When working with EU regulatory submissions, Submissions Publishing allows you to generate EU eCTD v3.0.1 DTD compliant XMLs for submission to the European Medicines Agency (EMA).

About Brexit

The United Kingdom (UK) formally withdrew from the European Union (EU) on January 31, 2020. The transition period began on February 1, 2020 and will end on December 31, 2020. As of January 1, 2021, Great Britain will be considered a third country to the EU. See Brexit Impact in RIM Vaults for more information, including some actions you can take in your Vault to continue licensing or to license new products in either the UK or the EU.

About Procedure Types

When creating an EU Application, you must select a Procedure Type. Depending on the Procedure Type selected, different countries are applicable for that Application:

  • National: A single country is selected for the Application and Submission.
  • Mutual Recognition Procedure (MRP): Two or more countries are selected on the Application, and the product is authorized in at least one country. In this case, you’ll also need to select the Common country.
  • Decentralised Procedure (DCP): Two or more countries are selected on the Application, and the product is not authorized in any country. In this case, you’ll also need to select the Common country.
  • Centralised Procedure (CP): The European Union or the European Directorate for the Quality of Medicines is selected as the country on the Application and Submission.

About Node Extensions

EU Submissions require node extensions instead of Study Tagging Files (STFs). To publish node extensions, you’ll need to do the following:

  • Set the Create Node Extensions field on the Submission record to Yes
  • Define node extensions on the Content Plan by setting the XML Element Name field to node-extension
  • Enter a value in the XML Title field on the Content Plan

Copying a Content Plan for EU Submissions

When copying a content plan from a US submission to an EU submission, Vault removes all US-specific data with the exception of the STF Content Plan Item record to support other regions that accept STFs.

In order for the publishing process to work correctly for copied EU submissions, you must delete the STF Content Plan Item. You’ll also need to set the Continuous Publishing and Continuous Validation fields Yes on all Content Plan Items.

Submissions with Unreferenced Files

Submissions for EU eCTDs often include unreferenced files, also known as working documents. Working documents support the submission but aren’t referenced within the XML. Organizations can import submissions into Vault containing working documents in the submission structure. See Preparing Submissions for Import for information about importing eCTD submissions with unreferenced files to RIM Submissions Archive.

Content Plan Configuration

Vault includes an Other (other__v) object type for all content plan objects (Content Plan Template, Content Plan Item Template, Content Plan, and Content Plan Item) to allow users to capture working documents within a child Content Plan record under the root Content Plan.

An Admin must set the Other object type to Active on all content plan objects.

Including Working Documents in Submissions

To include working documents in the submission structure, first navigate to the Content Plan record:

  1. Set the Name to ${submission__v.xml_submission_id__v} working documents.
  2. Scroll to the Publishing Details section.
  3. Set the XML Element Name field to unreferenced-files. This indicates that all child Content Plan Item records of this Content Plan are working documents.
  4. In the Title (xml_title__v) field, enter ${submission__v.xml_submission_id__v}-workingdocuments to set the Content Plan Title to the name of the working documents section as it will appear in Submissions Archive.

Next, navigate to Publishing Details section on the Content Plan Item record and set the Published Output Location field to ../${submission__v.xml_submission_id__v}-workingdocuments.

You can also create additional unreferenced Content Plans containing Content Plan Items under the ‘working documents’ Content Plan. These must also have the XML Element Name field set as defined above and the Title field populated.

About the Publishing Process for Submissions with Unreferenced Files

During the publishing process, for any Content Plan Item record within the Content Plan that has the XML Element Name field set to unreferenced-files:

  • Vault excludes these Content Plan Item records from the published XML
  • Vault does not apply validation criteria to these Content Plan Item records

For each Content Plan record that has the XML Element Name field set to unreferenced-files, Vault also creates a section within the Submissions Archive binder using the XML Title field value.

Upon publishing, these files appear within the Submissions Archive Binder structure. Any links from the submission to the working documents do not work. When you export the submission, Vault respects the Source for Published Output Location field.