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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

 

b) Due to a failure to fulfill the requirements of the CEP procedure:
 

Date

Substance name            

CEP Number

29/01/19 Simvastatin     CEP 2010-116 
29/01/19 Losartan Potassium Form I  CEP 2009-247
14/01/19 Losartan Potassium Process II  CEP 2010-139
14/01/19 Irbesartan                                                                                                      CEP 2010-033
19/12/18 Valsartan CEP 2011-174
17/12/18 Valsartan CEP 2011-231
14/12/18 Ampicillin trihydrate                       CEP 1996-059                                 
14/12/18 Amoxicillin trihydrate                    CEP 1996-060                                 
14/12/18 Flucloxacillin sodium                      CEP 2004-120                                 
14/12/18 Ketoprofen                                      CEP 2009-242                                 
14/12/18 Glimepiride                                      CEP 2009-299                                 
14/12/18 Amlodipine besilate                       CEP 2010-089                                 
16/11/18 Valsartan CEP 2009-396
08/10/18 Irbesartan                                 CEP 2009-283
10/09/18 Meropenem trihydrate CEP 2015-148
24/08/18 Valsartan CEP 2014-162
17/08/18 Valsartan CEP 2013-159
17/08/18 Valsartan CEP 2016-069
09/07/18 Valsartan CEP 2010-072

 

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

Date              

Substance name

CEP Number

28/11/18 Albendazole   CEP 2001-448
07/08/18 Colchicine CEP 2002-062
04/06/18 Ascorbic acid CEP 2008-185

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CEP Withdrawals

 

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

Date             

Substance name

CEP Number

18/12/2018 Ambroxol Hydrochloride CEP 2013-115
18/12/2018 Glimepiride                                                                               CEP 2015-224
07/05/2018 Cefixime  CEP 2003-014
07/05/2018 Cefuroxime axetil CEP 2011-173

 

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

14/02/2019 Ambroxol Hydrochloride   CEP 2015-012  

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Restoration of suspended CEP

 

Date

Substance name

CEP Number

03/01/2019 Thiopental sodium and sodium carbonate   CEP 2007-181
12/10/18 Imipenem monohydrate, sterile CEP 2010-163
12/10/18 Cilastatin sodium, sterile CEP 2010-184
12/10/18 Potassium clavulanate, sterile CEP 2013-133
12/10/18 Amoxicillin sodium, sterile CEP 2013-125
28/09/18 Folic acid hydrate                        CEP 2005-031
14/08/18 Oxytetracycline hydrochloride  CEP 2001-125

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