What do you need to know if you want medicine registration in Kazakhstan?
- You need to have reports of comparative clinical trials with the original medicine in accordance with the GCP requirements to register generics (except for aqueous solutions with the same composition). Clinical studies can be carried out in any country (not necessary to carry it in KZ)
- If a company enters the Kazakhstani market for the first time, a GMP inspection is required (inspection can be carried out during the registration process or before starting the registration)
- Registration of the medicine requires an analytical regulatory document preparation (paid separately)
- In order to avoid problems with the import of products before printing layouts and IFUs, it must first be agreed with us again
- Before registering a medicine, it is necessary have a company that will be responsible for pharmacovigilance on the KZ territory
Stages of work
- Signing a non-disclosure agreement (if necessary)
- Checking the dossier for completeness
- Invoicing for 50% payment of services (prepayment)
- Preparation of a regulatory document and request for samples of the finished product and reference materials for analytical testing
- Dossier preparation for submission
- Expertise (elimination of additional requests, GMP inspection organization, if necessary)
- Registration certificate issue
- Invoicing for remaining 50% payment of services
Terms of registration process
- Registration 8-12 months
- Re-registration 4-8 months
- Alteration (making changes) 1-4 months
Note: The terms are indicated as realistic as possible based on our experience.
