+Artikolu 1
---+Article 1 1.
---+Article 1 2.
---+Article 1 3.
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Artikolu 1
Artikolu 1 1. Din id-Direttiva għandha tapplika għall-ispezzjoni u verifika tal-proċessi ta' l-organizzazzjoni u l-kondizzjonijiet taħt liema studji laboratorji huma ppjanati, magħmula, reġistrati u rapportati għat-test mhux klinika, maħruġa in konformita' mar-regoli u regolamenti, tal-kimiċI kollha (eż. kosmetiċI, kimiċI industrijali, prodotti mediċinali, addittivi ta' l-ikel, addittivi ta' l-għalf, pestiċidi) sabiex jeżaminaw l-effett ta' tali prodotti fuq il-bniedem, l-annimali u l-ambjent. 2. Għall-għanijiet ta' din id-Direttiva, “prassi tajba tal-laboratorji”(GLP), għandha tfisser prassi tal-laboratorju maħruġ in konformita' mall-prinċipji stabbiliti fid-Direttiva 2004/10/KE. 3. Din id-Direttiva ma tikkonċernax l-interpretazzjoni u evalwazzjoni ta' riżultati tat-test.
1. Ħarsa ġenerali
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Regolamentazzjoni |
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Article 1 1.
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This Directive shall apply to the inspection and verification of the organisational processes and the conditions under which laboratory studies are planned, performed, recorded and reported for the non-clinical testing, carried out in accordance with the rules and regulations, of all chemicals (e.g. cosmetics, industrial chemicals, medicinal products, food additives, animal feed additives, pesticides) in order to assess the effect of such products on man, animals and the environment.
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Article 1 2.
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For the purposes of this Directive, ‘good laboratory practice’ (GLP), shall mean laboratory practice conducted in accordance with the principles set out in Directive 2004/10/EC.
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Article 1 3.
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This Directive does not concern the interpretation and evaluation of test results.
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1.1 Referenzi
1.2 Rekwiżiti identifikati
1.3 Standards relatati
2. Rekwiżiti identifikati
3. Standards relatati
- Builddate: 26.07.2019 00:00:00 -Doknr: CELEX:32004L0009
- EULAW -
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