Kazakhstan approves new Rules for the preparation of PIL and SmPC for medicinal products and medical devices

New Rules for the preparation of patient information leaflet and summary of product characteristics for medicinal products and medical devices was approved by order of the Minister of Health of the Republic of Kazakhstan dated September 10, 2020 No. ҚR DSM-101/2020.

The changes was adopted in the framework of harmonisation of national legislation with the requirements and rules of the EAEU.

The order will be put into effect on September 26, 2020 – 10 calendar days from the date of the first official publication on September 16, 2020.

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