CESP: Common European Submission Portal

CESP is operated on behalf of the Heads of Medicines Agencies and is accepted by every EU and EEA national competent authority for submissions to national, mutual recognition and decentralised procedures, including initial applications, variations, renewals, responses to questions and Article 61(3) notifications. It is not a review system: it is a secure transfer route that replaces couriers and national portals, delivering the submission package to each selected authority with a delivery note that carries the procedure number, the product, the submission type and the sequence. Each authority then runs its own technical validation of the eCTD sequence and its own business validation of the content. For centrally authorised products the route is different: submissions to EMA go through the Agency's own eSubmission channels in the PLM Portal, not CESP.

In practice a company registers an organisation and users, creates a delivery for each submission, selects the receiving authorities, uploads the package and the delivery note, and receives an acknowledgement of receipt from the portal and, in many cases, a separate receipt from the authority. One delivery can go to the reference member state and all concerned member states at once, which is what makes CESP the normal route for a decentralised procedure. Some national authorities require CESP for all electronic submissions; others also accept their own portals, so the submission plan has to record which route each authority expects for which submission type.

What goes wrong: the delivery note metadata does not match the eCTD envelope, so the authority cannot file the sequence and asks for a resubmission; the same sequence is sent to a concerned member state twice with different delivery notes; a submission is uploaded to CESP after the authority's cut-off time and misses a procedural start date; the submitter assumes a CESP receipt means the authority has validated the dossier; and periodic safety update reports are sent through CESP when they belong in the EMA PSUR Repository. CESP also carries file size limits, so very large sequences have to be split or delivered another way, which must be agreed with the authority in advance, and the agreement recorded with the submission.