On 20.03.2016 the Ordinance № 31 of 12.08.2007 for the determination of the rules of Good clinical practice was significantly amended. Good clinical practice is a combination of internationally acknowledged ethical and scientific quality requirements. They are to be observed in accordance with the planning, implementing, coverage and reporting of clinical trials.

Changes introduced in the Ordinance

  • In case of providing administrative services related to authorization of clinical trials of medical products certain documents that contain publicly available information are no more require.
  • The requirement for presentation of permit or certificate for activity of the hospitals and day-to-day summary of the relevant medicinal products is abolished.

Changes, introduced in related Ordinances

  • Requirement for a contract between the marketing

autorisations holder and the manufacturer responsible for the release of the medical products is abolished;

  • The administrative burden related to the issuance of authorizations for withdrawing, destruction or provision for educational or scientific medical purposes of blood or blood components that do not meet the medical standard is abolished;
  • Reduction of the administrative burden upon provision of organs, tissues and cells that could not be used for medical transplantation for other medical diagnostic and scientific-medical purposes.
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