# Generating Form 2253 (PromoMats) You can use a _Compliance Package_ binder and connected promotional pieces to generate an FDA Form 2253 from within Vault. The form auto-populates using field values from the binder and from connected documents. This feature can also generate continuation pages for the form if the Compliance Binder includes more than eight promotional pieces. With the correct configuration, Vault can generate the supplementary sheet required for multi-product 2253 submissions. Please note that XFA form mapping must be used in order to utilize the FDA's new 2253 form. This feature must be enabled by an Admin. Note that this article only applies to the existing Compliance Package functionality. To comply with FDA guidelines on Post Marketing 2253 and Pre Clearance (APLB and OPDP) Submissions for June 2021, Admins must [configure the Post Marketing and Pre Clearance Compliance Packages](/en/lr/65733/). Users can then [generate Post Marketing and Pre Clearance Compliance Packages](/en/lr/65734/) based on FDA guidelines released in June 2019.
## How to Generate Compliance Packages with Bulk Actions You can use a bulk document action to create a compliance package binder, add documents, and generate FDA Form 2253 as a single action. To do this: 1. Select the promotional materials documents that will belong to the compliance package binder using the standard process for bulk document actions. Note that you do not need to select reference documents. See [details](/en/lr/18822/) on the selection process. 2. From the **Choose Action** page (Step 2), select **Create Compliance Package Binder**. To check if you have the correct permissions on the selected documents, click **Calculate Permissions**. 3. Click **Next**. 4. On the **Create Compliance Package** page (Step 3), select a binder template. See details on the templates [below](/en/lr/9746/#templates). 5. Populate fields for the new binder. Required fields appear with a yellow background. The product you select should be the primary brand. To make selection easier, you can set the **Limit to products on selected documents** checkbox, which will filter the list to only those selected on at least one of the documents in the bulk action. Select _United States_ as the **Country**. 6. Click **Next**. 7. From the **Confirmation** page (Step 4), review the summary of changes. 8. Click **Finish**. Vault will send you an email with details of the changes once the bulk action is complete.When this action is complete, there will be a new binder with all the documents selected in Step 1 and a new PDF document with the _Health Authority Form_ document type. ## How to Generate Form 2253 from a Binder To generate a Health Authority Form 2253: 1. Create a binder with the document type **Compliance Package**. 2. Select a single product for the binder. 3. If Vault uses the _Country_ object, select _US_. 4. Add documents to the binder. These documents should have the same product as the binder. 5. From the Actions menu, select **Generate 2253**. 6. Vault will start the generation process and send an email notification when it is complete. 7. Once completed, the Form 2253 (PDF) is saved as a new **Health Authority Form** document in the binder. ### Criteria for 2253 Generation In order to generate a Health Authority Form 2253, the binder must meet these conditions: * For Vaults that use the _Country_ object, the selected country must be _United States_ for the _Compliance Package_ binder. Vaults that do not use the country object do not include this restriction. * The binder's document type is _Compliance Package_. Vault does not confirm that there are _Promotional Piece_ documents in a binder before allowing you to generate a form, so you can create an incomplete form. ### Steady State Validation Admins can configure your Vaults to prevent non-steady state promotional content from being added to a compliance package.
To enable this: 1. Navigate to **Admin > Settings > Application Settings.** 2. In the **Compliance Package Generation** section, select **Enforce Documents are in Steady State**. This prevents users from completing the _Generate Compliance Package_ bulk action if all included documents are not in a Steady state. Optionally, configure the **Set binder content version binding to Steady State** entry action. This feature automatically sets binding rules on binder content to bind to the latest _Steady_ state content. ### Versioning You can use the **Generate 2253** action as many times as necessary. Each time, Vault creates a new version of the existing form. You cannot version if: * The binder contains more than one _Health Authority Form_ document. * The existing _Health Authority Form_ document is checked out (locked). ## Multi-Product 2253 Generation If your Vault uses multi-product 2253 generation, the product field mapped to the form's _Secondary Brands_ field will auto-populate with all product values other than the one selected as the binder's product. ## Additional Notes * Vault does not confirm that there are _Promotional Piece_ documents in a binder before allowing you to generate a form, so you can create an incomplete form. * Vault will ignore any documents in a binder that are not for the same product as the binder when generating a form. Documents can have multiple products selected, but one must be the same product as the binder. * If rendering a populated 2253 form fails, Vault will try to generate an XML file with all of the data that would be in the 2253 form. You can then download the XML file and manually import it into a 2253 form using Adobe Acrobat Professional. * When generating a 2253 form using XFA Form Mapping, Vault orders documents by Document Number (Material ID), first numerically and then alphabetically. ## Related Permissions To generate Form 2253 and work with generated forms, you should have the following permissions. If your Vault uses the XFA form generation feature, you'll also need the [permissions listed for that](/en/lr/37170/). | Type | Permission Label | Controls | | --- | --- | --- | | Security Profile | Application: Library: Bulk Update | Ability to access the _Generate Compliance Package_ action | | Document Type: Compliance Binder | Create Binder | Ability to successfully complete the G_enerate Compliance Package_ action | | Document Type: Health Authority Form | Create Document | Ability to successfully complete the _Generate Compliance Package_ action | | Document Role | View Document | On binder component documents: Ability to select documents for the _Generate Compliance Package_ action
On Compliance Package binder: Ability to view the binder
On generated Form 2253: Ability to view the generated form | | Document Role | Version | Allows you to generate an update to the _Health Authority Form_ document if it's in Steady state | | Document Role | Edit Document | Allows you to generate an update to the _Health Authority Form_ document if it's in any state other than the lifecycle's Steady state. | ## Generated Form & Field Mapping Every field on the generated Form 2253 maps to a field on the binder, on the binder's component documents, or on an object record referenced by the binder. However, these mappings vary between Vaults. Contact your Vault administrator for information on your Vault's field mappings. If documents in your _Compliance Package_ binder include _Linked Documents_ relationships to documents with the _Prescribing Information_ subtype, Vault adds the related documents to the binder in a separate section for references. The _Prescribing Information_ documents linked to the binder are [bound to the version currently in use](/en/lr/5489/). You must have permission to the _Prescribing Information_ documents for this to occur. ## Compliance Binder Templates {#templates} Vault provides standard binder templates for the _Compliance Package_ document type: * _Compliance Package Template_/_Offline Submission Compliance Package_: This template provides a generic way to collect documents included in a submission. * _eCTD Compliance Package_: This binder template is based on the FDA's latest guidance for eCTD Module 1 submission. ## Default Vault Objects and Fields for 2253 Generation New Vaults provisioned after V15 are automatically configured with the required fields, objects, and mappings. However, there are a number of features that can be enabled for existing Vaults to auto-provision the required fields and objects for mapping to the Form 2253. The table below describes some of the differences between the fields provided by default prior to V15 and post-V15: | 2253 fields | Prior to V15 | V15 and later | | --- | --- | --- | | Product | Manual entry | Manual entry | | Secondary Brands | Not available
Single product 2253 generation only | Automatically populated through Create Compliance Package bulk action
Can be edited manually | | Application Type | Manual entry | _Inferred from Product_
Binder field should be hidden | | Application Number | Manual entry | _Inferred from Product_
Binder field should be hidden | | Applicant | Manual entry | _Inferred from Application_
Binder field should be hidden | | Contact | Not available
The details exist as part of the selected Applicant | Manual entry
Allows the appropriate Responsible Official to be selected | The V15 default configuration is necessary for the 2253 Supplementary Sheet to be populated correctly. For each secondary brand (product values), the _Application Type_ and _Application Number_ must be listed, so there must be a link between _Product_ and _Application_.