Certificate of registration for medicinal product is valid for 5 years. To prolong registration for the next 5 years product should be re-registered (hereinafter – renewed).
Renewal procedure is manly the same as new registration, but it does not include some steps.
Particularities of the renewal of medicinal products in Ukraine:
- Requirements to dossier do not include preclinical and clinical part*, except PSUR (periodic safety update report). Quality assurance is not required*.
- That means that there will be no need to import the samples and perform tests in accordance with control methods. For that reason there are no expenses for quality assurance, cost of the procedure is lower.
- Submission of the Application has to be done in 90 calendar days (3 months) before expiry of registration. If during renewal process the registration will expire – product should be withdrawn from sale before finish of the procedure.**
- State obligatory fees are reduced.
* That particularity is applicable only in case that chemical part of the dossier would stay unchanged.
** Situation can be solved with assistance of our company.
Average term to obtain renewal of registration for medicinal product is 6-9 month.
Average term to renew the product with our assistance is 3 months.
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