The procedure for registration of medicines in Ukraine in 2023
Import and further sale of medicines in Ukraine involves a number of actions, which are called the state registration of the medicines, as well as compliance of medicines with the established quality requirements.
Depending on the type of drugs, its characteristics and even indications for use, there will be different application forms and different types of expertise, and, accordingly, the procedure and the period of drug registration may be different.
Today, we will talk about the general rules of drug registration in Ukraine, which will help you to map and understand the procedure. If you want to get the clear picture of the drug registration procedure, please contact our specialists for a personal consultation.
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Stages of drug registration in Ukraine
Only the medicines and drugs that are manufactured specifically by order of medical and preventive institutions that have permission to use the active means, as well as medicines made in pharmacies on prescription are not subject to state registration.
The drug registration procedure in Ukraine consists of the following steps:
Preparation of documents, drawing up a dossier. We have already written here about the documents required for registration of medicines;
Submitting an application and relevant documents to the Ministry of Health for review. At this stage, the Ministry of Health itself sends a letter with the documents to the State Expert Center (SEC) for an initial review and recommendations;
Preparing and conducting expert examinations of the drug. In order to conduct the necessary expertise, the Applicant signs an agreement with the SEC to conduct the expertise and pays for the SEC’s services. At least two expert examinations must be carried out — a preliminary expert examination of the Dossier materials and a specialized expert examination of the medicines. The second expertise can take up to 210 days, depending on the type of the medicine;
Issuance of a Registration Certificate. The SEC forwards its conclusions to the Ministry of Health, which then takes a decision on the registration of the drug.
Both a resident and non-resident of Ukraine — for example, the foreign manufacturer — may apply for registration of drugs. However, if the applicant and the drug manufacturer are two different persons, it will be necessary to submit documents confirming their relationship.
The total period of drug registration consists of the period of examination (from 5 to 210 days) + 2-4 months for other stages of the procedure.
A Registration Certificate is issued for 5 years and may be re-registered — for this purpose, it is necessary to submit the application not later than 90 days before the expiry date of the Certificate. We recommend doing it 9-11 months in advance.
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What is important to know about the drug registration procedure in Ukraine?
There are many nuances to this process. For example, when working with the documents that will later be submitted for drug registration, the following must be taken into account:
All required documents must be submitted in paper form;
There are clear requirements for the design of documents, including the Dossier, including the number of pages in the folder, their numbering, etc;
Individual documents may have to be revised in the process of expert examinations and inspections;
The Dossier must be submitted in four copies, each of which must be accompanied by a sample of the medicinal product;
Individual parts (modules) of the Dossier must be translated into Ukrainian, and the translation must be certified by a notary.
It is also important not to miss the following aspects of the procedure:
All stages of the registration procedure have their own deadlines, violation of which may lead to rejection of registration — the fees paid will not be refunded;
The Dossier must include Drug Quality Control Methods developed according to the manufacturerєs documentation, which must comply with the requirements of current legislation;
The Dossier must contain instructions on the use of the product, translated into the Ukrainian language;
There are also requirements for labeling of packages of medicines, including the Braille type;
The cost of state registration of a medicines is the same for all Applicants;
Expertise is a mandatory condition for drug registration. It depends on the type of drug and other factors.
Our company offers you services for registration of medicines in Ukraine, as well as the development of a “Road Map” — a step-by-step guide for registration of medicines applicable in your situation and for your product. You can then use this instruction for independent registration of medicines in Ukraine.
You can find the price of registration of medicines in Ukraine with our lawyers here or check with our specialists.
Do you want to easily and safely register a medicinal product in Ukraine? Don’t hesitate to contact us! We’ll help you to make this process simple and the result achievable.
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