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. 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 167/1998Coll, 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.
