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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

16/04/20 Tropicamide CEP 1998-077
16/04/20 Chlorhexidine digluconate solution CEP 2003-094
16/04/20 Dihydrotachysterol CEP 2005-285
16/04/20 Bupivacaine hydrochloride CEP 2009-038
16/04/20 Glimepiride CEP 2009-176
16/04/20 Omeprazole CEP 2009-298
16/04/20 Chlorhexidine dihydrochloride CEP 2010-215
16/04/20 Cetirizine dihydrochloride CEP 2012-200
16/04/20 Ropivacaine hydrochloride monohydrate CEP 2012-281
 

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

 

Date

Substance name

CEP Number

27/01/20 Irbesartan CEP 2012-156
27/01/20 Irbesartan CEP 2014-029
08/01/20 Olmesartan medoxomil CEP 2012-239

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CEP Withdrawals

1. Due to GMP non-compliance

n/a

 

 

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

 

Date

Substance name

CEP Number

13/03/20

Gemcitabine Hydrochloride Product code GAI

CEP 2011-023
13/03/20 Gemcitabine Hydrochloride Product code GMI CEP 2011-025
 

Restoration of suspended CEP

 

Date

Substance name

CEP Number

23/10/20 Etofenamate CEP 2012-114
15/10/20 Oxybutynin hydrochloride CEP 2003-112
15/09/20 Fluoxetine hydrochloride CEP 1999-071

06/08/20

   Lamotrigine CEP 2010-382
29/07/20 Pethidine hydrochloride CEP 2003-087
29/07/20 Pethidine hydrochloride
For use in the manufacture of parenteral dosage forms
CEP 2003-088
29/07/20 Prednisolone acetate micronized CEP 2017-286
22/07/20 Clindamycin phosphate CEP 2000-097
22/07/20 Cyclopentolate Hydrochloride CEP 2016-078

19/06/20

Clindamycin hydrochloride CEP 2000-041
31/01/20 Amoxicillin trihydrate CEP 2007-315  
08/01/20 Amoxicillin trihydrate compacted CEP 2016-310

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