Renewal of registration

The marketing authorization certificate is issued for 5 years, except for shorter validity under specific registration procedures. The renewal procedure must be performed to extend the validity of the registration. 

After the renewal, the marketing authorization is issued for an unlimited period, except the cases to renew for 5 years due to safety reasons (pharmacovigilance). 

The Application for renewal should be submitted to the Ministry of Health of Ukraine no later than 180 calendar days prior to the expiration of the marketing authorization. It is recommended to submit the Application in 12 months before expiry. 

After the re-registration, the same number of the marketing authorization is kept.

A smaller set of documents is required for the re-registration than for the new registration. The dossier is based on the documentation related to safety (pharmacovigilance). Properly legalized administrative documents and specific national forms must be submitted. The re-registration includes expert assessment of updated data on the benefit-risk ratio.

Variations to the registration materials may be applied during the re-registration. Applications for variations are submitted in parallel with and independently of the renewal.

Renewal procedure

MAH must fill the Application for renewal and relevant documents (dossier) according to national requirements. Application form, cover letters and other forms, specific national documents must be submitted in the Ukrainian language. Documents are submitted to the competent authority in paper form. 

The MAH submits the Application form for renewal to the competent authority. The authority issues invoices for expert assessment that should be paid before the submission of the dossier. The dossier should be submitted not later than three months after the submission of the Application form.

The competent authority performs the preliminary assessment of the registration materials (dossier) within 14 business days from submission. If there are no deficiencies, the specialized expert assessment of the dossier starts.

The timeline of the specialized expert assessment should not exceed 90 business days, not including 60 days clock-stops for answers on the deficiencies. 

Steps of the renewal in brief : 

• filling of the Application form and renewal dossier; 
• submission and assessment of the Application form, answers on the deficiencies if any, issue and payment of the Invoices for state fees; 
• submission of the renewal dossier, preliminary (initial) expert assessment of the dossier; 
• specialized expert assessment of the dossier; 
• answers on the deficiencies, corrections of the instructions for use and labeling; 
• product is recommended for renewal at the meeting of the scientific council; 
• Ministry of Health prepares the draft of the Order for renewal that should be signed and published in the official gazette; 
• Competent authority issues and grants the renewal certificate to MAH. 

Overall realistic timelines of the renewal are from 8 to 12 months. We recommend starting the renewal in 12-15 months before the expiration of the marketing authorization, submitting the Application for renewal 12 months,, and submitting the dossier in 10-11 months before the expiry of the registration certificate. 

Our services

Since 2006 we support the pharmaceutical business in regulatory affairs, pharmacovigilance, and quality. We are a leading regulatory consultant in Ukraine and 11 countries of the CIS region. Our extensive team has the necessary knowledge, experience, and skills and is proficient in English.

We have provided regulatory services for more than 200 manufacturers of medicines, many of which recommend us as a regulatory partner. 

We offer: 

• consultation, development of registration strategy;
• establishment of new registration, renewals, and variations;
• establishment and maintaining a pharmacovigilance system, outsourcing the functions of the local contact person;
• confirmation of manufacturing conditions with GMP requirements through recognition or inspection.

In addition to the main services, we also offer:

• translation of the scientific, medical, technical, and legal documentation;
• back-office operations: preparation of the registration dossier or any of its parts without submission;
• development and pre-printing verification of labeling artworks and instructions for use;
• medical writing of parts of the registration dossier;
• development of documentation and import licensing;
• writing of documentation for inclusion of the medicinal product in the National List (HTA).