Pharmeca info | Pharmeca a.s.

Decisions of the State Institute for Drug Control and the Ministry of Health of the Czech Republic in the Area of Pricing and Reimbursement

From January 1, 2025, Pharmeca a.s. offers an overview of SÚKL and Ministry of Health decisions on pricing and reimbursement.

Pharmeca a.s. 01/08/2025

EMA Information for MAH Medicines Pharmeca info

EMA Launches New Platform to Monitor Medicine Shortages

The European Medicines Agency (EMA) has announced the launch of a new platform designed to routinely monitor shortages of centrally authorized medicines.

Pharmeca a.s. 12/16/2024

Information for MAH Legislation Pharmeca info Medicines

European Health Data Space 2024 update

The European Health Data Space (EHDS) has advanced significantly since the initial concept of a digital transformation in healthcare across all EU member states.

Pharmeca 11/18/2024

Information for MAH Medicines Pharmeca info

Save the date: EMA organizuje Information Day for CTIS 17. října 2024

Informační systém klinických studií (CTIS) – pokračující proces přechodu

Pharmeca a.s. 10/07/2024

EMA Legislation Pharmeca info

Clinical Trials Information System (CTIS) - present and future

CTIS podporuje interakce mezi sponzory klinických studií (výzkumníky nebo společnostmi, které provádějí klinickou studii a shromažďují a analyzují data) a regulačními orgány v členských státech EU...

Pharmeca 03/08/2024

Information for MAH Medicines Pharmeca info

Change in VAT Rates for Medicines

Based on the amendment to Act No. 235/2004 Coll., on Value Added Tax, as of January 1, 2024, there has been a change in VAT rates, particularly impacting the increase in prices and reimbursements...

Pharmeca a.s. 02/27/2024

Pharmeca a.s. provides services in the areas defined by this legislative framework:

Act No. 48/1997 Coll., on Public Health Insurance and on Amendments to Some Related Acts, as amended.

Implementing legislations:

Decree No. 376/2011 Coll., which implements certain provisions of the Public Health Insurance Act, as amended,
Decree No 384/2007 Coll., on the list of reference groups, as amended,
Decree No 385/2007 Coll., on the list of active substances for adjunct or add-on therapy;
Decree No. 63/2007 Coll., on reimbursement of medicines and foodstuffs for special medical purposes, as amended,
Decree No. 618/2006 Coll., which issues framework agreements, as amended,
Decree No. 134/1998 Coll., which issues a list of medical services with point values, as amended,
Decree on the determination of point values, the amount of payments for paid services and regulatory restrictions - always issued for the current year.

Act No. 551/1991 Coll., on the General Health Insurance Company of the Czech Republic, as amended.

Act No. 280/1992 Coll., on departmental, branch, corporate and other insurance companies, as amended.

Act No. 592/1992 Coll., on public health insurance premiums, as amended.

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

Act No. 378/2007 Coll., on Pharmaceuticals, as amended.

Implementing legislations:

Decree No. 228/2008 Coll., on the marketing authorisation of medicinal products, as amended,
Decree No. 54/2008 Coll., on the method of prescribing medicinal products, particulars to appear on medical prescriptions, and rules governing the use of medical prescriptions, as amended,
Decree No. 84/2008 Coll., on good pharmaceutical practice, detailed conditions of handling pharmaceuticals in pharmacies, healthcare facilities and other operators and facilities supplying medicinal products, as amended,
Decree No. 85/2008 Coll., which lays down a list of active substances and excipients which may be used in the preparation of medicinal products, as amended,
Decree No 226/2008 Coll., on good clinical practice and detailed conditions of clinical trials on medicinal products, as amended,
Decree No. 228/2008 Coll., on the marketing authorisation of medicinal products, as amended,
Decree No. 229/2008 Coll., on the manufacture and distribution of pharmaceuticals, as amended,
Decree No. 236/2015 Coll., on the determination of conditions for prescription, preparation, distribution, dispense and use of individually prepared medicinal products containing cannabis for medical use, as amended,
Decree No. 415/2017 Coll., on the implementation of certain provisions of the Act on Medicinal Products relating to electronic prescriptions, as amended,
Decree No. 329/2019 Coll., on prescribing medicinal products in the provision of health services, as amended.

Act No 167/1998 Coll, on addictive substances and amending certain other acts, as amended

Implementing legislations:

Decree No. 123/2006 Coll., on evidence and documentation of addictive substances and preparations, as amended,
Decree No. 243/2009 Coll., on establishing a list of persons indicating their workplaces for their work is not required permit to treatment of addictive substances and preparations containing them, as amended,
Government Regulation No. 463/2013 Coll., on lists of addictive substances, as amended.

Act No. 268/2014 Coll., on medical devices and amending Act No. 634/2004 Coll., on administrative fees, as amended,

Implementing legislations:

Decree No. 62/2015 Coll., on the implementation of certain provisions of the Medical Devices Act, as amended,
Government Regulation No. 56/2015 Coll., on technical requirements for in vitro diagnostic medical devices,
Government Regulation No. 55/2015 Coll., on technical requirements for active implantable medical devices,
Government Regulation No. 54/2015 Coll., on technical requirements for medical devices.

Act No. 22/1997 Coll., on Technical Requirements for Products and amendments to some related acts, as amended.

Act No. 90/2016 Coll., on the assessment of the conformity of specified products when they are placed on the market, as amended.

Act No. 372/2011 Coll., on health services and conditions for their provision (the Health Services Act), as amended.

Decree No. 373/2016 Coll., on the transfer of data to the National Health Information System, as amended.

Act No. 500/2004 Coll., Administrative Code, as amended.

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

Instructions and methodologies of SÚKL.

Information for MAH Pharmeca info Medicines Medical devices

Important sources of legislative information

An up-to-date overview of legislative resources regarding medicines and medical devices, which Pharmeca a.s. uses within the provided services.

Pharmeca 01/02/2022

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