Standard Summary Project Fiche Project No. TR 0402.03 Twinning No. TR/2004/IB/EC/06 1. Basic Information 1.1 Title: Strengthening the Ministries of Health, Environment and Forests, and Agriculture and Rural Affairs to harmonise and implement legislation in the field of Good Laboratory Practice for Non Clinical Health and Environmental Protection. 1.2 Sector: Free Movement of Goods 1.3 Location: Ankara, Turkey 1.4 Duration : 24 months 2. Objectives 2.1 Overall Objective Further facilitating the free movement of goods, particularly chemicals, while ensuring that environmental conditions in Turkey continue to improve with the enforcement of the environmental acquis. 2.2 Project Purpose Strengthening the institutional and administrative capacity of the Ministries to adopt and implement the EU Directives on Good Laboratory Practice (GLP) (2004/9/EC, 2004/10/EC) 2.3 Accession Partnership and NPAA priority The Accession Partnership 1 2003 sets out the principles, priorities, intermediate objectives and conditions decided by the European Council and Turkey. In the short term, for 2003/4, those priorities are: Free movement of goods - Remove technical and administrative barriers to trade. Accelerate alignment and application of European standards. Ensure effective in- market control and free movement of goods in line with internal market legislation. Environment - Adopt a programme for transposition of the acquis. 1 Council Decision of 8 March 2001 on the principles, priorities, intermediate objectives and conditions contained in the Accession Partnership with the Republic of Turkey (OJ L 85, 24.03.2001, page 13) and Accession Partnership AP 2003 1
- Begin to transpose and implement the acquis related to the framework legislation, legislation on nature protection, water quality, Integrated Pollution Prevention Control and waste management. - Implement and enforce the environmental impact assessment directive. Consumer protection and Health - Further align legislation with the acquis and develop infrastructure for effective implementation, in particular with regard to market surveillance. - Further develop systems for notification of dangerous products on national level and exploit the possibilities to exchange such notifications - on international level through TRAPEX or other relevant systems. In the medium term, commencing 2003/4, those priorities are: Free movement of goods - Complete alignment with the acquis; complete strengthening of existing certification, market surveillance and conformity-assessment structures. Environment the NPAA for 2003 - Complete the transposition of the acquis and strengthen the institutional, administrative and monitoring capacity to ensure environmental protection, including data collection. Consumer protection and Health - Complete legislative alignment with the acquis - Raise awareness for the new provisions among consumers and producers and reinforce consumer organisations. The Turkish Government has adopted the NPAA 2003 and in line with the Free Movement of Goods-Chemicals section, the following should become a priority: The monitoring, auditing and inspection and approval of GLP compliance by testing bodies and the use of GLP principles for the testing and authorization of the use of chemical substances This project is designed to assist the Turkish Government to meet these criteria and priorities. 2.4 National development plan Turkey has completed its first national development plan, which was published at the end of 2003 3. Description Fully transposed Turkish Legislation corresponding to the Directive 2004/9/EC and 2004/10/EC. 2
3.1 Background and Justification 3.1.1 Good Laboratory Practice Government and industry are concerned about the quality of non-clinical health and environmental safety studies upon which hazard assessments are based. As a consequence, OECD Member countries have established criteria for the performance of these studies. The purpose of these principles of good laboratory practice is to promote the development of quality test data. Comparable quality of test data forms the basis for the mutual acceptance of data among countries. If individual countries can confidently rely on the test data developed in other countries duplicate testing can be avoided, thereby saving time and resources. The application of these principles should help to avoid the creation of technical barriers to trade; therefore it will contribute to the free movement of goods and further improve the protection of health and the environment. This twinning component will therefore assist Turkey in building the necessary institutional structure, the institutional capacity and the legal framework for implementation of the key EU GLP Directive in Turkey, with special focus on the requirements of the 04/10/EC. 3.1.2 Justification Detailed and thorough strategies for the implementation and enforcement of the Directives, with relevant institutional strengthening and methodological support, are necessary to make the regulatory infrastructure in Turkey compatible and efficient in providing and assuring the protection of public health. The project addresses this need. 3.2 Linked activities Under the Programming of Pre-Accession Financial Assistance for the year 2003, within the scope of Air Quality, Chemicals, and Waste Project, a technical assistance element was included under Component 1.2 to assist the Ministry of Environment and Forests in implementing the Directives relating to Chemicals. This work urgently needs the existence of the GLP Directive to be fully effective. 3.2 Results The following three results are expected from the project: 1 The Enforcement of the EU Directives 2004/9/EC and 2004/10/EC, in accordance with the transposition of the Directives into Turkish Law 2 The Establishment of a Monitoring, Auditing and Inspection Body 3. The Establishment of an agreed framework for GLP procedures in the field of Chemicals 3.3 Activities To achieve the objectives mentioned above, the following actions should be undertaken: 3
1. Elaboration of a strategy for implementing the Directives to include a. Twinning from the Monitoring and Auditing Department of a Member State to establish the Monitoring Authority in Turkey will be provided. The programme should also ensure the achievement of ISO 9002 Certification for the Monitoring Authority before completion of the project. b. On the job training in the same Member State for potential Auditors and Inspectors will be given. This training should be of at least two months duration. c. On the job training in the same Member State for selected potential GLP study directors of two months duration each for at least two participants from each of the three Ministries involved will be provided d. Provision of Database of GLP studies undertaken elsewhere e. Study Visits of one weeks duration for potential Principal Investigators to a Member State from each of the three Ministries will be held. f. Technical Assistance for at least 3 Awareness Seminars for potential sponsors of GLP studies will be given. Seminars to be held in the three sectors of Health, Environment and Agriculture. Each seminar should be followed by a workshop for the sector to explain in detail how the GLP system operates. g. Training Courses will be organised to show how GLP studies are Planned, Performed, Monitored, Recorded, Archived and Reported in each of the three sectors of Health, Environment and Agriculture h. Technical Assistance will be provided for laboratories from each of the three Ministries to enable them to prepare for a GLP Compliance Audit. 5 Laboratories will be made GLP compliant i. Training course will be held for Laboratory QA Managers from each of the three Ministries to educate them on the differences between Accreditation and GLP and to provide training in carrying out QA activities in relation to a GLP study. j. Technical Assistance will be given by an EU expert in Laboratory design for the carrying out of animal testing. 4. Institutional Framework This project will be implemented through a twining covenant. It will be the responsibility of the Twinning Partner to identify which of the three Ministries with an interest in GLP namely the Ministry of Health, the Ministry of Agriculture and Rural Affairs or the Ministry of Environment and Forests should be designated as the Competent Authority. Whichever Ministry is chosen it is important to emphasise that each of the other two Ministries should second their own Auditor to work with the Competent authority and that a mechanism should be put in place which ensures that all non clinical testing results are made available to the Ministry of Health in case there is a Clinical implication. 5. Detailed Budget Investment Support EU Support Institution Building Total EU (=I+IB) National Co financing* TOTAL Twinning 1.5 1.5 1.5 4
Total 1.5 1.5 1.5 * In cases of co-financing only Turkish contribution to the Twinning will cover provision of office equipment and space for RTA, organizational costs of training (accommodation and catering in local training, rental fees as well as local and international travel for trainees) and other costs non-eligible for funding as specified in the Reference Manual on Twinning Projects. 6. Implementation Arrangements 6.1 Implementation Agency The Implementing Agency for the project will be the Financial Cooperation and Coordination Unit (CFCU) that will be responsible for all procedural aspects of the tendering process, contracting matters and financial management (including payments) of the project activities. Contact at CFCU: PAO: Ercan Tortop Director, CFCU Tel: +90 312 285 20 02 Email: ercan.tortop@cfcu.gov.tr The principal Beneficiaries of GLP are the Ministry of Health, the Ministry of Environment and Forests and the Ministry of Agriculture. Contact at MoH: Dr. Arslan Umit Giray Director Department of the European Union Affairs Ministry of Health Nusret Fisek Cad 06100 Sıhhiye, Ankara Turkey Tel: + 90312 4357516 Fax: +90312 4353780 Email: agiray@saglik.gov.tr Contact at Ministry of Environment and Forestst: Name: Eyüp Yahşi Position: Head of Unit Department: Measurement and Audit Unit Adress: Çevre Referans Laboratuarı Haymana Yolu, 5.km Gölbaşı,Ankara Turkey Tel: +90.312.498 21 65 Fax: +90.312.498 2166 Email: yahsieyup@yahoo.com 5
Contact at Ministry of Agriculture and Rural Affairs: Name: Musa Arık Position: Head of Unit Department: Animal Health Adress: Ministry of Agriculture and Rural Affairs, General Directorate of Protection and Control, Ankara, Turkey Tel: +90.312.418 24 36 Fax: 090.312. 417 82 09 Email: musaa@kkm.gov.tr Close co-operation, communication and co-ordination will be required with: The Ministry of Culture and Tourism The Ministry of Energy and Natural Resources General Secretariat for EU Affairs Under Secretariat of Treasury General Directorate of Rural Affairs 6.2 Contracts One twinning covenant will be concluded covering the full amount of the project: 1.5 MEUR 1.5 MEUR 6.3 Twinning GLP will be implemented in the form of a Twinning covenant between Turkey and one EU Member State. The twinning partner will manage all aspects of execution in close cooperation with the Ministries concerned. The twinning partner will secure a pool of international experts for the purpose of advisory services and training according to the work plan that will be prepared for the covenant. Member States may form a consortium which will result in a wide range of qualified senior experts gathered from regulatory authorities, different national administrations, universities, major specialised consulting and nature protection firms or renowned independent experts from more than one Member State, provided that national approaches can be harmonised within the consortium. The beneficiary institution for the Twinning arrangement will be the Ministry of Health which will also assume responsibility for the administration related to the preparation, technical control and implementation. The Twinning partner will in addition assist the other beneficiary Ministries of Environment and Agriculture/ Long-term twinning expert: senior adviser to the Ministry of Health Resident Twinning Advisor (RTA) 24 Man Months. - At least ten years experience working on the implementation of the GLP Directives - A solid institutional background and strong track record of proven management skills of complex institutional projects; - Strong communication skills; - Independent from all Turkish stakeholders as mentioned in the project fiche; - At least 5 years of working experience as an GLP Auditor in a Member State; 6
- good knowledge of the European institutional environment related to the implementation and enforcement of EU legislation on chemicals management; - an extensive network of functional contacts with related EU and Member State institutions (proven functional contacts at the EU level are considered an asset); - proven understanding of the main issues regarding EU accession; - senior experience in carrying out strategic and organisational analyses; - Advanced university degree in chemistry or other relevant subject; - International advisory experience; - Good written and oral command of English; - Experience in developing, coordinating and conducting training programmes, in particular group processes. Short term experts 24 Man Months total All EU institutional and technical experts will be in principle deployed on a short-term basis. The short-term experts should have substantial experience in the relevant subject matter fields. It is envisaged that all of the project s experts should possess at least 5 to 10 years of past experience and knowledge as an Auditor, Inspector or Study Director of GLP projects. In particular the short term experts should have an appropriate mix of the following expertise: - Information management and databases related to chemicals (in particular EINEC and ELINCS databases) as well as chemicals inventory work in at least one EU Member State - Experience with the application of the Animals Experiments Directive 86/609/EEC - Experience with the design of Laboratories for Animal Experiments - Experience in all aspects of Quality Assurance on GLP Projects - Experience with economic instruments and financial analyses; - Legal expertise in the field of chemicals management; - Relevant experience of work in the international field and in Central and Eastern Europe and/or Turkey in particular will be considered an advantage during the evaluation; - Strong communicative skills; - Experience in conducting training programmes, in particular group processes; Good written and oral command of English. 7. Implementation Schedule 7.1 Time schedule Component Start of negotiation of Start of Project Activity Project Completion twinning covenant Twinning 2004,3 rd Quarter 2005,2 nd Quarter 2007,2 nd Quarter 7.2 Equal Opportunity The project will comply with the European Commission s equal opportunity policy. 7.3 Environment The project itself is focused on the achievement of long-term public health and environmental improvements in Turkey. 7.4 Rates of return 7
N/A 7.5 Investment criteria 7.5.1 Catalytic effect The project will provide a fresh impetus for the implementation of the environmental acquis in Turkey. 7.5.2 Conditionality 7.5.3.2 Good Laboratory Practice Since Animal experiments are a frequent requirement in GLP studies, it is essential that the adoption by the Turkish Government and bringing into full effect the Directive 1986/609/EEC on Animal Experiments regarding the protection of animals used for experimental and other scientific purposes be undertaken before the signing of the Twinning Contract. ANNEXES TO PROJECT FICHE 1. Logical framework matrix 2. Detailed implementation chart 3. Contracting and disbursement 8
ANNEX 1: LOGFRAME PLANNING MATRIX LOGFRAME PLANNING MATRIX for Project: Strengthening the Ministry of Health and other Ministries to harmonise and implement legislation in the field of Good Laboratory Practice for Non Clinical Health and Environmental Protection Contracting period expires: 31/5/2007 Total budget: 1.50 MEUR Disbursement period expires: 31/9/2007 EU budget: 1.50 MEUR Overall objective Objectively verifiable indicators Sources of Verification Overall objective is to further facilitate the free movement of goods, particularly chemicals, while ensuring that environmental conditions in Turkey continue to improve with the enforcement of the environmental acquis. Turkey meets requirements under environmental acquis EU Regular Reports for 2003, 2004,2005 and 2006 State of Environment reports for 2004,2005 and 2006 Turkish national statistics Ministry of Health reports Project Purpose Objectively verifiable indicators Sources of Verification Assumptions To strengthen the Institutional and administrative capacity of the Ministry of Health and other Ministries to adopt and implement the EC GLP Directives (2004/9/EC, 2004/10/EC) Institutional and administrative capacity for implementation of the EU Directives in place by the end of 2006. EU Regular Reports Annual reports of MoH, RSHC MoE and others Budget and staffing allocations within the MoH State of Environment reports Turkish National Statistics Full legal transposition of Directives Turkish government makes available sufficient financial, technical and human resources Willingness of staff at MoH and other ministries to work in collaboration and co-ordination with each other and with project team 9
Results Objectively verifiable indicators Sources of Verification Assumptions Technical Assistance (Twinning) The Enforcement of the EU Directives 2004/9/EC, 2004/10/EC, in accordance with the transposition of the Directives into Turkish Law 1. The Establishment of a Monitoring, Auditing and Inspection Body 2. The establishment of an agreed framework for GLP procedures in the field of Chemicals Turkish GLP Monitoring and Auditing Department fully trained and operational by end of 2006. Inspection by GLP Monitoring Unit of a Member State at end of 2006 MoH Auditing Dept confirms publication of Framework and Guidelines.Statement issued by Member State Monitoring Unit that the Department is satisfactory, Ministries Annual reports GLP Monitoring and Auditing Unit Annual report Reports by MoH and MoE Adequate budget allocations made Human resources provided by Ministries 10
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Activities Means Sources of Verification Assumptions 1. Establishment of a GLP Monitoring and Auditing Department and Training of Specialists. Twinning.. 1. Elaboration of a strategy for implementing the Directives by the end of 2004 to include: a) Twinning from the Monitoring and Auditing Department of a Member State to establish the Monitoring Authority in Turkey. The programme should also ensure the achievement of ISO 9002 Certification for the Monitoring Authority by the end of 2006. b) The provision of on the job training in the same Member State for potential Auditors and Inspectors. This training should be of at least two months duration. c) Provision of on the job training in the same Member State for selected potential GLP study directors of two months duration each for at least two participants from each of the three Ministries involved. d) Provision of Database of GLP studies undertaken elsewhere e) Study Visits of one weeks duration for potential Principal Investigators to a Member State from each of the three Ministries. f) Technical Assistance for at least 3 Awareness Seminars for potential sponsors of GLP studies. Seminars to be held in the three sectors of Health, Environment and Agriculture. Each seminar should be followed by a workshop for the sector to explain in detail how the GLP system operates. g) Training Courses to show how GLP studies are Planned, Performed, Monitored, Recorded, Archived Member State sends RTA to Turkey and Short Term Experts to assist in establishment and training of Monitoring Authority Training by Member State and Turkish Standards Institute given Member State providing Twinning to provide from own resources Reports of Member State and Ministries. Certificates of Competence issued by Member State Certificate issued by Turkish Standards Institute certificates of competence issued on completion certificates of competence on completion MoH confirmation of receipt Database available MoH, MoE and MARA reports Report by MoH on effectiveness of Seminars MoH, MoE and MARA reports Suitable Human resources and accommodation provided by Ministries Financial resources available to meet requirements 12
and Reported in each of the three sectors of Health, Environment and Agriculture h) Technical Assistance for laboratories from each of the three Ministries to enable them to prepare for a GLP Compliance Audit. 5 Laboratories GLP compliant by end of 2006. i) Training course for at least 9 Laboratory QA Managers from each of the three Ministries to educate them on the differences between Accreditation and GLP and to provide training in carrying out QA activities in relation to a GLP study. j) Technical Assistance by an EU expert in Laboratory design for the carrying out of animal testing. 5 Laboratories apply for GLP Registration Certificates issued on completion of training course GLP Monitoring Authority reports receipt of applications Certificates issued on com-letion of course Reports of EU experts and Reports of MoH and MARA Conditions Transposition of Animal Experiments Directive 86/609/EEC fully implemented 13
ANNEX 2: DETAILED TIME IMPLEMENTATION CHART FOR PROJECT NUMBER TR-04 XX XX Strengthening the Ministry of Healthand other Ministries to harmonise and implement legislation in the field Good Laboratory Practice (Strengthening the Institutional and Administrative capacity of the Ministry of Health to adopt and implement the Acquis Communautairee) Activity 2005 2006 2007 Twinning Good Laboratory Practice. Establishment of a Monitoring Authority for GLP X X X X X X X X X Training in Member State of Auditors and Inspectors X X X X X Training in Member State for Study Directors X X X X X Training for Quality Assurance and Awareness Seminars X X X X X Technical assistance with Lab design for Animal testing X X X X Training for performing GLP studies X X X X Technical assistance to laboratories seeking GLP compliance X X X X X X X ANNEX 3: CUMULATIVE CONTRACTING AND DISBURSEMENT SCHEDULE Strengthening the Ministry of Health, Ministry of Environment and Forests and Ministry of Agriculture to harmonise and implement legislation in the field Good Laboratory Practice TA in the form of Twinning for the implementation of GLP Directives 1.5 MEURO II/2005 III/2005 IV/2005 I/2006 II/2006 III/2006 IV/2006 I/2007 II/2007 CONTRACTED 1,500,000 1,500,000 1,500,000 1,500,000 1,500,000 1,500,000 1,500,000 1,500,000 1,500,000 DISBURSED 600,000 225,000 225,000 225,000 225,000 14
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