the initial period, this Agreement ceases automatically to be valid.3. The initial period may be terminated before the two-year period, provided the Community has acknowledged that the Israeli GLP monitoring system has entered into operation satisfactorily.Article 12During the initial period referred to in Article 11, the empowered authorities in the Community shall verify conformity of the test facilities with GLP in Israel, as described in the attached Agreed Minutes. The Community shall recognise any test facility found in conformity with GLP requirements.Article 13During the initial period referred to in Article 11, Israel shall accept the data coming from GLP recognised test facilities in the Community and the Community shall accept data coming from the Israeli test facilities GLP recognised by it acording to Article 12.FINAL PROVISIONSArticle 14Either party may terminate this Agreement by giving the other party six months notice in writing.Article 15This Agreement shall apply, on the one and, to the territories in which the Treaty establishing the European Community is applied and under the conditions laid down in that Treaty and, on the other hand, to the territory of the State of Israel.Article 16This Agreement shall be approved or ratified by the parties in accordance with their own procedures. It shall enter into force on the first day of the second month following the date on which the parties have exchanged notes confirming the completion of the respective procedures for the entry into force of this Agreement.This Agreement is drawn up in two originals in the Danish, Dutch, English, Finnish, French, German, Greek, Italian, Portuguese, Spanish, Swedish and Hebrew languages, each of these languages being equally authentic.In witness whereof the undersigned, being duly authorised, have signed this Agreement.For the Government of the State of Israel>PIC FILE= "L_1999263EN.001301.EPS">For the European Community>PIC FILE= "L_1999263EN.001302.EPS">ANNEX ILIST OF CHEMICALS COVERED BY THE AGREEMENT ON MUTUAL RECOGNITION OF THE OECD PRINCIPLES OF GOOD LABORATORY PRACTICE AND COMPLIANCE MONITORING PROGRAMMES BETWEEN THE EUROPEAN COMMUNITY AND THE STATE OF ISRAELChemicals, either substance or preparations, covered in the Agreement on mutual recognition of the OECD principles of good laboratory practice between the European Community and the State of Israel are:- cosmetics,- industrial chemicals,- medicinal products/pharmaceuticals,- food additives,- animal feed additives,- pesticides.These chemicals are defined by the legal instruments of the country of destination, which are:FOR THE EUROPEAN COMMUNITY:1. Council Directive 87/18/EEC of 18 December 1986 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L 15, 17.1.1987, p. 29) as last amended by Commission Directive 1999/11/EC (OJ L 77, 23.3.1999, p. 8).2. Council Directive 88/320/EEC of 9 June 1998 on the inspection and verification of good laboratory practice (GLP) (OJ L 145, 11.6.1998, p. 35) as last amended by Commission Directive 1999/12/EC (OJ L 77, 23.3.1999, p. 22).3. Council Directive 92/32/EEC of 30 April 1992 amending for the seventh time Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ L 154, 5.6.1992, p. 1).4. Council Directive 88/379/EEC of 7 June 1998 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (OJ L 187, 16.7.1988, p. 14).5. Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances (OJ L 84, 5.4.1993, p. 1).6. Council Directive 87/19/EEC of 22 December 1996 amending Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products (OJ L 15, 17.1.1987, p 31).7. Commission Directive 91/507/EEC of 19 July 1991 modifying the Anenx to Council Directive 75/318/EEC on the approximation of the laws of Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products (OJ L 270, 26.9.1991, p. 32).8. Council Directive 87/20/EEC of 22 December 1986 amending Directive 81/852/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (OJ L 15, 17.1.1987, p. 34).9. Council Directive 92/18/EEC of 20 March 1992 modifying the Annex to Council Directive 81/852/EEC on the approximation of the laws of Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (OJ L 97, 10.4.1992, p. 1).10. Council Directive 89/397/EC of 14 June 1989 on the official control of foodstuffs (OJ L 186, 30.6.1989, p. 23).11. Council Directive 93/99/EEC of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs (OJ L 290, 24.11.1993, p. 14).12. Council Directive 87/153/EEC of 16 February 1987 fixing guidelines for the assessment of additives in animal nutrition (OJ L 64, 7.3.1987, p. 19) as amended by Commission Directive 95/11/EC (OJ L 106, 11.5.1995, p. 23).13. Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1) as last amended by Commission Directive 95/35/EC (OJ L 172, 22.7.1995, p. 6).14. Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).15. Council Directive 93/35/EEC of 14 June 1993 amending for the sixth time Directive 76/68/EEC on the approximation of the laws of the Member States relating to cosmetic products (OJ L 151, 23.6.1993, p. 32).ISRAELI LAWS AND REGULATIONS(UNOFFICIAL TRANSLATION)DrugsPharmacists Ordinance (New Version) - 1981Pharmacist Regulations (Medical Preparations) - 1986Food additivesPublic Health Ordinance (Food) (new version) - 1983Public Health Regulations (Food) (bases of emulsifier and stabilisers in food products) - 1966Public Health Regulations (Food) (dietic food and sweeteners) - 1987Public Health Regulations (Food) (vitamin and mineral additives in food) - 1983Public Health Regulations (Food) (food colouring) 1984Public Health Regulations (Food) (sealing of food packaging) - 1993Public Health Regulations (Food) (pesticide traces) - 1991Public Health Regulations (Food) (aflatoxins in food) - 1989Public Health Regulations (Food) (provisions of findings) - 1980Public Health Regulations (Food) (labelling) - 1935Public Health Regulations (Food) (nutritional labelling) - 1993Public Health Regulations (Food) (food products preservation through radiation) - 1988Common Health Ordinance - 1942Common Health Regulations (sanitary quality of drinking water) - 1977Common Health Regulations (mineral and spring water) - 1987Common Health Regulations (method of taking samples and their transfer for testing) - 1957Common Health Regulations (preservative bases in food (foods) - 1965Commodities and Services Control Law - 1957Commodities and Services Control Order (quality of food) - 1958Commodities and Services Control Order (production of food products) - 1976Commodities and Services Control Order (labelling of food additives) - 1968Animal feed additivesCommodities and Services Contrrol Order (production and sale of fodder) - 1971Animal Disease Ordinance (new version) - 1985Animal Disease Regualtions (chemical preparations) - 1982PesticidesCommodities and Services Control Order (pesticide preparations against hazards to humans) - 1962Hazardous Substances Regulations (regulation of pesticide preparations against hazards to humans) - 1994Plant Protection Law - 1956Plant Protection Regulations (regulation of import and sale of chemical preparations) - 1994Agricultural Fertilisers Ordinance - 1938Agricultural Fertilisers Regulations - 1938CosmeticsCommodities and Services Control Order (cosmetics) - 1973Industrial chemicalsHazardous Substances Law - 1993Hazardous Substances Regulations - 1994Hazardous Substances Regulations (import and export of hazardous substances waste) - 1994Hazardous Substances Regulations (classification and exemption) - 1996ANNEX IILIST OF MONITORING AUTHORITIES>TABLE>ANNEX IIIAGREED MINUTESconcerning the Agreement on mutual recognition of OECD principles of good laboratory practice (GLP) and compliance monitoring programmes between the European Community and the State of IsraelHaving regard to the Transitional Provisions of the Agreement on mutual recognition of OECP principles of good Laboratory practice (GLP) between the European Community (EC) and the State of Israel, the Contracting Parties state as follows:TEST FACILITIES CONCERNED- The list of test facilities that Israel wants to be GLP recognised is annexed to the present minute.PRELIMINARY MISSION- Before the signature of the Agreement, a preliminary mission of two experts of the EC will take place in order to:- assess the state of affairs concerning the test facilities in Annex that eventually could be GLP recognised,- give their advice for the setting up of the national GLP monitoring authority,- Both parties agree to accept the findings of the report of the experts concerning the above mission as submitted.INITIAL PERIOD- All inspections during the initial period will be performed by at least two inspectors designated by the EC.The reports of these inspections will be sent by the inspectors to the test facility concerned and, in addition, to the authorities of the Contracting Parties(1),- inspections will start as soon as possible after the signature of the Agreement and on request of the Israeli Authorities, in order to inspect the test facilities interested to be GLP recognised,- all the costs pertaining to the missions, both the preliminary mission and the inspections during the initial period, will be supported by the State of Israel.For the Government of the State of Israel>PIC FILE= "L_1999263EN.000801.EPS">For the European Community>PIC FILE= "L_1999263EN.000802.EPS">(1) European CommissionDG I/M/2Rue de la Loi/Wetstraat 200 B - 1049 Bruxelles/Brussel Israel LaboratoryAccreditation AuthorityHabonim Street, 2 Ramat Gan 52522 ( Israel )ANNEX IVISRAELI TEST FACILITIES CANDIDATES TO BE GLP RECOGNISED1. AGAN CHEMICAL MANUFACTURERS LTD>TABLE>2. AMINOLAB LTD ANALYTICAL LABORATORY SERVICES>TABLE>3. ANALYST RESEARCH LABORATORIES>TABLE>4. HARLAN BIOTEC ISRAEL LTD>TABLE>

Summary: EU-Israel mutual recognition agreement (MRA) EU-Israel mutual recognition agreement (MRA) SUMMARY OF: Agreement on mutual recognition of OECD principles of good laboratory practice (GLP) and compliance monitoring programmes between the European Community and Israel Council Decision 99/662/EC approving the agreement WHAT IS THE AIM OF THE AGREEMENT AND OF THE DECISION? This mutual recognition agreement (MRA)* between the European Community (now the EU) and Israel relates to the Organisation for Economic Co-operation and Development (OECD) principles of good laboratory practice (GLP) and compliance monitoring programmes. The decision approves the MRA on behalf of the EU countries. KEY POINTS The chemicals covered by the agreement are: cosmetics, industrial chemicals, medicinal products/pharmaceuticals, food additives, animal feed additives, pesticides. Main features of the agreement: both parties (the EU and Israel) will ensure the high quality, validity and reliability of safety evaluation data obtained during non-clinical chemical testing; both parties recognise that each other’s GLP compliance monitoring programmes are equivalent; each party accepts the data produced by test facilities located on the territory of the other party if they participate in the GLP compliance monitoring programme, and agree that it can be used in decisions to place chemicals on the market; good laboratory practice, test facility inspection and study audits conform to the principles adopted by the OECD; test facilities conform with good laboratory practice according to the respective principles of each party; the two parties will keep each other informed of changes to their legislation that could affect good laboratory practice compliance standards or programmes; the EU will verify that the laboratories and national monitoring system in Israel conform; the MRA provides for a 2-year transitional period to establish a national GLP monitoring system; the MRA automatically lapses if the parties fail to agree on Israel’s national GLP monitoring system and on its extension after the initial period. FROM WHEN DOES THE AGREEMENT APPLY? It has applied since 1 May 2000. BACKGROUND In their resolution of 21 December 1989, EU countries agreed on the principle of MRAs. On 21 September 1992, they authorised the European Commission to negotiate mutual recognition agreements on behalf of the EU with certain non-EU countries. See also: Mutual Recognition Agreement (European Commission) Good Laboratory Practice (European Commission). KEY TERMS Mutual recognition agreement: an international agreement where 2 or more countries recognise each other’s conformity assessment results. MAIN DOCUMENT Agreement on mutual recognition of OECD principles of good laboratory practice (GLP) and compliance monitoring programmes between the European Community and the State of Israel — Agreed Minutes (OJ L 263, 9.10.1999, pp. 7-18) Council Decision 99/662/EC of 19 July 1999 concerning the conclusion of the Agreement on mutual recognition of OECD principles of good laboratory practice (GLP) and compliance monitoring programmes between the European Community and the State of Israel (OJ L 263, 9.10.1999, p. 6) RELATED DOCUMENTS Consolidated version of the Treaty on the Functioning of the European Union — Part Five — The Union’s external action — Title II — Common commercial policy — Article 207 (ex Article 133 TEC) (OJ C 202, 7.6.2016, pp. 140-141) Agreement on the European Economic Area — Protocol 12 on conformity assessment agreements with third countries (OJ L 1, 3.1.1994, pp. 174-175) Uruguay Round of Multilateral Trade Negotiations (1986-1994) — Annex 1 — Annex 1A — Agreement on Technical Barriers to Trade (WTO-GATT 1994) (OJ L 336, 23.12.1994, pp. 86-99) Council Resolution of 21 December 1989 on a global approach to conformity assessment (OJ C 10, 16.1.1990, pp. 1-2) last update 26.10.2018


EUR-Lex - 32000R0141 - EN Avis juridique important | 32000R0141 Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products Official Journal L 018 , 22/01/2000 P. 0001 - 0005 REGULATION (EC) No 141/2000 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILof 16 December 1999on orphan medicinal productsTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the Economic and Social Committee(2),Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),Whereas:(1) some conditions occur so infrequently that the cost of developing and bringing to the market a medicinal product to diagnose, prevent or treat the condition would not be recovered by the expected sales of the medicinal product; the pharmaceutical industry would be unwilling to develop the medicinal product under normal market conditions; these medicinal products are called "orphan";(2) patients suffering from rare conditions should be entitled to the same quality of treatment as other patients; it is therefore necessary to stimulate the research, development and bringing to the market of appropriate medications by the pharmaceutical industry; incentives for the development of orphan medicinal products have been available in the United States of America since 1983 and in Japan since 1993;(3) in the European Union, only limited action has been taken so far, whether at national or at Community level, to stimulate the development of orphan medicinal products; such action is best taken at Community level in order to take advantage of the widest possible market and to avoid the dispersion of limited resources; action at Community level is preferable to uncoordinated measures by the Member States which may result in distortions of competition and barriers to intra-Community trade;(4) orphan medicinal products eligible for incentives should be easily and unequivocally identified; it seems most appropriate to achieve this result through the establishment of an open and transparent Community procedure for the designation of potential medicinal products as orphan medicinal products;(5) objective criteria for designation should be established; those criteria should be based on the prevalence of the condition for which diagnosis, prevention or treatment is sought; a prevalence of not more than five affected persons per 10 thousand is generally regarded as the appropriate threshold; medicinal products intended for a life-threatening, seriously debilitating or serious and chronic condition should be eligible even when the prevalence is higher than five per 10 thousand;(6) a Committee composed of experts appointed by the Member States should be established to examine applications for designation; this Committee should also include three representatives of patients' associations, designated by the Commission, and three other persons, also designated by the Commission, on a recommendation from the European Agency for the Evaluation of Medicinal Products (hereinafter referred to as "the Agency"); the Agency should be responsible for the adequate coordination between the Committee on orphan medicinal products and the Committee on proprietary medicinal products;(7) patients with such conditions deserve the same quality, safety and efficacy in medicinal products as other patients; orphan medicinal products should therefore be submitted to the normal evaluation process; sponsors of orphan medicinal products should have the possibility of obtaining a Community authorisation; in order to facilitate the granting or the maintenance of a Community authorisation, fees to be paid to the Agency should be waived at least in part; the Community budget should compensate the Agency for the loss in revenue thus occasioned;(8) experience in the United States of America and Japan shows that the strongest incentive for industry to invest in the development and marketing of orphan medicinal products is where there is a prospect of obtaining market exclusivity for a certain number of years during which part of the investment might be recovered; data protection under Article 4(8)(a)(iii) of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products(4) is not a sufficient incentive for that purpose; Member States acting independently cannot introduce such a measure without a Community dimension as such a provision would be contradictory to Directive 65/65/EEC; if such measures were adopted in an uncoordinated manner by the Member States, this would create obstacles to intra-Community trade, leading to distortions of competition and running counter to the single market; market exclusivity should however be limited to the therapeutic indication for which orphan medicinal product designation has been obtained, without prejudice to existing intellectual property rights; in the interest of patients, the market exclusivity granted to an orphan medicinal product should not prevent the marketing of a similar medicinal product which could be of significant benefit to those affected by the condition;(9) sponsors of orphan medicinal products designated under this Regulation should be entitled to the full benefit of any incentives granted by the Community or by the Member States to support the research and development of medicinal products for the diagnosis, prevention or treatment of such conditions, including rare diseases;(10) the specific programme Biomed 2, of the fourth framework programme for research and technological development (1994 to 1998), supported research on the treatment of rare diseases, including methodologies for rapid schemes for the development of orphan medicinal products and inventories of available orphan medicinal products in Europe; those grants were intended to promote the establishment of cross national cooperation in order to implement basic and clinical research on rare diseases; research on rare diseases continues to be a priority for the Community, as it has been included in the fifth framework programme for research and technological development (1998 to 2002); this Regulation establishes a legal framework which will allow the swift and effective implementation of the outcome of this research;(11) rare diseases have been identified as a priority area for Community action within the framework for action in the field of public health; the Commission, in its communication concerning a programme of Community action on rare diseases within the framework for action in the field of public health has decided to give rare diseases priority within the public health framework; the European Parliament and the Council have adopted Decision No 1295/1999/EC of 29 April 1999 adopting a programme of Community action on rare diseases within the framework for action in the field of public health (1999 to 2003)(5), including actions to provide information, to deal with clusters of rare diseases in a population and to support relevant patient organisations; this Regulation implements one of the priorities laid down in this programme of action,HAVE ADOPTED THIS REGULATION:Article 1PurposeThe purpose of this Regulation is to lay down a Community procedure for the designation of medicinal products as orphan medicinal products and to provide incentives for the research, development and placing on the market of designated orphan medicinal products.Article 2DefinitionsFor the purposes of this Regulation:(a) "medicinal product" means a medicinal product for human use, as defined in Article 2 of Directive 65/65/EEC;(b) "orphan medicinal product" means a medicinal product designated as such under the terms and conditions of this Regulation;(c) "sponsor" means any legal or natural person, established in the Community, seeking to obtain or having obtained the designation of a medicinal product as an orphan medicinal product;(d) "Agency" means the European Agency for the Evaluation of Medicinal Products.Article 3Criteria for designation1. A medicinal product shall be designated as an orphan medicinal product if its sponsor can establish:(a) that it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10 thousand persons in the Community when the application is made, orthat it is intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the Community and that without incentives it is unlikely that the marketing of the medicinal product in the Community would generate sufficient return to justify the necessary investment;and(b) that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in the Community or, if such method exists, that the medicinal product will be of significant benefit to those affected by that condition.2. The Commission shall adopt the necessary provisions for implementing this Article in the form of an implementing Regulation in accordance with the procedure laid down in Article 72 of Council Regulation (EEC) No 2309/93(6).Article 4Committee for Orphan Medicinal Products1. A Committee for Orphan Medicinal Products, hereinafter referred to as "the Committee", is hereby set up within the Agency.2. The task of the Committee shall be:(a) to examine any application for the designation of a medicinal product as an orphan medicinal product which is submitted to it in accordance with this Regulation;(b) to advise the Commission on the establishment and development of a policy on orphan medicinal products for the European Union;(c) to assist the Commission in liaising internationally on matters relating to orphan medicinal products, and in liaising with patient support groups;(d) to assist the Commission in drawing up detailed guidelines.3. The Committee shall consist of one member nominated by each Member State, three members nominated by the Commission to represent patients' organisations and three members nominated by the Commission on the basis of a recommendation from the Agency. The members of the Committee shall be appointed for a term of three years, which shall be renewable. They may be accompanied by experts.4. The Committee shall elect its Chairman for a term of three years, renewable once.5. The representatives of the Commission and the Executive Director of the Agency or his representative may attend all meetings of the Committee.6. The Agency shall provide the secretariat of the Committee.7. Members of the Committee shall be required, even after their duties have ceased, not to disclose any information of the kind covered by the obligation of professional secrecy.Article 5Procedure for designation and removal from the register1. In order to obtain the designation of a medicinal product as an orphan medicinal product, the sponsor shall submit an application to the Agency at any stage of the development of the medicinal product before the application for marketing authorisation is made.2. The application shall be accompanied by the following particulars and documents:(a) name or corporate name and permanent address of the sponsor;(b) active ingredients of the medicinal product;(c) proposed therapeutic indication;(d) justification that the criteria laid down in Article 3(1) are met and a description of the stage of development, including the indications expected.3. The Commission shall, in consultation with the Member States, the Agency and interested parties, draw up detailed guidelines on the required format and content of applications for designation.4. The Agency shall verify the validity of the application and prepare a summary report to the Committee. Where appropriate, it may request the sponsor to supplement the particulars and documents accompanying the application.5. The Agency shall ensure that an opinion is given by the Committee within 90 days of the receipt of a valid application.6. When preparing its opinion, the Committee shall use its best endeavours to reach a consensus. If such a consensus cannot be reached, the opinion shall be adopted by a majority of two-thirds of the members of the Committee. The opinion may be obtained by written procedure.7. Where the opinion of the Committee is that the application does not satisfy the criteria set out in Article 3(1), the Agency shall forthwith inform the sponsor. Within 90 days of receipt of the opinion, the sponsor may submit detailed grounds for appeal, which the Agency shall refer to the Committee. The Committee shall consider whether its opinion should be revised at the following meeting.8. The Agency shall forthwith forward the final opinion of the Committee to the Commission, which shall adopt a decision within 30 days of receipt of the opinion. Where, in exceptional circumstances, the draft decision is not in accordance with the opinion of the Committee, the decision shall be adopted in accordance with the procedure laid down in Article 73 of Regulation (EEC) No 2309/93. The decision shall be notified to the sponsor and communicated to the Agency and to the competent authorities of the Member States.9. The designated medicinal product shall be entered in the Community Register of Orphan Medicinal Products.10. Each year the sponsor shall submit to the Agency a report on the state of development of the designated medicinal product.11. To have the designation of an orphan medicinal product transferred to another sponsor, the holder of the designation shall make specific application to the Agency. In consultation with the Member States, the Agency and interested parties, the Commission shall draw up detailed guidelines on the form in which applications for transfer shall be made and the content of such applications and all the particulars of the new sponsor.12. A designated orphan medicinal product shall be removed from the Community Register of Orphan Medicinal Products:(a) at the request of the sponsor;(b) if it is established before the market authorisation is granted that the criteria laid down in Article 3 are no longer met in respect of the medicinal product concerned;(c) at the end of the period of market exclusivity as laid down in Article 8.Article 6Protocol assistance1. The sponsor of an orphan medicinal product may, prior to the submission of an application for marketing authorisation. request advice from the Agency on the conduct of the various tests and trials necessary to demonstrate the quality, safety and efficacy of the medicinal product, in accordance with Article 51(j) of Regulation (EEC) No 2309/93.2. The Agency shall draw up a procedure on the development of orphan medicinal products, covering regulatory assistance for the definition of the content of the application for authorisation within the meaning of Article 6 of Regulation (EEC) No 2309/93.Article 7Community marketing authorisation1. The person responsible for placing on the market an orphan medicinal product may request that authorisation to place the medicinal product on the market be granted by the Community in accordance with the provisions of Regulation (EEC) No 2309/93 without having to justify that the medicinal product qualifies under Part B of the Annex to that Regulation.2. A special contribution from the Community, distinct from that provided for in Article 57 of Regulation (EEC) No 2309/93, shall be allocated every year to the Agency. The contribution shall be used exclusively by the Agency to waive, in part or in total, all the fees payable under Community rules adopted pursuant to Regulation (EEC) No 2309/93. A detailed report of the use made of this special contribution shall be presented by the Executive Director of the Agency at the end of each year. Any surplus occurring in a given year shall be carried forward and deducted from the special contribution for the following year.3. The marketing authorisation granted for an orphan medicinal product shall cover only those therapeutic indications which fulfil the criteria set out in Article 3. This is without prejudice to the possibility of applying for a separate marketing authorisation for other indications outside the scope of this Regulation.Article 8Market exclusivity1. Where a marketing authorisation in respect of an orphan medicinal product is granted pursuant to Regulation (EEC) No 2309/93 or where all the Member States have granted marketing authorisations in accordance with the procedures for mutual recognition laid down in Articles 7 and 7a of Directive 65/65/EEC or Article 9(4) of Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products(7), and without prejudice to intellectual property law or any other provision of Community law, the Community and the Member States shall not, for a period of 10 years, accept another application for a marketing authorisation, or grant a marketing authorisation or accept an application to extend an existing marketing authorisation, for the same therapeutic indication, in respect of a similar medicinal product.2. This period may however be reduced to six years if, at the end of the fifth year, it is established, in respect of the medicinal product concerned, that the criteria laid down in Article 3 are no longer met, inter alia, where it is shown on the basis of available evidence that the product is sufficiently profitable not to justify maintenance of market exclusivity. To that end, a Member State shall inform the Agency that the criterion on the basis of which market exclusivity was granted may not be met and the Agency shall then initiate the procedure laid down in Article 5. The sponsor shall provide the Agency with the information necessary for that purpose.3. By way of derogation from paragraph 1, and without prejudice to intellectual property law or any other provision of Community law, a marketing authorisation may be granted, for the same therapeutic indication, to a similar medicinal product if:(a) the holder of the marketing authorisation for the original orphan medicinal product has given his consent to the second applicant, or(b) the holder of the marketing authorisation for the original orphan medicinal product is unable to supply sufficient quantities of the medicinal product, or(c) the second applicant can establish in the application that the second medicinal product, although similar to the orphan medicinal product already authorised, is safer, more effective or otherwise clinically superior.4. The Commission shall adopt definitions of "similar medicinal product" and "clinical superiority" in the form of an implementing Regulation in accordance with the procedure laid down in Article 72 of Regulation (EEC) No 2309/93.5. The Commission shall draw up detailed guidelines for the application of this Article in consultation with the Member States, the Agency and interested parties.Article 9Other incentives1. Medicinal products designated as orphan medicinal products under the provisions of this Regulation shall be eligible for incentives made available by the Community and by the Member States to support research into, and the development and availability of, orphan medicinal products and in particular aid for research for small- and medium-sized undertakings provided for in framework programmes for research and technological development.2. Before 22 July 2000, the Member States shall communicate to the Commission detailed information concerning any measure they have enacted to support research into, and the development and availability of, orphan medicinal products or medicinal products that may be designated as such. That information shall be updated regularly.3. Before 22 January 2001, the Commission shall publish a detailed inventory of all incentives made available by the Community and the Member States to support research into, and the development and availability of, orphan medicinal products. That inventory shall be updated regularly.Article 10General reportBefore 22 January 2006, the Commission shall publish a general report on the experience acquired as a result of the application of this Regulation, together with an account of the public health benefits which have been obtained.Article 11Entry into forceThis Regulation shall enter into force on the day of its publication in the Official Journal of the European Communities.It shall apply as from the date of adoption of the implementing Regulations provided for in Article 3(2) and Article 8(4).This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 16 December 1999.For the European ParliamentThe PresidentN. FONTAINEFor the CouncilThe PresidentK. HEMILÄ(1) OJ C 276, 4.9.1998, p. 7.(2) OJ C 101, 12.4.1999, p. 37.(3) Opinion of the European Parliament of 9 March 1999 (OJ C 175, 21.6.1999, p. 61), Council Common Position of 27 September 1999 (OJ C 317, 4.11.1999, p. 34) and Decision of the European Parliament of 15 December 1999 (not yet published in the Official Journal).(4) OJ 22, 9.2.1965, p. 369. Directive as last amended by Directive 93/39/EEC (OJ L 214, 24.8.1993, p. 22).(5) OJ L 155, 22.6.1999, p. 1.(6) OJ L 214, 24.8.1993, p. 1. Regulation as amended by Commission Regulation (EC) No 649/98 (OJ L 88, 24.3.1998, p. 7).(7) OJ L 147, 9.6.1975, p. 13. Directive as last amended by Council Directive 93/39/EEC (OJ L 214, 24.8.1993, p. 22).

Summary: Medicines for rare diseases - orphan drugs Medicines for rare diseases - orphan drugs SUMMARY OF: Regulation (EC) No 141/2000 on orphan medicinal products SUMMARY WHAT DOES THE REGULATION DO? It lays down criteria for designating certain medicinal products as orphan drugs* to prevent, diagnose and treat rare conditions. It provides incentives for their research, development and marketing. KEY POINTS For a product to acquire orphan drug status, manufacturers must show that: it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting fewer than 5 in 10,000 people in the EU, or without incentives, the sale of the drug in the EU would not generate sufficient income to justify the necessary investment, and no satisfactory alternative exists or, if there are treatments, the proposed treatment should have a significant benefit. The Committee for Orphan Medicinal Products: examines applications for orphan drug status; gives its opinion within 90 days of receiving the application; advises the European Commission on developing an EU orphan drug policy; assists the Commission in liaising internationally on orphan drug issues; helps the Commission to draw up detailed guidelines. The Commission adopts the final opinion on an orphan drug application within 30 days of receiving the committee's opinion. The European Medicines Agency may: offer advice on the necessary tests and trials if the developer of an orphan drug so requests; waive all or part of the market authorisation fees. Manufacturers of an orphan drug can benefit from: exclusive marketing rights for up to 10 years (this may be cut to 6 years if the drug is sufficiently profitable after 5 years; it may be extended to 12 years if the product's possible effects on children have been studied), other incentives, particularly for SMEs, to support the research and development of orphan drugs. Before 22 January 2001, the Commission was to publish a detailed inventory of all the available incentives and update it regularly. Before 22 January 2006, the Commission was to publish a report on the legislation’s implementation and its public health benefits. In 2016, the Commission published an updated version of the inventory. FROM WHEN DOES THE REGULATION APPLY? It has applied since 22 January 2000. BACKGROUND Some medical conditions are so rare that under normal market conditions, pharmaceutical companies would be unwilling to invest in their research. Products to treat these conditions are known as orphan drugs and require incentives if they are to be successfully developed. For more information, see: ‘Orphan designation’ on the European Medicines Agency’s website ‘Orphan medicinal products’ on the European Commission’s website KEY TERM * Orphan drugs: drugs developed to treat rare diseases. They are so called because the pharmaceutical industry has little financial interest in developing and marketing products intended for only a small number of patients suffering from very rare conditions. ACT Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, pp. 1–5) Subsequent amendments to Regulation (EC) No 141/2000 have been incorporated into the basic text. This consolidated version is of documentary value only. RELATED ACTS Commission Regulation (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts ‘similar medicinal product’ and ‘clinical superiority’ (OJ L 103, 28.4.2000, pp. 5–8) Communication from the Commission on Regulation (EC) No 141/2000 of the European Parliament and of the Council on orphan medicinal products (OJ C 178, 29.7.2003, pp. 2–8) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, pp. 1–33). See consolidated version. Commission Regulation (EC) No 2049/2005 of 15 December 2005 laying down, pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises (OJ L 329, 16.12.2005, pp. 4–7) Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 92, 30.3.2006, pp. 6-9) Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, pp. 1–19) Guideline on aspects of the application of Article 8(2) of Regulation (EC) No 141/2000 of the European Parliament and of the Council: Review of the period of market exclusivity of orphan medicinal products (OJ C 242, 23.9.2008, pp. 8–11) Guideline on aspects of the application of Article 8(1) and (3) of Regulation (EC) No 141/2000: Assessing similarity of medicinal products versus authorised orphan medicinal products benefiting from market exclusivity and applying derogations from that market exclusivity (OJ C 242, 23.9.2008, pp. 12–16) last update 24.05.2016