4. Submission


2. Electronic Application forms (eAF), eSubmission-Gateway and -Web Client and Common European Submission Platform (CESP)

2.3. Common European Submission Platform (CESP)

The HMA network (collaboration between Heads of Medicines Agencies in all member states) has developed the CESP mainly for national procedures (NPs, MRPs, DCPs).

CESP is an online delivery system with the following features:

  • a simple and secure mechanism for exchange of information between stakeholders and agencies;
  • allows submission of an application through one portal and distributing it to one or more agencies simultaneously (upload a dossier only once into the system);
  • currently provides a delivery system for:
  • accepts all submission types and includes mechanisms to handle resubmitting of updated information;
  • is a unidirectional system, from Industry to Regulator, with simple notification systems; CESP is purely a delivery system.
  • can manage files and folders of varying sizes
  • eliminates the effort for both Industry and Regulators in handling CD/DVD submissions

The CESP is optional for agencies to participate but is in operation in the majority of member states. All member states involved can extract the submission from the CESP repository.

The system will not perform validation, the respective agency will still validate the submission on receipt, but companies should carry out their own validation prior to submission.

For the interested

The progressive development of the electronic handling of regulatory processes between companies and regulatory authorities is an ongoing activity between the partners. An example are recent changes in Application Forms:

1) Implementation of mandatory use of the eAF is part of the HMA eSubmission roadmap. New version of all eAFs is available for use from 1 October 2021. Mandatory use of these from 1 November 2021

2) The changes, in summary, are an updated section on Medical Devices in the human MAA form, addition of a new section on Medical Devices in the variation form, addition of new sections on parallel variations and on Harmonisation relating to National Variations.