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 |
|---|---|---|
|
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 |
|---|---|---|
| 21/09/21 | Losartan Potassium Process II | CEP 2019-317 |
| 27/04/21 | Cefixime | CEP 2008-124 |
| 27/04/21 | Lamotrigine | CEP 2009-278 |
| 14/04/21 | Ramipril | CEP 2006-006 |
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 |
|---|---|---|
| 21/05/21 | Simvastatin | CEP 2010-116 |
| 21/05/21 | Sulfadimidine | CEP 1995-039 |
| 21/05/21 | Sulfadiazine | CEP 1997-008 |
| 21/05/21 | Trimethoprim | CEP 1997-009 |
| 21/05/21 | Sulfamethoxazole | CEP 1999-097 |
|
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 |
|---|---|---|
|
01/07/21 |
Ranitidine Hydrochloride |
CEP 2001-228 |
|
23/06/21 |
Oxytetracycline Hydrochloride |
CEP 2002-070 |
|
23/06/21 |
Lovastatin |
CEP 2001-406 |
|
12/05/21 |
Ketorolac trometamol |
CEP 2015-190 |
|
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 |