Pharmeca.cz

A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelants Zentiva, k.s., Angelini Pharma Česká republika s.r.o., H. Lundbeck A/S, +pharma arzneimittel GmbH, Teva Pharmaceuticals CR, s.r.o., Actavis Group PTC ehf., Krka, tovarna zdravil, d.d. and Pfizer, spol. s r.o., against the decision of the State Institute for Drug Control from 30. 9. 2020, under the no: SUKLS115675/2009:

• the decision is reversed and the proceedings are terminated.

More information: MZCR.cz.

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.