How To Register A Medicine In Ukraine? Legal Advice

During the pandemic, the issue of importation of medicines is more than urgent. Today in Ukraine there are a number of companies that import medicines to Ukraine mostly from foreign manufacturers. However, this procedure is not as easy in practice as it sounds.

What is the main problem?

Foreign drug manufacturers always have a GMP Certificate as proof of quality production. Ukrainian companies wishing to import medicinal products into Ukraine should first ask the manufacturer to make appropriate changes to this Certificate and determine a new trade name for such medicinal product in Ukraine. We will tell you why it happens so below.

In addition, the manufacturer shall also make changes to its drug manufacturing License, so that a Ukrainian company could import and sell such medicine in future without any problems. However, these changes must be made so that the Ukrainian state authorities (the Ministry of Health, the State Service of Ukraine on Medicines and Drugs Control, the State Customs Service) will not ask questions about such changes when you apply for documents. 

All these steps are often too expensive for manufacturers who do not understand the aspects of Ukrainian laws and registration procedures. Of course, this leads to the fact that the manufacturers will not concentrate too much on whether they are doing everything right. Therefore, to optimize the entire procedure for the importer, we offer our comprehensive services for drug registration in Ukraine.

The Drug Re-Registration Procedure in Ukraine

We divide the procedure into several steps, and will elaborate on the most problematic issues here.

Making changes to the manufacturer’s documents.

Our practice shows that the procedure of re-registering a medicinal product takes 8 months minimum. Such a period is due to the fact that one of the stages is quality control of the drug. Therefore, if the manufacturer (very often) does not make changes to the GMP Certificate, the procedure will be suspended.

Since manufacturers are often large companies which do not have all the processes fast - we always recommend our Clients to sign an agreement with the manufacturer stating that their foreign partner is obliged to make changes to the Certificate. The text of the agreement must comply with all regulations of the law, which will allow and oblige the manufacturer to make changes promptly without leaving it too late or postponing the process. No one wants to spend their money, submit documents, and then miss because the manufacturer failed to amend the documents. 

Checking the Drug Master File.

One of the documents that must be prepared and submitted to the State Service of Ukraine on Medicines and Drugs Control is the Drug Master File (DMF). In 100% of cases the state authorities have comments to the DMF. 

Our lawyers always conduct a preliminary analysis of the DMF in order to understand how many comments will need to be eliminated before registration with the State Service of Ukraine on Medicines and Drugs Control. In the licensing authority’s practice, there has never been a single expert committee that has agreed on a DMF the first time. 

In addition, as a rule, the specialists of such a commission writes several pages of comments, and in the future these comments must be properly answered. Of course, these answers have to be coordinated with the manufacturer, so as not to lie to the experts. As a rule, we provide for such a possibility in the agreement with the manufacturer. 

Work with the State Expert Center.

When registering a medicinal product, the documents must also be submitted to the State Expert Center (SEC), which subsequently invoices for its services. The complexity of this stage is that in order for the SEC to account for this money, a number of lobbying actions must be taken. That being said, once the documents are filed, the applicant works with the SEC agent. 

In addition, you must sign agreements with the SEC and the expert laboratory, which will then be used to make payments. At this stage the work is also built in the Question - Answer form.

At this stage, the manufacturer must give samples of pharmaceutical material. Without that, it will be impossible to move forward. We always recommend stipulating this issue in the agreement with your partner manufacturer during the analysis stage of such agreements.  

Checking technical details.

When registering medicines, it’s worth taking into account that there are specific requirements for drug packaging, such as the font, its size and the placement of language versions.

In addition, it is important to consider that some of your rights can be transferred to the distributor, while limiting it in some points.

With our experience in drug registration, we will look at your particular case, analyze it and tell you exactly how to proceed. 

If you want to have a deeper understanding of all processes or have specific questions that we have not covered in this article - you can talk to our specialist at a consultation, where he will analyze the risks, calculate the possible algorithms of action and offer you the best option.

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The procedure of importing medicines to Ukraine

The drug must be imported by the company that will sell it in the future. Accordingly, for this purpose it is necessary to obtain a power of attorney from the manufacturer. Only in this way the company can import the drugs legally. 

Of course, the power of attorney must be apostilled and certified by a notary in Ukraine. In addition, the power of attorney is the document, which will be checked by several state authorities, so each of them may have their own comments and their vision of this document. An ordinary businessman can’t know them all, and the re-signing of the document with the manufacturer several times can create a bad impression about you in the eyes of your partner. We can help you avoid this.

Please note! The importing company does not have to be an applicant for registration of the medicinal product, however, in the future the selling company will need to confirm the legality of the importation of pharmaceutical products.

Do you want to register a medicinal product and import it into Ukraine without any problems? Don’t hesitate to contact us! We will help you with the preparation of missing documents and find the best solution to any problems that may arise in the process.

Didn’t find an answer to your question?

Learn more about the Drug Registration Procedure in Ukraine here.

Learn more about the Drug Importer Dossier here.

Publication date: 18/01/2021

About author

Name: Bohdan Kosokhatko

Position: Lawyer

Education: Taras Shevchenko National University of Kyiv

Knowledge of languages: Ukrainian, Russian

Email: [email protected]

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