Pursuant to Article 23 of Code on Public Health and Healthcare System of the Republic of Kazakhstan No. 360-VI dated July 7, 2020, all pharmaceutical products, whether manufactured in Kazakhstan or imported from abroad, are subject to mandatory state registration. Without state registration, manufacturing, importation, and sale of pharmaceutical products are prohibited.
Consequences of Non-Compliance:
Violation of the prohibition on the sale of unregistered pharmaceutical products may result in administrative liability, including fines and suspension of business activities.
If such a violation results in harm to human health, more severe sanctions may apply. These measures are also provided for under administrative legislation but involve significantly stricter penalties.
LEGAL FRAMEWORK
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Arrangement of laboratory testing
Coordination with accredited expert and testing centers
Obtaining official conclusions based on testing results
Monitoring the review and approval status
Resolution of emerging issues during the review process
Obtaining the Registration Certificate and delivering it to the client
Compilation of the registration dossier in accordance with regulatory requirements
Translation and notarization of documents (if required)
Submission of the complete application package to the competent authority
Analysis of submitted documentation
Assessment of the readiness of the registration dossier
Identification of deficiencies and recommendations for corrective actions
02
STEP
Preparation and Submission of Documentation
04
STEP
Support Through Completion
03
STEP
Testing and Quality Assessment
01
STEP
Preliminary Expert Review
WORK PROCESS
! Important to Know: If a pharmaceutical product differs from the information specified in the Registration Certificate (for example, if the manufacturer, composition, or instructions for use have changed), its distribution may be considered a regulatory violation. This may result in administrative liability, including suspension of the product’s circulation on the market.
Therefore, before taking any action, contact us. We will advise you on the correct and risk-free course of action.
Re-Registration of Pharmaceutical Products
The validity period of a pharmaceutical product state registration in Kazakhstan is generally five years. Upon expiration, the holder of the Registration Certificate must undergo the re-registration procedure to maintain the right to market and distribute the product.
Re-registration includes:
The validity period of a pharmaceutical product state registration in Kazakhstan is generally five years. Upon expiration, the holder of the Registration Certificate must undergo the re-registration procedure to maintain the right to market and distribute the product.
Re-registration includes:
- Submission of an application to the competent authority (the Medical and Pharmaceutical Control Committee of the Ministry of Health of the Republic of Kazakhstan).
- Updating the registration dossier in accordance with the current requirements of the EAEU and the Republic of Kazakhstan.
- Additional expert assessment or testing, if required.
Amendments to the Registration Dossier
If changes have been made to the composition, manufacturing process, instructions for use, packaging, labeling, or manufacturer information, the holder of the Registration Certificate is required to officially register such changes.
Amendments may be:
If changes have been made to the composition, manufacturing process, instructions for use, packaging, labeling, or manufacturer information, the holder of the Registration Certificate is required to officially register such changes.
Amendments may be:
- Planned amendments – for example, updates to the instructions for use based on new clinical data.
- Unplanned amendments – such as changes to the manufacturer, manufacturing site address, composition, or dosage strength.
RE-REGISTRATION AND AMENDMENTS
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66 Navoi Street,
Almaty, Kazakhstan
Almaty, Kazakhstan