After granting the marketing authorization, the Marketing Authorization Holder (MAH, Applicant) must inform the State Expert Center of the Ministry of Health of Ukraine about any variations.
Types of variations in Ukraine are similar to the types of variations in the EU:
- correction of technical errors (mistakes);
- change of the Applicant (Marketing Authorization Holder transfer);
- type IA: insignificant variations having no significant influence on the quality, safety and efficacy;
- type ІАIN: type IA variations with immediate notification;
- type IB: insignificant variations under type IA or II;
- type II: variations having an influence on the quality, safety and efficacy;
- variations causing the new registration.
Classification of variations and requirements to the registration materials are described in Annex 17 to the Order of the Ministry of Health No. 426.
The concept of “notification” in Ukraine is different from European practice. There are no deficiencies during the assessment process of notification-class variations: either positive or negative decisions. Any incompliance means a negative result.
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Procedure and timelines
MAH must fill the Application for variation and relevant documents (dossier) according to national requirements. Application, cover letters and forms, specific national documents must be filled in the Ukrainian language. Documents are submitted in paper form.
The MAH submits the Application (the registration form) for variations to the competent authority. The authority issues invoices for expert assessment that should be paid before the submission of the dossier.
The competent authority performs the preliminary assessment of the registration materials (dossier) within 14 business days from submission. If there are no deficiencies, the dossier is transferred to the specialized expert assessment.
Specialized expert assessment timelines:
- not more than 90 workdays: variations requiring new registration;
- not more than 60 workdays: type IA, IB, and II variations, change of the MAH (this period can be reduced due to urgent reasons related to the safety);
- not more than 45 workdays: variations related to seasonal, pre-pandemic or pandemic vaccines for influenza prevention;
- not more than 20 workdays: correction of the technical mistake.
In the process of specialized expert evaluation, the competent authority may request the missing documents or information. The MAH has 60 calendar days to provide a response to such comments justification for another term. In case if the MAH fails to provide the response within the established term, the procedure shall be withdrawn from consideration and the money paid shall not be returned.
According to the results of the expert evaluation, the competent authority recommends (or does not recommend) variations to the registration materials and provides appropriate conclusions to the Ministry of Health. The variations are approved by Orders of the Ministry of Health, recorded in the electronic register and provided to the MAH in the form of inserts (annexes) to the marketing authorizations.
Timelines for submission of the variations
The legislation defines that MAH must submit the Application for variations in the following timelines, depending on the variation type and content:
- Urgent safety variations are submitted to the competent authority immediately and are introduced in case if no objections are received within 24 hours after submission. The MAH shall submit such variations within the following 48 hours (under the legal requirements).
- Safety variations are submitted within 60 calendar days after the date of receipt of information about the need to make such variations.
- Type IA variations (except for type IАIN variations with immediate notification) should be submitted within 12 months after such variations are introduced by the MAH.
- Type IB variations: The MAH shall apply for variations before its introduction.
MAH can apply for the transition period for type IA administrative variations (changes in the instruction for use and/or labeling), type IB and type II variations. The competent authority assesses the Application and decides on the possibility and length of the transition period.
The maximum transition period is six months from the approval date of such variations.
Change of the MAH (holder, Applicant): transfer of rights
The MAH (holder of the marketing authorization for the medicinal product) is the authorization owner, responsible for the quality, safety, and efficacy of the medicinal product.
MAH can transfer the rights for the product to another company.
Transfer of the rights requires submission of the Application. The dossier should include the documents on the transfer of the right from one entity to another, the suggested MAH’s obligations to take responsibility for the quality, safety and efficacy of the medicinal product, the manufacturer’s consent to produce the medicinal product for the suggested MAH and other documents.
Documents for MAH transfer must consider the national requirements; some of them require proper legalization.
The variations can influence approved national documents, e.g.:
- previously registered graphic mock-ups of packaging;
- recognition decision / GMP certificate;
- finished product quality control methods, certificate of analysis;
- instruction for use, etc.
The impact of the introduced variations on other regulatory documents should be evaluated and considered.
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We have provided regulatory services for more than 200 manufacturers of medicines, many of which recommend us as a regulatory partner.
- 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;
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- development of documentation and import licensing;
- writing of documentation for inclusion of the medicinal product in the National List (HTA).