+Člen 4
---+Article 4 1.
---+Article 4 2.
---+Article 4 3.
---+Article 4 4.

Člen 4

Člen 4

1.  Vsako leto države članice pripravijo poročilo v zvezi z izvajanjem DLP na svojem ozemlju.

Poročilo vsebuje seznam inšpekcijsko pregledanih laboratorijev, datume opravljenih inšpekcijskih pregledov in kratke povzetke zaključkov inšpekcijskih pregledov.

2.  Poročilo se pošlje Komisiji vsako leto najpozneje do 31. marca. Komisija poročila pošlje odboru iz člena 7(1). Odbor lahko zahteva dodatne informacije k podatkom, navedenim v odstavku 1 tega člena.

3.  Države članice zagotovijo, da so komercialno občutljive in druge zaupne informacije, do katerih imajo dostop zaradi dejavnosti nadzora skladnosti z DLP, na voljo samo Komisiji, nacionalnim nadzornim organom in imenovanim organom, laboratoriju ter naročniku študije, ki jih inšpekcijski pregled ali pregled študije neposredno zadeva.

4.  Imena laboratorijev, ki jih imenovani organ inšpekcijsko pregleda, njihovo stanje skladnosti z DLP ter datumi opravljenih inšpekcijskih pregledov laboratorijev ali pregledov študij, se ne štejejo kot zaupni.

1. Pregled

,
Article 4 1.
Each year, Member States shall draw up a report relating to the implementation of GLP within their territory.

This report shall contain a list of laboratories inspected, the date on which such inspection was carried out and a brief summary of the conclusions of the inspections.
Article 4 2.
The reports shall be forwarded to the Commission each year, not later than 31 March. The Commission shall communicate them to the Committee referred to in Article 7(1). The Committee may request information in addition to those elements mentioned in paragraph 1 of this Article.
Article 4 3.
Member States shall ensure that commercially sensitive and other confidential information to which they gain access as a result of GLP compliance monitoring activities is made available only to the Commission, to national regulatory and designated authorities and to a laboratory or study sponsor directly concerned with a particular inspection or study audit.
Article 4 4.
The names of laboratories subject to inspection by a designated authority, their GLP compliance status and the dates upon which laboratory inspections or study audits have been conducted shall not be considered to be confidential.

1.1 Sklici

1.2 Ugotovljene zahteve

1.3 Povezani standardi

2. Ugotovljene zahteve

Zahteve

3. Povezani standardi

Standardi
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