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RegisterNecessity of ISR [Bioanalytics]
Dear Olacy,
The introduction to Annex I to Directive 2001/83/EC reads:
In assembling the dossier for application for marketing authorisation, applicants shall also take into account the scientific guidelines relating to the quality, safety and efficacy of medicinal products for human use as adopted by the Committee for Proprietary Medicinal Products (CPMP) and published by the European Medicine Evaluation Agency (EMEA)
Consequence: what matters is not the date when the trial was performed, but the date when the application is submitted. Submitting now data which do not comply with the guideline (including ISR) has a risk.
Regards
Ohlbe
The introduction to Annex I to Directive 2001/83/EC reads:
In assembling the dossier for application for marketing authorisation, applicants shall also take into account the scientific guidelines relating to the quality, safety and efficacy of medicinal products for human use as adopted by the Committee for Proprietary Medicinal Products (CPMP) and published by the European Medicine Evaluation Agency (EMEA)
Consequence: what matters is not the date when the trial was performed, but the date when the application is submitted. Submitting now data which do not comply with the guideline (including ISR) has a risk.
Regards
Ohlbe
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Necessity of ISR olacy 2012-03-01 11:43
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Necessity of ISROhlbe 2012-03-01 12:28
- Necessity of ISR olacy 2012-03-01 13:31
- Necessity of ISROhlbe 2012-03-01 12:28
Ing. Helmut Schütz