Europe – Delays in treatment of requests for revision and renewal of CEPs

The EDQM is currently having some difficulty in achieving the assessment times for revisions and renewals of CEP applications – both initial requests and assessment of responses to requests for information. The delay is currently around 5 weeks (i.e. the outcome of the assessment is being communicated 5 weeks after the expected date). EDQM does assure applicants that the outcome will be communicated as soon as the assessment is complete.

EDQM takes the opportunity to apologise for the inconvenience that these delays may cause. The revisions/renewals are being treated based on the deadline assigned at reception, which is dependent on the type of revision/renewal. EDQM is also taking every effort to improve the efficiency of the process of performing the assessment of the revision/renewals in order to decrease the delays currently being experienced. EDQM believes that the delays will be eliminated by the end of 2019 barring unforeseen events.

EDQM is communicating about the delays being experienced to enable the applicants to adjust their planning around the regulatory activities involving CEPs. This also allows any CEP holders intending to submit any revision/renewals in the later part of 2019 to be aware of the current situation and plan accordingly.

The performance of EDQM regarding the treatment “on-time” of all submitted requests is included in the Certification monthly report available on the EDQM website. In the report the percentage of revisions in time and the mean difference between the actual time taken and the deadline can be seen…