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

Članak 4.

Članak 4.

1.  Države članice svake godine sastavljaju izvješće o provođenju DLP-a na svom državnom području.

To izvješće sadržava popis pregledanih laboratorija, datum provedbe spomenutog pregleda i kratak sažetak zaključaka pregleda.

2.  Izvješća se upućuju Komisiji svake godine najkasnije do 31. ožujka. Komisija ih dostavlja Odboru iz članka 7. stavka 1. Odbor osim podataka iz stavka 1. ovog članka može zatražiti dodatne podatke.

3.  Države članice osiguravaju da su poslovno osjetljivi i drugi povjerljivi podaci, kojima imaju pristup kao rezultat aktivnosti nadzora provođenja DLP-a, dostupni samo Komisiji, nacionalnim regulatornim ili određenim tijelima, i laboratoriju ili pokrovitelju ispitivanja kojega se određeni pregled ili revizija ispitivanja neposredno tiču.

4.  Ne smatraju se povjerljivima nazivi laboratorija koje je pregledalo određeno nadležno tijelo, njihov status s obzirom na sukladnost s DLP-om kao ni datumi provođenja tog pregleda ili revizija ispitivanja.

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 Reference

1.2 Utvrđeni zahtjevi

1.3 Povezani standardi

2. Utvrđeni zahtjevi

Zahtjevi

3. Povezani standardi

Standardi
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