Suspension and Withdrawal of CEPs by EDQM

The EDQM announced on May 17, 2011 the availability of the revised policy document 'Suspension or Withdrawal of a Certificate of Suitability'. According to a press release the following updates have been made:

  • More transparency on the possibility for companies to appeal against a decision taken by the EDQM.
  • Description of the procedures applied when the holder of a CEP asks for its withdrawal.

The revised document is available here.

The EDQM also announced a new monthly report containing information about the current activities of EDQM with regard to the certification of substances. In the April report the EDQM states that it has received 136 new applications already this year. In total 5 CEPs have been suspended, 2 expired, 12 have been withdrawn by the holder and 9 CEPs have been withdrawn by EDQM.

Following an inspection of the manufacturing sites the following CEPs have been suspended in April:

12/04/11 Naltrexone hydrochloride CEP 2008-167
12/04/11 Buprenorphine CEP 2007-065
12/04/11 Fentanyl CEP 2005-164
12/04/11 Buprenorphine hydrochloride CEP 2001-278

In March the following CEP has been suspended due to a temporary inability to produce API(s) under the approved conditions:

09/03/11 Metronidazole CEP 1997-083

In 2011 the following CEPs have been withdrawn due to a failure to fulfill - after a suspension - the requirements of the CEP procedure with regard to updating the application and complying with GMP:

14/03/11 Cloxacillin sodium CEP 1997-131
11/03/11 Amoxicillin trihydrate CEP 1997-129
07/03/11 Ephedrine hydrochloride CEP 2004-152
07/03/11 Pseudoephedrine hydrochloride CEP 2004-153
18/02/11 Chlorpropamide CEP 2000-020
18/02/11 Tolbutamide CEP 2000-021
18/02/11 Diclofenac sodium CEP 1999-075
18/02/11 Mefenamic acid CEP 2000-043

Source: EDQM Webpage

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