2、registration certificate valid on the territory of the Republic of Kazakhstan;

3、approved instructions for the medical use of the medicinal product, medical devices in the state and Russian languages;

4、an agreed regulatory document on the quality and safety control of a medicinal product, a medical device with an assigned number;

5、approved mock-ups of packaging, labels, stickers on medicines, medical products.

Period of validity of the Registration Certificate

When state registration is established, the validity of the registration certificate is 5 years for medicines, up to 10 years for medicinal substance, medicinal plant raw materials, 5 years for medical products, 7 years for MT.

Upon expiration of the registration certificate of medicines, medical devices and medical equipment is subject to re-registration.

Is a registration certificate issued in the CU member states valid in Kazakhstan?

On the territory of the Republic of Kazakhstan, only the registration certificate issued by the state body of the Republic of Kazakhstan is valid.

Dates of examination

1、Examination of the medicinal product during state registration and introduction of changes requiring new registration shall be carried out within a period not exceeding two hundred and ten calendar days.

2、Duration of the examination of medical devices and medical equipment, depending on the safety class is 90-160 days.

Safety and quality assessment

The deadline for work to assess the safety and quality of medicines and medical products is 30 days.