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

Artikolu 6

Artikolu 6

1.  Fejn Stat Membru għandu raġuni biżżejjed li jemmen li laboratorju fi Stat Membru ieħor jistqarr li konformita' mall-GLP ma ħariġx test in konformita' ma' GLP, jista' jitlob iktar informazzjoni minn dak l-Istat Membru u b'mod partikolari jita' jitlob eżami ta' studju, possibbiliment flimkien ma' spezzjoni ġdida.

Jekk ma huwix possibbli għall-Istati Membri konċernati li jilħqu ftehim, l-Istati Membri in kwistjoni għandhom immedjatament jinfurmaw lill-Istati Membri l-oħra u lill-Kummisjsoni, u jagħtu raġjunijiet għad-deċIżjoni tagħhom.

2.  Il-Kummissjoni għandha teżamina mill-iktar fis possibbli r-raġunijiet miġjuba 'l quddiem mill-Istati Membri fil-Kumitat imsemmi fl-Artikolu 7(1); għandu imbagħad jieħu l-miżuri adegwati in konformita' mall-proċedura msemmija fl-Artikolu 7(2). F'din il-konnessjoni jista' jsaqsi għall-opinjonijiet ta' esperti minn awtoritajiet maħtura fl-Istati Membri.

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3.  Il-Kummissjoni għandha s-setgħa li tadotta atti delegati f’konformità mal-Artikolu 6a li jemendaw din id-Direttiva sabiex jiġu riżoluti l-kwistjonijiet imsemmija fil-paragrafu 1. L-emendi għall-Anness I ma għandhomx ibiddlu n-natura tiegħu li jipprovdi gwida għall-proċeduri ta’ kontroll ta’ konformità għall-GLP u għat-twettiq ta’ spezzjonijiet tal-faċilità tat-testijiet u l-eżamijiet tal-istudju.

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1. Ħarsa ġenerali

,
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 Referenzi

1.2 Rekwiżiti identifikati

1.3 Standards relatati

2. Rekwiżiti identifikati

Rekwiżiti

3. Standards relatati

Standards
  • Builddate: 26.07.2019 00:00:00 -Doknr: CELEX:32004L0009
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