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
a) As a result of an inspection of the manufacturing site(s)
| Date | Substance name | CEP Number |
b) Due to a failure to fulfill the requirements of the CEP procedure:
|
Date |
Substance name |
CEP Number |
| 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 |
| 08/10/18 | Irbesartan | CEP 2009-283 |
| 10/09/18 | Meropenem trihydrate | CEP 2015-148 |
| 24/08/18 | Valsartan | CEP 2014-162 |
| 17/08/18 | Valsartan | CEP 2013-159 |
| 17/08/18 | Valsartan | CEP 2016-069 |
| 09/07/18 | Valsartan | CEP 2010-072 |
c) Upon request from the holder, due to a temporary inability to produce the product under the approved conditions:
|
Date |
Substance name |
CEP Number |
| 28/11/18 | Albendazole | CEP 2001-448 |
| 07/08/18 | Colchicine | CEP 2002-062 |
| 04/06/18 | Ascorbic acid | CEP 2008-185 |
CEP Withdrawals
a) As a result of an inspection of the manufacturing site(s):
|
Date |
Substance name |
CEP Number |
| 18/12/2018 | Ambroxol Hydrochloride | CEP 2013-115 |
| 18/12/2018 | Glimepiride | CEP 2015-224 |
| 07/05/2018 | Cefixime | CEP 2003-014 |
| 07/05/2018 | Cefuroxime axetil | CEP 2011-173 |
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 |
| - | - | - |
Restoration of suspended CEP
|
Date |
Substance name |
CEP Number |
| 03/01/2019 | 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 |
| 14/08/18 | Oxytetracycline hydrochloride | CEP 2001-125 |