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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

28/11/18

Albendazole  

CEP 2001-448

 

2. Due to GMP non-compliance

 

Date

Substance name

CEP Number

-

-

-

 

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

10/09/18

Meropenem trihydrate

CEP 2015-148

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CEP Withdrawals

1. Due to GMP non-compliance

 

Date

Substance name

CEP Number

18/12/2018

Ambroxol Hydrochloride

CEP 2013-115

18/12/2018

Glimepiride

CEP 2015-224

 

 

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

02/04/19

Irbesartan                                       

CEP 2009-283

03/01/19

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

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