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Certification of Suitability to the Monographs of the European Pharmacopoeia: News & General Information
Certification Monthly Report of Activities
(16/01/12) The Certification of Substances Division (DCEP) will publish on a monthly basis, a report containing some relevant figures relating to its main activities. December 2011 Certification Monthly Report
Events
CEP Suspensions:
Following inspection of the manufacturing site(s):
| Date | Substance name | CEP Number |
| 20/12/11 | Azathioprine | CEP 2001-341 |
| 20/12/11 | Ticlopidine Hydrochloride | CEP 2003-066 |
| 20/12/11 | Haloperidol | CEP 2003-206 |
| 20/12/11 | Risperidone | CEP 2004-135 |
| 20/12/11 | Diphenoxylate Hydrochloride | CEP 2005-084 |
| 20/12/11 | Nifuroxazide | CEP 2006-074 |
|
04/11/11 |
Isosorbide mononitrate, diluted |
CEP 2002-104 |
|
04/11/11 |
Protamine sulfate |
CEP 2000-162 |
| 06/10/11 | Oxytetracycline Dihydrate | CEP 2002-211 |
| 06/10/11 | Oxytetracycline Hydrochloride | CEP 2002-070 |
| 06/10/11 | Oxytetracycline Hydrochloride | CEP 2001-125 |
Due to a failure to comply with a declaration of willingness to be inspected and/or to operate according to EU GMP (e.g. refusal, of inspection, reconstruction/restoration of site(s), to achieve GMP level, and temporary closure):
| Date | Substance name | CEP Number |
|
20/12/11 |
Troxerutin |
CEP 2006-153 |
|
15/09/11 |
Theophylline |
CEP 1998-094 |
Upon request from the holder, due to a temporary inability to produce the API under the approved conditions
| Date | Substance name | CEP Number |
| None |
CEP Withdrawals:
As a result of an inspection of the manufacturing site(s):
| Date | Substance name | CEP Number |
|
15/09/11 |
Paclitaxel |
CEP 2008-005 |
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 |
|
12/09/11 |
Tiamulin hydrogen fumarate for veterinary use |
CEP 2007-008 |
|
12/09/11 |
Ribavirin |
CEP 2009-257 |
Additional Information & Documentation
List of all assessors (Updated 18/10/11)
EDQM Policy ‘Suspension or Cancellation of a Certificate of Suitability' PA/PH/CEP (08) 17, R2
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