In the context of having switched to working remotely during the COVID-19 pandemic, the EDQM has prioritised certain activities linked with CEPs over others and it is important to share this with our stakeholders.
Priority is being given to activities related to assessment of all kinds of CEP applications (e.g. new applications, notifications, revisions and renewals), granting of new and revised CEPs and communication of the outcome of assessments to the applicants/holders. Certain other activities are being considered lower priority and will be treated at a future date, for example the closure of CEP applications and cancellation (withdrawal) of CEPs when requested by the holder. Where there is a risk to public health, however, the suspension or withdrawal of a CEP will be treated as a priority and will be handled following our normal procedures.
The EDQM is aware that companies may have issues regarding submissions of information linked to CEP dossiers under assessment and we remind you that we expect to be informed by CEP holders/substance manufacturers if the deadlines cannot be met.
The EDQM is continuously reviewing the impact of the pandemic on all activities and timelines, and will do everything possible to mitigate the effects and will communicate any new action that will be put in place.