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

Artikolu 4

Artikolu 4

1.  Kull sena, l-Istati Membri għandhom itellgħu rapport li jirrigwarda l-implimentazzjoni tal-GLP fit-territorju tagħhom.

Dan ir-rapport għandu jkollu lista tal-laboratorji spezzjonati, id-data meta l-ispezzjoni seħħet u taqsira tal-konklużjonijiet ta' l-ispezzjoni.

2.  Ir-rapporti għandhom jintbgħatu lill-Kummisjsoni kull sena, mhux iktar tard mill-31 ta' Marzu. Il-Kummissjoni għandha tikkommunika dan lill-Kumitat imsemmi fl-Artikolu 7(1). Il-Kumitat jista' jitlob informazzjoni addizzjonali ma' dawk l-elementi msemmija fil-paragrafu 1 ta' dan Artikolu.

3.  L-Istati Membri għandhom jassiguraw li informazzjoni li hija kummerċjalment sensittiva u informazzjoni kondfidenzali oħra li biha jġibu aċċess bħala riżultat ta' attivitajiet ta' kontroll ta' konformita' mall-GLP hija disponibbli biss lill-Kummissjoni, lill-awtoriajiet nazzjonali regolatorji u awtoritajiet maħtura u lill-sponsor laboratorju jew sponsor ta' studju direttament konċernat ma' l-ispezzjoni partikolari jew eżami ta' l-istudju.

4.  l-ismijiet ta' laboratorji soġġetti għall-ispezzjoni minn awtorita' maħtura, l-istat ta' konformita' mall-GLP u d-dati meta l-ispezzjonijiet tal-laboratorji jew eżami ta' studji ġew kondotti għandhom ikunu kkunsidrati li huma kunfidenzali.

1. Ħarsa ġenerali

,
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 Referenzi

1.2 Rekwiżiti identifikati

1.3 Standards relatati

2. Rekwiżiti identifikati

Rekwiżiti

3. Standards relatati

Standards
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