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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

 

a) As a result of an inspection of the manufacturing site(s)

Date Substance name CEP Number
10/07/17 Lansoprazole CEP 2008-204

 

b) Due to a failure to fulfill the requirements of the CEP procedure with regards to updating the application:

Date

Substance name            

CEP Number

02/10/17 Ranitidine hydrochloride CEP 2005-280

 

c) Upon request from the holder, due to a temporary inability to produce the product under the approved conditions:

Date              

Substance name

CEP Number

n/a n/a n/a

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CEP Withdrawals

 

a) As a result of an inspection of the manufacturing site(s):

Date             

Substance name

CEP Number

n/a n/a n/a

 

b) Due to a failure to fulfill the requirements of the CEP procedure with regards to updating the application and complying with GMP:

Date

                      Substance name

CEP Number

n/a                       n/a n/a

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Restoration of suspended CEP

 

 

Date

Substance name

CEP Number

31/10/17 Lovastatin CEP 2004-115
31/10/17 Mycophenolate mofetil CEP 2009-361
31/10/17 Pravastatin sodium CEP 2010-018
31/10/17 Vancomycin hydrochloride CEP 2010-120
31/10/17 Ciclosporin CEP 2010-214
31/10/17 Mupirocin CEP 2015-041
31/10/17 Mupirocin calcium CEP 2015-119
25/08/17 Lovastatin CEP 2004-026
25/08/17 Simvastatin CEP 2004-051
25/08/17 Simvastatin CEP 2007-210
25/08/17 Simvastatin CEP 2005-242
24/08/17 Pseudoephedrine hydrochloride  CEP 2002-217

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