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 Regulation:
- 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 the reimbursement of medicinal products and foods 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
No. 527/2021 Coll.,
on determination of the amount of reimbursement of expenses for
professional acts and the method of determination of the amount of
compensation of expenses for professional consultations carried out by the
State Institute for Drug Control under the Public Health Insurance Act, 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,
- Government
Regulation No. 307/2012
Coll., on local and temporal availability of health 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
departmental, branch, corporate and other insurance companies, as amended.
Act No. 592/1992 Coll., on
public health insurance premiums, as amended.
Implementing Regulation:
- Decree
No. 351/2022 Coll.,
on the transmission of data on the consumption of medicinal products by
insured persons of the public health insurance when changing the health
insurance company, as amended
Act No. 526/1990 Coll., on
Prices, as amended.
Price Regulations – Medicinal Products:
- Price
Regulation of the Ministry of Health No. 4/2024/OLZP, on the
determination of a special distribution surcharge for medicinal products
released from the reserve stock system,
- Price
Decision of the Ministry of Health No. 3/2024/OLZP, dated November 29,
2023, setting out lists of ATC groups with the relevant route of
administration, for which the ex-factory price of the medicinal product is
not subject to price regulation or maximum price regulation,
- Price
Regulation of the Ministry of Health No. 2/2024/OLZP, dated November
29, 2023, on the price regulation of medicinal products and foods for
special medical purposes,
- Price
Regulation of the Ministry of Health No. 11/2023/OLZP, dated October
25, 2023, on the determination of the distribution and dispensing
surcharge for medicinal products reimbursed under Section 32c of Act No.
48/1997 Coll.,
- Price
Regulation No. 3/2022/OLZP, on the price regulation of individually
prepared medicinal products containing cannabis for medical use.
Price Regulations – Medical Devices:
- Price
Regulation of the Ministry of Health No. 1/2024/OLZP, dated October
25, 2023, on the price regulation of medical devices and in vitro
diagnostic medical devices,
- Price
Regulation of the Ministry of Health No. 2/2022/OLZP, dated January 7,
2022, amending Price Regulation No. 1/2019/CAU, dated May 22, 2019, on the
price regulation of medical devices,
- Price
Decision 2/13-FAR, establishing a list of medical devices with
deregulated manufacturer prices.
Act No. 378/2007 Coll., on
Pharmaceuticals, as amended.
Implementing Regulation:
·
Decree No. 457/2023 Coll.,
establishing a list of human medicinal products exempt from the obligation of
the marketing authorization holder to ensure their supply after the announced
date of supply interruption or discontinuation, 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. 329/2019 Coll.,
on prescribing medicinal products in the provision of health services, as
amended,
- Decree
No. 463/2021 Coll.,
on the detailed conditions for conducting a clinical trial of medicinal
products for human use, as amended.
Act No 167/1998 Coll,
on addictive substances and
amending certain other acts, as amended
Implementing Regulation:
- Decree
No. 53/2014 Coll.,
on forms under the Addictive Substances Act, as amended,
- 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,
- 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 compensation of expenses for
professional acts performed by the State Institute for Drug Control
pursuant to the Act on Addictive Substances, as amended.
Act No. 375/2022 Coll., on
medical devices and in vitro diagnostic medical devices, as
amended.
Implementing Regulation:
- Decree
No 377/2022 Coll.,
on the implementation of certain provisions of the Act on medical devices
and in vitro diagnostic medical devices, as amended,
·
Decree No. 378/2022 Coll., on the
template of the inspector's identification card of the State Institute for Drug
Control under 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 compensation of
expenses for professional acts performed 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., on
medical devices and amending Act No. 634/2004 Coll., on administrative
fees, as amended.
Act No. 89/2021 Coll., on
medical devices and amending Act No. 378/2007 Coll., on pharmaceuticals and on
amendments to certain related acts (Act on pharmaceuticals), 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 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. 40/1995 Coll., on the
regulation of advertising and on amending and supplementing Act No. 468/1991
Coll., on the operation of radio and television broadcasting, as
amended.
Act No 242/2022 Coll., on the
services of video sharing platforms and amending certain related acts (Act
on the services of video sharing platforms), as amended.
Act No. 387/2024
Coll., on General Product Safety and Amendments to Certain Related Acts, 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.