Medicines: human drugs and biologics

Renewal of registration

Marketing authorization of medicinal product should be renewed each 5 years. Renewal of registration is a process that requires submission of Application and renewal materials (dossier for renewal), payment of state fees, detailed state expertise of materials, answering on deficiency letters till approval of the product for renewal. There is no laboratory analysis of the samples during renewal.

Renewal process itself is much easier than new registration, but:

• registration certificate and it’s annexes should be updated according to up-to-date legislation requirements (for example – Braille should be applied to package drawings, PIL is usually should be updated with new safety data etc.);
• renewal process can include in-process variations to registration materials; each variation should be presented by separate Application and necessary justifications;

Timing. Submission of Application form with micro-dossier should be done not later than 90 days before expiry of registration certificate. Official timing of state expertise is limited by 90 days not including timing required by Applicant for answers on deficiency letters. Additionally renewed registration certificate is issued only after signature of Minister of Health; that additional time is officially limited by 2 months.  

We recommend start communication and first steps in filling the dossier not later than 10 months before expiry of registration certificate. In case if new registration certificate will not be issued before expiry of existing one – medicinal product should be withdrawn from shelves in pharmacies.

Dossier. Dossier for renewal is not as complicated as dossier for new registration. Applicant should provide full administrative data, updated chemical-pharmaceutical data and retrospective study of safety of medicinal product (PSUR). All variations (changes) to registration materials should be submitted by separate Applications with all justifying materials.

Expertise procedure.Procedure is initiated by submission of Application form with “micro-dossier” to State Expert Center. Expertise of renewal dossier starts only after payment of relevant state fees. 

State experts have the right to inquire additional information by official deficiency letters. Applicant has 90 days for official reply to the questions; otherwise product can be withdrawn from registration.

There is no laboratory analysis during renewal.  

After positive conclusion from all experts product is adopted for renewal at the session of State Exert Center. Within several weeks original registration certificate is issued and product is included to State Registry of Medicines. 

State fees. Applicant should perform several payments to relevant state authorities of Ukraine during renewal of medicinal product:

• Payment of state duty to the State Treasury of Ukraine should be done prior to submission of the dossier – 100 EURO (+10 EURO for every additional dosage or package);
• Payment for state expertise of renewal materials to State Expert Center should be done prior to submission of the dossier – app. 1000 EURO (+100 EURO for every additional dosage or package);

We offer comprehensive service of renewal of marketing authorization of medicinal products. All works will be performed by big professional and experienced team of regulatory professionals, chemists and doctors. We provide our knowledge and experience to many companies and have necessary capacities for new projects. Cratia has all necessary permissions and accreditations for all in-process activities.

It is obvious that all preliminary advices and consulting are free of charge. 

You can contact us by e-mail info@cratia.ua, telephone +38 (044) 332-42-94, 221-71-29 or at the meeting in our office.