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 If during renewal process the registration will expire – product should be withdrawn from sale before finish of the procedure.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.
List of required documents for renewal of medicines
The following documents are submitted together with the application for renewal:
1. Cover letter.
2. Comprehensive table of contents.
3. The application for the state renewal with following annexes:
3.1. Details about authorized persons (qualified person of applicant in Ukraine for pharmacovigilance).
3.2. Statement of GMP compliance (by competent authority for at least three years), if any.
3.3. Copy of manufacturing license.
3.4. Certificate or conclusion of GMP compliance issued by State Service of Ukraine on medicinal products.
3.5. List of countries, where the product is on the market and indicating the date of the first registration.
4. Chronological list of claims for the product, received during recent 5 years in Ukraine, with the analyses of details which caused the claims and the measures taken by the applicant to prevent it in future.
5. Chronological list of guarantees and specific obligations, submitted since the registration/renewal indicating scope, status, date of submission and date when the issue has been solved (recommendations for post-registration investigation, elimination of any defects, specified by control and other agencies, etc.).
6. Revised list of all remaining guarantees and obligations and signed letter of commitment (where applicable).
7. Product information;
7.1. The drafts of the updated SPC, package (labeling) and package leaflet. The current SPC in Ukrainian, Russian or English (with relevant translation) or, if appropriate, the proposed SPC with all changes clearly highlighted in Ukrainian, Russian or English (with relevant translation);
8. Approved at registration and up-dated methods of quality control of the finished product.
9. Approved at registration and up-dated technological regulation or data concerning the manufacturing technique.
10. Periodic safety updated report on medicinal product or bridging summary report.
11. The manufacturer’s/Applicant’s (or his representative) summary data about safety status of medicinal product in Ukraine during the validity period of the most recent registration certificate in the format approved according to Annex 8 to the Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use approved by Order of the Ministry of Health of Ukraine dated 27.12.2006 № 898.