Information on EDQM's procedure for withdrawal or suspension of Certificates of Suitability

02 October 2009, Updated 06 September 2016

A marketing authorisation holder (MAH) has a duty to stay updated on the status of the Certificates of Suitability (CEP) which are authorised under the marketing authorisation.

If the European Directorate for the Quality of Medicines and Healthcare (EDQM) withdraws or suspends a CEP, the marketing authorisation holder must take the necessary measures to ensure that active substances from the concerned active substance manufacturer are not used, either permanently or for a defined period.

Update changes to the status of CEPs

The Danish Medicines Agency and the EDQM currently update changes to the status of CEPs on its website.

The Danish Medicines Agency: News on product defects and withdrawals of medicinal products

EDQM: Certification of Suitability to the Monographs of the European Pharmacopoeia

List of valid or non-valid CEPs

You can generate a list of valid or non-valid CEPs by searching the EDQM’s CEP-database: Certification or you can go to EDQM Databases.

Procedure for withdrawal of CEPs

If you want to know more about the procedure for withdrawal of CEPs: EDQM: Policy ‘Suspension or Cancellation of a Certificate of Suitability' PA/PH/CEP (08) 17, R4 (pdf)

Did you get answers to your questions?

Please tell us how we can improve our website? Please note that we do not answer questions asked via this feature.