# Working with CH Regulatory Submissions (RIM) 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.
## 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][1]. ### Excluding Application Numbers {#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. [1]: #excluding-application-numbers