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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
02/11/16 Losartan potassium CEP 2012-209
28/10/16 Doxorubicin hydrochloride CEP 1999-151
28/10/16 Ivermectin CEP 1999-176
28/10/16 Epirubicin hydrochloride CEP 2000-077
28/10/16 Cytarabine CEP 2001-390
28/10/16 Lovastatin CEP 2001-406
28/10/16 Pravastatin sodium CEP 2002-009
28/10/16 Simvastatin CEP 2002-172
28/10/16 Cyclophosphamide CEP 2005-279
28/10/16 Acarbose CEP 2006-144
28/10/16 Granisetron hydrochloride CEP 2006-285
28/10/16 Methotrexate CEP 2007-357
28/10/16 Simvastatin CEP 2008-149
28/10/16 Letrozole CEP 2010-331
28/10/16 Gemcitabine hydrochloride CEP 2011-117
28/10/16 Mitomycin CEP 2012-013
28/10/16 Fluvastatin sodium CEP 2012-063
28/10/16 Cladribine CEP 2012-132
28/10/16 Bleomycin sulfate CEP 2012-197
28/10/16 Daunorubicin hydrochloride CEP 2012-380
28/10/16 Adenosine CEP 2013-044
28/10/16 Valsartan CEP 2013-095
28/10/16 Bicalutamide CEP 2013-195
28/10/16 Doxorubicin hydrochloride CEP 2013-262
28/10/16 Atorvastatin calcium trihydrate CEP 2013-339
28/10/16 Celecoxib CEP 2014-340
28/10/16 Capecitabine CEP 2015-009
28/10/16 Fludarabine phosphate CEP 2006-076
28/10/16 Docetaxel trihydrate CEP 2013-261
28/10/16 Oxaliplatin CEP 2014-037
28/10/16 Praziquantel CEP 2002-137
28/10/16 Vinorelbine tartrate CEP 2005-146
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

26/10/16 Ferrous fumarate CEP 2010-147
26/10/16 Fluconazole CEP 2010-247
26/10/16 Chlorobutanol hemihydrate CEP 2009-112
26/10/16 Metoprolol succinate CEP 2009-170
26/10/16 Metoprolol tartrate CEP 2009-152
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

12/10/16 Fenticonazole nitrate CEP 2013-056
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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