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Instructions

Administrative Fee Refund Application

Submission of the marketing authorisation application via DCP, MRP

Submission of the marketing authorisation application via national procedure

SIDC as RMS

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

Submission of ASMF to SIDC

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

Fees for drug registrations connected to the amendment of the Act on Administrative fees

Changes in the registration processes connected to the amendment of the Act on Administrative Fees

Submission of registration documentation concerning the new Marketing Authorisation Applications in the eCTD format from 1. June 2012

Electronically submitted applications regarding marketing authorisation in Slovak Republic - Information on status and national requirements

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

PROCESSING OF ELECTRONIC SUBMISSION ECTD – ONGOING ISSUES

Submission of an application for a marketing authorization, variation or renewal on electronic media (CDs)

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

SIDC as RMS for 2011

Phase I: eApplication submission launch September 7th, 2009

Phase I: eApplication submission planned launch from September 7, 2009

Annex No. 23 to the marketing authorization application

SIDC Guidance on the Processing of Type IA and IB Notifications

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