State Institute for Drug Control (SUKL)

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63850 1504871583HCLSReviewHongKongSeptember2017.pdf
Energy Boardroom

State Institute for Drug Control (SUKL)

Czech Republic

Address: Šrobárova 48
100 41 Praha 10

Tel: +420 272 185 111

Web: http://www.sukl.eu/

Company description

History of the State Institute for Drug Control is connected with the formation of Czechoslovakia as an independent state. The State Institute’s for Drug Control immediate predecessor was ‘The Institute for Investigation of Medicines’ established as early as in 1918 .The former Institute’s laboratories were located in several buildings of Charles University Prague. In 1931, laboratories of the Institute were concentrated on the premises of the State Health Institute and the Institute’s headquarters is situated there until today.

The Institute got its today’s name in 1952 following its complete separation from the State Health Institute’s organizational structure. On this occasion, the activities of the Institute were extended to control of ‘medical devices, in particular therapeutic and diagnostic aids and disinfectants or other devices/products’. In 1969 all the Institute’s workplaces were brought together in a new building.

So called ‘medicines control laboratories’ charged with control of pharmacies, control of handling medicinal products supplied to health care centres and control of quality of raw materials distributed to pharmacies were incorporated in the Institute in 1992. Until then these laboratories formed a part of Pharmacy Services under the control of regional National Healthcare Centres. In 1992 the Institute took charge of the area of medical devices assessment including issuance of approval certificates for medical devices used in health care facilities.

Following the Minister of Health’s decision of 1997 this activity was extended to all approvals of medical devices of any type. The Act on Pharmaceuticals no. 79/1997 Coll. laid down details of the Institute’s activities in the area of medicines in 1997. In the sphere of medical devices, the scope of activities of the Institute was stipulated in particular by Act no. 123/2000 Coll., on Medical Devices, which focused SÚKL’s operation in this area to safeguarding the safety of products already placed on the market. The process of approving medical devices was transferred to the Ministry of Health of the Czech Republic.

In compliance with Act no. 138/2002 Coll., amending the Act on Advertising Regulation, as of June 01 2002 SÚKL has become the competent authority responsible for surveillance over advertising of human medicinal products.

As of January 01 2008, pursuant to Act no. 48/1997 Coll., on Public Health Insurance, SÚKL has been given the competence to determine the maximum prices of medicinal products and to determine the level and conditions of reimbursement of medicinal products. As of the same date, SÚKL has been performing the price control of medicinal products, foods for special medical purposes, and medical devices.
Moreover, Act no. 296/2008 Coll., on Human Tissues and Cells, has also extended the scope of SÚKL’s operation by assigning SÚKL with surveillance over the quality and safety of human tissues and cells intended for use in man.

The latest change in the scope of operation to date has been implemented by the amended Act no. 167/1998 Coll., on Dependency Producing Substances, which extended the surveillance activities also to the sphere of narcotic and psychotropic substances.

Products and services

In the Czech Republic the Institute ensures the following activities:

State supervision of properties of human medicinal products in all areas of handling such products. Activities of the Institute relate to monitoring of quality, safety and efficacy of medicines in all stages of development and use. For this purpose the Institute uses a system of preliminary reporting, licensing/authorisation and registration procedures, inspections, laboratory controls and monitoring of practical use of medicines and gathers appropriate information. As of January 1 2008 the Institute performs price control of medicinal products, foods for special medical purposes and medical devices. As of the same date it has been authorised to issue, in administrative procedures, decisions on maximum prices of medicinal products or foods for special medical purposes, and on the amounts and conditions of their reimbursement from health insurance. The Institute is entitled to take action in case a risk to public health arises, to impose penalties, and to request necessary documentation.

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