EUR-Lex - 32003R1946 - EN Avis juridique important | 32003R1946 Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms (Text with EEA relevance) Official Journal L 287 , 05/11/2003 P. 0001 - 0010 Regulation (EC) No 1946/2003 of the European Parliament and of the Councilof 15 July 2003on transboundary movements of genetically modified organisms(Text with EEA relevance)THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the European Economic and Social Committee(2),Having regard to the opinion of the Committee of the Regions(3),Acting in accordance with the procedure laid down in Article 251 of the Treaty(4),Whereas:(1) The Cartagena Protocol on Biosafety to the Convention on Biological Diversity (hereinafter referred to as the Protocol), was signed by the Community and its Member States in 2000 and Council Decision 2002/628/EC(5) to conclude the Protocol, on behalf of the Community, was taken on 25 June 2002.(2) Article 1 of the Protocol specifies that, in accordance with the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, the objective of the Protocol is to contribute to ensuring an adequate level of protection in the field of safe transfer, handling and use of genetically modified organisms (GMOs) resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health and specifically focusing on transboundary movements.(3) The Protocol requires each Party to take necessary and appropriate legal, administrative and other measures to implement its obligations under the Protocol. Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms(6) invited the Commission to bring forward a legislative proposal for implementing the procedures laid down in the Protocol and, in accordance with the Protocol, requiring Community exporters to ensure that all requirements of the Advance Informed Agreement Procedure, as set out in Articles 7 to 10, 12 and 14 of the Protocol, are fulfilled.(4) It is important to organise the supervision and control of transboundary movements of GMOs in order to contribute to ensuring the conservation and sustainable use of biological diversity, taking also into account risks to human health, and so as to enable citizens to make a free and informed choice in regard to GMOs.(5) Since Community legislation does not contain specific requirements for exports of GMOs to third countries, and in order to ensure compliance with the obligations in the Protocol regarding transboundary movements of GMOs, a common legal framework should be established for such exports.(6) It is necessary to recognise the need to respect the Party or non-Party of import's regulatory biosafety framework, in a manner consistent with the Protocol.(7) Pharmaceuticals for humans that are addressed by other international agreements, to which the Community or the relevant Member State is party, or organisations, of which the Community or the relevant Member State is a member, should be excluded from the scope of this Regulation.(8) Exports of GMOs intended for deliberate release into the environment should be notified to the Party or non-Party of import, allowing it to make an informed decision, based on a risk assessment carried out in a scientifically sound manner.(9) The notification should be ensured by the exporter. The exporter should be responsible for the accuracy of the information provided in the notification.(10) Exporters should await the prior written express consent of the Party or non-Party of import before proceeding with the first transboundary movement of a GMO intended for deliberate release into the environment.(11) Recognising that some developing countries, and some countries with economies in transition, may lack the capacities which would enable them to take such informed decisions, the Commission and Member States should make sustained efforts to enable them to develop and strengthen human resources and institutional capacities.(12) According to the Protocol, the Community or any other Party may take action that is more protective of the conservation and sustainable use of biological diversity than that called for in the Protocol, provided that such action is consistent with the objective and the provisions of the Protocol and in accordance with that Party's other obligations under international law.(13) According to the Protocol, the Community may apply its domestic legislation in respect of the movements of GMOs within its customs territory.(14) As existing Community legislation, and in particular Directive 2001/18/EC and sectoral legislation providing for a specific risk assessment to be carried out in accordance with the principles set out in that Directive, already contain rules which are in line with the objective of the Protocol, there is no need to adopt supplementary provisions with regard to imports of GMOs into the Community.(15) It is necessary to ensure the safe transport, handling and packaging of GMOs. As existing Community legislation, in particular Council Directive 94/55/EC of 21 November 1994 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by road(7) and Council Directive 96/49/EC of 23 July 1996 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by rail(8), already contain appropriate rules, there is no need to adopt supplementary provisions in this respect.(16) It is necessary to ensure the identification of GMOs being exported from or imported into the Community. With regard to traceability, labelling and identification of imports into the Community, such GMOs are subject to rules in Community legislation. With regard to exports similar rules should apply.(17) The Commission and Member States support the process with respect to the appropriate elaboration of international rules and procedures in the field of liability and redress for damage resulting from transboundary movements of GMOs, to be agreed, as provided for in Article 27 of the Protocol, at the first meeting of the Conference of the Parties to the Convention serving as the meeting of the Parties to the Protocol.(18) The Commission and the Member States support the further development and the application of the common formats for accompanying documentation on identification of GMOs, which is undertaken in accordance with Article 18 of the Protocol.(19) In order to respond efficiently to unintentional transboundary movements of GMOs that are likely to have a significant adverse effect on the conservation and sustainable use of biological diversity, taking into account risks to human health, a Member State should, as soon as it becomes aware of an event under its jurisdiction resulting in a release that may lead to an unintentional transboundary movement of a GMO that is likely to have such effects, take the appropriate measures to inform the public and inform without delay the Commission, all other Member States, affected or potentially affected States, the Biosafety Clearing-House (BCH) and, where appropriate, relevant international organisations. Also, that Member State should consult without delay affected or potentially affected States to enable them to determine appropriate responses and initiate necessary action.(20) In order to help develop the BCH, the Community and its Member States should ensure that relevant information is communicated to the BCH, and that monitoring and reporting on the implementation of the Protocol in the Community are performed.(21) Member States should lay down rules on penalties applicable to infringements of this Regulation and ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive.(22) The precautionary principle should be taken into account when applying this Regulation.(23) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union,HAVE ADOPTED THIS REGULATION:CHAPTER I OBJECTIVES, SCOPE AND DEFINITIONSArticle 1ObjectivesIn accordance with the precautionary principle, and without prejudice to the provisions of Directive 2001/18/EC, the objectives of this Regulation are to establish a common system of notification and information for transboundary movements of genetically modified organisms (GMOs) and to ensure coherent implementation of the provisions of the Protocol on behalf of the Community in order to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of GMOs that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.Article 2Scope1. This Regulation shall apply to the transboundary movements of all GMOs that may have adverse effects on the conservation and sustainable use of biological diversity, also taking into account risks to human health.2. Pharmaceuticals for humans that are addressed by other relevant international agreements or organisations are excluded from the scope of this Regulation.Article 3DefinitionsFor the purpose of this Regulation, the following definitions shall apply:1. "organism" means organism as defined in Article 2(1) of Directive 2001/18/EC;2. "genetically modified organism", or "GMO", means genetically modified organism as defined in Article 2(2) of Directive 2001/18/EC, excluding organisms obtained through the techniques of genetic modification listed in Annex IB to Directive 2001/18/EC;3. "deliberate release" means deliberate release as defined in Article 2(3) of Directive 2001/18/EC;4. "placing on the market" means placing on the market as defined in Article 2(4) of Directive 2001/18/EC;5. "contained use" means:(a) activities defined in Article 2(c) of Directive 90/219/EEC(9);(b) activities in which organisms other than micro-organisms are genetically modified or in which such GMOs are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures, based on the same principles of containment as in Directive 90/219/EEC, are used appropriately to limit their contact with the general population and the environment;6. "food" means food as defined in Article 2 of Regulation (EC) No 178/2002(10);7. "feed" means feed as defined in Article 3(4) of Regulation (EC) No 178/2002;8. "notification" means the submission of the information required from the exporter under this Regulation to the competent authority of a Party to the Protocol or to the competent authority of a non-Party;9. "the Biosafety Clearing-House" or "the BCH" means the Biosafety Clearing-House established under Article 20 of the Protocol;10. "export" means:(a) the permanent or temporary leaving of the customs territory of the Community of GMOs meeting the conditions of Article 23(2) of the Treaty;(b) the re-export of GMOs not meeting the conditions referred to in (a) which are placed under a customs procedure other than transit procedure;11. "import" means the placing under a customs procedure, other than transit procedure, of GMOs introduced into the customs territory of a Party or non-Party outside the Community from a Party within the Community;12. "exporter" means any natural or legal person by whom or on whose behalf a notification is made, that is to say the person who, at the time when the notification is sent, holds the contract with the consignee in the third country and has the power to determine that the GMO is to be sent out of the customs territory of the Community. If no export contract has been concluded or if the holder of the contract does not act on its own behalf, the power to determine that the GMO is to be sent out of the customs territory of the Community shall be decisive;13. "importer" means any natural or legal person, under the jurisdiction of the Party or non-Party of Import, who arranges for a GMO to be imported;14. "transboundary movement" means the intentional or unintentional movement of a GMO between one Party or non-Party and another Party or non-Party, excluding intentional movements between Parties within the Community;15. "Party" means any country or regional economic integration organisation being a Party to the Protocol;16. "non-Party" means any country or regional economic integration organisation not being a Party to the Protocol;17. "the Protocol" means the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (the Convention);18. "biological diversity" means the variability among living organisms from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this includes diversity within species, between species and of ecosystems;19. "competent authority" means a competent authority designated by a Party to the Protocol, or the relevant equivalent body of a non-Party, which is responsible for performing the administrative functions required by the Protocol, or equivalent functions in the case of a non-Party, and is authorised to act on its behalf with respect to those functions;20. "focal point" means the entity designated by a Party to be responsible on its behalf for liaising with the Secretariat;21. "Secretariat" means the Secretariat to the Protocol.CHAPTER II EXPORTS OF GMOs TO THIRD COUNTRIESSection 1 GMOs intended for deliberate release into the environmentArticle 4Notification to Parties and non-Parties of importThe exporter shall ensure notification, in writing, to the competent authority of the Party or non-Party of import prior to the first intentional transboundary movement of a GMO intended for deliberate release into the environment and destined for the use specified in accordance with Annex I, point (i). The notification shall contain, as a minimum, the information specified in Annex I. The exporter shall ensure the accuracy of the information contained in the notification.Article 5Cases of non-decision1. A failure by the Party of import to acknowledge receipt of a notification or to communicate its decision shall not imply its consent to an intentional transboundary movement. No first intentional transboundary movement may be made without prior written express consent of the Party or, where appropriate, non-Party of import.2. In cases where the Party of import does not communicate its decisions in response to a notification within 270 days from the date of receiving the notification, the exporter shall send a written reminder, with a deadline for response of 60 days from receipt of this reminder, to the competent authority of that Party of import, with a copy to the Secretariat, to the Member State of export, and to the Commission. In calculating the time within which a Party of import is to respond, the number of days it has to wait for additional relevant information shall not be taken into account.3. Without prejudice to paragraph 1, the exporter shall not proceed with the first intentional transboundary movement of a GMO intended for deliberate release unless the procedures determined by the Party of import in accordance with Articles 9 and 10 of the Protocol or, where appropriate, equivalent procedures required by a non-Party of import have been followed.4. Paragraphs 1, 2 and 3 shall not apply to cases of transboundary movements covered by simplified procedures or bilateral, regional and multilateral agreements or arrangements entered into in accordance with Article 13 and 14 of the Protocol.5. The Commission and the Member States shall, in consultation with the Secretariat, take appropriate action in accordance with any appropriate procedures and mechanisms to facilitate decision-making or to promote compliance with the provisions of the Protocol by the Parties of import as decided by the Conference of the Parties to the Convention serving as the meeting of the Parties to the Protocol.Article 6Informing the Party of exportThe exporter shall for a period of a minimum of five years keep a record of the notification referred to in Article 4 and the acknowledgement of receipt and the decision of the Party or, where appropriate, non-Party of import and send a copy of these documents to the competent authority of the Member State from which the GMO is exported and to the Commission.Without prejudice to Article 16, the Commission shall make these documents available to the public in accordance with the Community rules on access to environmental information.Article 7Review of decisions1. If the exporter considers that a change in circumstances has occurred that may influence the outcome of the risk assessment upon which the decision was based or that additional relevant scientific or technical information has become available, he may ask the Party or, where appropriate, non-Party of import to review a decision it has made concerning notification pursuant to Article 10 of the Protocol.2. Where a Party or non-Party of import does not respond to such a request within 90 days, the exporter shall send a written reminder to the competent authority of that Party or, where appropriate, non-Party of import, with a copy to the Secretariat, requesting a response within a set period following receipt of the reminder.Article 8Exceptions to Section 1 of this Chapter1. GMOs intended for deliberate release into the environment identified in a decision of the Conference of the Parties to the Convention serving as the Meeting of the Parties to the Protocol as being not likely to have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, shall be excluded from the scope of section 1 of this Chapter.2. Section 1 of this Chapter shall not apply to GMOs intended for direct use as food or feed, or for processing.3. The obligations referred to in section 1 of this Chapter shall not apply if the Party of import has specified in advance to the BCH, in accordance with Article 13(1)(b) and Article 14(3) of the Protocol, that such imports of GMOs are to be exempted from the Advance Informed Agreement Procedure, as set out in Articles 7 to 10, 12 and 14 of the Protocol, provided that adequate measures are applied to ensure their safe intentional transboundary movement in accordance with the objective of the Protocol.Section 2 GMOs intended for direct use as food or feed, or for processingArticle 9Information to the BCH1. The Commission on behalf of the Community or, where appropriate, the Member State which made the decision shall inform the BCH and other Parties through the BCH of any final decision regarding use, including placing on the market, within the Community or use within a Member State, of a GMO that may be subject to transboundary movements for direct use as food or feed or for processing. This information shall be sent to the BCH within 15 days of the adoption of that decision.This paragraph shall not apply to decisions regarding the deliberate release in accordance with Part B of Directive 2001/18/EC of a GMO which is not intended for direct use as food or feed or for processing in a third country without a subsequent decision.2. The information referred to in paragraph 1 and sent to the BCH shall contain as a minimum the information specified in Annex II.3. The Commission or the Member State referred to in paragraph 1 shall process requests submitted to them by any Party or non-Party for additional information regarding the decisions referred to in paragraph 1.4. A copy of the information referred to in paragraphs 1, 2 and 3 shall be sent by the Commission or the Member State referred to in paragraph 1, in writing, to the focal point of each Party that informs the Secretariat in advance that it does not have access to the BCH.Article 10Parties' and non-Parties' national decisions on import1. The exporter shall respect any decision on the import of GMOs intended for direct use as food or feed, or for processing, taken by a Party in accordance with Article 11(4) of the Protocol, or by a non-Party of import under its domestic regulatory framework that is consistent with the objective of the Protocol.2. If a developing country Party or non-Party of import or a Party or non-Party of import with an economy in transition has declared through the BCH that it will take a decision prior to an import of a specific GMO intended for direct use as food or feed, or for processing, in accordance with Article 11(6) of the Protocol, the exporter shall not proceed with the first export of such GMO unless the procedure provided for under that provision has been followed.3. Failure by the Party or non-Party of import to acknowledge receipt of a notification or to communicate its decision in accordance with paragraph 2 shall not imply its consent or refusal to the import of a GMO intended for direct use as food or feed, or for processing. No GMO that may be subject to transboundary movements for direct use as food or feed or for processing may be exported, unless it is authorised within the Community or the competent authority of a third country has expressly agreed to the import as required under Article 12 of Regulation (EC) No 178/2002.Section 3 GMOs intended for contained useArticle 111. The provisions of Chapter II, section 1 shall not apply to transboundary movements of GMOs intended for contained use where such transboundary movements are undertaken in accordance with the standards of the Party or non-Party of import.2. Paragraph 1 shall be without prejudice to any right of a Party or non-Party to subject all GMOs to risk assessment prior to decisions on import and to set standards for contained use within their jurisdiction.Section 4 Common provisionsArticle 12Identification and accompanying documentation1. Exporters shall ensure that the following information is stated in a document accompanying the GMO and is transmitted to the importer receiving the GMO:(a) that it contains or consists of GMOs;(b) the unique identification code(s) assigned to those GMOs if such codes exist.2. For GMOs intended for direct use as food or feed, or for processing, the information referred to in paragraph 1 shall be supplemented by a declaration by the exporter:(a) stating that the GMOs are intended for direct use as food or feed, or for processing and indicating clearly that they are not intended for deliberate release into the environment; and(b) giving details of the contact point for further information.Paragraph 1(b) shall not apply to products consisting of or containing mixtures of GMOs to be used only and directly as food or feed, or for processing. These products shall be subject to the traceability requirements of Directive 2001/18/EC and, when applicable, future Community legislation covering traceability, labelling and identification of such GMOs.3. For GMOs intended for contained use, the information referred to in paragraph 1 shall be supplemented by a declaration by the exporter which shall specify:(a) any requirements for the safe handling, storage, transport and use of these GMOs;(b) the contact point for further information, including the name and address of the individual or institution to whom or which the GMOs are consigned.4. For GMOs intended for deliberate release into the environment and any other GMO to which this Regulation applies, the information referred to in paragraph 1 shall be supplemented by a declaration by the exporter which shall set out:(a) the identity and relevant traits and characteristics of the GMOs;(b) any requirements for the safe handling, storage, transport and use of these GMOs;(c) the contact point for further information and, as appropriate, the name and address of the importer and exporter;(d) a declaration that the movement is in conformity with the requirements of the Protocol applicable to the exporter.5. Paragraph 1 to 4 shall be without prejudice to other specific requirements imposed by Community legislation and to international identification requirements to be developed in accordance with Article 18 of the Protocol.Article 13TransitThe exporter shall ensure notification of the transit of GMOs to Parties that have taken the decision to regulate transit of GMOs through their territory and have informed the BCH of this decision.CHAPTER III UNINTENTIONAL TRANSBOUNDARY MOVEMENT OF GMOsArticle 141. Member States shall take appropriate measures to prevent unintentional transboundary movements of GMOs.2. As soon as a Member State becomes aware of an occurrence, under its jurisdiction, resulting in a release of GMOs that leads, or may lead, to an unintentional transboundary movement that is likely to have significant adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health, that Member State shall:(a) take the appropriate measures to inform the public and inform without delay the Commission, all other Member States, affected or potentially affected States, the BCH, and, where appropriate, relevant international organisations;(b) without delay consult the affected or potentially affected States to enable them to determine appropriate responses and initiate necessary action, including emergency measures in order to minimise any significant adverse effects.3. Any information arising from paragraph 2 shall include the information specified in Annex III.CHAPTER IV COMMON PROVISIONSArticle 15Participation in the international information procedure1. The Member States shall, without prejudice to the protection of confidential information in accordance with the provisions of the Protocol, inform the BCH and the Commission of:(a) national legislation and guidelines relevant to the implementation of the Protocol, in accordance with Article 11(5) and Article 20(3)(a) of the Protocol;(b) national contact points for notification of unintentional transboundary movements, in accordance with Article 17 of the Protocol;(c) any bilateral, regional and multilateral agreement and arrangements entered into by the Member State regarding intentional transboundary movements of GMOs, in accordance with Article 20(3)(b) of the Protocol;(d) any information concerning cases of unintentional or illegal transboundary movements pertaining to them, in accordance with Articles 17 and 25 of the Protocol;(e) any final decision taken by a Member State, on the use of GMOs within that Member State, including decisions:- on contained use classified in risk class 3 or 4 of GMOs which are likely to be subject to transboundary movements,- on the deliberate release of GMOs in accordance with part B of Directive 2001/18/EC, or- on import into the Community of GMOs,in accordance with Article 11 and Article 20(3)(d) of the Protocol, within 15 days of the adoption of that decision;(f) any summary of risk assessments or environmental reviews of GMOs generated by the Community's regulatory process and carried out in accordance with Article 15 of the Protocol, including, where appropriate, relevant information regarding products thereof, namely, processed materials that are of GMO origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology, in accordance with Article 20(3)(c) of the Protocol;(g) any review of national decisions regarding an intentional transboundary movement, in accordance with Article 12 of the Protocol;(h) any decision taken by a Member State on safeguard measures under Article 23 of Directive 2001/18/EC or emergency measures taken by a Member State under Community legislation on genetically modified food and feed.2. The Commission shall in accordance with the provisions of the Protocol inform, on behalf of the Community, the BCH of:(a) Community legislation and guidelines relevant for the implementation of the Protocol, in accordance with Article 11(5) and Article 20(3)(a) of the Protocol;(b) any bilateral, regional and multilateral agreement and arrangements at Community level regarding intentional transboundary movements of GMOs, in accordance with Article 20(3)(b) of the Protocol;(c) any final decision taken at Community level regarding the use of a GMO within the Community, including decisions on the placing on the market or the importation of a GMO, in accordance with Article 11 and Article 20(3)(d) of the Protocol;(d) any summary of risk assessments or environmental review of GMOs generated by the Community regulatory process and carried out in accordance with procedures similar to those laid down in Annex II to Directive 2001/18/EC, including, where appropriate, relevant information regarding products thereof, namely, processed materials that are of GMO origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology, in accordance with Article 20(3)(c) of the Protocol;(e) any review of decisions at Community level regarding an intentional transboundary movement, in accordance with Article 12 of the Protocol;(f) any application of Community legislation instead of the procedures of the Protocol for intentional movements of GMOs within the Community and imports of GMOs into the Community in accordance with Article 14(3) and (4) of the Protocol;(g) reports submitted pursuant to Article 19 of this Regulation, including those on implementation of the advanced informed agreement procedure, in accordance with Article 20(3)(e) of the Protocol.Article 16Confidentiality1. The Commission and the Member States shall not divulge to third parties any confidential information received or exchanged under this Regulation.2. The exporter may indicate the information in the notification submitted under Article 4 which should be treated as confidential. Justification shall be given in such cases upon request.3. In no case may the following information when submitted according to Articles 4, 9 or 12 be kept confidential:(a) name and address of the exporter and importer,(b) general description of the GMO or GMOs,(c) a summary of the risk assessment of the effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and(d) any methods and plans for emergency response.4. If, for whatever reasons, the exporter withdraws the notification, the Member States and the Commission must respect the confidentiality of commercial and industrial information, including research and development information, as well as information on which the Party or non-Party of import and the exporter disagree as to its confidentiality.Article 17Competent authorities and focal points1. The Commission shall designate a Community focal point and shall, where appropriate, identify any Community competent authority.2. Each Member State shall designate one focal point, as well as one or more competent authorities. A single entity may fulfil the functions of both focal point and competent authority.3. The Commission, on behalf of the Community, and each Member State respectively shall, no later than the date of entry into force of the Protocol for them, inform the Secretariat of the names and addresses of their focal points and their competent authorities. Where a Member State or the Commission designates more than one competent authority, it shall, when conveying this to the Secretariat, include relevant information on the respective responsibilities of those authorities. Where applicable, such information shall, as a minimum, specify which competent authority is responsible for which type of GMO. The Commission and the Member States shall forthwith inform the Secretariat of any changes in the designation of their focal points or in the name and address or responsibilities of their competent authority or authorities.Article 18PenaltiesThe Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measure necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission, by not later than 5 November 2004 and shall notify it without delay of any subsequent amendment affecting them.Article 19Monitoring and reporting1. At regular intervals and at least every three years, unless otherwise determined under Article 33 of the Protocol, Member States shall forward to the Commission a report on the implementation of this Regulation.2. The Commission shall, at intervals to be determined by the Conference of the Parties to the Convention serving as the meeting of the Parties to the Protocol, compile a report on the basis of the information provided by the Member States and present it to the Conference of the Parties to the Convention serving as the meeting of the Parties to the Protocol.Article 20Entry into force1. This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.2. This Regulation shall apply from the date of entry into force of the Protocol, in accordance with Article 37(1) of the Protocol, or from the date of entry into force of this Regulation, whichever shall be the later.This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 15 July 2003.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentG. Tremonti(1) OJ C 151 E, 25.6.2002, p. 121.(2) OJ C 241, 7.10.2002, p. 62.(3) OJ C 278, 14.11.2002, p. 31.(4) Opinion of the European Parliament of 24 September 2002 (not yet published in the Official Journal), Council Common Position of 4 March 2003 (OJ C 107 E, 6.5.2003, p. 1), Decision of the European Parliament of 4 June 2003 (not yet published in the Official Journal) and Council Decision of 16 June 2003.(5) OJ L 201, 31.7.2002, p. 48.(6) OJ L 106, 17.4.2001, p. 1.(7) OJ L 319, 12.12.1994, p. 7. Directive as last amended by Commission Directive 2003/28/EC (OJ L 90, 8.4.2003, p. 45).(8) OJ L 235, 17.9.1996, p. 25. Directive as last amended by Commission Directive 2003/29/EC (OJ L 90, 8.4.2003, p. 47).(9) Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms (OJ L 117, 8.5.1990, p. 1). Directive as last amended by Decision 2001/204/EC (OJ L 73, 15.3.2001, p. 32).(10) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).ANNEX IINFORMATION REQUIRED IN NOTIFICATIONS UNDER ARTICLE 4(a) Name, address and contact details of the exporter.(b) Name, address and contact details of the importer.(c) Name and identity of the GMO, as well as the domestic classification, if any, of the biosafety level of the GMO in the State of export.(d) Intended date or dates of the transboundary movement, if known.(e) Taxonomic status, common name, point of collection or acquisition, and characteristics of recipient organism or parental organisms related to biosafety.(f) Centres of origin and centres of genetic diversity, if known, of the recipient organism and/or the parental organisms and a description of the habitats where the organisms may persist or proliferate.(g) Taxonomic status, common name, point of collection or acquisition, and characteristics of the donor organism or organisms related to biosafety.(h) Description of the nucleic acid or the modification introduced, the technique used, and the resulting characteristics of the GMO.(i) Intended use of the GMO or products thereof, namely, processed materials that are of GMO origin, containing detectable novel combinations of replicable genetic material obtained through techniques listed in Annex I A, Part 1 of Directive 2001/18/EC.(j) Quantity or volume of the GMO to be transferred.(k) A previous and existing risk assessment report consistent with Annex II of Directive 2001/18/EC.(l) Suggested methods for the safe handling, storage, transport and use, including packaging, labelling, documentation, disposal and contingency procedures, where appropriate.(m) Regulatory status of the GMO within the State of export (for example, whether it is prohibited in the State of export, whether there are other restrictions, or whether it has been approved for general release) and, if the GMO is banned in the State of export, the reason or reasons for the ban.(n) Result and purpose of any notification by the exporter to other States regarding the GMO to be transferred.(o) A declaration that the abovementioned information is factually correct.ANNEX IIINFORMATION REQUIRED UNDER ARTICLE 9(a) The name and contact details of the applicant for a decision for domestic use.(b) The name and contact details of the authority responsible for the decision.(c) Name and identity of the GMO.(d) Description of the gene modification, the technique used, and the resulting characteristics of the GMO.(e) Any unique identification of the GMO.(f) Taxonomic status, common name, point of collection or acquisition, and characteristics of recipient organism or parental organisms related to biosafety.(g) Centres of origin and centres of genetic diversity, if known, of the recipient organism and/or the parental organisms and a description of the habitats where the organisms may persist or proliferate.(h) Taxonomic status, common name, point of collection or acquisition, and characteristics of the donor organism or organisms related to biosafety.(i) Approved uses of the GMO.(j) A risk assessment report consistent with Annex II to Directive 2001/18/EC.(k) Suggested methods for the safe handling, storage, transport and use, including packaging, labelling, documentation, disposal and contingency procedures, where appropriate.ANNEX IIIINFORMATION REQUIRED UNDER ARTICLE 14(a) Available relevant information on the estimated quantities and relevant characteristics and/or traits of the GMO.(b) Information on the circumstances and estimated date of the release, and on the use of the GMO in the originating Party.(c) Any available information about the possible adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, as well as available information about possible risk management measures.(d) Any other relevant information, and(e) A contact point for further information.

Summary: Exports of genetically modified organisms to non-EU countries Exports of genetically modified organisms to non-EU countries SUMMARY OF: Regulation (EC) No 1946/2003 – transboundary movement of genetically modified organisms SUMMARY WHAT DOES THIS REGULATION DO? — It seeks to implement certain points of the Cartagena Protocol on preventing biotechnological risks. This is because some genetically modified organisms (GMOs) may have adverse effects on the environment and human health. — To ensure an adequate level of protection, it creates a system for notifying and exchanging information on the export of GMOs to non-EU countries. KEY POINTS — This Regulation distinguishes between GMOs intended for deliberate release into the environment (i.e. field tests, or to cultivate, import or transform GMOs into industrial products) and GMOs intended for food or feed, or for processing. — Exporters of GMOs intended for deliberate release into the environment must notify the competent national authority of the non-EU country importing the GMOs (and notify it again if there is no reply). The notification must contain the information specified in Annex I to this Regulation. The exporter must keep this notification and acknowledgment of receipt for 5 years, plus send copies to the authorities in their EU country and to the European Commission. — The European Commission or the EU country that took the decision must notify the Biosafety Clearing House (BCH) of any decision regarding the use of GMOs intended for food or processing that may be transferred across international borders. The notification must contain the information specified in Annex II to this Regulation. These GMOs may not be moved across boundaries if they have not been authorised within the EU. — If an EU country becomes aware of an unintentional export of potentially dangerous GMOs, it must inform the public, notify the European Commission and consult the affected country to enable them to take the necessary remedial action. — EU countries must submit reports on the application of this Regulation every 3 years. BACKGROUND In 2000, the EU and its countries signed the Cartagena Protocol, which is designed to ensure that movements of GMOs (especially between countries) do not pose a risk to the environment or human health. Since then, in 2011, the EU signed the Nagoya-Kuala Lumpur Supplementary Protocol. This elaborates on the international rules and procedures of the Cartagena Protocol to respond to damage caused by GMOs transferred across international borders. KEY TERM * Genetically modified organisms: organisms to which gene therapy has been applied. This can artificially change their genetic makeup, giving them new properties (e.g. a plant’s resistance to drought, insects or disease). Since the long-term impact of GMOs on the environment and human health remain largely unknown, the EU takes the precautionary approach. ACT Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movement of genetically modified organisms (OJ L 287, 5.11.2003, pp. 1–10) RELATED ACTS Council Decision 2002/628/EC of 25 June 2002 concerning the conclusion, on behalf of the European Community, of the Cartagena Protocol on Biosafety (OJ L 201, 31.7.2002, pp. 48–49) Council Decision 2013/86/EU of 12 February 2013 on the conclusion on behalf of the European Union of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety (OJ L 46, 19.2.2013, pp. 1–3) last update 24.11.2015


EUR-Lex - 32003L0094 - EN Avis juridique important | 32003L0094 Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (Text with EEA relevance) Official Journal L 262 , 14/10/2003 P. 0022 - 0026 Commission Directive 2003/94/ECof 8 October 2003laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(1), as last amended by Commission Directive 2003/63/EC(2), and in particular Article 47 thereof,Whereas:(1) All medicinal products for human use manufactured or imported into the Community, including medicinal products intended for export, are to be manufactured in accordance with the principles and guidelines of good manufacturing practice.(2) Those principles and guidelines are set out in Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use(3).(3) Article 13(3) of Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use(4) requires that detailed guidance be drawn up, in accordance with the guidelines on good manufacturing practice, on the elements to be taken into account when evaluating investigational medicinal products for human use with the object of releasing batches within the Community.(4) It is therefore necessary to extend and adapt the provisions of Directive 91/356/EEC to cover good manufacturing practice of investigational medicinal products.(5) Since most of the provisions of Directive 91/356/EEC need to be adjusted, for the sake of clarity that Directive should be replaced.(6) In order to ensure conformity with the principles and guidelines of good manufacturing practice, it is necessary to lay down detailed provisions on inspections by the competent authorities and on certain obligations of the manufacturer.(7) All manufacturers should operate an effective quality management system of their manufacturing operations, which requires the implementation of a pharmaceutical quality assurance system.(8) Principles and guidelines of good manufacturing practice should be set out in relation to quality management, personnel, premises and equipment, documentation, production, quality control, contracting out, complaints and product recall, and self-inspection.(9) In order to protect the human beings involved in clinical trials and to ensure that investigational medicinal products can be traced, specific provisions on the labelling of those products are necessary.(10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Medicinal Products for Human Use, set up under Article 121 of Directive 2001/83/EC,HAS ADOPTED THIS DIRECTIVE:Article 1ScopeThis Directive lays down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use whose manufacture requires the authorisation referred to in Article 40 of Directive 2001/83/EC and in respect of investigational medicinal products for human use whose manufacture requires the authorisation referred to in Article 13 of Directive 2001/20/EC.Article 2DefinitionsFor the purposes of this Directive, the following definitions shall apply:1. "medicinal product" means any product as defined in Article 1(2) of Directive 2001/83/EC;2. "investigational medicinal product" means any product as defined in Article 2(d) of Directive 2001/20/EC;3. "manufacturer" means any person engaged in activities for which the authorisation referred to in Article 40(1) and (3) of Directive 2001/83/EC or the authorisation referred to in Article 13(1) of Directive 2001/20/EC is required;4. "qualified person" means the person referred to in Article 48 of Directive 2001/83/EC or in Article 13(2) of Directive 2001/20/EC;5. "pharmaceutical quality assurance" means the total sum of the organised arrangements made with the object of ensuring that medicinal products or investigational medicinal products are of the quality required for their intended use;6. "good manufacturing practice" means the part of quality assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate to their intended use;7. "blinding" means the deliberate disguising of the identity of an investigational medicinal product in accordance with the instructions of the sponsor;8. "unblinding" means the disclosure of the identity of a blinded product.Article 3Inspections1. By means of the repeated inspections referred to in Article 111(1) of Directive 2001/83/EC and by means of the inspections referred to in Article 15(1) of Directive 2001/20/EC, the Member States shall ensure that manufacturers respect the principles and guidelines of good manufacturing practice laid down by this Directive. Member States shall also take into account the compilation, published by the Commission, of Community procedures on inspections and exchange of information.2. For the interpretation of the principles and guidelines of good manufacturing practice, the manufacturers and the competent authorities shall take into account the detailed guidelines referred to in the second paragraph of Article 47 of Directive 2001/83/EC, published by the Commission in the "Guide to good manufacturing practice for medicinal products and for investigational medicinal products".Article 4Conformity with good manufacturing practice1. The manufacturer shall ensure that manufacturing operations are carried out in accordance with good manufacturing practice and with the manufacturing authorisation. This provision shall also apply to medicinal products intended only for export.2. For medicinal products and investigational medicinal products imported from third countries, the importer shall ensure that the products have been manufactured in accordance with standards which are at least equivalent to the good manufacturing practice standards laid down by the Community.In addition, an importer of medicinal products shall ensure that such products have been manufactured by manufacturers duly authorised to do so. An importer of investigational medicinal products shall ensure that such products have been manufactured by a manufacturer notified to the competent authorities and accepted by them for that purpose.Article 5Compliance with marketing authorisation1. The manufacturer shall ensure that all manufacturing operations for medicinal products subject to a marketing authorisation are carried out in accordance with the information provided in the application for marketing authorisation as accepted by the competent authorities.In the case of investigational medicinal products, the manufacturer shall ensure that all manufacturing operations are carried out in accordance with the information provided by the sponsor pursuant to Article 9(2) of Directive 2001/20/EC as accepted by the competent authorities.2. The manufacturer shall regularly review his manufacturing methods in the light of scientific and technical progress and the development of the investigational medicinal product.If a variation to the marketing authorisation dossier or an amendment to the request referred to in Article 9(2) of Directive 2001/20/EC is necessary, the application for modification shall be submitted to the competent authorities.Article 6Quality assurance systemThe manufacturer shall establish and implement an effective pharmaceutical quality assurance system, involving the active participation of the management and personnel of the different departments.Article 7Personnel1. At each manufacturing site, the manufacturer shall have a sufficient number of competent and appropriately qualified personnel at his disposal to achieve the pharmaceutical quality assurance objective.2. The duties of the managerial and supervisory staff, including the qualified persons, responsible for implementing and operating good manufacturing practice, shall be defined in job descriptions. Their hierarchical relationships shall be defined in an organisation chart. Organisation charts and job descriptions shall be approved in accordance with the manufacturer's internal procedures.3. The staff referred to in paragraph 2 shall be given sufficient authority to discharge their responsibility correctly.4. The personnel shall receive initial and ongoing training, the effectiveness of which shall be verified, covering in particular the theory and application of the concept of quality assurance and good manufacturing practice, and, where appropriate, the particular requirements for the manufacture of investigational medicinal products.5. Hygiene programmes adapted to the activities to be carried out shall be established and observed. These programmes shall, in particular, include procedures relating to health, hygiene practice and clothing of personnel.Article 8Premises and equipment1. Premises and manufacturing equipment shall be located, designed, constructed, adapted and maintained to suit the intended operations.2. Premises and manufacturing equipment shall be laid out, designed and operated in such a way as to minimise the risk of error and to permit effective cleaning and maintenance in order to avoid contamination, cross contamination and, in general, any adverse effect on the quality of the product.3. Premises and equipment to be used for manufacturing operations, which are critical to the quality of the products, shall be subjected to appropriate qualification and validation.Article 9Documentation1. The manufacturer shall establish and maintain a documentation system based upon specifications, manufacturing formulae and processing and packaging instructions, procedures and records covering the various manufacturing operations performed. Documents shall be clear, free from error and kept up to date. Pre-established procedures for general manufacturing operations and conditions shall be kept available, together with specific documents for the manufacture of each batch. That set of documents shall enable the history of the manufacture of each batch and the changes introduced during the development of an investigational medicinal product to be traced.For a medicinal product, the batch documentation shall be retained for at least one year after the expiry date of the batches to which it relates or at least five years after the certification referred to in Article 51(3) of Directive 2001/83/EC, whichever is the longer period.For an investigational medicinal product, the batch documentation shall be retained for at least five years after the completion or formal discontinuation of the last clinical trial in which the batch was used. The sponsor or marketing authorisation holder, if different, shall be responsible for ensuring that records are retained as required for marketing authorisation in accordance with the Annex I to Directive 2001/83/EC, if required for a subsequent marketing authorisation.2. When electronic, photographic or other data processing systems are used instead of written documents, the manufacturer shall first validate the systems by showing that the data will be appropriately stored during the anticipated period of storage. Data stored by those systems shall be made readily available in legible form and shall be provided to the competent authorities at their request. The electronically stored data shall be protected, by methods such as duplication or back-up and transfer on to another storage system, against loss or damage of data, and audit trails shall be maintained.Article 10Production1. The different production operations shall be carried out in accordance with pre-established instructions and procedures and in accordance with good manufacturing practice. Adequate and sufficient resources shall be made available for the in-process controls. All process deviations and product defects shall be documented and thoroughly investigated.2. Appropriate technical or organisational measures shall be taken to avoid cross contamination and mix-ups. In the case of investigational medicinal products, particular attention shall be paid to the handling of products during and after any blinding operation.3. For medicinal products, any new manufacture or important modification of a manufacturing process of a medicinal product shall be validated. Critical phases of manufacturing processes shall be regularly re-validated.4. For investigational medicinal products, the manufacturing process shall be validated in its entirety in so far as is appropriate, taking into account the stage of product development. At least the critical process steps, such as sterilisation, shall be validated. All steps in the design and development of the manufacturing process shall be fully documented.Article 11Quality control1. The manufacturer shall establish and maintain a quality control system placed under the authority of a person who has the requisite qualifications and is independent of production.That person shall have at his disposal, or shall have access to, one or more quality control laboratories appropriately staffed and equipped to carry out the necessary examination and testing of the starting materials and packaging materials and the testing of intermediate and finished products.2. For medicinal products, including those imported from third countries, contract laboratories may be used if authorised in accordance with Article 12 of this Directive and point (b) of Article 20 of Directive 2001/83/EC.For investigational medicinal products, the sponsor shall ensure that the contract laboratory complies with the content of the request referred to in Article 9(2) of Directive 2001/20/EC, as accepted by the competent authority. When the products are imported from third countries, analytical control shall not be mandatory.3. During the final control of the finished product before its release for sale or distribution or for use in clinical trials, the quality control system shall take into account, in addition to analytical results, essential information such as the production conditions, the results of in-process controls, the examination of the manufacturing documents and the conformity of the product to its specifications, including the final finished pack.4. Samples of each batch of finished medicinal product shall be retained for at least one year after the expiry date.For an investigational medicinal product, sufficient samples of each batch of bulk formulated product and of key packaging components used for each finished product batch shall be retained for at least two years after completion or formal discontinuation of the last clinical trial in which the batch was used, whichever period is the longer.Unless a longer period is required under the law of the Member State of manufacture, samples of starting materials, other than solvents, gases or water, used in the manufacturing process shall be retained for at least two years after the release of product. That period may be shortened if the period of stability of the material, as indicated in the relevant specification, is shorter. All those samples shall be maintained at the disposal of the competent authorities.Other conditions may be defined, by agreement with the competent authority, for the sampling and retaining of starting materials and certain products manufactured individually or in small quantities, or when their storage could raise special problems.Article 12Work contracted out1. Any manufacturing operation or operation linked thereto which is carried out under contract shall be the subject of a written contract.2. The contract shall clearly define the responsibilities of each party and shall define, in particular, the observance of good manufacturing practice to be followed by the contract-acceptor and the manner in which the qualified person responsible for certifying each batch is to discharge his responsibilities.3. The contract-acceptor shall not subcontract any of the work entrusted to him under the contract without written authorisation from the contract-giver.4. The contract-acceptor shall comply with the principles and guidelines of good manufacturing practice and shall submit to inspections carried out by the competent authorities pursuant to Article 111 of Directive 2001/83/EC and Article 15 of Directive 2001/20/EC.Article 13Complaints, product recall and emergency unblinding1. In the case of medicinal products, the manufacturer shall implement a system for recording and reviewing complaints together with an effective system for recalling, promptly and at any time, medicinal products in the distribution network. Any complaint concerning a defect shall be recorded and investigated by the manufacturer. The manufacturer shall inform the competent authority of any defect that could result in a recall or abnormal restriction on supply and, in so far as is possible, indicate the countries of destination.Any recall shall be made in accordance with the requirements referred to in Article 123 of Directive 2001/83/EC.2. In the case of investigational medicinal products, the manufacturer shall, in cooperation with the sponsor, implement a system for recording and reviewing complaints together with an effective system for recalling promptly and at any time investigational medicinal products which have already entered the distribution network. The manufacturer shall record and investigate any complaint concerning a defect and shall inform the competent authority of any defect that could result in a recall or abnormal restriction on supply.In the case of investigational medicinal products, all trial sites shall be identified and, in so far as is possible, the countries of destination shall be indicated.In the case of an investigational medicinal product for which a marketing authorisation has been issued, the manufacturer of the investigational medicinal product shall, in cooperation with the sponsor, inform the marketing authorisation holder of any defect that could be related to the authorised medicinal product.3. The sponsor shall implement a procedure for the rapid unblinding of blinded products, where this is necessary for a prompt recall as referred to in paragraph 2. The sponsor shall ensure that the procedure discloses the identity of the blinded product only in so far as is necessary.Article 14Self-inspectionThe manufacturer shall conduct repeated self-inspections as part of the quality assurance system in order to monitor the implementation and respect of good manufacturing practice and to propose any necessary corrective measures. Records shall be maintained of such self-inspections and any corrective action subsequently taken.Article 15LabellingIn the case of an investigational medicinal product, labelling shall be such as to ensure protection of the subject and traceability, to enable identification of the product and trial, and to facilitate proper use of the investigational medicinal product.Article 16Repeal of Directive 91/356/EECDirective 91/356/EEC is repealed.References to the repealed Directive shall be construed as references to this Directive.Article 17Transposition1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 April 2004 at the latest. They shall forthwith communicate to the Commission the text of the provisions and correlation table between those provisions and the provisions of this Directive.When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The Member States shall determine how such reference is to be made.2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.Article 18Entry into forceThis Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.Article 19AddresseesThis Directive is addressed to the Member States.Done at Brussels, 8 October 2003.For the CommissionErkki LiikanenMember of the Commission(1) OJ L 311, 28.11.2001, p. 67.(2) OJ L 159, 27.6.2003, p. 46.(3) OJ L 193, 17.7.1991, p. 30.(4) OJ L 121, 1.5.2001, p. 34.

Summary: Medicines and investigational medicines for human use — safe production Medicines and investigational medicines for human use — safe production SUMMARY OF: Commission Directive 2003/94/EC — good manufacturing practice for medicines and investigational medicines for human use SUMMARY WHAT DOES THE DIRECTIVE DO? It sets out the principles and guidelines of good manufacturing practice for medicines and investigational medicines* for human use. KEY POINTS National authorities must organise inspections to ensure manufacturers comply with the principles and guidelines set out in the legislation. Manufacturers must: ensure that their activities are properly authorised and respect good manufacturing practice; regularly review their manufacturing methods in the light of scientific and technical progress; establish and implement an effective pharmaceutical quality assurance system, involving management and staff; have enough competent and qualified staff to ensure quality standards are met; define the duties of the managerial and supervisory staff and provide them with appropriate training; establish and maintain documentation records, a quality control system under a suitably qualified person and hygiene programmes; conduct frequent inspections of their operations and take any necessary corrective action; implement a system to respond to, and investigate, complaints and have measures in place to promptly recall any medicines if necessary, while informing the competent authorities of their action. The premises and equipment used must be located, designed, constructed, adapted and maintained to suit their intended purpose, minimise the risk of error and allow effective cleaning and maintenance. The documentation system must contain details of each batch of products and kept for at least a year after their expiry date for medicines; and for investigational medicines, at least 5 years after the end of the clinical trial in which they were used. Electronic data must be protected against any loss or damage. Different production operations must comply with pre-established instructions and procedures. The quality control system includes access to quality control laboratories and must retain samples of each batch of products for at least a year after their expiry date for medicines; and for investigational medicines, at least 2 years after the end of the clinical trial in which they were used. Any work contracted out must be authorised by a written contract setting out the responsibilities of both parties in complying with good manufacturing practice. Importers must ensure that imported products have been manufactured according to standards that are at least equivalent to those in the EU. Separate legislation (Regulation (EU) No 536/2014) sets out the conditions that clinical trials must meet. FROM WHEN DOES THE DIRECTIVE APPLY? It has applied since 3 November 2003. EU countries had to incorporate it into national law by 30 April 2004. BACKGROUND For more information, see: ‘Quality of medicines and Good Manufacturing Practices (GMP)’ on the European Commission’s website ‘Good-manufacturing-practice and good-distribution-practice compliance’ on the European Medicines Agency’s website KEY TERM * Investigational medicine: a pharmaceutical form of an active substance or placebo that is being tested or used as a reference in a clinical trial. ACT Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (OJ L 262, 14.10.2003, pp. 22–26) RELATED ACTS 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). Subsequent amendments to Regulation (EC) No 726/2004 have been incorporated into the basic text. This consolidated version is of documentary value only. Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ L 136, 30.4.2004, pp. 34–57) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, pp. 67–128). See consolidated version. Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, pp. 1–76) last update 19.04.2016