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Marketing authorisations based on studies conducted by the company Micro Therapeutic Research Labs in India: suspension of marketing authorisations
2017.07.13
Active substance: various
13.07.2017 - Notice wihtin the graduated plan procedure ("Stufenplanverfahren")
In a notice dated 13 July 2017, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the provisional suspension of generic marketing authorisations based on clinical trials conducted by the company Micro Therapeutic Research Labs in India. This is the realisation of the EU Commission'simplementing decision of 23 June 2017.
12.05.2017 - Notice wihtin the graduated plan procedure ("Stufenplanverfahren")
In a notice dated 12 May 2017, the Federal Institute for Drugs and Medical Devices (BfArM) ruled the provisional suspension of various generic marketing authorisations that were based on clinical trials conducted by the company Micro Therapeutic Research Labs in India.
28.03.2017 - CHMP recommendation
The German Federal Institute for Drugs and Medical Devices (BfArM) informs about the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for drug approvals based on bioequivalence studies of the company Micro Therapeutic Research Labs in India.
Further information
For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):
To the risk assessment procedure (available in German only)