The main goal of this draft law is to improve the regulatory framework in the field of drug circulation, which includes optimizing the processes of state registration and eliminating duplicative norms and gaps in legal regulation.
According to the justification note, a legal monitoring of the current law "On Circulation of Medicines" was conducted by the Ministry of Health, based on which this draft law was developed.
One of the main aspects of the new draft law will be the implementation of a digital traceability system for medicines and medical devices. It is proposed to maintain electronic registers and monitor the movement of drugs through a fully automated process with the support of the Department of Medicines and Medical Devices, which is subordinate to the Ministry of Health.
Additionally, it is planned to expand the powers of the body responsible for regulation in the healthcare sector regarding programs for the use of experimental drugs.
This pertains to the principle of compassionate access for patients with rare and life-threatening diseases who are not helped by registered drugs.The draft law also includes updates to the approaches to the use of pharmacopoeias. It is proposed to apply only current pharmacopoeias that correspond to modern scientific and technological achievements, which, according to the authors, should improve the quality, safety, and effectiveness of medicines.
Some provisions may be deemed invalid due to their transfer to other articles of the law or loss of relevance. The Ministry of Health emphasizes that the adoption of this draft law will not require additional expenditures from the state budget and will not lead to negative social or economic consequences.Comparative table for the draft law. The image on the main page is illustrative: exclusive.kz.
