The pharmaceutical industry can now use a new online platform called CESP (Common European Submission Platform) to submit applications and material related to the licensing of medicines to the Danish Health and Medicines Authority. CESP reduces the administrative burdens of submitting and handling applications on CD/DVD for both the Danish Health and Medicines Authority and the industry, which is why we encourage applicants to switch to CESP submission.
What is CESP?
CESP is a common European online platform which can be used by applicants to submit applications and related material within medicines licensing. In practice, the applicant uploads its material to the CESP server, which is then distributed automatically to the regulatory authorities which are involved in the procedure and participate in the CESP project.
By using CESP, the applicant as well as the Danish Health and Medicines Authority will avoid having to handle and store physical media (CD/DVD), and we therefore hope that our applicants will start using CESP right away.
What can be submitted via CESP
CESP can be used for all marketing authorisation-related submissions, including applications, renewals, variations, PSUR, etc. - whether or not it is a first submission of an application or supplemental information for both human and veterinary medicines.
To begin with, CESP can be used for national procedure, mutual recognition procedure (MRP) and decentralised procedure (DCP), but we expect to accept submissions under the central procedure when CESP is expanded with this option.
At present, CESP cannot be used to submit material within medical devices, GxP, ”Scientific Establishments” and cosmetics to the Danish Health and Medicines Authority, but these areas are nonetheless available on the CESP platform.
Unaltered format and content requirements
CESP submissions are subject to the same format and content requirements that apply to CD/DVD submissions, and they are technically validated according to the same rules.
Therefore, when a company makes a submission to us via CESP (or using another medium), a duplicate copy must not be sent via any other channel (e.g. not both via CESP and CD/DVD or both CESP and Eudralink).
The submissions that the Danish Health and Medicines Authority receives via CESP do not have to be signed.
You can find more information in the Danish Health and Medicines Authority's Guidelines on submission of electronic applications and at cesp.hma.eu, where there is also information about how to be set up as a user on the CESP platform.
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