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 current Non-Compliance Reports

 

Read the updates on the last six months:

• CEP suspensions

• CEP withdrawals

• CEP restoration

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
03/01/20	Prednisolone acetate Micronised, sterile	CEP 2017-286
19/12/19	Fluoxetine hydrochloride	CEP 1999-071
19/12/19	Clindamycin hydrochloride	CEP 2000-041
19/12/19	Clindamycin phosphate	CEP 2000-097
19/12/19	Pethidine hydrochloride	CEP 2003-087
19/12/19	Pethidine hydrochloride: For use in the manufacture of parenteral dosage forms	CEP 2003-088
19/12/19	Zolpidem tartrate	CEP 2005-193
19/12/19	Lamotrigine	CEP 2010-382
19/12/19	Etofenamate	CEP 2012-114
19/12/19	Ketorolac trometamol	CEP 2015-190
19/12/19	Cyclopentolate hydrochloride	CEP 2016-078
19/12/19	Omeprazole magnesium	CEP 2016-087
19/12/19	Esomeprazole magnesium dihydrate	CEP 2016-088
19/12/19	Valaciclovir hydrochloride	CEP 2017-003
21/11/19	Metronidazole benzoate	CEP 2007-056
05/11/19	Cefotaxime sodium, sterile	CEP 2014-197
05/11/19	Cefuroxime sodium, sterile	CEP 2014-021

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
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

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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
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
31/01/20	Amoxicillin trihydrate	CEP 2007-315
08/01/20	Amoxicillin trihydrate compacted	CEP 2016-310
16/12/19	Valsartan	CEP 2010-072
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

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