The amendment
introduced a new type of reimbursement procedure for products intended for
immunisation (vaccines), designed primarily for non-mandatory vaccination. As
of 1 May 2026, according to information from the State Institute for
Drug Control (the Institute), 10 administrative proceedings had been
initiated and are currently at various stages of progress.
This type of
procedure is intended to apply the principle of multi-criteria assessment,
placing emphasis not only on economic but primarily on non-economic criteria
reflecting broader societal needs and interests. In addition to
the standard reimbursement criteria (safety, efficacy and, in the case of
vaccines, immunogenicity), the criteria assessed also include, for example:
the severity of the disease targeted by the
vaccine,
the broader societal importance of prevention,
the public health benefit, including increased herd
immunity, prevention of threats to public health, and support for and
improvement of population health,
recommendations issued by professional societies
and institutions.
A different
approach also applies tobudget impact, where a high budget impact may
reflect high vaccination uptake, which is desirable in this context. Budget
impact is therefore assessed as the difference between the costs of prevention
and the costs of treatment, diagnostics and broader societal costs that would
arise in the absence of immunisation.
The Institute’s
assessment report will also include an opinion of theNational Institute of
Public Health (SZÚ). SZÚ has already provided opinions in the first two
administrative proceedings, focusing in detail on the epidemiology of the
diseases concerned. It also addresses the health, societal and economic impacts
of the diseases and the extent to which these may be mitigated through
vaccination. The opinion further includes a recommended time horizon for the
budget impact analysis, taking into account the characteristics of the disease,
as well as an overview of currently applicable vaccination recommendations.
As in the case
of orphans, the assessment report will subsequently be reviewed by the advisory
body of the Ministry of Health (MoH) during a closed session, in which a
conciliation procedure will take place.
The
subsequently issued binding opinion of the MoH will then be incorporated into
the final decision issued by the Institute.
Our knowledge, your opportunity.
The article is based on publicly available information concerning administrative proceedings conducted by SÚKL in the area of pricing and reimbursement.
The amendment to the Public Health Insurance Act, effective from the beginning of 2026, introduced a dedicated reimbursement procedure for selected vaccines. The first proceedings are already...
At
the beginning of April, a draft amendment to the Act on the Regulation of
Advertising and the Act on Medical Devices and In Vitro Diagnostic Medical
Devices was circulated to Members of Parliament. Among other things, it focuses
on advertising of selected sensitive commodities, including human medicinal
products and medical devices. The
scope of the Act is not limited to B2C relationships, i.e. advertising
directed at the general public, but also extends to B2B relationships,
including advertising targeted at healthcare professionals and employees of
healthcare providers. The
expected effective date of the amendment is 1 January 2027.
In
the following article, we present selected areas of the proposal in relation to
specific product categories.
Medicinal
Products
The
draft expands the definition of advertising, under which all forms of
information, market research or incentives intended to promote prescribing,
sale, dispensing or consumption will newly be considered advertising.
The
amendment also sets out strict conditions under which patient programmesmay be conducted so that they are not regarded as impermissible advertising.
Changes
will also affect advertising targeted at healthcare professionals. Commercial
representatives will newly be allowed to provideSummaries of Product
Characteristics (SPC) and reimbursement information also in the form of a
link to a source enabling remote access.
Conversely,
stricter rules will apply to the provision offree samples, including
limits related to the duration of treatment.
The
amendment also introduces exemptions from regulation, particularly for
incentive programmes run by health insurance funds and for educational
programmes aimed at non-physician healthcare professionals.
Medical
Devices (MD) and In Vitro Diagnostic Medical Devices (IVD)
For
medical devices and in vitro diagnostic medical devices, the definition of
advertising is both expanded and clarified. Advertising will explicitly
include, for example, lotteries, similar games, or consumer experience-based
testing.
A
more precise definition is also introduced for therecipients of comparative
advertising, replacing the previously used general term “professionals”.
As
with medicinal products, certain exemptions from regulation are defined.
A
separate section is dedicated to patient programmes, which aim to
improve awareness of diseases, diagnosis and treatment, as well as to support
patient cooperation in healthcare provision and to provide training and
guidance on the proper use of prescribed medical devices.
Fines
The
amendment introduces new obligations and therefore significantly expands the
list of actions(administrative offences) subject to penalties.
A fine of
up to CZK 500,000 may newly be imposed, for example, for conducting
patient programmes in breach of the law—whether due to violation of their
intended purpose, content, or the provision of prohibited benefits to
patients. The same fine applies to failure to meet notification
obligations towards SÚKL, breaches of hospitality rules in online
professional meetings, and similar cases.
Fines of
up to CZK 2,000,000 are newly expressly applicable to organising
prohibited competitions, lotteries and user tests for medicinal products
and medical devices, for missing or outdated information in advertising
directed at professionals, or for exceeding limits on the number of
samples.
Fines of
up to CZK 5,000,000 may be imposed for suggesting that the safety
of a medicinal product is guaranteed by its natural origin, for using
inappropriate depictions of bodily changes, or for providing gifts and
benefits to healthcare professionals that are unrelated to their professional
activities, among other violations.
Healthcare
professionals themselves may newly face fines of up to CZK 100,000 if
they actively request prohibited benefits or excessive hospitality, rather than
merely accepting them.
Would you like to stay informed about changes in legislation? Feel free to contact us. At Pharmeca, we help you navigate the complex landscape of
pharmaceutical and medical device information. We also offer flexible services
that can be tailored to your needs at any time.
Our market position and experience allow us to support you whenever you
need expert guidance.
As of January next year, the currently discussed draft amendment to the Act on the Regulation of Advertising may come into force. It introduces a number of new regulatory requirements and...
In proceedings concerning the determination or modification of the
amount and conditions of permanent reimbursement of medicinal products, where
pharmacoeconomic evidence is submitted, comparative clinical efficacy and
safety must be demonstrated against all relevant comparators. According to
the methodology of the State Institute for Drug Control (SÚKL), relevant
comparators may include therapies that are commonly or routinely used and
reimbursed from public health insurance. These are not limited to medicinal
products.
The requirement for relevant comparators was modified in 2022 for
proceedings on the reimbursement of orphan medicinal products (Section 39da),
when the advisory body of the Ministry of Health introduced the following
requirement for this specific type of proceedings: “…that any future application for reimbursement of an orphan
medicinal product for which comparators reimbursed from public health insurance
exist (whether with reimbursement determined by the Institute in administrative
proceedings or under Section 16 of Act No. 48/1997 Coll.) must include a
cost-effectiveness analysis against such comparators.” As a result, in reimbursement proceedings for orphan medicinal
products conducted under Section 39da, therapies reimbursed not routinely but
under exceptional reimbursement pursuant to Section 16 are commonly
included among comparators—even in cases where their use is off-label
within the given indication.
This approach has also been identified in proceedings concerning
the determination of permanent reimbursement for a non-orphan medicinal
product, where SÚKL likewise accepted as a comparator a product reimbursed
under Section 16. However, in another case involving the use of a comparator
reimbursed under Section 16, SÚKL argued in its assessment report, for example,
as follows: “…treatment provided under Section 16 of the Public Health
Insurance Act is, by its nature, exceptional and cannot be considered the least costly standard option for the purposes of general reimbursement
setting…’”
It remains to be seen whether, in the future, the approach to the
use of Section 16 comparators will become harmonised across different
groups of medicinal products, and whether the position of Section 16–reimbursed
treatments will gain greater importance even in standard reimbursement
proceedings.
Section 16 of Act No. 48/1997 Coll., on Public Health Insurance The competent health insurance fund shall reimburse, pursuant to
Section 19(1)(a), in exceptional cases healthcare services otherwise not
covered by health insurance, provided that the provision of such healthcare
services constitutes the only option in view of the insured person’s health
condition.
Are you interested in reading regular commentaries on decisions by
Pharmeca a.s.? Feel free to contact us.
At Pharmeca, we help you navigate the complex landscape of
pharmaceutical and medical device information. We also offer flexible services
that can be tailored to your needs at any time.
Our market position and experience allow us to support you whenever you
need expert guidance.
In the case of rare diseases, it is not uncommon in practice that reimbursement is granted under Section 16. However, a medicinal product reimbursed in this way may also play a significant role in...
The
Public Health Insurance Act No. 48/1997 Coll. provides in Section 16:
“The
competent health insurance fund shall reimburse, pursuant to Section 19(1)(a),
in exceptional cases healthcare services otherwise not covered by health
insurance, provided that the provision of such healthcare services constitutes
the only option in view of the insured person’s health condition.”
That
such requests are not rare is evidenced, for example, by statistics published
by the General Health Insurance Company of the Czech Republic.
In cases of non-reimbursed treatment, its use pursuant to Section 16—which allows reimbursement in justified cases—is not uncommon in practice. The complexity of such assessments is also reflected...
Each European country approaches
the pricing and reimbursement of medicines in its own way. The common objective
is to ensure access to medicines that meet EU-wide standards of quality, safety
and efficacy. However, differences in the design of national systems have a
direct impact not only on price levels, but also on the availability of
medicines, market structure and manufacturers’ behaviour. Number of Initiated
Proceedings: The Reality of the Czech Market
According to the European
Medicines Agency Annual Report (European Medicines Agency, 2025), a total of
114 medicines were authorised through the centralised procedure in 2024,
including 46 medicines containing a new active substance (the authorisation of
one product was subsequently withdrawn).
Our analysis, conducted as of 1
March 2026, confirms that among medicines containing a new active substance
approved by the European Medicines Agency in 2024:
✅ Price and reimbursement
have been determined for only 5 of the 45 medicines,
⏳ Administrative proceedings
on price and reimbursement determination are ongoing for 20 medicines,
🛑 For 20 medicinal products, the marketing authorisation holder has not yet submitted an application for inclusion in the List of Reimbursed Medicines,
🚚 Distribution has
been initiated for 16 medicines, regardless of whether reimbursement has
been established.
These figures suggest that the
path of new innovative medicines to the Czech market is often slow and
administratively demanding, which may have a direct impact on both patients and
manufacturers. The Question: Reasons for
Delays
The 2025 study Medicines:
Regulation versus Patient Needs, conducted by the Initiative for Efficient
Healthcare (Hlávka et al., 2025), points out that the strict and long-standing
rules governing reimbursement determination are primarily focused on limiting
the budgetary impact. Typical measures include:
reimbursement limited to only part of the indicated
patient population,
prescription restrictions limited to specific
medical specialties or specialised healthcare facilities.
Such restrictions directly affect
the availability of medicines and may reduce the attractiveness of the Czech
market for manufacturers, which can lead to delayed market entry of innovative
therapies. Recommendations: Flexibility
and Modern Financing Instruments
The authors of the study
recommend:
introducing a more flexible willingness-to-pay
(WTP) threshold, better reflecting disease severity, the level of
innovation and patient needs,
using modern financing mechanisms, such as coverage
with evidence development (CED) or risk-sharing arrangements,
further developing multi-criteria decision analysis
(MCDA) for very high-cost medicines.
The study also highlights
additional factors affecting the market, including dependence on imports, the
underutilised potential of pharmacists, the need to work with real-world data,
and the importance of supporting competitiveness and self-sufficiency in the
pharmaceutical sector. The patient perspective is not
overlooked either:
“For medicines to be
effective, it is essential that patients understand their disease and therapy,
and that they know why and how to use medicines correctly and safely.”
Source:
European
Medicines Agency. (2025). Annual report 2024. Publications Office.
https://data.europa.eu/doi/10.2809/6143038
Hlávka, J., Klimková, V., Brychtová, M., Selinger, E.,
Přecechtěl, Š., Milošič, A., Chadimová, K., Decker, B., Navrátil, M., Vaniš,
K., & Kučera, M. (2025, září). IEZ_Studie_Zdravotnictvi pro
budoucnost_4-Leciva.pdf. Studie 2025: Léčiva: regulace versus potřeby
pacientů.
https://www.efektivnizdravotnictvi.cz/post/studie-2025-leciva-regulace-versus-potreby-pacientu
Each European country approaches the pricing and reimbursement of medicines in its own way. The common objective, however, is to ensure that patients have access to medicines that meet EU-wide...
In
2025, 12 decisions of the State Institute for Drug Control(SÚKL) became
legally effective in administrative proceedings relating to the determination
of price and reimbursement for orphan medicinal products. Although the system
introduced in 2022 is formally structured around SÚKL decisions, the Institute
may not deviate from the binding opinion of the Ministry of Health of the Czech Republic.
In 2025, SÚKL issued a total of 12 final decisions in proceedings concerning the determination of price and reimbursement for orphan medicinal products, based on binding opinions of the Ministry of...
The determination of prices and reimbursement of medicinal
products is based on external price referencing, within which foreign
prices denominated in foreign currencies are converted into Czech crowns.
Currently, foreign prices are converted using the quarterly
average exchange rate published by the Czech National Bank for the calendar
quarter preceding the calendar quarter in which the administrative proceedings
were initiated (the “relevant exchange rate”).
According to the amendment to the implementing decree, where
no more than three manufacturer prices of a given medicinal product are
available and the relevant exchange rate differs by more than 10 % from
the average exchange rates over the six quarters preceding the relevant
exchange rate, the conversion for the affected medicinal product is carried
out using the average exchange rate over those six quarters.
Where more than three manufacturer pricesof a given
medicinal product are availableand the relevant exchange rate differs by more
than 10 %from the average exchange rates over the six quarters preceding
the relevant exchange rate, such a price is excluded from the calculation.
To make it easier to assess whether these conditions are
met, we have updated a visual support tool on our website.
With a single
click, you can now find not only the relevant average exchange rate for the
preceding quarter but also its deviation compared to the previous six quarters.
The amendment to the Public Health Insurance Act and its implementing decrees has introduced changes, effective from the beginning of the year, also in the way exchange rates are applied for price...
Pharmeca a.s. provides
services within the scope defined by the following legislative framework:
Act No. 48/1997 Coll.,on
Public Health Insurance and on Amendments to Certain Related Acts, as
amended.
Implementing regulations
(selected):
Decree
No. 376/2011 Coll.,
implementing certain provisions of the Public Health Insurance Act, as
amended,
Notice of the Ministry of Health No. 529/2025 Coll., on the
antigenic composition of vaccines against pneumococcal infections for
vaccination of insured persons over 65 years of age
Notice of the Ministry of Health No. 23/2024 Coll., on the
antigenic composition of vaccines against pneumococcal infections for childhood
vaccination and for insured persons with health risk factors
Notice of the Ministry of Health No. 273/2024 Coll., on the
antigenic composition of reimbursed vaccines for influenza vaccination of
persons over 65 years of age
Notice of the Ministry of Health No. 474/2021 Coll., on the
antigenic composition of reimbursed vaccines against human papillomavirus
Decree No. 432/2025 Coll., on the
determination of the value of a point, reimbursement levels for reimbursed
services, advance payments, and regulatory limitations for 2026
Notice of the Czech Statistical Office No. 159/2018 Coll.,
introducing the CZ-DRG classification of hospitalized patients
Decree No 384/2007 Coll., on
the list of reference groups, as amended,
Decree No 385/2007 Coll., on
the list of medicinal substances intended for supportive or adjunctive
treatment, as amended,
Decree No. 63/2007 Coll., on reimbursement
of medicinal products and foods for special medical purposes, as amended.
Decree No. 618/2006 Coll., issuing
framework contracts, as amended,
Decree No. 134/1998 Coll., issuing
the list of healthcare procedures with point values, as amended,
Decree No. 527/2021 Coll., on
the determination of the amount of reimbursement of expenses for expert
acts and the method for determining the amount of reimbursement of
expenses for expert consultations carried out by the State Institute for
Drug Control pursuant to the Act on Public Health Insurance, as amended,
Decree on the determination of the value of a
point, reimbursement levels for reimbursed services and regulatory
limitations – issued annually for the relevant period,
Government Regulation No. 307/2012 Coll., on
local and temporal availability of healthcare services, as amended.
Act No. 551/1991 Coll.,
on the General Health Insurance Company of the Czech Republic, as
amended.
Act No. 280/1992 Coll.,
on sectoral, professional, company and other health insurance companies, as
amended.
Implementing regulations to the
Health Insurance Acts (selected):
Decree No. 421/2025 Coll., on the
determination of certain contributions from the fund of generally
beneficial activities of the General Health Insurance Company of the Czech
Republic and sectoral, professional, company and other health insurance
companies for 2026, as amended
Decree No. 125/2018 Coll., on
information contained in health insurance plans and outlooks and on the
method of their submission by health insurance companies, as amended
Decree No. 362/2010 Coll., on the
method of providing information on the financial management of health
insurance companies and its scope, as amended
Decree No. 418/2003 Coll., laying
down more detailed specification of the scope and amount of income and
expenditure of public health insurance funds of health insurance
companies, the conditions for their creation, use, permissibility of
mutual transfers of financial resources and their management, the limit of
operating costs of health insurance companies covered from the resources
of the basic fund including the method of calculation of this limit, as
amended
Decree No. 41/2000 Coll., laying
down detailed conditions for the creation and use of financial resources
of the funds of the Military Health Insurance Company of the Czech
Republic for reimbursement of healthcare provided beyond the scope of
public health insurance from the state budget resources of the Ministry of
Defence, as amended
Measure of the Ministry of Health determining
financial performance indicators of health insurance companies for the
relevant year
Act No. 592/1992 Coll.,
on Premiums for Public Health Insurance, as amended.
Implementing Regulation:
Government Regulation No. 357/2025 Coll., on the
assessment base for public health insurance premiums paid by the state for
2026
Decree No. 107/2025 Coll., on
adjustable parameters of redistribution of public health insurance
premiums for 2026 and on the content, structure and format of data for
calculation of the calculated redistribution parameters
Decree No. 65/2025 Coll., on the
method of valuation of costs of healthcare services for the purposes of
redistribution of public health insurance premiums
Decree No. 351/2022 Coll., on
the transfer of data on consumption of medicinal products by insured
persons of public health insurance when changing a health insurance
company, as amended
Price Decision of the Ministry of Health No.
1/2026/OLZP, on price regulation of medicinal products and foods for special
medical purposes
Price Decision of the Ministry of Health No.
2/2026/OLZP, establishing the list of ATC groups of medicinal products
significant for the provision of healthcare, for which the maximum manufacturer
price is determined in the public interest of ensuring availability
Price Decision No. 2/2025/OLZP, on price regulation
of individually prepared medicinal products containing cannabis for medical use
Price Regulation of the Ministry of Health No.
4/2024/OLZP, on the determination of a special distribution margin for
medicinal products released from reserve stock system,
Price Decision of the Ministry of Health No.
3/2026/OLZP of 24 October 2025, on price regulation of medical devices and
in vitro diagnostic medical devices
Act No. 378/2007 Coll.,
on Medicinal Products and on Amendments to Certain Related Acts, as
amended.
Implementing regulation
(selected):
Government Regulation No. 552/2025 Coll., on
conditions for prescribing, dispensing and use of individually prepared
medicinal products containing psilocybin for medical use
Decree No. 457/2023 Coll., laying down
the list of human medicinal products to which the obligation of the marketing
authorisation holder to ensure their supply after the notified date of
interruption or termination of supplies does not apply, as amended.
Decree No. 84/2008 Coll., on
Good Pharmacy Practice, on detailed conditions for handling medicinal
products in pharmacies, healthcare facilities and by other operators and
establishments dispensing medicinal products, as amended,
Decree No. 85/2008 Coll., laying
down the list of medicinal substances and excipients that may be used for
the preparation of medicinal products, as amended,
Decree No. 86/2008 Coll., laying
down the principles of Good Laboratory Practice in the field of medicinal
products, as amended
Decree No. 106/2008 Coll., on
Good Practice for sellers of restricted medicinal products and on the
professional training course for sellers of restricted medicinal products,
as amended
Decree No. 143/2008 Coll., on
human blood, as amended
Decree No. 228/2008 Coll., on
registration of medicinal products, as amended,
Decree No. 229/2008 Coll.,
on the manufacture and distribution of medicinal products, as amended,
Decree No. 236/2015 Coll., laying
down the conditions for prescribing, preparation, distribution, dispensing
and use of individually prepared medicinal products containing cannabis
for medical use, as amended,
Decree No. 329/2019 Coll.,
on prescribing medicinal products in the provision of healthcare services,
as amended,
Decree No. 463/2021 Coll.,
on the detailed conditions for conduct of clinical trials of human medicinal
products, as amended.
Act No 167/1998 Coll,
on Addictive Substances and on Amendments to Certain Other Acts, as amended
Implementing regulation
(selected):
Government Regulation No. 552/2025 Coll., on the
conditions for prescribing, dispensing and use of individually prepared
medicinal products containing psilocybin for medical use, as amended
Government Regulation No. 456/2025 Coll., on the list
of psychomodulatory substances, as amended
Decree No. 448/2025 Coll., on
psychomodulatory substances, as amended
Decree No. 349/2025 Coll., on the
requirements for notifications submitted by persons cultivating opium poppy and
technical hemp, as amended
Decree No. 147/2025 Coll., on specimen
forms and records of psychomodulatory substances and classified psychoactive
substances, as amended
Government Regulation No. 11/2025 Coll., on the list
of classified psychoactive substances, as amended
Decree No. 53/2014 Coll., on
official forms pursuant to the Act on Addictive Substances, as amended,
Decree No. 123/2006 Coll., on
records and documentation of addictive substances and preparations
containing them, as amended,
Decree No. 243/2009 Coll., laying
down the list of persons, including specification of their workplaces, for
whose activities no permit for handling addictive substances or
preparations containing them is required, as amended,
Government Regulation No. 463/2013 Coll.,
on the lists of addictive substances, as amended,
Decree No. 235/2022 Coll.,
on the cultivation and processing of cannabis plants for medicinal use, as
amended,
Decree No 53/2022 Coll., on
the determination of the amount of reimbursement of expenses for expert
acts carried out by the State Institute for Drug Control pursuant to the
Act on Addictive Substances, as amended.
Decree No. 329/2019 Coll., on
prescribing medicinal products in the provision of healthcare services, as
amended by Decree No. 53/2020 Coll., as amended
Act No. 288/2025 Coll., on the
Categorisation of Medical Devices Prescribed on Vouchers Reimbursed from Public
Health Insurance and on Amendments to Act No. 48/1997 Coll., on Public Health
Insurance and on Amendments to Certain Related Acts (the Medical Devices
Categorisation Act), as amended
Act No. 375/2022 Coll.,
on Medical Devices and In Vitro Diagnostic Medical Devices, as
amended.
Implementing regulation
(selected):
Decree No 377/2022 Coll., implementing
certain provisions of the Act on Medical Devices and In Vitro Diagnostic
Medical Devices, as amended,
Decree No. 378/2022 Coll., on the
specimen inspector identification card of the State Institute for Drug Control
pursuant to the Act on Medical Devices and In Vitro Diagnostic Medical Devices,
as amended.
Decree No 379/2022 Coll., on
the determination of the amount of reimbursement of expenses for expert
acts carried out by the State Institute for Drug Control pursuant to the
Act on Medical Devices and In Vitro Diagnostic Medical Devices, as
amended.
Act No 376/2022 Coll.,
amending certain Acts in connection with the adoption of the Act on Medical
Devices and In Vitro Diagnostic Medical Devices, as amended.
Act No.268/2014 Coll.,In
Vitro Diagnostic Medical Devices, as amended.
Act No. 89/2021 Coll.,
on Medical Devices and on Amendments to Act No. 378/2007 Coll., on Medicinal
Products and on Amendments to Certain Related Acts (the Medicinal Products Act),
as amended.
Implementing regulation:
Notification of the Ministry of Health No. 54/2022 Coll., on the
commissioning of the central repository of electronic vouchers.
Act No. 22/1997 Coll., on
Technical Requirements for Products and on Amendments to Certain Related Acts,
as amended.
Act No. 90/2016 Coll.,
on Conformity Assessment of Specified Products when Supplied on the Market, as
amended.
Act No. 325/2021 Coll., on
Healthcare Digitalisation, as amended, and other related acts, as amended
Act No. 372/2011 Coll.,
on Health Services and Conditions for Their Provision (the Health
Services Act), as amended.
Implementing regulations
(selected):
Decree No. 380/2025 Coll., on
emergency medical on-call services, as amended
Decree No. 30/2025 Coll., on
telemedicine health services, as amended
Decree No. 444/2024 Coll., on
healthcare documentation, as amended
Decree No. 373/2016 Coll., on the
transfer of data to the National Health Information System, as amended
Decree No. 70/2012 Coll., on
preventive medical examinations, as amended
Decree No. 39/2012 Coll., on
dispensary care, as amended
Act No. 40/1995 Coll.,
on Regulation of Advertising and on Amendments to Act No. 468/1991 Coll., on
the Operation of Radio and Television Broadcasting, as amended.
Act No 242/2022 Coll.,
on Video-sharing Platform Services and on Amendments to Certain Related Acts (the
Video-Sharing Platform Services Act), as amended.
Act No. 387/2024 Coll.,on
General Product Safety and on Amendments to Certain Related Acts, as
amended.
Act No. 500/2004 Coll.,
the Administrative Procedure Code, as amended.
