New registration

Import, advertising, sale, medicinal use and marketing of medicinal products are allowed only state registration (marketing authorization) of the product. State registration of all types of medicines is performed by Ministry of Health of Ukraine, as a result of centralized expertise of safety, quality and efficiency of the product by State Expert Center of Ministry of Health of Ukraine.

Registration certificate is valid for 5 years from the date of it’s issue. Application for renewal of registration should be submitted not later than 90 days before expiry of valid certificate.
Dossier. Application should be amended with registration materials formed in accordance with specified structure (registration dossier).
Two types of registration dossier are applicable in Ukraine – CTD format (in general harmonized with EU) and “simple” format that is similar to NTA format. Applicant is free to choose the format for submission.
Depending on status of the product (original, generic, fixed combination, well established use, traditional etc.) relevant parts of the dossier should be formed.
Dossier should be submitted in paper form in 4 copies. Some parts of the dossier require translation into Ukrainian language. Additionally registration dossier should contain specific materials prepared in accordance with Ukrainian guidelines:
  • AND (summary on quality: composition, specification and control methods of finished product, package system, storage conditions, information on manufacturers;
  • Package mock-ups (drawings of the primary and secondary package);
  • Package insert (instruction for medical use of the product);
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CTD format

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Simple format

There are lots of specific requirements to the mentioned above documents. Mistakes during registration can lead to very serious problems during quality control at custom clearance.
Some administrative documents and certificates require proper legalization depending on country of issue of these documents: Power of Attorney, CPP (certificate of pharmaceutical product), GMP certificate and manufacturing license.
Expertise of quality, safety and efficiency means expertise of registration materials (registration dossier), quality assurance of samples of finished products in State Laboratory and additional expertise.
State fees. Applicant should perform several payments to relevant state authorities of Ukraine during state registration of medicinal product:
  1. Payment of state duty to the State Treasury of Ukraine should be done prior to submission of the dossier – 100 EURO (+10 EURO for every additional dosage or package);
  2. Payment for state expertise of registration materials to State Expert Center should be done prior to submission of the dossier – app. 2500 EURO (+250 EURO for every additional dosage or package);
  3. Payment for laboratory analysis of samples of medicinal product to State Laboratory should be done prior to analysis – app. 2500 EURO;
Orphan drugs and active pharmaceutical ingredients (API) have other structure of state fees.
Expertise procedure. Procedure is initiated by submission of Application form with “micro-dossier” to State Expert Center. Expertise of full registration dossier starts only after payment of relevant state fees.
State experts have the right to inquire additional information by official deficiency letters. Applicant has 90 days for official reply to the questions; otherwise product can be withdrawn from registration.
Laboratory analysis can start after positive conclusion of the expert on chemical-pharmaceutical part of the dossier. Laboratory analysis requires import of samples of finished product, reference standards and other products than can be required for evaluation of all control methods of finished product. Import of the samples usually requires official import permission from Ministry of Health.
After positive conclusion from all experts and laboratory analysis product is adopted for registration in Ukraine on the session of State Exert Center. Within several weeks original registration certificate is issued and product is included to State Registry of Medicines.
Timing. Expertise procedure is officially limited by 210 days, not including timing required by Applicant for answers on deficiency letters and timing of laboratory expertise.
Establishment of new registration  | Cratia 3 We offer comprehensive service of establishement of marketing authorization of medicinal products. All works will be performed by big professional and experienced team of regulatory professionals, chemists and doctors. We provide our knowledge and experience to many companies and have necessary capacities for new projects. Cratia has all necessary permissions and accreditations for all in-process activities. 
Process of establishment of marketing authorization is very complicated and require deep specific knowledge and experience. Most companies trust regulatory procedures only to specialists – either experienced regulatory managers or professional trird-party consultants.

Following works and services will be handled by Cratia during marketing authorization of medicinal product in Ukraine:

  • all necessary consulting and advises, rapid communication in excellent English;
  • detailed expertise of the dossier, inquiries on missing parts or information that requires special attention;
  • receipt of necessary scientific advices in State Expert Center, submission of the preliminary letters (inquiries) to the State Authorities;
  • printing of the dossier from eCTD or from any other electronic form (if needed);
  • translation of the required parts of the dossier, notary certification of translation of administrative documents;
  • filling the Application from;
  • medical writing (preparation) of specific local documents – AND (control methods of finished product) and PIL (package insert);
  • localization of package mock-ups/package drawings (we can edit the design by ourselves in Abode Illustrator or Corel Draw, or we can only guide the process via recommendations), including Ukrainian Braille;
  • preparation of the registration dossier according to local requirements: cover letters, numbering the pages, prepare of the content etc.;
  • contract management – signing contracts for state expertise of registration materials with state authorities;
  • submission of the Application and micro-dossier to the State Expert Center;
  • receipt of Invoices for State fees, delivery of Invoices to Customer;
  • receipt of the confirmation of the payment from State Treasury of Ukraine;
  • submission of the dossier to State Expert Center;
  • negotiation and communication with state authorities on all stages of registration process;
  • handling of deficiency letters, immediate communication with Customer, assistance in answers on deficiencies;
  • we control all timings in expertise process, send reminding and alerting messages, able to extend time for answering on deficiencies;
  • organization of import of the samples, reference standards and other products for laboratory analysis – receipt of the import permission, assistance to the Customer in presentation of custom documents;
  • custom clearance of samples to our name (we have all necessary authorization by Kiev regional, Kiev-Boryspil and Central Customs offices of Ukraine);
  • check of the draft of registration certificate;
  • delivery of registration certificate to Customer;
  • we continually inform our Customer regarding the registration process and immediately respond on any inquiry;
  • our service fee covers completely all charges required for state registration of medicinal product, except State fees;

Cooperation scheme:

Confidentiality agreement

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You send us dossier for preliminary expertise and analysis

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As a result of the expertise we send you list of missing documents and quesitons, calculation of the service fee

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Agreement for establishment of registration

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Filling the Application and “micro-dossier”, translation of documentation, development of AND, package insert and package mock-ups

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Contracting of state authorities, submission of Application and receipt of Invoices for state fees

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Submission of the dossier, start of state expertise

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Defficiency letters, mutual efforts for fast reponding

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Import of the samples for laboratory analysis

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Product’s approval for registration in Ukraine

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Issue of original certificate of markeitng authorization

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Cratia’s service fee depends on many factors and is calculated as a sum of expenses that should be bear for registration process. We can discuss our service fee as well as total budget for registration process after we will realize scope of work. General up-to-date information on our prices you can obtain on inquiry.

You can contact us by e-mail, telephone +38 (044) 332-42-94, 221-71-29 or at the meeting in our office.