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Actions on CEPs

GMP Non-Compliance

Information is now publicly available via the EudraGMDP data base.

The European Medicines Agency (EMA) has launched a new version of the EudraGMDP database which includes, among other changes, the publication of statements of non-compliance with Good Manufacturing Practice. Statements of non-compliance contain information on the nature of the non-compliance and the actions taken or proposed by the issuing authority in order to protect public health.

These statements aim to establish a coordinated and harmonized response by the network of European Union (EU) medicines regulators. Some non-compliance statements are the result of inspections carried out by the EDQM with the participation of EU/EEA national inspectorates. Any statement of GMP non-compliance that is related to a manufacturing site covered by a CEP application initiates the decision making process on the validity of the CEPs concerned by the EDQM, regardless of whether the EDQM has been involved in the inspection or not.

Information of a commercially or personally confidential nature is not made public. The decision on which information to make public is taken by the medicines regulatory authority in the EU Member State that adds the information to the database.

 

Read the updates on the last six months:

CEP Suspensions

 

a) As a result of an inspection of the manufacturing site(s)

Date Substance name CEP Number
09/08/16 Simvastatin CEP 2003-257
09/08/16 Simvastatin CEP 2006-091
09/08/16 Simvastatin CEP 2007-155
18/05/16 Simvastatin CEP 2004-051
18/05/16 Lovastatin CEP 2004-026
18/05/16 Simvastatin CEP 2007-210
18/05/16 Simvastatin CEP 2005-242
19/04/16 Erythromycin ethylsuccinate CEP 2007-235
19/04/16 Erythromycin CEP 2005-205
19/04/16 Pyrazinamide CEP 2005-059
12/04/16 Enoxaparin sodium CEP 2005-258
07/04/16 Cefixime CEP 2003-014
07/04/16 Cefuroxime axetil CEP 2011-173
05/04/16 Diosmin CEP 2012-359

 

b) Due to a failure to fulfill the requirements of the CEP procedure with regards to updating the application and complying with GMP :

Date

Substance name            

CEP Number

n/a        n/a n/a

 

c) Upon request from the holder, due to a temporary inability to produce the product under the approved conditions:

Date              

Substance name

CEP Number

n/a  n/a  n/a 

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CEP Withdrawals

 

a) As a result of an inspection of the manufacturing site(s):

Date             

Substance name

CEP Number

21/07/16 Nitrofurantoin CEP 2011-240
26/04/16 Isosorbide mononitrate, diluted CEP 2002-104

 

b) Due to a failure to fulfill the requirements of the CEP procedure with regards to updating the application and complying with GMP:

Date

                      Substance name

CEP Number

10/08/16 Povidone CEP 2011-061
09/08/16 Glucose CEP 2004-274

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Restoration of suspended CEP

 

 

Date

Substance name

CEP Number

19/07/16 Aceclofenac CEP 2013-274
19/07/16 Candesartan cilexetil CEP 2013-007
19/07/16 Telmisartan CEP 2013-135
19/07/16 Celecoxib CEP 2012-404
19/07/16 Gabapentin CEP 2011-264
07/04/16 Indometacin CEP 2009-314

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