ROMANIA THE TRANSPOSED U.E. LEGISLATION ON GOOD LABORATORY PRACTICE.

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Presentation transcript:

ROMANIA THE TRANSPOSED U.E. LEGISLATION ON GOOD LABORATORY PRACTICE

Council Directive 76/768 on the approximation of he laws of the Member states relating to cosmetic products  Law 178/ 2000 relating to cosmetic products

GOOD LABORATORY PRACTICE  Application of principles of Good Laboratory Practice  Inspection and verification of Good Laboratory Practice

Application of principles of Good Laboratory Practice and verification for tests on chemical substances  Council Directive 87/18/EEC on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of Good Laboratory Practice and the verification of their application for tests on chemical substances AND adaptation to technical progress: Commission Directive 99/11/EC, Commission Directive 99/12/EC – Section A TRANSPOSED IN ROMANIAN LEGISLATION BY:  Government Decision 63/2002 approving the principles of Good Laboratory Practice and the verification of their application for tests on chemical substances

Inspection and verification of Good Laboratory Practice for tests on chemical substances Council Directive 88/320/EEC on the inspection and the verification of the principles of Good Laboratory Practice for tests on chemical substances AND adaptation to technical progress: Commission Directive 90/18/EEC, Commission Directive 99/12/EC –Section B TRANSPOSED IN ROMANIAN LEGISLATION BY: ORDER 117/2002 of: Ministry of Industry and Resources, Ministry of Health and Family, Ministry of Agriculture, Food and Forestry, relating to the inspection and the verification of the principles of Good Laboratory Practice for tests on chemical substances

GOOD LABORATORY PRACTICE:CERTIFICATION AND INSPECTION BODIES:  THE NATIONAL AGENCY FOR DANGEROUS CHEMICAL SUBSTANCES AND PREPARATIONS  THE NATIONAL MEDICINES AGENCY  THE NATIONAL SANITARY VETERINARY AGENCY

THE NATIONAL AGENCY FOR DANGEROUS CHEMICAL SUBSTANCES AND PREPARATIONS PREROGATIVES RELATING TO THE G.L.P.:  Certifying the testing installations regarding the compliance with the good laboratory practice for dangerous chemical substances and preparations, pesticides, cosmetics, human foodstuff additives, industrial chemical products  Inspecting and checking for the compliance with the good laboratory practice in the above- mentioned field

THE NATIONAL MEDICINES AGENCY PREROGATIVES RELATING TO THE G.L.P.:  Certifying the testing installations regarding the compliance with the good laboratory practice for human medicinal products  Inspecting and checking for the compliance with the good laboratory practice for human medicinal products

THE NATIONAL SANITARY VETERINARY AGENCY PREROGATIVES RELATING TO THE G.L.P.:  Certifying the testing installations regarding the compliance with the good laboratory practice for veterinary medicinal products and animal foodstuff additives  Inspecting and checking for the compliance with the good laboratory practice for veterinary medicinal products and animal foodstuff additives