Council for europe portal
Language : en Search
Choose language

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
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
02/02/16 Gabapentin CEP 2011-264
02/02/16 Celecoxib CEP 2012-404
02/02/16 Candesartan cilexetil CEP 2013-007
02/02/16 Telmisartan CEP 2013-135
02/02/16 Aceclofenac CEP 2013-274
18/12/15 Metronidazole CEP 2007-309
19/10/15 Fenticonazole nitrate CEP 2013-056

 

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

26/11/15 Lincomycin hydrochloride CEP 2013-114
14/10/15 Metoprolol succinate CEP 2005-223
14/10/15 Tamoxifen citrate CEP 2005-197

Return to top

 

CEP Withdrawals

 

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

Date             

Substance name

CEP Number

26/04/16 Isosorbide mononitrate, diluted CEP 2002-104
23/10/15 Diosmin CEP 2009-032

 

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

Return to top

 

Restoration of suspended CEP

 

 

Date

Substance name

CEP Number

07/04/16 Indometacin CEP 2009-314
17/11/15 Simvastatin CEP 2004-051
17/11/15 Lovastatin CEP 2004-026
17/11/15 Simvastatin CEP 2007-210
16/10/15 Trimethoprim CEP 1999-037

Return to top

twitter facebook googleplus pinterest linkedin email
twitter facebook googleplus pinterest linkedin email