Recommendations for submitting electronic documents

E-mail addresses for submitting documents

evikno@dec.gov.ua

• Applications for state registration and re-registration of medicinal products, and for amendments to registration materials during the validity of the registration certificate
• Application for conducting a clinical trial of a medicinal product
• Application for a substantial amendment

rm@dec.gov.ua

• Medicinal product registration form
• Registration dossier materials (the set of documents submitted for state registration, re-registration, amendments, emergency registration)
• Additional/revised materials for the registration dossier, as well as a GMP certificate (a certificate of compliance with good manufacturing practice requirements or a conclusion confirming compliance with good manufacturing practice requirements), with a cover letter.
• Response to comments (form 10, 16)

kv@dec.gov.ua

• Clinical trial materials in accordance with the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Clinical Trial Materials, approved by MoH order of 23.09.2009 No. 690
• Substantial amendment materials in accordance with the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Clinical Trial Materials, approved by MoH order of 23.09.2009 No. 690
• Additional materials, responses to comments on clinical trials and substantial amendments

contract@dec.gov.ua

• Contracts, supplementary agreements
• All the requirements are set out at the link below, please review them:
  On organizing contract work during martial law (dec.gov.ua)

Applicant memo

General technical requirements to be observed when scanning materials:

• scanned copies of all pages in chronological order with continuous numbering
• the scanned copy must be in color
• scanned copies must be clear and show all details of the document (signatures, seals, etc.)
• scanning resolution – at least 200 dpi
• save scanned copies in pdf format
• the size of each file must not exceed 49 Mb; if this size is exceeded, several files may be generated
• the file name must begin with the protocol or application number (for clinical trial materials) or the registration form number (for additional materials on state registration/re-registration/amendments)

Recommendations for preparing dossier materials submitted in electronic form

• Dossier modules are prepared in scanned form in one copy, in separate volumes of no more than 250 sheets each. Each generated PDF document is named in the following format: RF number, Module numbering, volume number (if the Module volume exceeds 250 sheets) (a detailed example is shown in the image).
• The cover letter to the materials must state that the materials are submitted in one copy in electronic form, with mandatory indication of the number of documents (modules, volumes, pages). It is specified separately which Modules/volumes, and in what quantity, must be sent separately to each expert commission.
• If the dossier materials need to be revised following the experts' comments, responses are prepared taking into account items I and II, and the response to F10 is added to the file name after the registration form number.