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About SIDC
eKolok
Quality Policy
Leadership of SIDC
Mission
Organigramme
Advisory Bodies
Annual Reports
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Fees Guide
List of administrative fees - "eKolok"
Registration of Medicinal Product
Scope of activities
Instructions
Scientific Advice
Contact
Fees
Forms/Tlačivá
Inspection
Scope of activities
Instructions
Drug manufacture
Pharmacy
Distribution
Transfusiology
Post-authorisation quality control
Contact
Pharmacovigilance
Scope of activities
Instructions
Contact
Clinical trials
Scope of activities
Instructions
Clinical Trials Procedures
Contact
Fees
Laboratory Control
Scope of activities
Instructions
Contact
Medical Devices
Scope of activities
Instructions
List of registered / announced medical devices, codes and economic operators from 1.1.2018
Contact
Links
Pharmacopoeia
Pharmacopoeia department
Main menu
COVID-19
About SIDC
List of administrative fees - "eKolok"
Info
eKolok
eKolok - Information for applicants and users of the services of SIDC
eKolok - List of administrative fees 2024
Bank account affidavit
Administrative Fee Refund Application (TL 129)
Fees Guide
Quality Policy
Leadership of SIDC
Mission
Organigramme
Advisory Bodies
Committee for Drug Safety
Members
Pharmacopoeia Committee
Members
Annual Reports
Annual Report 2016
Annual Report 2015
Key Performace Indicators in 2014
Key Performace Indicators in 2013
Key Performace Indicators in 2012
Key Performace Indicators in 2011
Key Performace Indicators in 2010
Annual Report 2009
Annual report 2008
Annual report 2007
Annual report 2006
Annual report 2005
Annual report 2004
Annual report 2003
Links
Registration of Medicinal Product
Fees
Scope of activities
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
Scientific Advice
Forms/Tlačivá
Contact
Laboratory Control
Scope of activities
Instructions
Administrative batch release of vaccines and medicinal products derived from human blood or plasma
Internationally Harmonized Requirements for Batch Certification
Contact
Inspection
Scope of activities
Instructions
List of inspectors
Drug manufacture
List of drug manufacturers
Pharmacy
Online dispensing
List of pharmacies
List of online retailers
Distribution
List of issued certificates of compliance with the principles of GDP
Transfusiology
List of issued certificates of good preparation practice for blood products
Post-authorisation quality control
Parallel importation & Parallel distribution
Medicine shortages
Information on falsified medicines
Recall of medicinal products
Contact
Drug Precursors
Scope of activities
Legislation on Drug Precursors
Corrigendum to Commision Delegated Regulation (EU) 2015/1011 of 24 April 2015 supplementig Regulation (EC) No 273/2004 of the European Parliament and of the Coucil on drug precursors and Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors, and repealing Commision Regulation (EC) No 1277/2005
COMMISSION DELEGATED REGULATION (EU)
Corrigendum to the Commission Delegated Regulation (EU) 2015/1011 of 24 April 2015 supplementing Regulation (EC) of the European Parliament and of the Council on drug precursors
COUNCIL REGULATION (EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the M1 Union and third countries in drug precursors
REGULATION (EC) No 273/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 February 2004 on drug precursors
COMMISSION IMPLEMENTING REGULATION (EU) 2015/1013 of 25 June 2015 laying down rules in respect of Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and of Council Regulation (EC) No 111/2005 (drug precursors)
COMMISSION DELEGATED REGULATION (EU) 2015/1011 of 24 April 2015 supplementing Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and Council Regulation (EC) No 111/2005 (drug precursors)
COMMISSION REGULATION (EC) No 1277/2005 of 27 July 2005 laying down implementing rules for Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors
COMMISSION REGULATION (EC) No 297/2009 amending Regulation (EC) No 1277/2005
COMMISSION REGULATION (EU) No 225/2011 of 7 March 2011 amending Commission Regulation (EC) No 1277/2005 (drug precursors)
№ 331 ACT of 23 June 2005 on state administration authorities in matters of drug precursors, and on amendments and additions to some laws
REGULATION (EU) No 1258/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 November 2013 amending Regulation (EC) No 273/2004 on drug precursors
REGULATION (EU) No 1259/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 November 2013 amending Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors
Contact
Pharmacovigilance
Vaccines
Vaccines against COVID-19
Scope of activities
Contact
Clinical Trials
Scope of activities
Instructions
Form for submitting clinical trial documents to the SIDC
Labelling requirements for Investigational Medicinal Product
Adverse event/reaction in a clinical trial - Reporting requirements in the Slovak Republic
Main changes in Slovak Drug Law - Clinical trials (human)
Clinical Trials Procedures
Fees
Administrative fees for clinical trials under Regulation No. 536/2014
Contact
Pharmacopoeia
Scope of activities
Instructions
Contact
Medical Devices
Scope of activities
News
Instructions
Links
Contact
Media
News
From December 27, 2022 to January 5, 2023, the Post Registry Office and the Client Center of SIDC will be temporarily closed
Slovak human and veterinary medicines agencies hosted the second meeting of the Heads of Medicines Agencies
In October, the SIDC presidency meetings focused on medical devices issues and public relations
The Heads of Medicines Agencies was held in Bratislava
European Commission launches a new mandatory logo for online sale of medicines to protect patients from falsified medicines
Contact
Databases and Services
Database of Medicinal Products
Database of Medical devices
Database of Medicinal Products
Searching on the web
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Sitemap
A - Z index
Abbreviations
E
EMEA
EDQM
EDMF
EEA
EEC
EFPIA
EPAR
EWP
F
FDA
V
VICH
VMRFG
S
S+T
SZP
SZO
SVP
SPK
SPC
SNAS
SleP
SKP
SIDC
SAFS
SMF
SZU
Q
QWP
QRD
N
NTA
M
MAH
MV SR
MRP
MRK
MPSVaR
MHRA
MH SR
MF SR
MS
MRFG
MRA
MZ SR
I
ICH
IFAH
IWP
IMP
H
HMPC
G
GCP
GLP
GMP
W
P
PIC
PIL
PIC/S
Ph.eur.
PICS
PhVWP
PHARE
PERF
PECA
PSL
O
OMCL
OECD
ObÚ
B
BfArM
BPC
BWP
BOZP
A
ACRP
ATC
A.R.
ASMF
API
ANMAT
AIMD
AIM
AFSSAPS
AESGP
ADR
ADL
C
CHMP
CMS
CAP
CVMP
CTD
COMP
CEEC
CAVDRI
CAPs
CADREAC
ČSL
R
RSV
Contact
Business Hours
Bank Contact
Phone Numbers
Address
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