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RegisterICH = 2 Years after last approval based on study [Regulatives / Guidelines]
Dear Brus,
In ICH E6 (GCP), § 4.9.5:
Essential documents should be retained until at least 2-years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least 2-years have elapsed since the formal discontinuation of clinical development of the investigational product. These documents should be retained for a longer period however if required by the applicable regulatory requirements or by an agreement with the sponsor.
Cave: not 2 years after the end of the study, but 2 years after the last approval based on that study.
❝ 2 Years for ICH? Where did you find that?
In ICH E6 (GCP), § 4.9.5:
Essential documents should be retained until at least 2-years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least 2-years have elapsed since the formal discontinuation of clinical development of the investigational product. These documents should be retained for a longer period however if required by the applicable regulatory requirements or by an agreement with the sponsor.
Cave: not 2 years after the end of the study, but 2 years after the last approval based on that study.
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Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Document Retention Period for Bioequivalence study Turkish Submission yatish gosai 2020-08-10 14:36 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Website of the Turkish Medicines and Medical Devices Agency Helmut 2020-08-10 15:15
- Document Retention Period for Bioequivalence study Turkish Submission Brus 2020-08-31 14:21
- Document Retention Period: ICH = 2 Years, Nigeria = 5 Years, Turkey = ? Obinoscopy 2020-09-01 01:50
- Document Retention Period: ICH = 2 Years, Nigeria = 5 Years, Turkey = ? Brus 2020-09-01 09:06
- ICH = 2 Years after last approval based on studyOhlbe 2020-09-01 11:03
- Document Retention Period: ICH = 2 Years, Nigeria = 5 Years, Turkey = ? Brus 2020-09-01 09:06
- Document Retention Period: ICH = 2 Years, Nigeria = 5 Years, Turkey = ? Obinoscopy 2020-09-01 01:50
Ing. Helmut Schütz