Drug registration in Ukraine
Cost of services
Reviews of our Clients
... our work on joint projects assured us of your high level of professionalism
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 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.
Documents
Cost of drug registration in Ukraine
The service price depends on the completeness of the documentation required for drug registration.
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Basic Package — from USD 8,000, used in case the applicant has a Dossier, translation of documents, related documentation. In this case our company provides: initial consultation, analysis, preparation and registration of all documents, control of documentation acceptance procedure and registration of pharmaceuticals.
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The price of Premium Package starts at USD 20,000 and is prepared individually, based on the analysis of the existing documents. This is the case when the applicant has no Dossier (or there is a need to improve some parts of the Dossier), and other non-standard situations.
If, before starting the procedure, you want to fully understand whether it is beneficial for you and how exactly the registration of the drug will proceed in your case, we can offer you two types of legal consultation:
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Introductory Consultation on Registration of a Medicinal Product in Ukraine — it costs USD 500. Such consultation includes analysis of your documents, assessment of possible terms and algorithm of drug registration in Ukraine in your case. It will give you a clear understanding of the following steps and how to achieve your goals.
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Roadmap for registration of drug products in Ukraine (the cost is USD 3,000). This is a complete detailed analysis of the registration procedure for your drug product. Such step-by-step instructions will not only give you a full understanding of the procedure, risks and timing, but may also be used by you in the future for independent registration of medicines in Ukraine.
Please note! When ordering further support services for registration procedure, any consultation can be included in the full price of the service.
Drug registration in Ukraine is a long process that often stops in the middle. It is safer and more reliable to think everything through in advance and use the assistance of professionals, who will 100% drive a nail to the head.
Service packages offers
- 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
- 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
- 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
Our registration services consist of the following steps:
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Initial consultation at the State Expert Center (SEC) for the type of application;
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Analysis of the Dossier for availability and compliance of the documentation;
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Translation of the necessary documentation, certification by a notary;
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Drafting of the Drug Master File according to the requirements of the SEC and the manufacturer’s methods;
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Drafting of the Instructions for Medical Use in accordance with the requirements of the SEC and according to the manufacturer's SmPC;
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Labeling in accordance with the requirements of the SEC and according to the manufacturer’s layouts;
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Drawing up of the RMP document;
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Preparation of the Dossier for expert committees, making it consistent with MOH requirements. If necessary, we also develop missing parts of the Dossier (additional service);
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Template agreement for the Applicant, consultation on legal issues and availability of documents;
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Filling of the Application form, coordination with the Applicant and submission to the MOH;
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Preparation of the Registration Form, coordination with the Applicant;
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Preparation of response to the comments of the primary expertise, we consult the Applicant; we also communicate with the SEC regarding the problematic issues;
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If the initial examination is positive — receipt of invoice;
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We request confirmation of the state fee payment from the Treasury;
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Submitting the Dossier to the SEC no later than 3 months from the date of submission of the Application to the MOH;
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Elimination of the drawbacks of the initial examination after agreement with the Applicant;
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Bringing the Instruction and the Drug Master File into compliance with the expert requirements;
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Transfer to the Applicant the expert comments, consult and coordinate the documentation. We prepare a response to the comments;
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Preparation of responses to possible comments of the scientific secretary, coordination of documentation with the Applicant;
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Agreeing drafts with the Applicant;
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Receiving original registration documents and handing them over to the Applicant.
The price of application for drug registration is formed individually, based on the analysis of existing documents.
Why us
We are ready to help you!
Contact us by mail [email protected] or by filling out the form:How to register a medicinal product in Ukraine?
In order to import medicines to Ukraine and sell them, one must undergo the state registration of medicines at the Ministry of Health. This requirement has been strictly observed since 2005, due to the harmonization of Ukrainian legislation with European laws.
Despite the fact that the requirements of the procedure are very similar to the European directives, there are national peculiarities in the domestic process, which may affect the regulatory processes.
The first stage of the drug registration service, which begins with a preliminary consultation (if necessary), includes the following stages:
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Sending the application to the Ministry of Health of Ukraine;
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Drafting and sending the registration form and accompanying documents to the SEC;
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Receiving a review of the application and registration form (approval, notes and comments);
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Receipt, payment, receipt of confirmation of payment for state fee and expert work.
Next comes the primary examination procedure. It consists of the following steps:
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Making a Registration Dossier based on the type of Application, checking the completeness of the materials;
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Working through the corrections to the Dossier or submitting its materials for expert review;
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Sending the Dossier to the expert commissions;
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Working through the corrections and comments from the commissions, entering them into the medicinal product’s instructions;
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Checking the quality of the drug performed by a specialized laboratory;
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Decision on registration of the medicinal product in Ukraine (conducted at the SEC meeting ;
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Coordination of documents (in particular, the draft registration certificate, Drug Master File, instructions for use, labeling of the package), obtaining a package of documents by the Ministry of Health of Ukraine;
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The final stage of the procedure is the signing of the Order on registration of the drug, recording the decision in the State Register of Ukraine, issuance of the original registration documents (certificate) and delivering it to the applicant.
There are also a number of requirements for the Dossier and its documentation. For example, the registration dossier must include 5 Modules and must be submitted exclusively in CTD format. There are also requirements for the language of the Dossier. This issue often raises doubts. Meanwhile, the five modules of the dossier can be submitted in the following languages:
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Exclusively in Ukrainian;
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Recommended to be translated into the state language, but not required;
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Partial translation into Ukrainian;
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Not to be translated;
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Not to be translated (bioequivalence report may be translated).
Development and registration of medicines is a responsible stage that affects all your further activities.
Read more about the registration procedure and its stages in our articles at the bottom of the page.
Answers to frequently asked questions
Presence/absence of necessary documents in a client, which are listed in the section "Required documents"
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:
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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).
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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.
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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!
