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RegisterStart of referral: Micro Therapeutics Research Labs, India [GxP / QC / QA]
Dear all
The CHMP started a review of medicines for which studies have been conducted by Micro Therapeutic Research Labs at two sites in India. This follows a good clinical practice inspection which raised concerns about the study data used to support marketing authorisation applications of some medicines in the European Union.
Does anybody have an idea which were the findings that lead to this decision?
Edit: Category changed. [Helmut]
The CHMP started a review of medicines for which studies have been conducted by Micro Therapeutic Research Labs at two sites in India. This follows a good clinical practice inspection which raised concerns about the study data used to support marketing authorisation applications of some medicines in the European Union.
Does anybody have an idea which were the findings that lead to this decision?
Edit: Category changed. [Helmut]
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Start of referral: Micro Therapeutics Research Labs, IndiaDr_Dan 2016-12-20 09:33 [GxP / QC / QA]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Start of referral: Micro Therapeutics Research Labs, India Ohlbe 2016-12-20 10:04
- Start of referral: Micro Therapeutics Research Labs, India nobody 2016-12-20 10:15
- Start of referral: Micro Therapeutics Research Labs, India Dr_Dan 2016-12-20 11:05
- Start of referral: Micro Therapeutics Research Labs, India nobody 2016-12-20 11:19
- Start of referral: Micro Therapeutics Research Labs, India Dr_Dan 2016-12-20 11:05
- Start of referral: Micro Therapeutics Research Labs, India nobody 2016-12-20 10:15
- CHMP opinion Ohlbe 2017-03-24 14:30
- Oops! Helmut 2017-03-24 16:19
- Start of referral: Micro Therapeutics Research Labs, India Ohlbe 2016-12-20 10:04
Ing. Helmut Schütz