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
10/07/17 Lansoprazole CEP 2008-204
10/04/17 Ambroxol hydrochloride CEP 2013-115
10/04/17 Glimepiride CEP 2015-224
10/04/17 Ambroxol hydrochloride CEP 2015-012
16/03/17 Ceftazidime pentahydrate with sodium carbonate for injection CEP 2010-026
02/11/16 Losartan potassium CEP 2012-209

 

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

02/10/17 Ranitidine hydrochloride CEP 2005-280
23/05/17 Oxytetracycline hydrochloride CEP 2002-070
24/04/17 Oxytetracycline hydrochloride CEP 2001-125

 

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

Date              

Substance name

CEP Number

30/05/17 Atropine sulfate CEP 2015-323
30/05/17 Oxybutynin hydrochloride CEP 2003-112

Return to top

 

CEP Withdrawals

 

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

Date             

Substance name

CEP Number

n/a n/a n/a

 

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

29/09/17 Netilmicin sulfate CEP 2006-036
13/04/17 Erythromycin stearate CEP 2002-233
13/04/17 Erythromycin ethylsuccinate CEP 1999-138
20/03/17 Oxytetracycline dihydrate CEP 2002-211

Return to top

 

Restoration of suspended CEP

 

 

Date

Substance name

CEP Number

31/10/2017 Lovastatin CEP 2004-115
31/10/2017 Mycophenolate mofetil CEP 2009-361
31/10/2017 Pravastatin sodium CEP 2010-018
31/10/2017 Vancomycin hydrochloride CEP 2010-120
31/10/2017 Ciclosporin CEP 2010-214
31/10/2017 Mupirocin CEP 2015-041
31/10/2017 Mupirocin calcium CEP 2015-119
25/08/2017 Lovastatin CEP 2004-026
25/08/2017 Simvastatin CEP 2004-051
25/08/2017 Simvastatin CEP 2007-210
25/08/2017 Simvastatin CEP 2005-242
24/08/17 Pseudoephedrine hydrochloride  CEP 2002-217
02/05/17 Erythromycin ethylsuccinate CEP 2007-235
27/03/17 Oxytocin CEP 2011-003
14/03/17 Diosmin CEP 2012-359
17/02/17 Erythromycin CEP 2005-205
11/01/17 Pyrazinamide CEP 2005-059

Return to top

twitter facebook googleplus pinterest linkedin email