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

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 MAH 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

List of valid or non-valid CEPs

You can generate a list of valid or non-valid CEPs by searching the EDQMs CEP-database: Certification. Also see: Overview EDQM databases.

Procedure for withdrawal of CEPs

If you want to know more about the procedure for suspension or withdrawal of a CEP see: EDQM Policy "Suspension or Cancellation of a Certificate of Suitability"