As a member of the Eurasian Economic Union (EEU), regulatory affairs within Kazakhstan have developed rapidly and will continue to do so. Legislation at both the national and EEU level related to the healthcare sector is wide-ranging and complex.
The local registration process, for example, is comprehensive and includes physiochemical, biological and clinical tests designed to verify the efficiency, safety and quality of pharmaceuticals marketed in the country. Registration fees vary dependent on the drug type in question. The process can be lengthy (up to 18 months) and anticipating the regulatory requirements pertinent to a particular application is key.
As your local regulatory partner Grove has access to the key institutions regulating the market, notably, the Committee for Pharmacy (responsible for registrations and overseen by the National Center of Expertise). In turn, the National Center for Expertise operates within the Ministry of Health.
Grove provides regulatory consulting services in any one of a number of areas and can, if necessary, act as a full-service provider of regulatory services.
REGULATORY AFFAIRS CONSULTING SERVICES IN KAZAKHSTAN – PRE-SUBMISSION AND SUBMISSION ACTIVITIES
With their comprehensive understanding of local regulatory requirements, Grove’s in-country regulatory affairs consultants work closely with their clients through the necessary pre-submission and submission activities required. Key within this is:
- Regulatory consulting – regulatory submissions and registration related services
- Preparation and submission of relevant documentation for drug registration and marketing authorization
- Medical device registration
- Liaison with local agencies to monitor progress
- Assistance with packaging/labelling approval (packaging material submissions, labelling compliance/approval)
- Readability testing for local language Patient Information Leaflets
REGULATORY SERVICES IN KAZAKHSTAN – MAINTENANCE OF REGULATORY APPROVAL/MA
Grove’s in-country regulatory affairs team provides a full support service post-submission, and work with clients in the following areas:
- Post-marketing applications
- Marketing authorization transfer services
- Variations
- Renewals
- Notifications
- Support for the management of national Agency databases
- Submission of annual specific national declarations
- Packaging/labelling compliance
REGULATORY CONSULTING SERVICES IN KAZAKHSTAN – MONITORING OF LOCAL
REGULATORY REQUIREMENTS
Completing the full-service regulatory package that Grove’s regulatory affairs consulting team in the country provide, Grove will:
- Monitor local regulatory change and provide appropriate updates
- Assess national regulatory documentation and provide appropriate updates
- Ensure compliance with local requirements for regulatory submissions given any change in national legislation, regulations and policies
- Provide relevant safety updates
Key product areas covered:
- Pharmaceuticals/medicines/drugs/medicinal products
- Medical devices
- Biologics
- Cosmetics
- Food and dietary supplements
