+Člen 6
---+Article 6 1.
---+Article 6 2.
---+Article 6 3.

Člen 6

Člen 6

1.  Kadar ima država članica zadosten razlog za domnevo, da laboratorij iz druge države članice, ki trdi, da je skladen z DLP, preskusa ni izvedel skladno z DLP, lahko od te države članice zahteva nadaljnje informacije ter še zlasti pregled študije, po možnosti v povezavi s ponovnim inšpekcijskim pregledom.

Če zadevni državi članici ne moreta doseči soglasja, o tem takoj obvestita druge države članice ter Komisijo, ter navedeta razloge za svojo odločitev.

2.  Komisija v Odboru iz člena 7(1) čimprej preuči razloge, ki sta jih posredovali zadevni državi članici; nato takoj sprejme ustrezne ukrepe v skladu s postopkom iz člena 7(2). V zvezi s tem lahko zaprosi za strokovna mnenja izvedencev imenovanih organov v državah članicah.

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3.  Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 6a za spremembo te direktive zaradi reševanja zadev iz odstavka 1. S spremembami Priloge I ne bo spremenjena narava te priloge, ki zagotavlja vodila za postopke nadzora skladnosti za DLP in navodila za izvajanje inšpekcij laboratorijev in presoj študij.

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1. Pregled

,
Article 6 1.
Where a Member State has sufficient reason to believe that a laboratory in another Member State claiming GLP compliance has not carried out a test in accordance with GLP, it may request further information from that Member State and in particular may request a study audit, possibly in conjunction with a new inspection.

Should it not be possible for the Member States concerned to reach agreement, the Member States in question shall immediately inform the other Member States and the Commission, giving reasons for their decision.
Article 6 2.
The Commission shall examine as soon as possible the reasons put forward by the Member States within the Committee referred to in Article 7(1); it shall then take the appropriate measures in accordance with procedure referred to in Article 7(2). It may in this connection ask for expert opinions from the designated authorities in the Member States.
Article 6 3.
The Commission is empowered to adopt delegated acts in accordance with Article 6a amending this Directive in order to resolve the matters referred to in paragraph 1. Amendments to Annex I shall not change its nature of providing guidance for compliance monitoring procedures for GLP and for the conduct of test facility inspections and study audits.

1.1 Sklici

1.2 Ugotovljene zahteve

1.3 Povezani standardi

2. Ugotovljene zahteve

Zahteve

3. Povezani standardi

Standardi
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