+Člen 1
---+Article 1 1.
---+Article 1 2.
---+Article 1 3.

Člen 1

Člen 1

1.  Ta direktiva se nanaša za inšpekcijske preglede in preverjanje organizacijskih postopkov in pogojev, pod katerimi se za vse kemikalije (npr. kozmetične izdelke, industrijske kemikalije, zdravila, aditive za živila, dodatke h krmi, pesticide) v skladu s pravili in predpisi načrtujejo, izvajajo, zaznamujejo ter sporočajo rezultati laboratorijskih raziskav za neklinično preskuse, da se oceni učinek teh proizvodov na ljudi, živali in okolje.

2.  V tej direktivi „dobra laboratorijska praksa“ (DLP) pomeni laboratorijsko prakso, skladno z načeli, določenimi v Direktivi 2004/10/ES.

3.  Ta direktiva ne obravnava razlage in vrednotenja rezultatov preskusa.

1. Pregled

,
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 Sklici

1.2 Ugotovljene zahteve

1.3 Povezani standardi

2. Ugotovljene zahteve

Zahteve

3. Povezani standardi

Standardi
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