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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

 

1.Upon request from the holder, due to a temporary inability to produce under the approved conditions

 

Date

Substance name

CEP Number

05/11/2019

Methyl salicylate

CEP 2004-060

 

2. Due to GMP non-compliance

 

Date

Substance name

CEP Number

21/11/2019 Metronidazole benzoate CEP 2007-056
05/11/2019 Cefotaxime sodium, sterile CEP 2014-197
05/11/2019 Cefuroxime sodium, sterile CEP 2014-021
 

3. Due to a failure to fulfil the requirements of the Certification procedure

 

Date

Substance name

CEP Number

08/11/19 Ranitidine Hydrochloride CEP 2001-228
30/10/19 Ranitidine Hydrochloride CEP 2007-320
11/10/19 Ranitidine Hydrochloride CEP 1996-102
11/10/19 Ranitidine Hydrochloride CEP 2000-342
11/10/19 Ranitidine Hydrochloride CEP 2002-075
11/10/19 Ranitidine Hydrochloride CEP 2017-068
19/09/19 Ranitidine Hydrochloride CEP 2004-057
03/07/19 Glipizide CEP 2008-210

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CEP Withdrawals

1. Due to GMP non-compliance

 

Date

Substance name

CEP Number

14/11/19 Erythromycin CEP 2009-267
14/11/19 Bisoprolol fumarate CEP 2013-342
 

 

2. Due to a failure to fulfill the requirements of the Certification Procedure

 

Date

Substance name

CEP Number

-

-

-

 

 

Restoration of suspended CEP

 

Date

Substance name

CEP Number

22/10/19 Valsartan Process III CEP 2016-069
15/10/19 Irbesartan CEP 2010-033 
15/10/19 Losartan Potassium CEP 2010-139
08/10/19 Valsartan CEP 2011-174
18/07/19 Losartan Potassium Form I CEP 2009-247
21/06/19 Ceftazidime pentahydrate with sodium carbonate for injection CEP 2010-026
24/05/19 Valsartan CEP 2009-396
24/05/19 Valsartan CEP 2013-159

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