+Artikolu 5
---+Article 5 1.
---+Article 5 2.

Artikolu 5

Artikolu 5

1.  Mingħajr preġudizzju għal l-Artikolu 6, ir-riżultati ta' spezzjonijiet tal-laboratorji u eżami ta' l-istudji fuq konformita' mall-GLP maħruġa minn Stat Membru għandhom ikunu jorbtu fuq Stati Membri oħra.

2.  Fejn Stat Membru jikkonsidra li laboratorju fit-territorju tiegħu li jistqarr konformita' mall-GLP fil-fatt ma jikkonformax mall-GLP sa l-integrita' jew awtentiċita' ta' l-istudji li jagħmel jista' jkunu kkompromessi, għandu b'hekk jinforma l-Kummissjoni. Il-Kummissjoni għandha tgħarraf lill-Istati Membri l-oħra.

1. Ħarsa ġenerali

,
Article 5 1.
Without prejudice to Article 6, the results of laboratory inspections and study audits on GLP compliance carried out by a Member State shall be binding on the other Member States.
Article 5 2.
Where a Member State considers that a laboratory within its territory claiming GLP compliance does not in fact comply with GLP to the extent that the integrity or authenticity of the studies it performs might be compromised, it shall forthwith inform the Commission. The Commission shall inform the other Member States.

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
  • EULAW -

    EN: Legal acts of the European Union from EUR-Lex, https://eur-lex.europa.eu/. © European Union. Re-use is authorised by Decision 2011/833/EU, provided the source is acknowledged; the consolidated texts are licensed under CC BY 4.0 (EUR-Lex legal notice). Divided into sections and converted into the GRCA format, the wording unchanged. Only the legislation published in the Official Journal of the European Union is deemed authentic.

    DE: Rechtsakte der Europäischen Union aus EUR-Lex, https://eur-lex.europa.eu/. © Europäische Union. Weiterverwendung nach Beschluss 2011/833/EU mit Quellenangabe gestattet; die konsolidierten Fassungen stehen unter CC BY 4.0 (Rechtlicher Hinweis von EUR-Lex). In Abschnitte aufgeteilt und in das GRCA-Format umgewandelt, der Wortlaut unverändert. Verbindlich sind allein die im Amtsblatt der Europäischen Union veröffentlichten Rechtsakte.