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Directive 2004/9/EC of the European Parliament and of the CouncilShow full title

Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (Codified version) (Text with EEA relevance)

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  1. Introductory Text

  2. Article 1.(1) This Directive shall apply to the inspection and verification...

  3. Article 2.(1) Using the procedure laid down in Article 3, Member...

  4. Article 3.(1) Member States shall designate the authorities responsible for the...

  5. Article 4.(1) Each year, Member States shall draw up a report...

  6. Article 5.(1) Without prejudice to Article 6, the results of laboratory...

  7. Article 6.(1) Where a Member State has sufficient reason to believe...

  8. Article 6a.(1) The power to adopt delegated acts is conferred on...

  9. Article 7.(1) The Commission shall be assisted by the Committee established...

  10. Article 8.(1) The Committee may examine any question which is referred...

  11. Article 9.Directive 88/320/EEC is hereby repealed, without prejudice to the obligations...

  12. Article 10.This Directive shall enter into force on the 20th day...

  13. Article 11.This Directive is addressed to the Member States.

    1. ANNEX I

      1. The provisions for the inspection and verification of GLP which...

      2. PART A REVISED GUIDES FOR COMPLIANCE MONITORING PROCEDURES FOR GLP

        1. Definitions of terms

        2. Components of good laboratory practice compliance monitoring procedures

        3. Confidentiality

        4. Personnel and training

        5. (National) GLP compliance programmes

        6. Follow-up to test facility inspections and study audits

        7. Appeals procedures

      3. PART B REVISED GUIDANCE FOR THE CONDUCT OF TEST FACILITY INSPECTIONS AND STUDY AUDITS

        1. Introduction

        2. Definitions of terms

        3. Test facility inspections

        4. Inspection procedures

        5. Starting conference

        6. Organisation and personnel

        7. Quality assurance programme

        8. Facilities

        9. Care, housing and containment of biological test systems

        10. Apparatus, materials, reagents and specimens

        11. Test systems

        12. Physical and chemical systems

        13. Biological test systems

        14. Test and reference substances

        15. Standard operating procedures

        16. Performance of the study

        17. Reporting of study results

        18. Storage and retention of records

        19. Study audits

        20. Completion of inspection or study audit

    2. ANNEX II

      1. PART A

      2. PART B

    3. ANNEX III

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