Pharmeca.cz

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

Act No. 526/1990  Coll., on Prices, as amended.

Price regulations / price decisions – Medicinal Products (selected):

• 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 Decisions – Medical Devices:

• 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.

Current price decisions, opinions and methodological gudelines or regulations of the Ministry of Health of the Czech Republic.

Instructions and guidelines of SÚKL.

In the field of reimbursement and regulation of foods for special medical purposes (FSMP) reimbursed from public health insurance within outpatient care, significant changes will take effect from 1 January 2026 based on the amendment to the Public Health Insurance Act.

New rules for FSMP reimbursement

• FSMP will newly be classified into reimbursement groups listed in the categorisation tree attached to the Act, based on their composition and intended use (similarly to medical devices).

• The rules for price and reimbursement regulation are also changing, the new system will take into account whether a product is categorised (i.e., can be included in the categorisation tree and is substitutable with reimbursed FSMP) or non-categorised (i.e., cannot be included in the categorisation tree and is not substitutable with reimbursed FSMP).

• The reimbursement amount for specific FSMP will be derived from the base reimbursement set by a measure of general nature for the respective reimbursement group.

• A new obligation is introduced to notify the actual placing on the market and to maintain detailed records of FSMP.

Transitional period

• FSMP reimbursed at the end of 2025 will continue to be reimbursed under the same conditions and at the same reimbursement level.
  This applies until the State Institute for Drug Control (SÚKL) publishes their new reimbursement within the new system.

• The manufacturer/importer (notifier) of FSMP reimbursed in 2025 must submit a notification to SÚKL by the end of September 2026, otherwise, the respective FSMP will cease to be reimbursed.

• All administrative proceedings concerning FSMP that have not been concluded under the previous legislation will be discontinued as of 1 January 2026.

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.

Feel free to contact us.

Our knowledge, your opportunity.

The text was translated using ChatGPT 5.1.  

Inpatient care reporting

A health insurance fund may agree with an inpatient care provider on the method of reporting and reimbursement of medicinal products used in the provision of inpatient care, for which the fund has negotiated the reimbursement amount and conditions with the marketing authorization holder or manufacturer.

For the purpose of negotiating the reimbursement amount and conditions between payers and the marketing authorization holder for medicines used exclusively in inpatient care, the State Institute for Drug Control (the Institute) will, at the request of payers or the holder, conduct an assessment of benefits and costs (analogous to HTA). All entities concerned (including marketing authorization holders) are obliged to cooperate with the Institute.

Drug lump sums, which are no longer applied in practice, are abolished.

Deductible co-payments

The conditions for recognizing co-payments for children under 4 years of age are expanded by defining selected dosage forms and by specifying the calculation method of the co-payment in these cases.

Reimbursement of expenses

Changes also apply to the reimbursement of expenses for acts performed by the Institute, which will no longer apply to applicants requesting an increase in the maximum price in the public interest or to applicants for unregistered medicinal products whose use has been authorized under the Medicines Act.

In brief: the amendment

On 12 August 2025, the amendment to the Act on Public Health Insurance was promulgated in the Collection of Laws as No. 289/2025 Coll. Its general effective date is 1 January 2026, with selected provisions taking effect during 2026 or in subsequent years.

The amendment proposes substantial changes to the regulation of public health insurance. In the area of pricing and reimbursement of medicinal products, it will affect, for example: the process of external price referencing (EPR), the rules on deemed availability, the definition of Highly Innovative Medicinal Products (VILP), proceedings on reimbursement for VILPs and orphan medicinal products (LPVOs) used in combination, contractual commitments with payers, assessment of a product as an LPVO, similar medicinal products, lis pendens (litispendence), the submission of models, and review (revision) proceedings.

The reimbursement mechanism will also change—especially for vaccines and monoclonal antibodies intended for prophylaxis—and a special procedure for immunization medicines will be introduced.

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.

Feel free to contact us.

Our knowledge, your opportunity.

The text was translated using ChatGPT 5.1.  

Similar medicinal product

The amendment introduces the concept of an “original reimbursed product” and clarifies the definition of the “first similar product,” for which a marketing commitment will no longer be submitted; instead, its actual market availability will trigger an abbreviated revision due to its entry into the reimbursement system.

The Institute will newly assess the appropriateness of therapeutic intervention for similar products originating from the same marketing authorization holder, with the aim of preventing circumvention of contractual arrangements.

The conditions for the automatic recognition of an appropriate therapeutic intervention are defined.

The assessment of market availability of a similar product will now be governed by criteria focused on the total quantity of all supplied similar products and by calculating the average monthly volume.

Combination product

The amendment introduces a significant change in the calculation of reimbursement for combination products, taking into account situations where all included active substances are reimbursed individually on the one hand, and situations where one of the substances is not reimbursed on the other.

In brief: the amendment

On 12 August 2025, the amendment to the Act on Public Health Insurance was promulgated in the Collection of Laws as No. 289/2025 Coll. Its general effective date is 1 January 2026, with selected provisions taking effect during 2026 or in subsequent years.

The amendment proposes substantial changes to the regulation of public health insurance. In the area of pricing and reimbursement of medicinal products, it will affect, for example: the process of external price referencing (EPR), the rules on deemed availability, the definition of Highly Innovative Medicinal Products (VILP), proceedings on reimbursement for VILPs and orphan medicinal products (LPVOs) used in combination, contractual commitments with payers, assessment of a product as an LPVO, similar medicinal products, lis pendens (litispendence), the submission of models, and review (revision) proceedings.

The reimbursement mechanism will also change—especially for vaccines and monoclonal antibodies intended for prophylaxis—and a special procedure for immunization medicines will be introduced.

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.

Feel free to contact us.

Our knowledge, your opportunity.

The text was translated using ChatGPT 5.1.  

In-depth reimbursement revision
Under the new rules, in an in-depth revision in which a significant decrease in the basic reimbursement compared to the first in-depth revision is demonstrated, the State Institute for Drug Control (Institute) will carry out a review or, where applicable, cancellation of the indication restriction, and in certain cases also a reassessment of the prescribing restriction, depending on the nature of the medicinal product (Rx, ZULP).

A minimum interval between individual in-depth reimbursement revisions within the same reference group is introduced in order to minimise excessive administrative burden on the Institute.

Abbreviated price and reimbursement revision

The amendment introduces changes to the thresholds relevant for initiating an abbreviated reimbursement revision, depending on the type of medicinal products.

Revisions of maximum prices will newly be conducted for products included in the same reference group.

A deadline for commenting on the assessment report is introduced, excluding the possibility of submitting an obstruction appeal against the resolution setting this deadline.

The conditions for initiating a reimbursement revision due to product unavailability are updated.

As with in-depth revisions, a minimum interval between individual revisions is set, during which no new revision may be initiated. However, this time limitation does not apply to revisions initiated, for example, due to the entry of the first similar medicinal product or the need to ensure the availability of a fully reimbursed product.

In brief: the amendment

On 12 August 2025, the amendment to the Act on Public Health Insurance was promulgated in the Collection of Laws as No. 289/2025 Coll. Its general effective date is 1 January 2026, with selected provisions taking effect during 2026 or in subsequent years.

The amendment proposes substantial changes to the regulation of public health insurance. In the area of pricing and reimbursement of medicinal products, it will affect, for example: the process of external price referencing (EPR), the rules on deemed availability, the definition of Highly Innovative Medicinal Products (VILP), proceedings on reimbursement for VILPs and orphan medicinal products (LPVOs) used in combination, contractual commitments with payers, assessment of a product as an LPVO, similar medicinal products, lis pendens (litispendence), the submission of models, and review (revision) proceedings.

The reimbursement mechanism will also change—especially for vaccines and monoclonal antibodies intended for prophylaxis—and a special procedure for immunization medicines will be introduced.

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.

Feel free to contact us.

Our knowledge, your opportunity.

The text was translated using ChatGPT 5.1.