Instructions

Submission of applications

PROCEDURE FOR PAYMENT OF ADMINISTRATIVE FEE

Notice to users of the eVAR payment portal - change of the operating mode after 31. 08. 2024

General information on the power of attorney and letter of authorisation presented to SIDC including FAQ

Registration - Change of application submitting procedure from 1.1.2023

Receiving of applications for SRL

Procedure for submitting registration documentation to SIDC

Update of application for transfer of a marketing authorisation for human medicinal product

SK as RMS

Administrative Fee Refund Application

Submission of the marketing authorisation applications via DC, MR procedures – national requirements

Sunset clause

Announcement of a maintenance of the information system of SIDC

Notification about the possibility to submit authorisation applications and related documents through the CESP Portal

Electronic Application Forms (eAFs) mandatory for all precedures from January 2016

State Institute for Drug Control have joined the CESP system for a pilot phase

Withdrawal of the marketing authorization only for the certain strength of the product

Announcement for applicants/marketing authorization holders - procedure in relation to Commisiion Regulation (EC) No. 1234/2008 concerning the variation to the terms of MA

Annex No. 23 to the marketing authorization application

SIDC Guidance on the Processing of Type IA and IB Notifications

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