GUIDE FOR APPLICANTS ON THE PREPARATION OF DOCUMENTS
To ensure prompt and high-quality processing of incoming letters at the service center, documents are accepted with a cover letter.
When preparing a cover letter for documents, the following structure is observed:
- The heading states the name of the recipient institution;
- Then the date, outgoing number, and subject of the letter are written;
- Then address the addressee and state the name of the medicinal product, the applicant, the manufacturer, the procedure, and the registration form number (assigned at registration and displayed in the information system “Visualization 2.0”). For a clinical trial, the title and code are stated.
- Next, the names of documents, their numbers and dates, the number of volumes, and the number of sheets/pages are listed;
- Full name of the sender, their position and signature.
- Contact information (telephone, e-mail).
1. Preparation of files (registration materials, clinical trials) involves numbering the sheets in the file
The submission of documents with registration materials and clinical studies must be clear and understandable, in order to make it easier for the reviewer to check the submitted materials and to navigate the case file quickly.
Sheets are numbered with Arabic numerals in continuous numbering in the upper right corner with a soft black pencil or a mechanical numbering machine. Files consisting of several volumes are numbered separately in each volume. We strongly recommend using separate numbering of volumes in each module or in each part of the file. This implies that within each module or each part the volume numbering should start with “1” – the first page with continuous sequential numbering.
It is recommended that each volume of the file contain no more than 250 sheets. If the number of pages in a volume is exceeded, there should be enough space for adding further documents, free viewing and convenient archiving. In any case, the sheets must be securely fixed in the volume.
2. Sending the instructions for use of the medicinal product
Please send the package leaflet, the summary of product characteristics and the labeling text in electronic form to the mailbox instruction@dec.gov.ua
3. Return of draft documents after editorial agreement by the applicant
Both versions of the checklist are to be completed. If registration materials are returned, the necessary marks indicating the number of copies are made in the "Note" field. The draft registration certificate and/or the insert to the registration certificate must be endorsed by the applicant on the reverse side, even if there are comments. If the applicant (the applicant's representative) has comments, the necessary corrections are made clearly and legibly. The corrections will be checked and taken into account when preparing the final version of the draft registration certificate.
The checklist states the sender's full name, position, and signature.
