Drug registration in Ukraine

Cost of services

Cost of services:

from 8000 USD
Basic price
5.0
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What we offer

  • help you to understand the stages of the registration procedure of your medication, the optimal term of registration, costs minimization of medicines registration;
  • after signing the confidentiality (non-disclosure) agreement, we will review your case for free and prepare a detailed plan of further actions taking into consideration the following: necessary documentation, stages, registration budget, timeframes;
  • provide legal support in the appointment of an authorized representative;
  • hold preliminary consultations with the Center of Drug Evaluation and Research, analyze, revise or develop the dossier (fully or partially) in compliance with the requirements of the Ministry of Health of Ukraine and advisory committees;
  • draw up: methods of quality control, instructions, identification mark;
  • accompany the primary expert evaluation;
  • accompany the specialized examination

 

Content

Documents

List of documents
Information about the authorized representative
Registration dossier (if available)
Information on the medication

Application for drug registration process

In order to import medications into the territory of Ukraine and to sell them, a state registration must be conducted. These requirements have been strictly observed from 2005, in connection with the harmonization of Ukrainian legislation with European laws.

Despite the fact that requirements of the procedure are very similar to the European directives, the national process has its own peculiarities that may have impact on regulatory processes.

The first stage of registration, which begins with the prior consultation (if necessary), includes the following stages:

  1. Sending an application to the Ministry of Health of Ukraine.
  2. Drawing up and sending the registration form and related documents to the Center of Drug Evaluation and Research.
  3. Obtaining a review on the Application and the registration form (approval, marks and comments).
  4. Obtainment, payment, obtainment of confirmation of payment for state fee and expert works.

The procedure for initial examination is then followed. It consists of the following steps:

  1. Drawing up the registration dossier based on the type of application, checking  completeness of materials.
  2. Revision of dossier or provision of its materials for the examination.
  3. Submission of the dossier to the advisory committees.
  4. Work with the amendments and comments from the committees, their inclusion into the instructions on the medication.
  5. Medication quality review conducted by the relevant laboratory.
  6. Decision on the registration of a medication in Ukraine (held at meeting of the Center of Drug Evaluation and Research).
  7. Approval of documents (specifically, draft of registration certificate, methods of quality control, instructions on application, marking of packaging), obtainment of documentation package from the Ministry of Health of Ukraine.
  8. The final stage of the procedure is signing of the Order on the registration of medication, inclusion in the State Register of Ukraine and issuing original of registration documents (certificates) to the applicant

Moreover, there are a number of requirements that should only be conducted in the following way. The registration dossier must include 5 modules and is provided only in CTD format. There are requirements for preparation of administrative documents, which are certified by stamp of the Applicant. What is the language of the dossier? This question often causes doubt. Meanwhile, five dossier modules can be submitted in the following languages:

  1. Only in Ukrainian;
  2. It is recommended to translate into the state language, but not necessarily;
  3. Partial translation into Ukrainian language;
  4. NOT translated;
  5. Not translated (the conclusion on bioequivalence can be translated).

Service packages offers

Base
from 500 USD
  • Preliminary analysis of the Client's documents
  • Analysis of the submitted documents for completeness and compliance with the requirements of the CTD format of the drug dossier
  • Consultation on the organization and choice of the type of registration of the medicinal product
Standard
from 8 000 USD
  • Analysis of the submitted documents for completeness and compliance with the requirements of the CTD format of the drug dossier
  • Consultation on the organization and choice of the type of registration of the medicinal product
  • Sending the application to the Ministry of Health of Ukraine and accompanying documents to the SEC of the Ministry of Health
  • Obtaining a review of the Application and registration form (approvals, marks and comments)
  • Registration of a dossier with consultations
  • Preparation of cover letters and responses to possible comments
  • Translation and copying of documents
  • Registration of the registration application and conclusion of the contract for examination with SEC
  • Working out of edits of the dossier or transfer of its materials for examination
  • Sending dossiers to expert commissions
  • Working out of corrections and remarks from commissions, their entering in the instruction of a medicinal product
  • Tracking the current situation in the registration procedure and constantly informing the Client
  • Drawing up and sending the registration form
  • Receipt and payment of bills for the state fee
  • Expert works
  • Support of drug quality control carried out by a competent laboratory
  • Obtaining a permit for the import of samples and standards for quality control
  • Obtaining a decision for registration of a medicinal product in Ukraine (conducted at SEC commissions)
  • Approval of documents (in particular, draft registration certificate, ICC, instructions for use, labeling of packaging)
  • Obtaining a registration certificate and its approval
Premium
from 20 000 USD
  • Development of "turnkey" and approval of documents for the registration of a medicinal product (innovative products, original, orphan products, specific active substances, etc.)
  • Registration of a dossier before submission "turnkey" for new registration, re-registration, modification
  • Providing temporary outstaffing
  • Bioequivalence
  • Pharmacovigilance issues, support

Advice from a lawyer on registering a medicinal product

If you want to understand how the registration procedure of medicinal product in Ukraine works, you can address our experts for introductory consultation. A lawyer will explain which of our service packages is suitable for you and provide answers to the following questions:

  • What stages does the registration process consist of?

  • How long does it take?

  • What is the cost of the procedure?

  • What benefits do you get by contacting us?

If you order the drug registration service from us, the cost of the introductory consultation will be included in the total price.

If you have questions on how to do medical business in Ukraine, or your situation is complicated, you can order the development of a road map by our lawyers. Such consultation will allow you to receive a step-by-step algorithm for achievement of your goals and answers to your questions. You can find out more about the Road Map here.

Drug licence registration: cost and terms

The cost of the service is based on completeness of documentation required for the medication registration.

The “base price” is formed if the applicant has a dossier, translation of documents, and related documentation.

In this case, our firm provides: preliminary consultation, analysis, preparation and registration of all documents in approved forms, control of the procedure of acceptance of documentation and registration.

In case of absence of the applicant's dossier (or the need to revise parts of the dossier), as well as the need for translation of documentation on medication.

The price of application for drug registration is formed individually, based on the analysis of existing documents.

Why us

Analysis of available documents
Our lawyers carry out a thorough analysis of Your documents prior to filing in order to avoid rejection by the MOH.
Experience in medical law
You get not only permits, but also professional support of lawyers of medical law, who help you to pass all the procedures in the state bodies with a minimum of your participation.

We are ready to help you!

Contact us by mail [email protected], by phone number +38 044 499 47 99or by filling out the form:

Our services within a registration procedure consist of the following stages:

  • conduct preliminary consultation in the Center of Drug Evaluation and Research on compliance of the type of application;
  • analysis of the dossier on the availability and compliance with documentation;
  • translation of necessary documentation, notarization;
  • prepare the methods of quality control in accordance with requirements of the Center of Drug Evaluation and Research and according to the procedures of manufacturer;
  • draw up the Instruction on medical application in accordance with requirements of the Center of Drug Evaluation and Research and according to the SmPC of manufacturer;
  • draw up a marking document in accordance with requirements of the Center of Drug Evaluation and Research and according to the mock ups of manufacturer;
  • prepare a registration dossier for advisory committees, bring it in compliance with requirements of the Ministry of Health of Ukraine. Develop missing parts of the dossier if necessary (additional service);
  • provide the template of agreement for the Applicant, advise on legal issues and availability of documents;
  • fill out the Application Form, have it approved by the Applicant and submit it to the Ministry of Health of Ukraine;
  • fill out the Registration Form, have it approved by the Applicant;
  • prepare a response to comments of the primary expert evaluation, advise the Applicant, contact the Center of Drug Evaluation and Research on the issues of concern;
  • receive official fee invoice if the primary expert evaluation is positive;
  • request confirmation of payment of state fee in the Treasurer's Office;
  • submit the dossier to the Center of Drug Evaluation and Research within 3 months from the date of application submission to the Ministry of Health of Ukraine;
  • deal with comments of the primary expert evaluation upon approval with the Applicant;
  • bring in compliance with requirements of the experts the Instruction and the methods of quality control;
  • transfer comments of the experts to the Applicant, consult and agree on documentation. Form answer to comments;
  • prepare answers to possible comments of the secretary of committee, agree with the Applicant on documentation;
  • agree with the Applicant on drafts;
  • receive originals of registration documents and transfer them to the Applicant.

Answers to frequently asked questions

What influences pricing policy?

Presence/absence of necessary documents in a client, which are listed in the section "Required documents"

How long is a registration certificate issued for?

There are such expiration options:
For a specific period
Unlimited period

How to register a medicinal product in Ukraine?

The registration procedure for medicinal products in Ukraine today is rather complicated. This is due to the fact that the state protects citizens from medicines of poor quality. In order to successfully pass this procedure it is necessary to pass the following stages:

  • The manufacturer of the medicinal product, as the person responsible for its quality, submits an application for registration together with the documents (micro-dossier). After the documents have been reviewed by the MOH, it is submitted to the State Expertise Centre (SEC). 

  • Then a contract is signed with the SCE and the invoices for the expertise and the state fee are paid. After this, a complete dossier for the medicinal product is sent.

  • The GEC Commission conducts an examination, during which it may ask for additional documents. A conclusion on whether the medicine is safe and effective can be made after chemical-pharmaceutical examination and laboratory testing. If the conclusion is positive, a decision is made to register the medicine. Also, the manufacturer receives a registration certificate which is valid for 5 years.


Since Ukraine is currently integrating into Europe, there is a need to improve the legislation relating to medicines. For this reason, the successful completion of the procedure requires legal competence and a background in its specific details.

Registration of new medicines/drugs in Ukraine

We offer services on registration and re-registration of medicines/drugs (Ukraine) for those who wish to conduct this procedure simply, safely and efficiently.

The company "Pravovs Dopomoga" works in the market of legal services of Ukraine for more than 10 years. For a long time, one of the main directions of our activity remained the sphere of medicine. Licenses of any kinds, various allowing documents and, of course, registration of medicines.

During our work we have not only received a huge amount of invaluable knowledge and practical experience, but also were able to build their own system of providing legal services.

Our main goal is to make the solution of any legal issues simple, safe and effective. And our main principle is systematization with a personalized approach. How is it possible? Easy.

Based on our experience, we build a system of passing each process. Thus, when we provide a service, we already have a ready-made plan, written down to the smallest detail, which gives us the opportunity to work quickly and efficiently.

On the other hand, we carefully study the situation of each individual Client, because each case has its own peculiarities, and each person is unique in nature. We take into account your wishes, needs, and most importantly - always keep the course not on one task, but on your main goal.

Cooperating with us, you can always count on:
  • Reliability. If we take up the task, it will be done.
  • Simplicity. We always strive to make the legal aspects at least a little bit clearer for our Clients. After all, when you have a detailed understanding of the issue, the problem disappears as such.
  • Availability. We are always in touch and always ready to provide you with a full report on the situation.

If you want to register a medicine, contact us! You can ask our experts about the price of drug registration. We are always happy to cooperate! 

Our publications on this matter

Our team

Marina Losenko
Associate