+Articolo 1
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Articolo 1

Articolo 1

1.  La presente direttiva si applica all'ispezione e alla verifica delle procedure organizzative e delle condizioni alle quali sono programmate, svolte, registrate e comunicate le ricerche di laboratorio per le prove non cliniche effettuate ai fini previsti dalla regolamentazione e volte a valutare gli effetti sull'uomo, sugli animali e sull'ambiente di tutti i prodotti chimici (quali ad esempio cosmetici, prodotti chimici per l'industria, prodotti medicinali, additivi alimentari, additivi per la mangimistica, antiparassitari).

2.  Ai fini della presente direttiva si intende per «buona pratica di laboratorio» (BPL) la pratica di laboratorio conforme al principio stabilito nella direttiva 2004/10/CE.

3.  La presente direttiva non riguarda né l'interpretazione né la valutazione dei risultati sperimentali.

1. Panoramica

,
Article 1 1.
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.
Article 1 2.
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.
Article 1 3.
This Directive does not concern the interpretation and evaluation of test results.

1.1 Riferimenti

1.2 Requisiti identificati

1.3 Standard correlati

2. Requisiti identificati

Requisiti

3. Standard correlati

Standard
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