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 current Non-Compliance Reports
Read the updates on the last six months:
CEP Suspensions
Upon request from the holder, due to a temporary inability to produce under the approved conditions
|
Date |
Substance name |
CEP Number |
|---|---|---|
Due to GMP non-compliance
|
Date |
Substance name |
CEP Number |
|---|---|---|
| 07/04/2025 | Cefuroxime axetil, amorphous | CEP 2009-045 |
| 07/04/2025 | Ceftriaxone sodium, sterile | CEP 2010-342 |
| 07/04/2025 | Cefuroxime sodium, sterile | CEP 2011-062 |
| 07/04/2025 | Cefotaxime sodium, sterile | CEP 2011-226 |
| 07/04/2025 | Cefixime | CEP 2011-239 |
| 07/04/2025 | Cefepime dihydrochloride monohydrate, sterile | CEP 2012-242 |
| 07/04/2025 | Cefpodoxime proxetil | CEP 2015-354 |
| 07/04/2025 | Cefuroxime axetil, amorphous, Process-II | CEP 2016-170 |
| 07/04/2025 | Cefixime, Process II | CEP 2017-042 |
| 07/04/2025 | Ceftazidime pentahydrate with sodium carbonate for injection, sterile | CEP 2019-231 |
| 23/01/2025 | Biperiden Hydrochloride | CEP 2021-360 |
| 23/01/2025 | Biperiden Hydrochloride, Bipe HCl 38 | CEP 2020-317 |
| 18/10/2024 | Clomifene citrate | CEP 2003-193 |
| 18/10/2024 | Quetiapine fumarate | CEP 2015-334 |
| 18/10/2024 | Azaperone for veterinary use | CEP 2017-190 |
| 18/10/2024 | Chlortalidone | CEP 2017-285 |
Due to a failure to fulfil the requirements of the Certification procedure
|
Date |
Substance name |
CEP Number |
|---|---|---|
|
- |
- | - |
CEP Withdrawals
Due to GMP non-compliance
|
Date |
Substance name |
CEP Number |
|---|---|---|
| - | - | - |
Due to a failure to fulfill the requirements of the Certification Procedure
|
Date |
Substance name |
CEP Number |
|---|---|---|
| - | - | - |
Due to the deletion of the monograph from the European Pharmacopoeia
|
Date |
Substance name |
CEP Number |
|---|---|---|
| - | - | - |
Restoration of suspended CEP
|
Date |
Substance name |
CEP Number |
|---|---|---|
| 19/12/2024 | Solifenacin succinate | CEP 2021-510 |
| 11/03/2025 | Deferoxamine mesilate | CEP 2009-401 |
| 11/03/2025 | Tamoxifen citrate | CEP 2021-495 |
Looking for a CEP?
Search for a list of granted CEPs, their type, the name of the substance, the full CEP number, the issue date and validity status, using the Certification Database (updated daily).