Funded by the EU

SUKL

The State Institute for Drug Control (SUKL) is a public administration body operating in the area of regulation of medicinal products, clinical trials, medical devices, human blood products, human tissues and cells and medicinal cannabis. It was established by the Act on Pharmaceuticals in 1997, however, its history dates back to December 1918, when the first measures were taken by the Czechoslovak government to control the quality of medicines on the market after World War I.

The Act on Pharmaceuticals lays down the tasks of SUKL in the area of regulation of human medicines throughout their life-cycle, i.e. at both pre- and post-authorisation stages. This covers granting marketing authorisations, authorisation of clinical trials, pharmacovigilance, licensing and control of manufacturers, importers and wholesale distributors of medicinal products, as well as surveillance over pharmacy supply. SUKL also performs price control of medicinal products, foods for special medical purposes and medical devices. As of 2008, SUKL is the national competent authority for pricing and reimbursement of medicinal products and foodstuffs for special medical purposes.

Over the last two decades SUKL became responsible for some parts of regulation of medical devices and blood products and since 2013 it also fulfils the tasks of the State Agency for Medicinal Cannabis.

Since 2008, SUKL is the competent authority for human tissues and cells designated by the Czech Ministry of Health to implement the requirements laid down in Directive 2004/23/EU. It is responsible for surveillance over the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells to guarantee their quality and safety in compliance with the EU and national legislation. Under the Act on Human Tissues and Cells (Act No. 296/2008 Sb., as amended) and relevant implementing regulations, SÚKL is competent to authorise tissue establishments, procurement centres and diagnostic laboratories and to control their activities by performing regular inspections in order to verify their compliance with legal requirements. SÚKL also operates a vigilance mechanism for the notification of suspected serious adverse reactions and serious adverse events. Its control activities include on site investigation of all serious adverse events and monitoring of corrective measures.  As part of its responsibilities, SÚKL maintains a public register of tissue establishments specifying activities which they are authorised to perform, cooperates with the Member States and the Commission, and ensures exchange of information and reporting required by the EU legislation.  Besides its licensing and control activities SÚKL also develops guidelines, organizes seminars for healthcare professionals and provides advice for tissue establishments. 

 

© 2014 ARTHIQS

ARTHIQS (Grant agreement n. 20132101557886) has received funding from the European Commission in the framework of the Health Programme. The sole responsibility lies with the author and the Consumers, Health and Food Executive Agency is not responsible of any use that may be made of the information contained here.