Renewal of or changes to registration certificate

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.

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 If during renewal process the registration will expire – product should be withdrawn from sale before finish of the procedure.**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.

Variations are the changes to the valid registration certificate, for example: changes to the package design, changes to the text of leaflet or instruction for medical use of the product, changes to the name & address of the Applicant (sale of the registration certificate), changes to the manufacturing process and so on.
There are three types of changes (variations)
Type I (IA and IB) – are the small (minor) changes to the dossier that do not require special assurance plus changes related with sale of the certificate to another Applicant;
Type II – are the significant (major) changes to manufacturing process, manufacturer of the active substance, minor changes to the composition and so on; such changes can require special assurance in laboratory and expertise of additional documentation;
Type III (variation that cause changes to medicinal usage of product) – are the major changes to the composition and/or indications of the product. Such changes can be obtained only by new registration.

It is possible to perform renewal of registration simultaneously with changes type I and type II.

Time period for changes type I – from 30 to 75 days (with our assistance is less than one month), type 2 – from 60 to 120 days (45 days with our assistance), type 3 causes new registration.

If you are interested in obtaining more information about procedure or/and our services, you can: