About eCopy Submissions

eCopy Requirements

There are several requirements that apply to eCopy submissions. Market Registration helps enforce these requirements during the eCopy publication process. An eCopy submission must:

• Contain a PDF version of the signed submission cover letter.
  Note: You can manually add your signed submission cover letter to the root level of your Submission Dossier, but Market Registration does not automate this process. Market Registration will convert the file to PDF along with all other files during the eCopy publication process. You must organize the Submission Dossier so that it appears in the correct order in the published eCopy.
• If the submission is organized using volumes, consist of volumes named using the prefix VOL, a 3-digit number that indicates the order in the submission, and a descriptive name, each separated by an underscore. For example, the volume that includes testing information might be named VOL_003_Testing.
• Have a flat structure that does not include any subfolders under a volume.
• Have a structure that does not contain any empty volumes.
• Contain PDF files for all submission content except statistical files, video, and images, which must be zipped and included separately in folders labeled STATISTICAL DATA or MISC FILES to indicate the type of content they contain.
• Contain PDF files named using a 3-digit number that indicates the order in the submission and a descriptive name, separated by an underscore. For example, the cover letter file might be named 001_Cover Letter.pdf.
• Contain PDF files with names that do not use any special characters such as ~ | * / \ ' " > < ? : – — ™ © ® ± or any other non-Latin characters or mathematical symbols.
• Contain PDF files that do not have any embedded attachments or attributes.
• Contain PDF files that do not require a password to open.
• Contain PDF files that are each 50MB or smaller in size.
• Contain PDF files that were created using Adobe Acrobat version 11 or below.
• Contain PDF files with active bookmarks and hyperlinks to aid in navigation.

Market Registration eCopy Submission Capabilities

Market Registration ensures that the volumes and files in your Submission Dossier meet the eCopy requirements. Market Registration:

• Uses Adobe Acrobat version 11 to produce the PDF files in the eCopy submission.
• Renders PDF files for those submission dossier files that are not already in PDF format and regenerates any existing PDF files using the selected configuration.
• Validates file size during the eCopy publication process to ensure that all of the resulting PDF files do not exceed the file size restrictions.
• Automates, enforces, and validates the required naming conventions for volumes and files in the Submission Dossier structure.
• Removes any empty volumes during the eCopy publication process.
• Automatically organizes the relevant files into STATISTICAL DATA or MISC FILES folders to ensure that those files are treated appropriately during the eCopy publication process.
• Automatically generates a table of contents for the dossier, with volume numbering if applicable, when it contains multiple PDF files generated from supported file types. The table of contents links and any bookmarks in the files are active links that can be used to navigate within the submission dossier.
• Verifies that the submission dossier contains only the most recent version of the files, and if not, notifies you so that you can decide whether to continue publishing or to stop the process so that you can add the updated content to the dossier. Logs this information and adds it to the notifications sent to specified users when dossier publishing is complete.
• Reminds you that you cannot include files with embedded attachments or attributes in your eCopy submission.
• Reminds you not to password-protect any of the PDF files in the eCopy submission.
• Checks in a zipped version of the published eCopy submission to the Published Dossier folder in the eCopy tab for future reference.
• Allows you to select the users who will be notified that the PDF rendering process is underway, that the process completed successfully, and that the published dossier has been checked into the Published Dossier submission folder.

Submission Dossier Virtual Folders

When you configure a submission project to be published in the eCopy format, Market Registration automatically creates two virtual folders in the Submission Dossier structure on the eCopy tab. These virtual folders are not part of the actual folder structure shown on the Master Folder or Local Folder tabs. By default, these virtual folders are named STATISTICAL DATA and MISC FILES. Market Registration automatically organizes files with the appropriate file extensions into these virtual folders in the Submission Dossier structure on the eCopy tab.

The STATISTICAL DATA folder automatically contains all files with a file extension that indicates that they contain statistical data, such as sas, xport, xml, sgml, xls, xlsx, and mol, which are the default file extensions used to identify content for this folder.

The MISC FILES folder has two virtual sub-folders: Video Files and Image Files. The Video Files sub-folder automatically contains all files with a file extension that indicates that they are video files, such as avi and wmv, which are the default file extensions used to identify content for this folder. The Images Files sub-folder automatically contains all files with an extension that indicates that they are image files, such as gif, tif, jpg, and jpeg, which are the default image file extensions used to identify content for this folder.

Regardless of which controlled folders or sub-folders that the statistical, video, or image files are actually stored in on the Local Folder tab, they are always listed in the appropriate virtual folders in the Submission Dossier's structure on the eCopy tab. They are not listed in the volumes that correspond to their controlled folders because they cannot be converted to PDF during eCopy publication along with the other files in the volumes. These files are included in the published eCopy submission in the appropriate virtual folders in their native file formats.

Organizing the Submission Dossier Structure

The Submission Dossier structure displayed on the eCopy tab is the order in which the listed volumes and files will be included in the eCopy submission. This structure is based on, but different from, the list of the Submission Dossier's controlled folders and files displayed on the Local Folder tab. The Local Folder tab lists the controlled folders and files in alphabetical order by folder name and in numeric order by document name (which is usually an autonumber). The Submission Dossier structure on the eCopy tab lists all controlled folders by an autonumbered volume name and lists all documents by an autonumbered file name, with the autonumbers appended to the beginning of the actual volume and file names. The autonumbers allow you to quickly see which order the volumes and files will be included in the published eCopy submission.

The autonumbers initially assigned to volumes in the Submission Dossier structure are based on the alphabetical order in which the controlled folders are listed on the Local Folder tab. For example, the first controlled folder listed on the submission's Local Folder tab is renamed to VOL_001_<controlled folder name> on the eCopy tab. Each subsequent controlled folder gets a sequential autonumber appended to its name to create the volume name in the Submission Dossier structure—VOL_002_, VOL_003_, and so on.

The autonumbers initially assigned to files in the Submission Dossier structure are based on the numerical order in which the document names (which are autonumbered based on their creation order) are listed in the Submission Dossier's Local Folder tab, and not on the alphabetical order of the actual file name. The autonumbers used for files in the Submission Dossier structure on the eCopy tab reset within each volume, so each volume may contain a file with a name beginning with 001_, 002_, and so on.

The assigned autonumbers establish the initial order in which volumes and files are displayed in the Submission Dossier's structure on the eCopy tab. You can reorganize the order of volumes and files. Doing so automatically updates the autonumber appended to the volume or file name to reflect its new order in the Submission Dossier's structure. For example, if you move the second volume to the top of the list, its autonumber changes from VOL_002_<controlled folder name> to VOL_001_<controlled folder name> to denote that it is now the first volume in the Submission Dossier. Moving files to a different location in the structure has a similar affect on the file's autonumbered name.

You can choose whether you want to use volumes to organize the content in the Submission Dossier. The non-volume-based structure is useful for small submissions with fewer files; whereas, the volume-based structure is more suitable for larger submissions with many files. When you choose to structure the submission without using volumes, the Submission Dossier structure is flattened to show only autonumbered file names, in the order in which they are listed in the Local Folder tab (which is ordered numerically by document name, not alphabetically by file name), without the controlled folders (volumes) that contained them.

You can choose to exclude volumes and files from the Submission Dossier's published eCopy structure. Removing a volume or file from the publication structure does not delete it from the Submission Dossier's Local Folder tab. It just indicates that it will not be included in the content published in the eCopy submission. Removed volumes and files are still listed in the Submission Dossier structure on the eCopy tab, but their names are struck through in red.

Publishing an eCopy Submission

When you have organized your Submission Dossier in the appropriate order and have verified that all files are already released, you can publish the Submission Dossier as an eCopy submission. You can configure the settings used when converting the documents to PDF, including the contents of the page headers and footers, and any watermark used on each page. You can also select who will receive notifications when the eCopy submission is published, either by role or by name. The publication process converts all files to PDF, performs file size validation, then compresses the PDF files and all other electronic files in the virtual folders into a zipped eCopy submission package. Market Registration checks the zipped eCopy submission package into the Published Dossier folder in the Local Folder tab. It is ready to be copied to the appropriate media for submission to the regulatory authority.