Drug database
Mandatory disclosures
State Institute for Drug Control
The State Institute for Drug Control (hereinafter referred to as SÚKL or the Institute) is an administrative body of the Czech Republic, an organisational unit of the state and a national competent authority for human medicinal products reporting to the Ministry of Health. The SÚKL´s task is to ensure that only quality, safe and effective medicines, as well as functional and safe medical devices, are used in the Czech Republic. Its activities are regulated by Czech law and international treaties.
History of the Institute
The history of SÚKL goes back to the beginning of the formation of Czechoslovakia as an independent state. The immediate predecessor of today’s Institute was the ‘Institute for Drug Research’, which was established in 1918. The laboratories of this Institute were first located at several departments of Charles University in Prague and from 1931 were concentrated in the National Institute of Public Health (SZÚ), on the premises of which, in buildings 24 and 30, the State Institute for Drug Control is still located today.
SÚKL was separated from the organisational structure of the National Institute of Public Health (SZÚ) by a decree of the Ministry of Health on 24 April 1952. On this occasion, the Institute’s activities were extended to include “the control of medical and diagnostic aids and disinfectants or other”. In 1969, all the Institute’s departments were moved to a new building on the premises of SZÚ No 24.
In 1992, the so-called “drug control laboratories” were included in the Institute to control the operation of pharmacies, to control the handling of medicinal products supplied to hospitals and to control the quality of raw materials supplied to pharmacies by distributors. These laboratories were formerly part of the Pharmacy Service and operated regionally within Regional Institutes of National Health. In the same year, the Institute was assigned the agenda of the approval of medical devices and the assessment of medical devices used in the health sector.
In 1997, by decision of the Minister of Health, this agenda was extended to cover all approval activities relating to all types of medical devices. The scope of the Institute’s activities in the field of pharmaceuticals was refined in 1997 by Act No 79/1997 Coll., on pharmaceuticals. In the area of medical devices, the scope of the Institute’s activities was regulated by Act No 123/2000 Coll. on medical devices, which focused on the Institute’s activities in this area ensuring the safety of devices already on the market. The process of approval of medical devices was transferred to the Ministry of Health of the Czech Republic.
By Act No. 138/2002 Coll., which amended the Act on Advertising Regulation on 1st June 2002, the Institute became the supervisory authority for the supervision of advertising of medicinal products for human use.
With effect from 1st January 2008, Act No. 48/1997 Coll., on Public Health Insurance, the SÚKL was entrusted with setting the maximum prices of medicinal products and determining the amount and conditions of reimbursement of medicinal products. Since the same date, the Institute has been carrying out price control of medicinal products, food for special medical purposes and medical devices.
The activities of the Institute were extended by Act No 296/2008 Coll., on human tissues and cells, which, with effect from 18 October 2008, the Institute was ensuring supervision of the quality and safety of human tissues and cells intended for human use.
The Act No. 167/1998 Coll., on Addictive Substances, extended the supervisory activities of SÚKL to the area of psychotropic substances.
The last change in the scope of the Institute’s activities was brought by the amendment to Act No. 456/2023 Coll. on Medicinal Products, which set new rights and obligations for the entities ensuring the availability of medicinal products for patients in the Czech Republic.
Directors of SÚKL (since 1952):
- From 1952 – Prof. PhDr. PhMr. Eduard Skarnitzl
- From 1959 – Ing. Jan Buriánek, Csc.
- From 1982 – doc. MUDr. Jiří Elis, DrSc.
- 31.8.1990 – 25.2.1991 temporally assigned as director RNDr. Jan Mikeska, CSc.
- From 1991 – doc. RNDr. Jiří Portych, CSc.
- From 1993 – RNDr. Jan Mikeska, CSc.
- From 1994 – MUDr. Milan Šmíd, CSc.
- 12.7 2006 – 15.9.2006 temporally assigned as director MUDr. Michal Sojka
- 16.9.2006 – 31.12.2006 temporally assigned as director RNDr. Jitka Šabartová, CSc.
- From 2007 – PharmDr. Martin Beneš
- From 2012 – MUDr. Pavel Březovský, MBA
- From 2014 – PharmDr. Zdeněk Blahuta
- 1. 7. 2018 – 20. 9. 2024 Mgr. Irena Storová, MHA
- 21. 9. 2023 – 20. 12. 2023 Mgr. Kateřina Podrazilová, PhD.
- 21. 12. 2023 – 30. 4. 2024 temporally assigned as director PharmDr. Jakub Velík, PhD.
- From 1. 5. 2024 till now – MUDr. Tomáš Boráň
Contemporary role and activities of the Institute
The State Institute for Drug Control, with its registered office at Šrobárova 48, Prague 100 41, is an administrative body established by Act No. 79/1997 Coll. as organisational unit of the state and a national competent authority for human medicinal products reporting to the Ministry of Health.
The Institute’s scope of activities is established by national legislation.
The Institute establishes regional offices located outside the Institute’s registered office for securing designated tasks within the scope of activities of SÚKL.
The mission of the Institute is, in the interest of protecting the health of citizens:
- to ensure that only high quality, effective and safe human medicinal products are available in the Czech Republic,
- to ensure that only safe and functional medical devices are used in the Czech Republic, always provided with reliable and relevant information,
- to contribute to the rational use of medicinal products and medical devices and, where appropriate, to responsible and ethical clinical trials,
- ensure that regulatory measures are applied appropriately preventing unnecessary barriers to the availability of medicinal products and medical devices and during the introduction of new treatments.
The Institute performs the following activities in the Czech Republic:
state supervision over human medicinal products throughout their life-cycle. The Institute is responsible for the monitoring of the quality, efficacy and safety of medicinal products, including accompanying information, at all stages of their development and use. For these purposes, the Institute uses pre-notification, authorisation and registration procedures, inspections, laboratory controls, monitoring the use of medicinal products in practice, supervising the advertising of medicinal products and collecting all relevant information. Since 1 January 2008, the Institute has been carrying out price control of medicinal products, foodstuffs for special medical purposes and medical devices. Since the same date, it has been empowered to decide through administrative procedure about the maximum prices of medicinal products or foodstuffs for special medical purposes and about the amount and conditions of their reimbursement from health insurance.
The Institute is authorised to intervene in the event of health risks, to apply sanctions and to require the necessary documents.
In the field of medical devices, the Institute carries out inspections of healthcare providers, investigation of adverse incidents and clinical trial evaluation.
The scope of the Institute´s competencies in the field of regulation of medicinal products and medical devices is defined by national legislation and international law (see the section on legislation).
4.1. Contact postal address
State Institute for Drug Control
Šrobárova 49/48, 100 00 Prague 10, Czech Republic
Addresses and contact details of the regional offices of the Pharmacy and Distribution Control Section (OKL) are available on the page Regional Offices of SÚKL.
4.2. Address of the office for a personal visit
Contacts to the individual workplaces are available here.
4.3.Office hours
Mon to Thurs: 8am-3pm, Fri: 8am-2pm
4.4. Phone numbers
Switchboard office/general contact: +420 272 185 111
Mail room:+420 272 185 806
Checkout: +420 272 185 803
Information Department: +420 272 185 333 (Operating hours of the information line are Monday to Friday from 9:00 a.m. to 2:00 p.m.)
ePrescription Call centrum: +420 272 185 555
Contact for press: +420 272 185 712, +420 702 207 242
Continuous service* for reporting defects in the quality of medicinal products: Phone: +420 272 185 777 (Outside working hours Monday to Friday from 16:30, outside working days continuously)
Continuous service* for vigilance reporting for medical devices: Phone: +420 272 185 999 (Outside working hours Monday to Friday from 16:30, outside working days continuously)
Security: +420 272 185 113
* Round-the-clock service – ensures that SÚKL immediately deals with crisis situations that arise mainly as a result of the discovery of defects in the quality of medicines and serious adverse events of medical devices that may endanger life or cause a serious threat to health. The round-the-clock service only deals with serious cases that cannot be dealt with during working hours.
4.5. Website address
4.6. Mailroom address
State Institute for Drug Control, Šrobárova 49/48, 100 00 Prague 10, Czech Republic
List of technical data carriers on which the obliged entity receives documents in electronic form.
4.7. Electronic mailroom address
posta@sukl.gov.cz
4.8 Data Box
Data box qwfai2m (Maximum data message size is 100 MB), Mailbox
CIN: 000 23 817
VATIN : CZ00023817
8.1 List of main documents
Statutes
Strategic plan SÚKL 2021-2025
Quality Policy of the Institute
Anti-corruption strategy
8.2 Budget
The State Institute for Drug Control provides information on the basis of Act No 106/1999 Coll., on Free Access to Information, as amended, and Methodological Guideline of the Government on Uniform Procedure of Public Administration Bodies in Safeguarding the Right of Natural and Legal Persons for the Provision of Information Pursuant to Act No 106/1999 Coll., on Free Access to Information.
Requests or complaints, suggestions, instigations or other letters of request may be submitted via the Mailroom or electronic mailroom (see above). Decisions on rights and obligations are delivered in compliance with the Code of Administrative Procedure.
Information concerning the receipt of various kinds of applications is available in relevant SÚKL guidelines under Guidelines and Forms, structured by regulatory areas.
11.1 The most important regulations used
Below you can find all of the basic legal regulations governing the operation of the State Institute for Drug Control. For currently valid and effective texts of all of the aforementioned legal regulations in electronic format, please refer to the Collection of Laws available from the website of the Ministry of Interior of the Czech Republic. An adopted act comes into force (and hence becomes public) as at the day of its promulgation in the Collection of Laws and takes effect as at the date stipulated by the act.
Other sources of information from the legislative area are available on the website of the Chamber of Deputies of the Parliament of the Czech Republic and the Senate of the Parliament of the Czech Republic.
11.2 Issued legal regulations
The State Institute for Drug Control does not issue any legal regulations.
12.1 Information provision reimbursement pricelist
For activities associated with the provision of information, the State Institute for Drug Control is authorised to require reimbursement in compliance with the provision of Section 17 of Act No 106/1999 Coll., on Free Access to Information, as amended.
Reimbursements as per the currently effective version of Guideline UST-29 Administrative fees, reimbursements of costs of expert activities, reimbursements of activities associated with the provision of information. Reimbursement of costs as per this Pricelist is required only in cases where the costs of the provision of information exceed 100,- CZK ex. postal service costs.
Reimbursement of costs of activities associated with the provision of information:
A/ Printing of copies:
A4 copy – single-sided 2 CZK/pc
A4 copy – double-sided 4 CZK/pc
A3 copy – single-sided 4 CZK/pc
A3 copy – double-sided 8 CZK/pc
A4 scan 2 CZK/pc
B/ Provision of technical data media
CD/DVD 10 CZK/pc
C/ Sending of the information to the applicant
Postal services as per the current pricelist of the Czech Post (Česká pošta, s.p.)
D/ Exceptionally extensive searches of information pursuant to the Act on Free Access to Information:
Information search: 305 CZK/hr (per every begun hour)
Compensation for services associated with the provision of information and services of expert library:
E/ Inter-library loan service (MVS):
Loan of a library item from the library is free of charge
Copy from a database 20 CZK/10 pages of the original (incl. incomplete pages)
F/ Review, information from expert databases:
Review processing: 80 CZK/0.5 hr (per every begun hour)
Fee for output – please refer to Reimbursement of costs of activities associated with the provision of information, sections A.-C.
12.2 Decision of a supervisory authority on the amount of reimbursements for the provision of information
Decision of the Ministry of Health ref. no. MZDR 37330/2019-2/PRO of 29 August 2019, confirming the amount of reimbursement for the provision of information pursuant to Act No 106/1999 Coll. in compliance with Section 16a(7)(a) of Act No 106/1999 Coll.
13.1 Specimen licence agreements
Not applicable to SÚKL.
13.2 Exclusive licence
Not applicable to SÚKL.
The Annual Report compliant to the Act on Free Access to Information is available from the website at Annual report on the provision of information.