The State Institute for Drug Control (SÚKL) has published an updated, already 3rd version of Guideline CAU-08 – Requirements for the structure of expert documentation supplementing an application and for the structure of statements of other participants when submitting evidence in proceedings on the determination or change of the amount and conditions of reimbursement of medicinal products / partially reimbursed medicinal products, effective as of 2 January 2026.
The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.
SÚKL has published an updated version of guideline CAU-08 - Requirements on the structure of technical documentation to be submitted along with applications and on the structure of opinions of...
The State Institute for Drug Control (SÚKL) has published an updated, already 3rd version of Guideline CAU-08 – Requirements for the structure of expert documentation supplementing an application and for the structure of statements of other participants when submitting evidence in proceedings on the determination or change of the amount and conditions of reimbursement of medicinal products / partially reimbursed medicinal products, effective as of 2 January 2026.
The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.
SÚKL has published an updated version of guideline CAU-08 - Requirements on the structure of technical documentation to be submitted along with applications and on the structure of opinions of...
The Ministry of Health (MoH) assessed whether the conditions
for increasing reimbursement on the grounds of ensuring at least one fully
reimbursed medicinal product within a group of substitutable products had been
met in the context of a comprehensive review (Section 39c(5) of the Public
Health Insurance Act).
According to the MoH, it was not possibleto designate the
product referenced in the proceedings as a relevant fully reimbursed medicinal
product for two main reasons:
the referenced product had
reported an interruption of its placing on the domestic market effective as of
25 December 2023, i.e. prior to the date on which the contested decision
(issued on 27 November 2023) became enforceable. In the case of a product with
a notified interruption, a temporary supply disruption may reasonably be
assumed, and consequently the practical impossibility of its full
reimbursement;
the referenced product is also
reimbursed for the treatment of bladder cancer. The products for which the
reimbursement increase was assessed are reimbursed exclusively for patients
with renal cancer and soft tissue sarcoma. Although bladder cancer and renal
cancer both fall under carcinomas of the urogenital tract, the MoH does not
consider them to constitute diseases of the same type within the meaning of the
legal opinion of the Constitutional Court.
Full reimbursement for the group of patients with the
indication of bladder cancer could therefore not be ensured through the
assessed product but was secured through other medicinal products.
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A continuously
updated overview of decisions issued by SÚKL and the Ministry of Health in the
field of pricing and reimbursement is available on the Pharmeca a.s. website.
The State Institute for Drug Control (SÚKL) has published an updated, already 3rd version of Guideline CAU-08 – Requirements for the structure of expert documentation supplementing an application and for the structure of statements of other participants when submitting evidence in proceedings on the determination or change of the amount and conditions of reimbursement of medicinal products / partially reimbursed medicinal products, effective as of 2 January 2026.
The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.
SÚKL has published an updated version of guideline CAU-08 - Requirements on the structure of technical documentation to be submitted along with applications and on the structure of opinions of...
The State Institute for Drug Control (SÚKL) has published an updated, already 3rd version of Guideline CAU-08 – Requirements for the structure of expert documentation supplementing an application and for the structure of statements of other participants when submitting evidence in proceedings on the determination or change of the amount and conditions of reimbursement of medicinal products / partially reimbursed medicinal products, effective as of 2 January 2026.
The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.
SÚKL has published an updated version of guideline CAU-08 - Requirements on the structure of technical documentation to be submitted along with applications and on the structure of opinions of...
The State Institute for Drug Control (SÚKL) has published an updated, already 3rd version of Guideline CAU-08 – Requirements for the structure of expert documentation supplementing an application and for the structure of statements of other participants when submitting evidence in proceedings on the determination or change of the amount and conditions of reimbursement of medicinal products / partially reimbursed medicinal products, effective as of 2 January 2026.
The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.
SÚKL has published an updated version of guideline CAU-08 - Requirements on the structure of technical documentation to be submitted along with applications and on the structure of opinions of...
The State Institute for Drug Control (SÚKL) has published an updated, already 3rd version of Guideline CAU-08 – Requirements for the structure of expert documentation supplementing an application and for the structure of statements of other participants when submitting evidence in proceedings on the determination or change of the amount and conditions of reimbursement of medicinal products / partially reimbursed medicinal products, effective as of 2 January 2026.
The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.
SÚKL has published an updated version of guideline CAU-08 - Requirements on the structure of technical documentation to be submitted along with applications and on the structure of opinions of...
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.
