Procedure for submitting registration documentation to SIDC

Registration documentation can be submitted:

  • the CESP portal for all submissions
  • only national registration on the information carrier (CD/DVD).

CESP (Common European Submission Platform)   is a portal for mass submission of applications within the EU and at the same time a platform that is technologically independent of the second application, which allows submission of submitted documentation as well as additional documentation fully in electronic form.

 For additional documentation, it is necessary to send an e-mail to the address cesp.responses@sukl.sk , in which the registration number of the application and the CESP number will be indicated.

Information for submission of PSUR

Information on providing documentation through the CESP portal, including ensuring access to this portal, is available on the HMA website.

Documentation submitted through the CESP portal is submitted compressed into one file in ZIP format. No other compressed file is placed in this ZIP file.

Frequently asked questions and answers about the CESP portal and its use are published on the HMA website.

The national requirements of individual Member States for documentation submitted via CESP are available here.

Documentation may be submitted on an information carrier (CD/DVD) only for national registration in accordance with Act 362/2011 Coll. (Act on Medicines and Medical Devices and on Amendments to Certain Acts). The registration documentation can be submitted together with the application along with a cover letter through the SIDC office.

The following information is required on the CD/DVD:

  • Applicant's name
  • Name of medicine with strength
  • Registration number or registration number
  • Sequence number (as media containing multiple sequences, all must be listed in the accompanying list)
  • Serial number of the media, if the documentation is on several CDs/DVDs – for example 1(3), 2(3), 3(3)
  • Type of submitted documentation (initial application, type of change, additional information, etc.)
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