When working with Swiss regulatory submissions, Submissions Publishing allows you to generate CH eCTD v1.5 XSD compliant XMLs for submission to Swissmedic. Vault can validate these submissions in accordance with the CH Swissmedic v1.5 Validation Criteria Version.
Note: This feature is only available on RIM Submissions Publishing Vaults.
About Node Extensions & Study Tagging Files
In certain situations, Swissmedic allows both node extensions and Study Tagging Files (STFs) in the same submission. If your submission contains both node extensions and STFs, they must exist in separate content plan sections.
Working with Pharmaceutical Forms
Swissmedic submissions include Pharmaceutical Forms, also known as Galenic Forms. The Pharmaceutical Forms exist within the envelope of the Regional XML and define the folder name for the content. When your submission contains documents that are applicable to all Pharmaceutical Forms, you can include a common Pharmaceutical Form. The output then includes a common folder for all documents assigned to the common form.
Your content plan includes one (1) content plan section for each Pharmaceutical Form included in the submission. After the submission has been published, you can see all Pharmaceutical Forms in the Galenic Forms section of the Submission Administrative Information view, including any Pharmaceutical Form content plan sections with the Use for Content Planning field set to No. Note that you won’t see any common Pharmaceutical Forms in the Galenic Forms section.
Creating Content Plan Templates with Pharmaceutical Forms
Admins can create a Content Plan Template that supports content plans containing Pharmaceutical Forms by adding the ${submission_pharmaceutical_form} token.
When users create a content plan from this template, Vault:
- Creates one (1) new content plan section for each Submission Pharmaceutical Form record with the Use for Content Planning field blank or set to Yes
- Populates the Submission Pharmaceutical Form field on the Content Plan record with a link to the corresponding Submission Pharmaceutical Form record
Configuring the Pharmaceutical Form Document Field
Vault includes the Pharmaceutical Forms shared document field to support Swissmedic submissions. Before users can match pharmaceutical form documents to content plan items, Admins must:
- Set this field to active and assign it to the document types to be used for pharmaceutical forms
- Set up a custom matching field and update the Matching Fields on the Content Plan record
Configuring & Overriding the Pharmaceutical Form Name
By default, Vault auto-populates the Pharmaceutical Form Name (galenic-form) value during publishing for both the envelope and M1 XMLs. When a different value should appear in the envelope XML, publishers can enter it into the XML Application Pharmaceutical Form Name text field. During publishing, Vault copies this new value to the XML Submission Pharmaceutical Form Name field and populates it in the envelope XML.
To configure this capability, an Admin must add the XML Application Pharmaceutical Form Name field to the Application Pharmaceutical Form object page layout, as well as the XML Submission Form Name field to the Submission Pharmaceutical Form object page layout.
Users can also view the overriding value within the Submission Wizard.
Copying a Content Plan for CH Submissions
When copying a content plan from a US 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 submissions, you must set the Continuous Publishing and Continuous Validation fields to Yes on all Content Plan Items.
Copying Content Plans with Pharmaceutical Forms
When you copy a content plan containing a Pharmaceutical Form, Vault updates the Submission Pharmaceutical Form field on the Content Plan record with a link to the correct Submission Pharmaceutical Form record. If the Pharmaceutical Form doesn’t exist on the Application Pharmaceutical Form record, Vault deletes the Submission Pharmaceutical Form record and the section in the content plan.
Viewing Submission Administrative Information
Vault supports viewing Submission Administrative Information for CH v1.0.1, v1.1, v1.2, v1.3, v1.4, and v1.5 DTDs. See Viewing Submission Administrative Information for details.
Managing Submission Administrative Information
Vault supports managing Submission Administrative Information for CH v 1.5 DTDs only. See Managing Submission Administrative Information for details.
Adding Multiple Application Numbers
Swissmedic guidance allows for multiple variations for the same medicinal product to be submitted jointly, as a multiple application. This could include variations of the same type or different types (IA, IB, II, extension).
To support this scenario, you can associate multiple application numbers to CH submissions by adding overrides to the Application Number’s Country Value. Vault presents the Country Value column in the Submission Administrative Information view for applications with an associated Country (Application Country) record.
When you add an override, Vault maintains the existing Application Number and includes the override to subsequent sequences without impacting any previous sequences. Similarly, when you delete an override, it remains for any previous sequences, and Vault does not include it in the current or future sequences.
Once you save the override, Vault republishes the submission and populates the overridden values after the default Application Number value in the Submission Administrative Information panel and regional XML of the selected and any subsequent submissions, unless and until it is excluded.
Excluding Application Numbers
In some cases, it is required to provide only a single Application Number that is different from the current XML Application Number on the Application record for a given submission. To do this, select Exclude Value from the field’s Actions menu.
This type of override excludes the selected number from Submission Administrative Information. However, Vault does not update the Application record’s XML Application Number when updating SAI in this way.