- Question: How eCTD services provider (hereinafter – vendor) should be chosen for the creation and submission of eCTD dossiers?
Answer: recommendations for choosing a vendor or technical support for eCTD implementation goes beyond the competences of the State Expert Center of MOH of Ukraine, since such vendors provide services on the basis of economic relations and their activities do not envisage special conditions for the eCTD creation, which is submitted to enterprise for expert evaluation.
- Question: If I have questions before submitting eCTD materials, where should I apply to get an advice?
Answer: If you have any questions when submitting eCTD materials, you can contact the State Expert Center of MOH of Ukraine via “online consultation” section on official website (https://www.dec.gov.ua/ ) or in writing to address ______ .
- Question: If technical problems arise during eCTD submission of registration dossier materials in test period, how can materials be submitted in alternative way, namely in electronic form?
Answer: If technical problems arise during eCTD submission of registration dossier materials by the applicant in test period, you can contact the State Expert Center of MOH of Ukraine via “online consultation” section on official website (https://www.dec.gov.ua/ ) or in writing to address ______to resolve issues related to elimination of such technical errors.
At the same time, in case of technical problems on the SEC part, the SEC technical staff will contact applicant, whose contact details are indicated in cover letter for resolving issue on eliminating such an error.
If issue on eliminating technical errors has not been resolved and there is no possibility to resolve it within a reasonable period of time, the applicant shall send a letter (template of which is attached) regarding the submission of materials in electronic form to SEC.
- Question: Will eCTD materials submission be implemented for medicinal products, which are registered or will be submitted for state registration according to MOH Ukraine Order dated 15.06.2020 No. 1391 “On approval of Procedure for checking authenticity of registration materials pertinent to medicinal product that is submitted for state registration for the purpose of its procurement by a person authorized for health care procurement or a specialized procurement organization” and MOH Ukraine Order dated 17.11.2016 No. 1245 “On approval of Procedure for review of registration materials pertinent to medicinal products submitted for the state registration (re-registration) and materials about introduction of changes to registration materials during the validity period of registration certificate for medicinal products registered by competent authorities of the United States of America, the Swiss Confederation, Japan, Australia, Canada and medicinal products registered by competent authority of the European Union through centralized procedure”?
Answer: The eCTD implementation is envisaged by the Law of Ukraine “On Medicinal Products” dated 28.07.2022 No. 2469-IX, however, submission of eCTD materials is not envisaged for the above mentioned registration procedures for medicinal products registered or submitted for state registration in accordance with the MOH Ukraine Order dated 15.06.2020 No. 1391 and MOH Ukraine Order dated 17.11.2016 No. 1245.
- Question: After participating in test period, is it possible to submit registration dossier materials for medicinal product in format other than eCTD, if the eCTD dossier has been submitted for this medicinal product?
Answer: According to item 1 of Section III of the Requirements to Module 1 electronic common technical document (eCTD) specification with recommendations for submitting registration dossier materials in electronic common technical document (eCTD), approved by the MOH Ukraine Order of April 23, 2024 No. 691 (hereinafter – Requirements), after providing eCTD, it is not allowed to return to another format in order not to break the MP life cycle.
- Question: Is there a different file format (other than pdf) for submitting registration dossier materials? Will the file formats, that are currently allowed in European countries, be implemented?
Answer: At the moment, the submission of registration dossier materials (Modules 1-5) is possible only in pdf format in Ukraine. Materials of .docx format can be provided in “Working documents” folder according to item 7 of section II of the Requirements. The need to submit document in other formats will be discussed and included in the Requirements after the end of the test period.
- Question: Is Baseline submission mandatory in Ukraine?
Answer: No, it is not mandatory. But in order to facilitate the management of MP life cycle, it is recommended to submit a baseline, which will include Module 1 and Module 3 materials, which tend to change most often. Baseline is mandatory for changes that require new registration in scope of Modules 2-5, in order to comply with the MOH Ukraine Order dated 26.08.2005 No. 426 “On approval of the Procedure for Conducting Expert Evaluation of Registration Materials Pertinent to Medicinal Products, which are Submitted for State Registration (Re-Registration) and Expert Evaluation of Materials about Introduction of Changes to the Registration Materials during the Validity Period of Registration Certificate” (as amended).
- Question: Is the submission of eCTD registration dossier materials envisaged for APIs, medicinal products produced according to the approved specification, technical error?
Answer: Yes, the procedure is described in the Requirements.
- Question: When does submission of eCTD registration dossier materials become mandatory in Ukraine?
Answer: According to item 6 of Article 13 of the Law of Ukraine “On Medicinal Products”, version of 2022 (hereinafter – the Law) “Submission of documents for state registration (re-registration, indefinite renewal) of medicinal products, variations to the drug registration dossier materials are conducted in electronic form in accordance with the Electronic Common Technical Document (eCTD) standard of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Document management related to the keeping of the State Register of Medicinal Products is conducted in compliance with the legal requirements on electronic documents and electronic document management” the mandatory submission of eCTD registration dossier materials in Ukraine is set three years after the date of publication of the Law – 18.08.2025.
For convenient adaptation, test period is envisaged during which it is possible for entities (who have agreed and submitted a written application) to submit eCTD registration dossier materials for the state registration procedure (marketing authorization) from 01.05.2024, and for re-registration procedure (renewal) and introduction of changes procedure (variations) from 01.07.2024.
The eCTD registration dossier materials, which are not involved in the test period, may be submitted from 01.01.2025.
- Question: What documents shall be signed with the qualified electronic signature (QES)? Is it necessary to submit a RMP signed with QES?
Answer: Documents of Module 1, folders 1.0 and 1.2, which are signed by the applicant’s official representative in Ukraine (for example, cover letters, applicant’s letters of guarantee, clarification letters) shall be signed with QES. According to the Pharmacovigilance Procedure, RMP shall be signed by QPPV with any signature.
- Question: Which QES shall be used by applicant to sign documents?
Answer: The applicant shall sign documents with QES of PAdES format
- Question: Will the system interface version for eCTD submission be available in English, or only in Ukrainian?
Answer: Currently, there is only a Ukrainian version of interface, an English version is under development.
- Question: Is it possible to submit/download registration dossier materials outside of Ukraine?
Answer: Yes, it is possible, if SEC has issued a login and password for the Applicant Account to applicant’s official representative.
- Question: How are answers to comments provided in eCTD?
Answer: Answers to comments are provided according to item 11 of Section IV of the Requirements
