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New legal rules of the good clinical practice

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

Changes, introduced in related Ordinances