+5 straipsnis
---+Article 5 1.
---+Article 5 2.

5 straipsnis

5 straipsnis

1.  Nepažeidžiant 6 straipsnio, GLP laikymosi patikrinimų ir tyrimų auditų, kuriuos atlieka viena valstybė narė, rezultatai yra privalomi kitoms valstybėms narėms.

2.  Kai valstybė narė mano, kad jos teritorijoje esanti laboratorija, teigianti laikantis GLP, faktiškai jos nesilaiko tokiu mastu, kad gali būti pakenkta jos atliekamų tyrimų vientisumui ir autentiškumui, ji nedelsdama apie tai praneša Komisijai. Komisija praneša kitoms valstybėms narėms.

1. Apžvalga

,
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 Nuorodos

1.2 Nustatyti reikalavimai

1.3 Susiję standartai

2. Nustatyti reikalavimai

Reikalavimai

3. Susiję standartai

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