The registration certificate is issued for a period of 5 years, and before its validity expiration it is possible to initiate the procedure of re-registration. Re-registration is carried out one time, and after that an unlimited registration certificate is issued (with the exception of cases when the MOH makes decision to conduct an additional re-registration procedure after 5 years for justified reasons related to pharmacovigilance).
In order to start the process of re-registration it is necessary to submit the relevant Application no later than 90 days before the registration certificate validity expiration. At the same time, the recommended deadline for submitting the Application is 10-11 months before the RC validity expiration.
Re-registration begins from the moment of submitting the Application to the Ministry of Health of Ukraine and ends with the approval of re-registration by the Order of the Ministry of Health of Ukraine and the issuance of the new registration certificate. The number of the registration certificate remains the same.
Documentation for re-registration
A smaller package of documents is required for the procedure of re-registration compared with the new registration. The dossier for re-registration is based on the documentation on pharmacovigilance, but other parts of the dossier are also submitted, including quality documentation, administrative documents and specific national forms:
- updated instructions for use;
- updated labeling text;
- RMP (risk management plan);
- addendum to quality summary;
- addendum to pre-clinical overview;
- addendum to clinical overview (ACO), etc.
NB! Prior to submission of the Application for re-registration, it is recommended to submit Applications for all changes (otherwise the need for changes will be indicated in the letter-remark from the SEC). These procedures shall be conducted simultaneously and independently of each other.
Stages of the re-registration procedure:
- Preliminary consultation, if needed.
- Submitting the Power of Attorney to the SEC and signing the Agreement for expert evaluation, if needed.
- Submitting the Application for re-registration to the Ministry of Health of Ukraine.
- Submitting the registration form (addendum to the Application) to the SEC.
- Expert evaluation of the data contained in the registration form for the purpose of checking the compliance of the information of the State Register of Medicinal Products of Ukraine and compliance with the requirements of the Procedure. Getting the positive conclusion, or observations.
- Obtaining the invoices for payments of government levy and expert evaluation cost.
- Carrying out payments, obtaining the payments confirmations and submitting to the SEC.
- Submission of dossier for re-registration.
- Preliminary expert evaluation conducted to check the completeness of the documents submitted by the Applicant in accordance with the requirements of the Procedure.
- Obtaining the positive conclusion on preliminary expert evaluation, or observations.
- Submission of the dossier to the expert commissions that carry out the expert evaluation of the benefit / risk ratio of the finished medicinal product.
- If there are changes that were not declared during re-registration, such changes must be submitted with separate Applications (which does not stop the expert evaluation procedure for re-registration).
- Obtaining observations, in-person communication with the corresponding expert on the substance of the observations, if needed.
- Responding to the observations, editing the Instruction for use.
- Making the decision (recommendation) regarding registration of the medicinal product in Ukraine at the SEC meeting.
- Verifying and reconciling a draft of the registration certificate, QCM, instruction and text of the packaging material labeling.
- Transfer of the documentation set to the MOH.
- Obtaining the documentation by the Ministry of Health and including into a draft of the Order on registration.
- Signing the Order on registration of the medicinal product.
- Including the medicinal product into the State Registry of Medicinal Products of Ukraine.
- Issuing the original of the registration certificate and its addenda.
Timeframe for re-registration
The expert evaluation period of the benefit / risk ratio of the finished medicinal product is 90 working days from the date of submission of the registration dossier. However, one should not confuse this term with the term of re-registration, since it does not include:
- the period of consideration of the Application and the registration form;
- payment of the government levy and receiving the payment confirmation;
- preliminary expert evaluation of completeness of the dossier for re-registration;
- 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 the registration of the medicinal product.
We recommend starting the works on documents before 11-12 months, submitting the application for re-registration before 9-10 months, and documentation for the initial expert evaluation before 8-9 months prior to the registration certificate validity expiration.
Timeframe for responses to the observations:
During the re-registration procedure, the competent authorities may request missing documents or information. Such requests can occur at any stage, and legislation provides for precise deadlines for responding to such remarks.
During specialized expert evaluation each commission of the SEC has the right to request the necessary additional materials from the Applicant. The Applicant has 90 working days to respond to these observations or to justify the timing of the response.
In case the Applicant doesn't provide the requested data or provided data are incomplete, the registration materials are withdrawn from consideration and paid amounts are not returned.
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 in registration of 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 registration dossier for compliance with the legislative requirements to re-registration;
- preliminary consultations with competent authorities;
- translation of the scientific, medical, technical and legal documents;
- juridical analysis and preparation of administrative documents;
- updating of specific national documents: instructions, labeling packaging and layouts;
- development of the documents in the pharmacovigilance system;
- preparation of the Application and registration form, compilation and formatting of the re-registration dossier according to all requirements and recommendations;
- submission of the Application, registration form and registration dossier to the 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.