Changes to the Dossier after registration of a medicinal product in Ukraine

We were contacted by a Client for whom we had previously helped register a medicinal product in Ukraine. As it turned out, after the registration of the drug, the company was forced by objective circumstances to change the manufacturer of substances, which was originally specified in the documents for registration.

In this regard, the Client had to make changes to the Dossier of the medicinal product.

At the same time, it was important for the Client to understand:

• Does he need to register the medicinal product all over again or can he make these changes in another way?

• What is the deadline for making changes in order not to get in trouble with the Ukrainian regulatory authorities?

• Will he be able to continue the supply of the drug uninterruptedly?

Ukraine has a certain procedure for making changes to the Dossier of the medicinal product. However, this option, as well as the terms depend on the changes and their type.

Using the example of our Client, we will describe this procedure, and tell you whether this issue can be solved simply, without losing the ability to continue marketing the drug in Ukraine.

You may also like: How to Register a Medicinal Product in Ukraine? 

How to make changes to the Medicinal Product Dossier in Ukraine?

If we divide all the possible changes into general types (there is a more detailed classification), we can name the following:

• Type 1A and 1B changes — minor changes that may relate to package design, labeling text, change in manufacturer’s address, etc;

• Changes of type 2 (II) — changes that relate to the quality, safety and effectiveness of the drug, including changes to the instructions regarding indications, contraindications, etc;

• Changes that result in a new drug registration — these are usually a change in the amount or addition of active ingredients, a change in dosage, or a change in the drug dose. 

There is also a procedure for correcting a technical error in the Dossier, which was made during registration or a previous change.

A change of substance manufacturer, as in the case of our Client, refers to changes of the first group (1A) and therefore does not require a new registration procedure.

The period of making changes to the Medicinal Product Dossier

Depending on the type of changes, there are different deadlines for making changes to the Dossier. For example, these can be urgent changes concerning the safety of a drug, which have to be made within 48 hours of their introduction. But individual changes related to drug safety and quality (type II) must be made within 60 days of their introduction. That is, deadlines will be set for the type and nature of changes.

As for our Client, the Type 1A changes had to be made within 12 months of their introduction. This meant that the Client had enough time to prepare the documents and to conduct the procedure in due time.

Please note! In order to introduce new data into the Dossier of the drug you have to do more than just collect the documents and submit them to the competent authority. Your documents will undergo a compulsory review of changes, the timing of which also depends on the type of changes.

For example, types II, IA and IB require an examination within 60 business days. But this period may be shortened if the change is urgent and relates to drug safety.

During the review of documents, you may be asked for missing documents or information. There is also a deadline for responding to such requests — if you miss this deadline or fail to provide the required information, the procedure will be suspended and the documents will not be reviewed further. The money you paid for the expertise will not be refunded.

In addition, you need to take into account the time required for:

• Review of your application by the authority;

• Payment of the state fees and waiting for confirmation of the application;

• Pre-examination of the Dossier;

• Responding to the authority’s inquiries;

• Completion of the procedure — proofreading, verification of the draft registration certificate, and issuance of the certificate.

That’s why, even though we had a decent 12-month period to make changes, we suggested that the Client start the procedure as early as possible to avoid the rush at the end of the deadline and mistakes in the procedure. The Client gave us all the information, and we proceeded to make the changes to the medicinal product.

As for the supply and sale of the drug in Ukraine — the changes that our Client had allowed him to continue nonstop supplies.

The cost of making changes to the Dossier of a medicinal product, of course, depends on the type of changes and the time needed to meet the deadline. Learn more about our services here, or contact our experts to make a personalized package.

Do you need legal assistance in making changes to a Medicinal Product Dossier? Don’t hesitate to contact us! We will analyze your situation and suggest the best plan of actions to solve your issue easily and safely.

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Everything about Registration of Medicines in Ukraine here.