Drug registration in Ukraine

Drug registration in Ukraine

What we do

  • 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

 

OUR FEES

Basic price
12 000 USD
Including preparation of documents
Negotiable price

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 is formed individually, based on the analysis of existing documents.

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Documents

  • Information about the authorized representative
  • Registration dossier (if available)
  • Information on the medication

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).

REFERENCES FROM OUR CLIENTS

L. Chervonyuk, LLC "Vitalux"

Vitalux company highly appreciates results of cooperation with Law firm “Pravova dopomoga”, can characterize it as a reliable partner and based on personal experience is ready to recommend it to interested persons...... More information

President Tedeev E.S., Ukrainian wrestling association

Ukrainian wrestling association would like to express its sincere appreciation to the team of Law firm "Pravova Dopomoga" for mutually beneficial cooperation... More information

Partner, Denis Y. Lysenko, Vasil Kisil & Partners

... we would like to express our respect and gratitude for the fruitful cooperation.
... our work on joint projects assured us of your high level of professionalism
... More information

General director Skibinskiy V., Yokogawa Electric Ukraine Ltd.

Yokogawa Electric Ukraine Ltd. recommends Vladimir Gurlov and his team of lawyers as a reliable legal partner and advisor for foreign businesses in Ukraine...... More information

General Manager Stashkevych I.Y., LLC “Trading company” Rud”

We would like to indicate that law firm "Pravova Dopomoga" has become a reliable partner for legal services provision and we can recommend it as a team of qualified professionals who are easy and pleasant to deal with... More information

Chief ophthalmologist of Ukraine, Oksana Vitovska, All-Ukrainian alliance of ophthalmologists

We would like to express sincere gratitute to the team of Law firm "Pravova dopomoga" and personally to Volodymyr Gurlov for professionalism and purposefulness in your work.... More information

General director I.Logvinenko , Bravo Airways

Bravo Airways company expresses its gratitude to law firm "Pravova Dopomoga" for high quality and timely provision of legal services.
... More information

Important to know

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 FAQs

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

SWIFT OBTAINMENT
AND BEST QUALITY PROVEN BY YEARS OF PRACTICE!

Volodymyr Gurlov, Managing partner

Volodymyr Gurlov, Managing partner

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