In October 2021, the EDQM (European Directorate for the Quality of Medicines and Healthcare) published a notification to CEP (Certificate of Suitability) holders stating that Supplement 10.7 of the European Pharmacopoeia is now available and should be implemented on April 1, 2022.

It is important to mention that, in the case of a substance covered by a CEP, it is the responsibility of the manufacturer to comply with the current version of a European Pharmacopoeia monograph, and therefore to update the specification when a revised monograph is issued.

The need to submit information to the EDQM following a revised monograph depends on the changes made to the monograph, These updates are classified in two categories, called “Case A” and “Case B”, as detailed below:

• Case A: The specification of the substance should be updated according to the revised monograph. Unless the CEP holder has referred to the “current version of the monograph” (without providing details on the European Pharmacopoeia tests and methods in the CEP application), the updated specification should be included in the next request for revision that is submitted to the EDQM (minor, major or renewal of the certificate) and identified as such at that time (such an update will be free of charge). Where the CEP holder has made reference to the “current version of the monograph”, the revised monograph should be implemented without the need to update the specification of the substance at the next request for revision.

• Case B: This case concerns amendments to the monograph which requires the submission of data to the EDQM. Therefore, an updated dossier demonstrating that the substance complies with the requirements of the revised monograph should be provided within three months of the EDQM contacting the CEP holder. Considering this scenario, CEP applications require an update and therefore any holder of a CEP for a substance in the “Case B” is expected to provide the requested information to the EDQM, even if no specific request for information was received (this may happen namely when information regarding a change of contact person has not been submitted to the EDQM in a timely manner). If the requested information has already been presented in the approved dossier, a simple letter stating this is deemed sufficient. It is important to emphasize that the failure to update the CEP application and to provide data to the EDQM may challenge the validity of the concerned granted CEP, or delay the ongoing evaluation process of the concerned application. Upon receipt, data will be reviewed within 3 months and the CEP holder will be informed of the outcome of the evaluation. The assessment may also result in a revised CEP being granted.

The EDQM also provided a table containing all substances impacted with the publication of Supplement 10.7 of the European Pharmacopoeia, as well as their classification in “Case A” or “Case B”, so that holders can proceed with the adjustments.

Access the full notice on EDQM’s website: https://bit.ly/3quNtIM.

Also check out our Whitepaper – CADIFA x CEP, containing more details on the issuance of the Certificate of Suitability, in the European Union:

• PT: https://bit.ly/3a84C1N

• EN: https://bit.ly/32chOyB

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