Calyx RIM 7.2 XEVMPD

Authorised Product Attachments

Every Authorised Product section can have Attachment file data that will be submitted in the final .zip file.

The content of the attachment cannot be updated. Each attachment must be uniquely identified within the Attachments element by the local number or EV code. The language must be specified using the two-letter language code in the published set.

The Result Set of attachments, ready for submission, include:
  • Attachment Name
  • Attachment Type - Printed Product Information (PPI)
  • File name
  • File Type
  • Attachment Version
  • Attachment Language
  • Attachment Link
  • Local Code
  • Version Date
  • EV Code

The results are presented in read-only format and are not available for selection.

If there are errors related to attachments, the attachments Result Set is not displayed. You will see the list of validation errors. The error message includes Attachment Name (hyperlink), Attachment Type, Attachment Version, and an Error Message indicating the reason for failure.

  • Substances, Pharmaceutical Forms, and Route of Administrations assigned to the MA should have data for Code Term Type in Data Administration XEVMPD Information subtabs.
  • Language Code and Procedure Type Code must be correctly specified.
  • Make sure that the Package Set Registration contains the Package Set. If not, you will not be able to view the Active Ingredient, Excipient, Adjuvant, and Indication Intended Use information.

When the Use Rendition field is set to Yes for the Registration Attachment and the Rendition Identifier value is selected, the existed in DMS location .pdf rendition file will be used instead of the source file in the submission creation:

  • If the source file has a rendition with the same type as selected in the Rendition Identifier drop-down list, then the rendition .pdf file is used during the submission creation.
  • If the source value has a rendition with a different type from the one selected in the Rendition Identifier drop-down list, then during the XEVMPD Submission wizard execution a warning message informs you that Rendition file has not been found.
Attachment types:
  • Registration Attachment for Authorised Product