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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

 

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

 

Date

Substance name

CEP Number

14/01/21

Calcipotriol monohydrate

CEP 2013-170

 

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

27/04/21 Cefixime CEP 2008-124
27/04/21 Lamotrigine CEP 2009-278
14/04/21 Ramipril CEP 2006-006

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CEP Withdrawals

1. Due to GMP non-compliance

 

Date

Substance name

CEP Number

- - -

 

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

 

Date

Substance name

CEP Number

14/04/21

Albendazole

CEP 2001-448

14/04/21

Meropenem trihydrate

CEP 2015-148
08/04/21 Ampicillin trihydrate CEP 1996-059
08/04/21 Amoxicillin trihydrate CEP 1996-060
08/04/21 Flucloxacillin sodium CEP 2004-120
08/04/21 Ketoprofen CEP 2009-242
08/04/21 Glimepiride CEP 2009-299
08/04/21 Amlodipine besilate CEP 2010-089
 

3. Due to the deletion of the monograph from the European Pharmacopoeia

 

Date

Substance name

CEP Number

07/01/21 Meprobamate CEP 2009-322
07/01/21 Nalidixic acid CEP 2009-216
07/01/21 Nalidixic acid CEP 2011-088

 

 

Restoration of suspended CEP

 

Date

Substance name

CEP Number

18/03/21 Adenosine CEP 2013-044
18/03/21 Simvastatin CEP 2008-149
17/03/21 Ivermectin CEP 1999-176
17/03/21 Pravastatin sodium CEP 2002-009
17/03/21 Simvastatin CEP 2002-172
17/03/21 Acarbose CEP 2006-144
23/10/20 Etofenamate CEP 2012-114
15/10/20 Oxybutynin hydrochloride CEP 2003-112
15/09/20 Fluoxetine hydrochloride CEP 1999-071

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