DISKUSSIONSFORUM

AW: EU-Retest von klin. Prüfarzneimitteln aus nicht-EU-Ländern

Beitrag von Bernd Renger geschrieben am 5.10.2009 um 11:23

Originalbeitrag: EU-Retest von klin. Prüfarzneimitteln aus nicht-EU-Ländern geschrieben von C. Brätter am 1.9.2009 um 08:37)

Aus der entsprechenden Richtlinie ist das nicht abzuleiten:

Directive 2001/20/EC

Article 13 (2)

… the qualified person … is responsible, … for ensuring:

(b) in the case of investigational medicinal products manufactured in a third country, that each production batch has been manufactured and checked in accordance with standards of good manufacturing practice …, in accordance with the product specification file, and that each production batch has been checked in accordance with the information notified pursuant to … (the request for authorization of a clinical trial).

(c) in the case of an investigational medicinal product which is a comparator product from a third country, and which has a marketing authorization, where the documentation certifying that each production batch has been manufactured in conditions at least equivalent to the standards of good manufacturing practice referred to above cannot be obtained, that each production batch has undergone all relevant analyses, tests or checks necessary to confirm its quality in accordance with the information notified pursuant to … (the request for authorization of a clinical trial).

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