Information for Marketing Authorization Applicants / Marketing Authorization Holders on the launch of the eApplication submission of new MA applications, variations, transfers or renewals of marketing authorization from September 7th, 2009.
State Institute for Drug Control (SIDC) informs all Marketing Authorization Applicants/Holders that from September 7th, 2009 new electronic system of submission is launched - Phase I: eApplication submission.
The main aim of new system eApplication is:
- electronic allocation of variable symbol - identification number which applicant is using for identifying when transferring fees for payable applications
- electronic tracking of transfers of fees for payable applications
- to obtain and use specific standard data from applications in electronic form
Applications with variable symbol already allocated prior to September 4th, 2009 will be proceeded without any change.
Further information and details are available on website https://portal.sukl.sk/.
