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Dear kamblpa2,
True. So the lab did their job correctly at that time: ISR was not required for EU submissions in 2007. The guideline only came in force on 1st February 2012.
The problem is that the date that matters is not the date when you did the trial, but the date the application was submitted to the Agency. To quote Annex 1 to Directive 2001/83/EC:
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) and the other pharmaceutical Community guidelines published by the Commission in the different volumes of The rules governing medicinal products in the European Community.
Translation: it is not just that the lab has to follow the guidelines. But also the applicants should make sure that the studies they submit follow the "state of the art" when they are submitted. Submitting now studies performed more than 2-3 years ago will now be difficult. If your dossier was submitted after 1st February 2012, you're in trouble.
Regards
Ohlbe
❝ Since the study was conducted in year 2007, that time ISR was not given in the guideline.
True. So the lab did their job correctly at that time: ISR was not required for EU submissions in 2007. The guideline only came in force on 1st February 2012.
The problem is that the date that matters is not the date when you did the trial, but the date the application was submitted to the Agency. To quote Annex 1 to Directive 2001/83/EC:
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) and the other pharmaceutical Community guidelines published by the Commission in the different volumes of The rules governing medicinal products in the European Community.
Translation: it is not just that the lab has to follow the guidelines. But also the applicants should make sure that the studies they submit follow the "state of the art" when they are submitted. Submitting now studies performed more than 2-3 years ago will now be difficult. If your dossier was submitted after 1st February 2012, you're in trouble.
Regards
Ohlbe
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Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Deficiency response kamblpa2 2012-08-13 10:33
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Deficiency responseOhlbe 2012-08-14 00:17
- CMDh reminder Ohlbe 2012-09-25 19:01
- CMDh reminder ElMaestro 2012-09-25 20:21
- CMDh reminder Ohlbe 2012-09-25 22:06
- CMDh reminder Dr_Dan 2012-09-26 11:35
- Long-term storage samples? Helmut 2012-09-26 14:48
- CMDh reminder ElMaestro 2012-09-26 17:30
- CMDh reminder Ohlbe 2012-09-27 23:15
- CMDh reminder Dr_Dan 2012-09-28 15:32
- CMDh reminder ElMaestro 2012-09-28 17:04
- 90%+ off-topic Helmut 2012-09-28 17:48
- 90%+ off-topic ElMaestro 2012-09-29 09:30
- 90%+ off-topic Helmut 2012-09-28 17:48
- CMDh reminder ElMaestro 2012-09-28 17:04
- CMDh reminder Dr_Dan 2012-09-28 15:32
- CMDh reminder Ohlbe 2012-09-27 23:15
- CMDh reminder Dr_Dan 2012-09-26 11:35
- CMDh reminder Ohlbe 2012-09-25 22:06
- CMDh reminder ElMaestro 2012-09-25 20:21
Ing. Helmut Schütz