Kazakhstan Pharmaceutical Companies: Recent Legislative Changes on Promotional Ethics and Ads of Medications.

Dear Friends,

We would like to share the information on recently approved Rules on Promotional Ethics and Advertisement in the area of Medications and Medical devices.

New Regulations of Ethics for the Promotion of Medications and Medical Devices[1]entered into force on 7 January 2021

These Regulations apply to health care subjects, subjects in the field of circulation of medications and medical devices, medical and pharmaceutical workers, members of professional associations.

According to the Regulations, activities to promote safe, high-quality, and effective medications and medical devices from the developer and (or) manufacturer of a medication or medical device to the consumer are carried out on the basis of the principles of fair competition and the responsibility of all parties involved.

New Regulations for Advertising of Medications and Medical Devices[2]entered into force on 3 January 2021

In addition to a visual and understandable recommendation before prescribing and using to carefully read the instructions for medical use, advertising materials should contain a warning with the following content "Self-medication can be harmful to your health."

In addition, it was determined that the following information should not be considered as advertising of medications and medical devices:

1)    Information related to human health or diseases;

2)    Instructions for medical use, trade catalogs, price lists, reference materials, scientific information material, methodological and educational materials of a medical nature;

3)    Information about an individual and (or) a legal entity that manufactures or sells medication and (or) a medical device;

4)    A logo, trade, and (or) international non-proprietary name applied to industrial products distributed among medical and pharmaceutical workers (pens, notebooks, bags, medical gowns, calendars, business card holders, flash drives, etc.).

The term for consideration of documents by an expert organization was reduced from 20 working days to 10 days.

[1] Resolution of the Minister of Health of the Republic of Kazakhstan dated 21 December 2020 No.ҚР DSM-294/2020 "On Approval of the Regulations of Ethics in the Promotion of Medications and Medical Devices."

[2] Resolution of the Minister of Health of the Republic of Kazakhstan dated 20 December 2020 No.ҚР DSM-288/2020 "On Approval of the Regulations for Advertising Medicines and Medical Devices."