Any changes regarding the quality, safety and efficacy of the medicinal product must be submitted by the Applicant according the procedure for introduction changes, which starts with the submission of the Application and ends with the receipt of the insert to the registration certificate.
Types of changes in Ukraine are similar to the types of changes in the EU:
- correction of technical error: correction of discrepancy made during the procedure of registration, re-registration or introduction of changes;
- change of the Applicant (owner) of the registration certificate;
- type IA: minor changes that do not have a significant impact on quality, safety and efficacy;
- type ІАIN: changes type IA with immediate notification;
- type IB: minor changes that are not of type IA and II;
- type II: changes that affect quality, safety and efficacy;
- changes requiring new registration of the medicinal product.
The concept of "notification" in Ukraine differs from the European practice: in fact, "notification" changes do not imply any mistakes or questions on the part of the competent authorities, since the issuance of a remark means a refusal to carry out the expert evaluation.
Declared changes may affect a number of approved national documents, for example:
- graphic layouts of the packaging, which were previously registered in the Unified Automated Information System (UAIS) of the State Service of Ukraine on Medicines and Drugs Control (SMDC);
- conclusion on recognition / GMP compliance certificate;
- methods of quality control of the finished product, certificate of analysis;
- instructions for use, etc.
Therefore, it is very important to assess in advance the result of the changes introduced, and their impact on regulatory documents.
Timeframe for submitting documents for changes
The Applicant must notify the Center of any changes in the registered medicinal product, providing information on the causes of such changes, and their possible impact on the efficacy, safety and quality of the medicinal product.
Depending on the type of changes, the Ukrainian legislation provides for the following terms of submission of the Application or the introduction of changes:
- Urgent changes regarding the safety of the medicinal product (temporary restrictions): are communicated by the Applicant to the SEC immediately, and are enforced if the SEC has no objections within 24 hours from the moment of submission of the information. Thereafter, within 48 hours from the moment of implementation of the temporary safety restrictions, the Applicant is obliged to apply for these changes in accordance with the requirements of the legislation, and to submit to the SEC the corresponding package of documents.
- Changes to the instruction concerning the safety of the medicinal product: are communicated by the Applicant to the SEC in any way, and the Application for introduction of changes is submitted not later than 60 calendar days from the date of receipt of information on the need to make these changes.
- Type IA changes: are applied for not later than 12 months after implementation of these changes by the Applicant. This does not apply to type IAIN changes (type IA changes with immediate notification) that are applied for immediately after their implementation with indication of date.
- Type IB changes: The Applicant must apply for these changes before they are introduced.
Timeframe for conducting expert evaluation of changes:
- not more than 90 working days: changes requiring new registration;
- not more than 60 working days: changes of types IA, IB, II and change of the Applicant (the period may be reduced due to the urgency of the issue if the changes relate to the safety of the use of the medicinal product);
- not more than 45 working days: changes for seasonal, pre-pandemic or pandemic vaccines for prevention of influenza;
- not more than 20 working days: correction of technical error.
During expert evaluation of introduction of changes, the competent authorities may request the missing documents or information. Legislation provides for precise deadlines for responses to observations that differ from the current stage of registration. In the case if the Applicant cannot provide answers to the observations within the specified time limits, the procedure is withdrawn from consideration and paid amounts are not returned.
NB! The above dates are only described for the duration of the specialized expert evaluation of registration materials, and do not include:
- the period of assessment of the Application and the registration form;
- payment of the government levy and receiving the payment confirmation;
- preliminary expert evaluation of the completeness of the registration dossier;
- the time required for the Applicant to respond to the observations;
- final actions after expert evaluation (verification/proofreading of drafts of the registration certificate and its addenda);
- period of signing the Order of the MOH on registration of the medicinal product.
The above actions take an average of 1.5 to 3 months, and accordingly, extend the resulting period for introduction of changes.
Change of the Applicant (owner): transfer of rights to the registration certificate
The registration certificate for the medicinal product is the property of the Applicant (owner, holder). The Applicant is responsible for the quality, safety and efficacy of the medicinal product, and may transfer (sell) the rights to another Applicant.
For this purpose, a corresponding Application is submitted with the corresponding package of documents. The documentation package should include the documents on the transfer of the rights from one person to another, the obligations of the new person to take responsibility for the quality, safety and efficacy of the medicinal product, the consent of the manufacturer of the finished product and other documents.
All documents submitted from the approved Applicant (which transfers the ownership rights) or from the new Applicant (which receives the ownership rights) must be executed on the official (firm) letterheads of the relevant legal entity.
Such documentation should be legally properly executed, and some documentation should be legalized.
Services and activities of Cratia:
For more than 12 years our company professionally performs the activities of registration of medicinal products in Ukraine. We have extensive experience for introduction of changes of all types for all types of medicinal products. Depending on your needs, we are ready to offer both the full range of activities to fulfill all the regulatory requirements, or any of the listed services:
- regulatory planning and preliminary consulting;
- checking the documents for introduction of changes for compliance with Ukrainian legislative requirements;
- preliminary consultations with competent authorities;
- translation of scientific, medical, technical and legal documents;
- legal analysis and preparation of the administrative documents;
- preparation of updates to the specific national documents: QCM, instructions, labeling of packaging and layouts;
- preparation of the Application and registration form, compilation and formatting of the dossier for introduction of changes according to all requirements and recommendations;
- submission of the Application, registration form and registration dossier to SEC of the MOH of Ukraine;
- arranging all payments and receiving the payment confirmation;
- support of the expert evaluation process, communication with competent authorities;
- analysis of observations, preparation of recommendations to respond to the observations;
- control of deadlines at all the stages of expert evaluation;
- checking a draft of the registration certificate and its addenda.