Home / SUKL / SUKL Notice Board / Information on SUKL / Policy of the Institute

Policy of the Institute

In order to achieve the tasks of the State Institute for Drug Control the Director sets forth the Policy of the Institute. The Policy of the Institute is a summary of the essential principles of the Institute defined with respect to its customers as well as partners. With a view to the position defined by the national and European legislative framework the Policy of the Institute reflects the approach of management and all employees of the Institute to the achievement of tasks, obligations, and powers of the Institute. It reflects both the focus on the integrity of interests of all major stakeholders in the area of regulation of pharmaceuticals and medical devices and the primary orientation on the performance of the authority with a view to the needs of the public in relation to ensuring the protection of public health and to the risks involved in use of medicinal products and medical devices.The tasks of the Institute are being achieved in compliance with legislation in force; they are aimed at fulfilment of the state policy in the sphere of public health and reflect generally recognised professional standards in the area of medicines policy.They are being achieved in compliance with ethical rules, in a transparent and foreseeable manner, with transparent documentation of the activities and with openness towards the queries and motions of the regulated entities and the public. The management of the Institute ensures involvement of each employee in the fulfilment of the Institute’s Policy within the scope of their competencies. The Institute’s customers and partners as well as any interested persons are continuously informed about the fulfilment of the Policy of the Institute.

The Institute has established the following strategic objectives: 

  •  It provides services and activities in the sphere of human pharmaceuticals at a high standard, in the shortest periods practicable, and without creating barriers to the use of pharmaceuticals.   
  • It proactively harmonises inconsistencies in differing regulations set forth by the Institute or by another regulator for identical or interchangeable objects of regulation.
  • By its increased activity in the sphere of surveillance over advertising and illegal handling of pharmaceuticals and by its increased interest in the quality and applicability of information about authorised medicinal products for patients it contributes to the autonomy of the users of pharmaceuticals in the process of care for their own health and in their decision-making about the use of pharmaceuticals based on information about the effects as well as risks of the treatment. 
  •  It ensures the administration of data repository for electronic prescription, with the objective to support pharmacovigilance activities and potential interventions of the Institute in protecting individuals and the public from pharmacotherapeutic risks.  
  •  It evaluates the effectiveness of the regulatory system by means of periodic reviews of indicators of various activities of its branches and the evaluation of customer and partner satisfaction. 
  •  It provides services and activities in compliance with the principles governing the quality management system consistently with the requirements stipulated by the ČSN EN ISO 9001:2001 standard and, in the area of control laboratories, by the ČSN EN ISO/IEC 17025 standard. 
  •  It develops the previously established information security system in compliance with the ČSN ISO/IEC 27001:2005 standard.
  • It develops information support for the state administration and for the public with the objective to eliminate  lack of awareness of the drug policy and current situation in handling pharmaceuticals. 
  •  It proactively presents the achieved objectives and forms a positive image of the Institute for the key regulation stakeholders and for the public. 
  • It strives for international recognition of its activities within the scope of cooperation among the medicines agencies in the EU and the EU structures associated with the future Czech presidency in the Council of Europe. In this respect, the active involvement of representatives of the Institute in international cooperation within the European Community and worldwide is being encouraged. 
  • It increases the qualification of its employees to a standard necessary for the conduct of expert activities; it encourages the enhancement of professional competencies and permanent professional growth of staff by verification of their needs and implementation of training plans. 
  • It fulfils the Policy by means of suitable motivation tools for the employees who are the primary source for the achievement of the Institute’s tasks. 
PharmDr. Martin Beneš
Director of the Institute
 

2010 © SÚKL. Šrobárova 48, 100 41 Praha 10, +420 272 185 111, posta@sukl_cz.

Web portal supplier - QCM, s.r.o.