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RegisterRetention period and quantity for Malaysian submission [Regulatives / Guidelines]
Dear Sriram,
Malaysia has adopted BE guidelines from EMA. Hence you can follow EU guidelines for retention quantity
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/pdfs-en/2005_12_14_annex19_en.pdf
You can refer section 4.1
The calculation of samples required for retention quantity shall be provided by the sponsor and retained by the site
Regards
Chirag
Malaysia has adopted BE guidelines from EMA. Hence you can follow EU guidelines for retention quantity
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/pdfs-en/2005_12_14_annex19_en.pdf
You can refer section 4.1
The calculation of samples required for retention quantity shall be provided by the sponsor and retained by the site
Regards
Chirag
Complete thread:
- Retention period and quantity for Malaysian submission Sriramprasad 2020-07-18 09:06
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Retention period and quantity for Malaysian submissioncakhatri 2020-08-10 08:04
- Retention period and quantity for Malaysian submission Sriramprasad 2020-10-17 13:54
- Retention period and quantity for Malaysian submissioncakhatri 2020-08-10 08:04
Ing. Helmut Schütz