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词条 State Institute for Drug Control
释义

  1. References

The State Institute for Drug Control (Státní ústav pro kontrolu léčiv), based in Prague is an institution of the government of the Czech Republic. Its powers stem from the Act on Public Health Insurance (Act No. 48/1997 Coll.).

Only part of its operating costs are directly funded. It is largely self-financing through charges for its services.[1]

It is responsible for regulation of the safe production of pharmaceuticals in the country, clinical evaluation of medicines and for monitoring the advertising and marketing of both medicines and medical devices.[2] It sets maximum ex-factory prices for reimbursement based on 195 reference groups of therapeutically interchangeable products of similar clinical efficacy.[3] More than 20% of the health budget is spent on medication and medical devices. From January 2019 it took responsibility for regulating the reimbursement of consumer medical devices prescribed as part of outpatient care.[4]

It allocates codes and names of medications for use in the electronic prescribing system.[5]

It has been criticised by KOPAC, the Patient Association for Cannabis Treatment, for failing to ensure a supply of Czech medical cannabis so that patients have to pay inflated prices for imported supplies.[6]

References

1. ^{{cite news |title=Case of SÚKL |url=http://www.nfpk.cz/en/case-of-sukl |accessdate=16 December 2018 |publisher=Nadační fond proti korupci |date=2014}}
2. ^{{cite news |title=The State Institute for Drug Control (SUKL) Czech Republic |url=https://pharmaboardroom.com/company/the-state-institute-for-drug-control-sukl-czech-republic/ |accessdate=16 December 2018 |publisher=Pharma Boardroom |date=2018}}
3. ^{{cite news |title=Prices & Reimbursement |url=http://www.pharmaceuticals-czech.com/prices-and-reimbursement |accessdate=16 December 2018 |publisher=Pharmaceuticals in the Czech Republic |date=2018}}
4. ^{{cite news |title=New reimbursement regulation for consumer medical devices |url=https://www.lexology.com/library/detail.aspx?g=706eed53-6f6a-468d-806e-297fbd38b638& |accessdate=18 March 2019 |publisher=Lexology |date=11 February 2019}}
5. ^{{cite news |title=The ePrescription System: Draft amending the Act on Medicines is under discussion in the Parliament of the Czech Republic |url=https://www.lexology.com/library/detail.aspx?g=a82ee2c5-4bfc-46d4-bbf9-f83d04f452a8&|accessdate=16 December 2018 |publisher=Lexology |date=9 November 2018}}
6. ^{{cite news |title=Czech patients have no reason to celebrate 5 years of legal medical cannabis, as the State Institute for Drug Control (SÚKL) forces them to break the law |url=https://kopac.cz/en/czech-patients-have-no-reason-to-celebrate-5-years-of-legal-medical-cannabis-as-the-state-institute-for-drug-control-sukl-forces-them-to-break-the-law/ |accessdate=16 December 2018 |publisher=Kopac |date=27 April 2018}}

2 : Pharmacy organizations|Medical and health organisations based in the Czech Republic

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