Leaflet for applicants on e-mail addresses for submitting documents in electronic form

Email addresses for submitting documents in electronic form

evikno@dec.gov.ua

• Application for emergency state registration of medicinal products, registration materials for medicinal products and other documents attached to the application for emergency state registration of a medicinal product
• 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

rm@dec.gov.ua

• Medicinal product registration form
• Registration dossier materials (the set of documents submitted for state registration, re-registration, amendments, and emergency registration)
• Additional/revised materials for the registration dossier
• Response to comments (form 10, 16)

Important: send the response to comments 2f to dec@dec.gov.ua.

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 requirements are set out at the link, please review them: On the organization of contract work during martial law.

General technical requirements to be followed 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 the 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 concerning state registration/re-registration/amendments).

Registration documents are accepted for review together with a letter of guarantee (provided with the materials as a separate file) in the form given in the appendix to the Procedure approved by Resolution of the Cabinet of Ministers of Ukraine No. 471 of 15.04.2022.

Other documents in electronic form are sent to dec@dec.gov.ua.