Re-registration of a medicinal product in Ukraine in 2023

A Certificate of Drug Registration in Ukraine is issued for a period of 5 years. After the expiry of the term, if you plan to continue to supply a medicinal product in Ukraine, you will have to undergo the re-registration procedure.

The re-registration procedure will require a smaller package of documents than the initial registration of the medicinal product, but the procedure is not easier or much faster.

The good news is that once you have re-registered your medicinal product, you will get a new Certificate of Registration, which will be valid indefinitely. However, if there are reasons related to pharmacovigilance, which dictate compulsory re-registration of such a drug every 5 years.

Our company offers services both for primary registration of a medicinal product and its re-registration in Ukraine. Today we will elaborate on the re-registration procedure, and key aspects of the procedure you should pay special attention to.

If you would like to get an exact answer on the terms, cost and procedure of re-registration of your medicinal product, please contact our specialists for a personal consultation.

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What is the drug re-registration procedure in Ukraine?

First of all, let’s talk about when you should start the process of preparing documents and submitting an Application for re-registration of a medicinal product.

The law establishes a deadline for submitting the Application - no later than 90 days before the expiry date of the Certificate. But we advise you to prepare and submit the Application 8-11 months before the expiry date, taking into account all the inspections and the time needed to provide information at the request of the state authority and other procedural aspects.

Such a long re-registration period is also due to the fact that one of the stages involves the drug quality check. It is important to make changes to the manufacturer’s GMP-certificate in time - if this is not done, the entire process will be suspended.

When planning to start the re-registration procedure, you need to take into account the time for:

• conducting an examination and evaluation of the benefit/risk ratio of the product (this stage takes 90 days);

• receiving and reviewing your application and registration form;

• paying re-registration fee - this stage is more time-consuming than it seems, as it involves signing a service agreement with the State Expert Center (SEC), communicating with a SEC agent and time required to confirm the payment;

• preliminary examination of the completeness of the dossier for re-registration;

• provision of additional information at the request of the state authority;

• final checks of documents, draft certificate, etc.

That’s why we recommend starting preparatory work 10-11 months in advance, and submitting your application 8-9 months before your Certificate expires.

Please note! If you are concerned about re-registration with slight delay and less than 6 months remain till the expiration of the certificate, you will need urgent re-registration, or you should be prepared that your medicinal product cannot be imported into Ukraine or supplied to the points of sale for some time - until the re-registration procedure is completed.

Documents required for drug re-registration in Ukraine.

The main documents to be submitted for re-registration include: an Application form, a Registration Form and an updated Dossier of the drug, including an updated RMP, as well as an SOP of the plant pharmacovigilance.

Our practice shows that, as with the initial registration of a drug, the biggest problems may arise from the text of the Dossier - in the practice of the licensing authority there have been only a few cases where the Dossier was approved the first time. You should be prepared for the fact that even a professionally prepared Dossier will require adjustments, which takes time.

Our team makes sure that the Dossier is pre-audited and that no additional comments or only minimal corrections are required by the controlling body. This saves you time and protects your interests as a supplier or manufacturer.

The Dossier must contain:

• updated instructions for use;

• new labeling text;

• risk management plan;

• plant pharmacovigilance SOP;

• additions to the quality summary and to the preclinical review;

• other information, depending on changes (if any) and government agency requirements.

Stages of the drug re-registration procedure in Ukraine.

• Check and preparation of the Dossier, Application, Registration Form, etc;

• Signing of an expert work agreement with SEC;

• Submission of the Application and other documents to the SEC, as well as the Application for re-registration to the MOH;

• Examination of the data provided in the registration form;

• Submission of the Dossier for re-registration;

• Pre-examination and submission of the Dossier to the expert committee for risk/benefit assessment of the drug (if no comments);

• Communication with the expert commission (receiving comments, preparing answers to them, making corrections if necessary);

• Following the SEC decision, checking the draft certificate and submitting documents to the MOH;

• Issuance of the certificate and inclusion of the drug in the State Register of Medicines of Ukraine.

Once the drug re-registration procedure has been completed, you will get a new Certificate, but the drug registration number will not change.

Please note! If you decide to make some changes during the re-registration process, for example, to the package design or other changes, it is better to make them in advance, through the procedure of making changes to the Dossier.

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Drug re-registration legal services in Ukraine

• Consultation on the drug re-registration procedure in Ukraine;

• “Roadmap” - a ready-made guide on re-registration of your medicinal product, taking into account the remaining terms, which you can use, if you wish, to re-register the medicine in Ukraine on your own;

• Pre-registration review of the Dossier and other documents for re-registration of the drug;

• Translation of all documents;

• Preparation of the application form, registration form and other documents needed to start the re-registration procedure;

• Submission of all documents to the SEC, monitoring their review and timely response to the comments of the state authority;

• Timing control at all stages of re-registration by our lawyers;

• Review of the draft Registration Certificate prior to issuance.

The cost of the drug re-registration procedure will depend on the services you need from our company. You can choose a ready-made package of services here, or contact our specialists to form a personal package and its cost.

Do you want to re-register your medicinal product in Ukraine on time and without unnecessary problems? Don’t hesitate to contact us! We will help you to prepare for the re-registration process in advance and ensure its successful completion.

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