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
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 |
|---|---|---|
| 16/04/20 | Tropicamide | CEP 1998-077 |
| 16/04/20 | Chlorhexidine digluconate solution | CEP 2003-094 |
| 16/04/20 | Dihydrotachysterol | CEP 2005-285 |
| 16/04/20 | Bupivacaine hydrochloride | CEP 2009-038 |
| 16/04/20 | Glimepiride | CEP 2009-176 |
| 16/04/20 | Omeprazole | CEP 2009-298 |
| 16/04/20 | Chlorhexidine dihydrochloride | CEP 2010-215 |
| 16/04/20 | Cetirizine dihydrochloride | CEP 2012-200 |
| 16/04/20 | Ropivacaine hydrochloride monohydrate | CEP 2012-281 |
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 |
CEP Withdrawals
1. Due to GMP non-compliance
n/a
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 |
|---|---|---|
|
06/08/20 |
Lamotrigine | CEP 2010-382 |
| 29/07/20 | Pethidine hydrochloride | CEP 2003-087 |
| 29/07/20 | Pethidine hydrochloride For use in the manufacture of parenteral dosage forms |
CEP 2003-088 |
| 29/07/20 | Prednisolone acetate micronized | CEP 2017-286 |
| 22/07/20 | Clindamycin phosphate | CEP 2000-097 |
| 22/07/20 | Cyclopentolate Hydrochloride | CEP 2016-078 |
|
19/06/20 |
Clindamycin hydrochloride | CEP 2000-041 |
| 31/01/20 | Amoxicillin trihydrate | CEP 2007-315 |
| 08/01/20 | Amoxicillin trihydrate compacted | CEP 2016-310 |