# Manage Products

Vault makes managing large groups of products efficient. You can configure a _Product_ record with product, registration, and substance details for each product on which your organization monitors and reports. Optionally, to group products with the same substance, you can create _Product Families_ for an _Organization_. _Product Families_ can include _Datasheets_, which are applied to all _Products_ in the family without a specified _Datasheet_. You must set up your _Product_ library to add <a href="/en/lr/01216/#add-a-study-product">_Study Products_</a> and <a href="/en/lr/01214/">_Combination Products_</a>.

Your company _Product_ library is a key component in many features, which includes the following:

* <a href="/en/lr/01145/">**E2B Import**</a>: During an E2B import, Vault attempts to match products in the E2B file to products configured in the _Product_ library.
* <a href="/en/lr/01224/">**ICSR Report Generation**</a>: When Vault generates ICSRs (including E2B, FDA 3500A, and CIOMS I reports) certain fields are mapped from the _Product_ library. These fields are identified in their descriptions below.
* <a href="/en/lr/01129/">**Aggregate Reports**</a>: Products added to an aggregate report <a href="/en/lr/01179/">Reporting Family</a> are used to filter _Cases_ to include in report tabulations.
* <a href="/en/lr/01256/">**Reporting Rules**</a>: Vault looks at local _Product Registrations_ for _Case Products_ to generate _Submissions_ according to reporting rules in your Vault.
* <a href="/en/lr/01192/">**Watchlists**</a>: You can set up _Watchlists_ to monitor _Cases_ with certain _Products_. _Case Products_ must be suspect or interacting to trigger watchlists.
* <a href="/en/lr/01198/">**Automatic Expectedness and Listedness**</a>: Set up _Products_ and _Product Datasheets_ for Vault to determine whether an adverse event is expected or unexpected.

## Prerequisites

To use this feature, your Admin must configure the following:
* To manage [_Substances_][9] on _Products_, <a href="/en/lr/01375/">enable Substances</a>.
* To use [unknown formulation _Products_][10], <a href="/en/lr/931735/">enable Unknown Formulation Product Selection</a>.
* To assign [_Default Alias_][19] values, <a href="/en/lr/727583/">enable Product Coding: Additional Matching Fields for Product Aliases</a>.
* To use [Inactivate Products and Product Registrations][18]:
  * <a href="/en/lr/808064/">Inactivate Products and Studies</a> 
  * <a href="/en/lr/736616/">Product Browser for Faster Case Product Selection</a>
  * <a href="/en/lr/672883/">Inactivate Product & Study Registrations</a>

## Create Products {#create-products}

Add a _Product_ for each company product for which you will process _Cases_ in Vault. When you add a <a href="/en/lr/917562/#products-section">_Case Product_</a> linked to a record in the company _Product_ library, Vault maps values from the _Product_ to the _Case Product_.

To support organizing and maintaining your _Product_ library, products can be grouped into _Product Families_. All _Products_ within a _Product Family_ must have the same _Substance_ and be linked to the same _Organization_. If products become inactive, you can [deprecate][7] the records.

### Add a Product Family {#add-a-product-family}

To add a _Product Family_:

1. Navigate to **Business Admin > Objects > Product Families**.
2. On the _Product Families_ page, select **Create**.
3. On the _Create Product Family_ page, complete the applicable [fields][11].
4. Select **Save**.

Upon saving a _Product Family_, a [_Products_ section][12] appears. Vault populates this section with any _Products_ that are linked to the _Product Family_. You can select **Add** to add existing _Products_ or to create new _Products_ to include in the _Product Family_. 

<a id ="create-unknown-formulation-products"></a>Depending on your Admin's configuration, Vault may create an [unknown formulation _Product_][10] on the _Product Family_.

#### Product Family Fields {#product-family-fields}

The following fields may be available:

<table>
    <thead>
        <tr>
            <th>Field</th>
            <th>Description</th>
        </tr>
    </thead>
    <tbody>
    <tr>
        <td><em>Name</em></td>
        <td>Enter a name for the <em>Product Family</em>.</td>
    </tr>
    <tr>
        <td><em>Organization</em></td>
        <td>Select the <em>Organization</em> to which the <em>Product Family</em> belongs.</td>
    </tr>
    <tr>
        <td><em>Product Family Abbreviation</em></td>
        <td>Enter an abbreviation for the <em>Product Family</em>.</td>
    </tr>
    <tr>
        <td><em>API Name</em></td>
        <td>
            <p>
                Enter a unique API Name for the <em>Product Family</em>.
            </p>
            <p>
                The <a href="/en/lr/01250/#product-family"><em>Product Family</em></a> reporting rule parameter uses this value to determine if a <em>Case Product</em> belongs to this <em>Product Family</em>.
            </p>
        </td>
    </tr>
    <tr>
        <td><em>Family Datasheet</em></td>
        <td>
            <p>
                Add a <a href="/en/lr/01198/"><em>Datasheet</em></a> that applies to all <em>Products</em> within the <em>Product Family</em> that do not have a specified datasheet.
            </p> 
            <p>        
                If the <em>Product Family</em>'s <em>Datasheet</em> changes, Vault applies those updates to those <em>Products</em>.
            </p>
        </td>
    </tr>
    <tr>
        <td><em>Therapeutic Area</em></td>
        <td>Select the <em>Therapeutic Area</em> for the <em>Product Family</em>.</td>
    </tr>
    <tr>
        <td><em>EMA Substance Group</em></td>
        <td>When <a href="/en/lr/01238/#field-mapping-from-ema-mlm-ris-files">importing literature references from an EMA MLM RIS file</a>, Vault populates the substance code used by the EMA MLM service.</td>
    </tr>
    </tbody>
</table>

### Add a Product {#add-a-product}

To add a _Product_:

1. Navigate to **Business Admin > Objects > Products**.
2. On the _Products_ page, select **Create**.
3. In the _Create Product_ window, select the type, then select **Continue**.
    * If the _Product_ has multiple _Product Type_ registrations to meet agency requirements, select **Product**. If not, select from the other options. When you select a product type registered in the FDA's jurisdiction, the product type determines how Vault generates submissions to the FDA.
4. On the _Create Product_ page, complete the applicable [fields][13].
5. Select **Save**.

#### Unknown Formulation Products {#unknown-formulation-products}

If your Admin has configured unknown formulation _Products_, Vault provides a standard method of handling cases with limited product information with the following:
* Vault creates an unknown formulation _Product_ on [newly created _Product Families_][14]
* You can select the [_Unknown Formulation_ checkbox][15] on a _Product_ to indicate that it has an unknown formulation
* Vault maps all updated [_Substances_][9] on any _Product_ in the _Product Family_ to the unknown formulation _Product_
* When <a href="/en/lr/01162/#browse-unknown-formulation-products">coding _Products_</a>, you can filter your search results to only unknown formulation _Products_ 
* The <a href="/en/lr/826980/">_Inbox Item to Case Compare_ page</a> considers all _Products_ in the _Product Family_ as potential matches

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: For unknown formulation <em>Products</em> to work as expected, you must organize your <em>Products</em> within <em>Product Families</em>.</p>
    </div>
  </div>
</div>



#### Product Fields {#product-fields}

The following fields may be available:
<table>
    <thead>
        <tr>
            <th>Field</th>
            <th>Description</th>
        </tr>
    </thead>
    <tbody>
    <tr>
        <td><em>Organization</em></td>
        <td><p>Select the organization to which the <em>Product</em> belongs.</p>
            <p>When adding a <em>Case Product</em>, the <em>Case</em> must be associated with this organization to allow users to select this product.</p></td>
    </tr>
    <tr>
        <td><em>Product Name</em></td>
        <td><p>Enter the primary name of the product. Vault references the product using the name that you enter in this field.</p> 
            <p>When a <em>Case Product</em> references this <em>Product</em>, Vault uses this field to generate the <a href="/en/lr/01275/#case-product-name"><em>Case Product Name</em></a>.</p></td>
    </tr>
    <tr>
        <td><em>Product Family</em></td>
        <td>Select the <em>Product Family</em> to which the <em>Product</em> belongs. Vault populates the <em>Product Families</em> section of the <em>Product</em> with this value.</td>
    </tr>
    <tr>
        <td><em>Abbreviation</em></td>
        <td>Enter the abbreviated name for the product. This field is for reference only.</td>
    </tr>
    <tr>
        <td><em>Generic Name</em></td>
        <td><p>Enter the generic name for the product.</p>
            <p>For Device-type products, Vault exports this value when generating <a href="/en/lr/700010/">FDA E2B(R2)</a>, <a href="/en/lr/700006/">FDA VAERS E2B(R3)</a>, and <a href="/en/lr/802644/">FDA MedWatch 3500A</a> report formats. For any <em>Case Product</em> with an <a href="/en/lr/01169/#drug-role">eligible <em>Drug Role</em></a>, Vault exports this value to <a href="/en/lr/01222/#suspect-products">CIOMS I</a> forms.</p></td>
    </tr>
    <tr>
        <td><em>Vaccine Type</em></td>
        <td><p>If the product is a vaccine, select the vaccine type.</p>
            <p>When a <em>Vaccine</em>-type <em>Case Product</em> references this <em>Product</em>, Vault maps this field to the <em>Case Product</em>.</p></td>
    </tr>
    <tr>
        <td><em>International Birthdate</em></td>
        <td>Enter the date when a regulatory authority first granted marketing authorization for the product. Vault uses this value in report generation for <a href="/en/lr/802644/">FDA MedWatch 3500A</a> formats.</td>
    </tr>
    <tr>
        <td><em>Expiration Date</em></td>
        <td><p>Enter the expiration date for the product. Partial dates are supported and the minimum precision required is the year.</p>
            <p>Vault maps this field to the <em>Case Product</em>. For Device-type products, this field is used in report generation for <a href="/en/lr/01288/#fda-e2b-r2">FDA E2B(R2)</a> (B.4.k.2.4.FDA.1).</p></td>
    </tr>
    <tr>
        <td><em>Manufacturer</em></td>
        <td>Select the organization that manufactures the product, if it is different from the one selected in the <em>Organization</em> field. For device-type <em>Products</em>, when this field contains an organization value, that organization is used in report generation for <a href="/en/lr/01288/#fda-e2b-r2">FDA E2B(R2)</a>, <a href="/en/lr/01288/#vaers-e2b-r3">FDA VAERS E2B(R3)</a>, and <a href="/en/lr/802644/">FDA MedWatch 3500A</a> report formats.</td>
    </tr>
    <tr>
        <td><em>Core Datasheet</em></td>
        <td><p>Select the <a href="/en/lr/01198/#core-datasheet">core <em>Datasheet</em></a> for the <em>Product Family</em>. Vault uses <em>Datasheets</em> to <a href="/en/lr/01198/">detect expectedness</a> for an adverse event and the suspect or interacting <em>Case Products</em>.</p></td>
    </tr>
    <tr>
        <td><em>Product Use Type</em><a id="prod-use-type"></a></td>
        <td>Select the <em>Product Use Type</em>. When users are searching for <em>Products</em> in the <a href="/en/lr/01162/#product-browsing"><em>Product Browser</em></a> on <em>Inbox Items</em> and <em>Cases</em>, Vault returns only <em>Products</em> for which this field is <em>Company Use</em> or blank.</td>
    </tr>
    <tr>
        <td>
            <em>Non-Company Product</em><a id="non-company-product"></a>
        </td>
        <td>
            If selected, Vault will consider Marketing→Investigational and Marketing→Marketing (Cross-Agency) <a href="/en/lr/01247/">cross reporting</a> scenarios for the <em>Product</em>.
        </td>
    </tr>
    <tr>
         <td><em>API Name</em></td>
         <td>
            Enter a unique identifier that can be used with the Safety "Product" <a href="/en/lr/01250/">rule parameter</a> to define a specific <em>Product</em> for a reporting rule.
         </td>
      </tr>
        <tr>
         <td><em>Market Segment</em></td>
         <td>Select a market segment from the picklist.</td>
      </tr>
      <tr>
         <td><em>Device Nomenclature Code</em></td>
         <td>Enter the numeric code corresponding to the device. During report generation, Vault maps this value to <a href="/en/lr/872182/#eu-mir-22b">EU MIR</a> and <a href="/en/lr/980119/#mhra-mir-22b">MHRA MIR</a> forms.</td>
      </tr>
      <tr>
         <td><em>Basic UDI-DI</em></td>
         <td>Enter the Basic UDI-DI key. During report generation, if the <em>Basic UDI-DI</em> on the <em>Case Product</em> is blank, Vault maps this value to <a href="/en/lr/872182/#eu-mir-21c">EU MIR</a> and <a href="/en/lr/980119/#mhra-mir-21c">MHRA MIR</a> forms.</td>
      </tr>
      <tr>
         <td><em>FEI Number</em></td>
         <td>Enter the unique FDA Establishment Identifier (FEI) assigned to the FDA-regulated facility. Vault exports this to the September 2025 version of the <a href="/en/lr/1037126/">FDA MedWatch 3500A form</a>.</td>
      </tr>
        <tr>
         <td><em>Brand Name</em></td>
         <td>Enter the brand name.</td>
      </tr>
        <tr>
         <td><em>Description of Device</em></td>
         <td>Enter a description of the device.</td>
      </tr>
      <tr>
         <td><em><a id ="unknown-formulation-field"></a>Unknown Formulation</em></td>
         <td>Select the checkbox to indicate an <a href="/en/lr/01215/#unknown-formulation-products">unknown formulation</a>. A <em>Product Family</em> can contain only one unknown formulation Product.</td>
      </tr>
    </tbody>
</table>

## Add Product Registration Details {#add-product-registration-details}

Add _Product Registrations_ for each country in which the product is registered. Vault looks at the _Product Registration Countries_ for _Case Products_ to generate _Submissions_ according to <a href="/en/lr/01256/">reporting rules</a> in your Vault. When you select the _Product Registration_ on a _Case Product_, upon saving the record, Vault maps fields from the _Product Registration_ to the _Case Product_.

If product registrations become inactive, you can [deprecate][8] the records.

### Add a Product Registration {#add-a-product-registration}

Add product registration details for each country in which the product is registered.

1. Navigate to **Business Admin > Objects > Products > [Product]**.
2. Under _Registrations_, select **Create**.
3. Complete the _Create Product Registration_ page.
4. Select **Save**.

#### Product Registration Fields {#product-registration-fields}

<table>
    <thead>
        <tr>
            <th>Field</th>
            <th>Description</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><em>Organization</em></td>
            <td><p>Vault populates this field with a reference link to the Organization on the parent <em>Product</em> record.</p>
                <p>If the <em>Registration Holder/Applicant</em> field is blank, Vault maps this field to the <em>Registration Holder</em> field on Case Products.</p></td>
        </tr>
        <tr>
            <td><em>Product</em></td>
            <td>Vault populates this field with a reference link to the Product parent record.</td>
        </tr>
        <tr>
            <td><em>Registration Name</em></td>
            <td>Enter a name for the Product Registration. Vault references the registration using the name that you enter in this field.</td>
        </tr>
        <tr>
            <td><em>Product Type</em></td>
            <td>Vault populates this field with the product type of the Product parent record.</td>
        </tr>
        <tr>
            <td><em>FDA Product Type</em></td>
            <td>Select a product type. Vault exports the value to the August 2024 and September 2025 versions of the <a href="/en/lr/802644/">FDA MedWatch 3500A form</a>.</td>
        </tr>
        <tr>
            <td><em>Combination Type</em></td>
            <td><p>If the product is a combination product, select the combination type.</p>
                <p>Vault maps this field to the Case Product and is used in report generation for the <a href="/en/lr/01288/#vaers-e2b-r3">FDA VAERS E2B(R3)</a> format.</p></td>
        </tr>
        <tr>
            <td><em>Registration Number</em></td>
            <td><p>Enter the product authorization or application number for the country where the product is marketed.</p>
                <p>For U.S. Registrations, ensure that the value you enter in this field adheres to the FDA E2B format requirements for element B.4.k.4.1 (Authorisation / Application Number).</p>
                <p>Vault maps this field to the Case Product and is used in report generation for <a href="/en/lr/01288/">E2B</a>, <a href="/en/lr/802644/">FDA MedWatch 3500A</a>, and <a href="/en/lr/01281/">PADER</a> formats.</p></td>
        </tr>
        <tr>
            <td><em>Registration Date</em></td>
            <td><p>Enter the date when the product was registered.</p>
                <p>This field is for reference only.</p></td>
        </tr>
        <tr>
            <td><em>Registration Type</em></td>
            <td><p>Select the registration type.</p>
                <p>
                    This field is used in report generation for <a href="/en/lr/802644/">FDA MedWatch 3500A</a> and <a href="/en/lr/01281/">PADER</a> formats.
                </p>
                <p>
                    This field is needed to correctly match <a href="/en/lr/01202/#transmission-profile-matching-for-submission-rules">Transmission Profile Scope</a> records for any Organization with multiple Transmission Profiles for the same destination Agency.
                </p>
            </td>
        </tr>
        <tr>
            <td><em>Country</em></td>
            <td><p>Select the country where the product is registered and authorized.</p>
                <p>Vault maps this field to the Registration Country field on a Case Product and is used in report generation for <a href="/en/lr/01288/">E2B</a> formats.</p></td>
        </tr>
        <tr>
            <td><em>Route of Administration</em></td>
            <td><p>Select the route of administration TermID code.</p>
                <p>This field is for reference only.</p></td>
        </tr>
        <tr>
            <td><em>Compounding Type</em></td>
            <td><p>For compounded products, select the compounding type.</p>
                <p>Vault maps this value to <em>Case Products</em> and references it in report generation for <a href="/en/lr/01288/">E2B</a> and <a href="/en/lr/01223/#compounded-product">FDA MedWatch 3500A</a> formats.</p></td>
        </tr>
        <tr>
            <td><em>Agency</em></td>
            <td><p>Based on the Country selected on the Product Registration, Vault populates this field with the Agency assigned jurisdiction over that country.</p>
                <p>If configured, <a href="/en/lr/01256/">reporting rules</a> generate Submissions to this Agency when a Case Product references this Product Registration.</p></td>
        </tr>
        <tr>
            <td><a id ="transmission-profile"></a><em>Transmission Profile</em></td>
            <td>Select a <em>Transmission Profile</em> for Vault to use when generating <em>Submissions</em> for this registration. We recommend populating this field when you have a <em>Transmission Profile</em> corresponding to this reporting destination and report type.</td>
        </tr>
        <tr>
            <td><em>Local Datasheet</em></td>
            <td><p>Select the <a href="/en/lr/01198/">Local Datasheet</a> for this product registration. A Local Datasheet is specific to a country or region, listing expected adverse events that apply to that product registration.</p>
                <p>Datasheets are used to <a href="/en/lr/01198/">detect expectedness</a> for an adverse event and the suspect or interacting Case Products.</p></td>
        </tr>
        <tr>
            <td><em>Registration Holder/Applicant</em></td>
            <td><p>Vault maps this value to the <em>Registration Holder/Applicant</em> field on <em>Case Products</em>. If this field is blank, Vault maps the <em>Organization</em> value.</p></td>
        </tr>
        <tr>
            <td><em>MAH</em></td>
            <td><p>This field may also be named <em>Reporting Organization</em> depending on your Admin's configuration.</p>
                <p>If you have a Marketing Authorization Holder (MAH) that manages your ICSR reporting obligations for this registration, select the Organization. Selecting an Organization in this field creates an <a href="/en/lr/01255/">MAH Distribution List</a>, and thereby a reporting obligation, for this registration.</p>
                <div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: Removing the last remaining MAH/Reporting Organization from an MAH Distribution List will also delete the MAH Distribution list.</p>
    </div>
  </div>
</div>


                <div class="note-border alert-warning">
  <div class="alert alert-warning" role="alert">
    <div><i class="far fa-exclamation-triangle"></i></div>
    <div class="alert-text">
      <p><strong>Warning</strong>: Use caution when setting this field. Reporting Obligations are for Distributions only and override agency submission rules. Do not select an Agency such as the FDA or EMA.</p>
    </div>
  </div>
</div>


                </td>
        </tr>
        <tr>
            <td><em>Registered As</em></td>
            <td><p>Select the product type for this registration. Vault maps this value to the <em>Registered As</em> field on <em>Case Products</em>.</p>
                <p>When generating E2B Transmissions for this registration, Vault maps this field, then uses that value to determine whether Device-type Combination Product Constituents are exported.</p>
                <p>See <a href="/en/lr/01214/#exclude-device-constituents-from-e2b-exports">Exclude Device Constituents from E2B Exports</a> for more information.</p>
                <p>
                    When generating an FDA 3500A form for a non-Combination Company Product, this field determines which section of the form is populated, as follows:
                    <ul>
                        <li>If the <em>Registered As</em> field is set to Device or OTC Device, populate the Suspect Medical Device sections.</li>
                        <li>If the <em>Registered As</em> field is not set to Device or OTC Device, populate the Suspect Product(s) section.</li>
                        <li>If the Company Product has multiple FDA registrations (one device, and one non-device, for example), populate the Suspect Product(s) section.</li>
                        <li>If the Company Product has no FDA registration, populate the Suspect Product(s) section.</li>
                    </ul>
                </p>
                <p>For information on how the product type for a registration is used when evaluating reporting rules, see the
                    <a href="/en/lr/01250/#product-registration-type-parameter">Product Registration Type</a> rule parameter.
                </p>
                <p>This field does not appear on layouts by default, but can be added to <em>Transmission</em> layouts by your Admin. Depending on your Admin's configuration, this field may be called <em>Transmission Product Type</em>.</p>
            </td>
        </tr>
        <tr>
            <td><em>Default Registration</em></td>
            <td>Designates the registration as the most current or commonly used registration for the selected country. <br>
            If the registration is the most commonly used for the selected country, select the checkbox. During data entry, in the Case <em>Product Registration</em> field, this registration is prioritized in the picklist, though all active Product Registrations remain available for use.</td>
        </tr>
        <tr>
            <td><em>Strength</em></td>
            <td>Enter the strength of the product.<br>
            In the first field, enter a numeric value. In the second field, select a unit of measurement from the picklist or enter a custom unit.</td>
        </tr>
        <tr>
            <td><em>MPID</em></td>
            <td><p>Enter the UMC Medicinal Product Identifier (MPID) for the product.</p>
                <div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: You can specify only one type of product identifier. Do not specify an MPID if you have entered an IDMP MPID or PhPID.</p>
    </div>
  </div>
</div>


                <p>Vault maps this field to the Case Product and is used in report generation for <a href="/en/lr/01288/#ich-e2b-r3">E2B(R3)</a> and <a href="/en/lr/01222/">CIOMS I</a> formats.</p></td>
        </tr>
        <tr>
            <td><em>IDMP MPID</em></td>
            <td><p>Enter the Identification of Medical Products (IDMP) MPID for the product.</p>
                <div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: You can specify only one type of product identifier. Do not specify an IDMP MPID if you have entered an MPID or PhPID.</p>
    </div>
  </div>
</div>


            </td>
        </tr>
        <tr>
            <td><em>PhPID</em></td>
            <td><p>Enter the Pharmaceutical Product Identifier (PhPID). </p>
                <div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: You can specify only one type of product identifier. Do not specify a PhPID if you have entered an MPID or IDMP MPID.</p>
    </div>
  </div>
</div>


                <p>Vault maps this field to the Case Product and is used in report generation for <a href="/en/lr/01288/#ich-e2b-r3">E2B(R3)</a> and <a href="/en/lr/01222/">CIOMS I</a> formats.</p></td>
        </tr>
        <tr>
            <td><em>National Drug Code</em></td>
            <td><p>Enter the US National Drug Code (NDC) or unique identifier for the product.</p>
                <p>This field is used in report generation for <a href="/en/lr/802644/">FDA MedWatch 3500A</a> formats.</p></td>
        </tr>
        <tr>
            <td><em>Product Code</em></td>
            <td><p>Enter the device Product Code.</p>
            <p>Vault maps this field to Device-type Case products, and it is used in report generation for <a href="/en/lr/01288/#fda-e2b-r2">FDA E2B(R2)</a>, <a href="/en/lr/01288/#vaers-e2b-r3">FDA VAERS E2B(R3)</a>, and <a href="/en/lr/802644/">FDA MedWatch 3500A</a> report formats.</p></td>
        </tr>
        <tr>
            <td><em>Local Product Code</em></td>
            <td>Enter the region-specific Medicinal Product Identification (MPID) code. This field is used for <a href="/en/lr/01290/">Localized Cases</a>.</td>
        </tr>
        <tr>
            <td><em>Trade Name</em></td>
            <td>Enter the trade name of the product registration. Vault maps this field to Device-type Case products, and it is used in report generation for <a href="/en/lr/700010/">FDA E2B(R2) (B.4.k.20.FDA.1)</a>.</td>
        </tr>
        <tr>
            <td><em>Applicable legislation unknown</em></td>
            <td>Select <strong>Yes</strong> or <strong>No</strong> to identify whether applicable legislation for the device is unknown. During report generation, Vault maps this value to <a href="/en/lr/872182/#eu-mir-24a-legislation">EU MIR</a> forms.</td>
        </tr>
        <tr>
            <td><em>MDD/AIMDD Risk Class</em></td>
            <td>Select the risk class of the medical device. During report generation, Vault maps this value to <a href="/en/lr/872182/#eu-mir-24c-mdd">EU MIR</a> and <a href="/en/lr/980119/#mhra-mir-24b-mdd">MHRA MIR</a> forms.</td>
        </tr>
        <tr>
            <td><em>IVDD Risk Class</em></td>
            <td>Select the risk class of the medical device. During report generation, Vault maps this value to <a href="/en/lr/872182/#eu-mir-24c-ivdd">EU MIR</a> and <a href="/en/lr/980119/#mhra-mir-24b-ivdd">MHRA MIR</a> forms.</td>
        </tr>
        <tr>
            <td><em>MDR Class</em></td>
            <td>Select the MDR class of the medical device. During report generation, Vault maps this value to <a href="/en/lr/872182/#eu-mir-24d-class">EU MIR</a> and <a href="/en/lr/980119/#mhra-mir-24c-class">MHRA MIR</a> forms.</td>
        </tr>
        <tr>
            <td><em>MDR Type</em></td>
            <td>Select the MDR type of the medical device. During report generation, Vault maps this value to <a href="/en/lr/872182/#eu-mir-24d-type">EU MIR</a> and <a href="/en/lr/980119/#mhra-mir-24c-type">MHRA MIR</a> forms.</td>
        </tr>
        <tr>
            <td><em>IVDR Class</em></td>
            <td>Select the IVDR class of the medical device. During report generation, Vault maps this value to <a href="/en/lr/872182/#eu-mir-24d-class-ivdr">EU MIR</a> and <a href="/en/lr/980119/#mhra-mir-24c-class-ivdr">MHRA MIR</a> forms.</td>
        </tr>
        <tr>
            <td><em>IVDR Type</em></td>
            <td>Select the IVDR type of the medical device. During report generation, Vault maps this value to <a href="/en/lr/872182/#eu-mir-24d-type-ivdr">EU MIR</a> and <a href="/en/lr/980119/#mhra-mir-24c-type-ivdr">MHRA MIR</a> forms.</td>
        </tr>
        <tr>
            <td><em>Notified Body ID</em></td>
            <td>Enter the identification number for the bodies that granted the CE mark for the device. During report generation, Vault maps this value to <a href="/en/lr/872182/#eu-mir-23p">EU MIR</a> and <a href="/en/lr/980119/#mhra-mir-23p">MHRA MIR</a> forms.</td>
        </tr>
        <tr>
            <td><em>Notified Body Certificate Number</em></td>
            <td>Enter the certificate number of the bodies entered in the <em>Notified Body ID</em> field. During report generation, Vault maps this value to <a href="/en/lr/872182/#eu-mir-23p">EU MIR</a> and <a href="/en/lr/980119/#mhra-mir-23p">MHRA MIR</a> forms.</td>
        </tr>
        <tr>
            <td><em>Device Market Date Type</em></td>
            <td>Select the device market date type. During report generation, Vault maps this value to <a href="/en/lr/872182/#eu-mir-23q">EU MIR</a> and <a href="/en/lr/980119/#mhra-mir-23q">MHRA MIR</a> forms.</td>
        </tr>
        <tr>
            <td><em>Device Market Date</em></td>
            <td>Use the calendar to select the device market date corresponding to the device market date type or enter the date manually. During report generation, Vault maps this value to <a href="/en/lr/872182/#eu-mir-23q">EU MIR</a> and <a href="/en/lr/980119/#mhra-mir-23q">MHRA MIR</a> forms.</td>
        </tr>
        <tr>
            <td><em>EU Market After Application Date</em></td>
            <td>Select <strong>Yes</strong> or <strong>No</strong> to indicate whether the device continued to be placed on the EU market after the MDR/IVDR date of application. During report generation, if the EU market after application date on the <em>Case Product</em> is blank, Vault maps this value to <a href="/en/lr/872182/#eu-mir-24e">EU MIR form field 2.e</a>.</td>
        </tr>
        <tr>
            <td><em>Deleted in RIM?</em></td>
            <td>For records generated by the <a href="/en/lr/01272/">Safety-RIM Connection</a>, this field indicates whether the source record has been deleted in the RIM Vault. Safety preserves the record in case other object records reference it.</td>
        </tr>
        <tr>
            <td><em>Expiration Date</em></td>
            <td>Indicates the date the registration expires if no renewal is submitted. Vault populates this field based on data received from the <a href="/en/lr/01272/">Safety-RIM Connection</a>.</td>
        </tr>
        <tr>
            <td><em>Marketing Start Date</em></td>
            <td>Indicates the date on which the product became available in this market. Vault populates this field based on data received from the <a href="/en/lr/01272/">Safety-RIM Connection</a>.</td>
        </tr>
        <tr>
            <td><em>Marketing End Date</em></td>
            <td>Indicates the date on which the product is no longer available in this market. Vault populates this field based on data received from the <a href="/en/lr/01272/">Safety-RIM Connection</a>.</td>
        </tr>
        <tr>
            <td><em>Marketing Status</em></td>
            <td>Indicates the marketing status for the registration and presentation in this market. Vault populates this field based on data received from the <a href="/en/lr/01272/">Safety-RIM Connection</a>.</td>
        </tr>
        <tr>
            <td><em>Product Alias</em></td>
            <td>Indicates the reference number for the product alias. Vault populates this field based on data received from the <a href="/en/lr/01272/">Safety-RIM Connection</a>.</td>
        </tr>
        <tr>
            <td><em>Product Family</em></td>
            <td>Indicates the <em>Product Family</em> of this registration. Vault populates this field based on data received from the <a href="/en/lr/01272/">Safety-RIM Connection</a>.</td>
        </tr>
        <tr>
            <td><em>Product Variant</em></td>
            <td>Indicates the registered presentation or product variant. Vault populates this field based on data received from the <a href="/en/lr/01272/">Safety-RIM Connection</a>.</td>
        </tr>
        <tr>
            <td><em>Registration End Date</em></td>
            <td>Indicates the date on which the registration ends. Vault populates this field based on data received from the <a href="/en/lr/01272/">Safety-RIM Connection</a>.</td>
        </tr>
        <tr>
            <td><em>Registration Status</em></td>
            <td>Indicates the date on which the registration moved to its current status. Vault populates this field based on data received from the <a href="/en/lr/01272/">Safety-RIM Connection</a>.</td>
        </tr>
        <tr>
            <td><em>RIM Lifecycle Status</em></td>
            <td>Indicates the lifecycle state of the source record in the RIM Vault. Vault populates this field based on data received from the <a href="/en/lr/01272/">Safety-RIM Connection</a>.</td>
        </tr>
        <tr>
            <td><em>RIM Registration Type</em></td>
            <td>Indicates the type of registration. Vault populates this field based on data received from the <a href="/en/lr/01272/">Safety-RIM Connection</a>.</td>
        </tr>
        <tr>
            <td><em>RIM Status</em></td>
            <td>Indicates whether the source record in the RIM Vault is <em>Active</em> or <em>Inactive</em>. Vault populates this field based on data received from the <a href="/en/lr/01272/">Safety-RIM Connection</a>.</td>
        </tr>
        <tr>
            <td><em>Additional Monitoring</em></td>
            <td>Select whether additional product monitoring is required by the health authority in this market. This field supports <a href="/en/lr/01240/#annex-h-reports">Annex H documents in PSMF reports</a>. </td>
        </tr>
        <tr>
            <td><em>Application Lead Market</em></td>
            <td>Indicates the primary market of the related application to which this registration applies. Vault populates this field based on data received from the <a href="/en/lr/01272/#psmf-annex-h">Safety-RIM Connection</a>. This field supports <a href="/en/lr/01240/#annex-h-reports">Annex H documents in PSMF reports</a>. </td>
        </tr>
        <tr>
            <td><em>Application Number</em></td>
            <td>Indicates the application number associated with the registration. Vault populates this field based on data received from the <a href="/en/lr/01272/#psmf-annex-h">Safety-RIM Connection</a>. This field supports <a href="/en/lr/01240/#annex-h-reports">Annex H documents in PSMF reports</a>. </td>
        </tr>
        <tr>
            <td><em>Non-Standard Aggregate Periodicity</em></td>
            <td>Select whether the product has a non-standard aggregate report submission cycle in this market. This field supports <a href="/en/lr/01240/#annex-h-reports">Annex H documents in PSMF reports</a>. </td>
        </tr>
        <tr>
            <td><em>Procedure Number</em></td>
            <td>Indicates the procedure number issued by the health authority. Vault populates this field based on data received from the <a href="/en/lr/01272/#psmf-annex-h">Safety-RIM Connection</a>. This field supports <a href="/en/lr/01240/#annex-h-reports">Annex H documents in PSMF reports</a>. </td>
        </tr>
        <tr>
            <td><em>Procedure Type</em></td>
            <td>Indicates the procedure type under which the related application will be reviewed in the European Union (EU). Vault populates this field based on data received from the <a href="/en/lr/01272/#psmf-annex-h">Safety-RIM Connection</a>. This field supports <a href="/en/lr/01240/#annex-h-reports">Annex H documents in PSMF reports</a>. </td>
        </tr>
    </tbody>
</table>

#### PMDA Fields

Use the PMDA fields to set up regional information <a href="/en/lr/01194/#add-a-japan-product-registration">when adding Japan Product Registrations</a>.

### Product-Manufacturer Site {#p-m-site}

Use the _Product-Manufacturer Site_ section to link <a href="/en/lr/01213/#manufacturer-site">_Manufacturer Sites_</a> with _Product Registrations_ for the United States. You can create a _Product-Manufacturer Site_ record for each _Product Registration_ to track adverse events by site. When a user adds a _Case Product_ for the _Product Registration_, Vault populates the <a href="/en/lr/01287/#manufacturer-site">_Manufacturer Site_ field</a>. Vault exports this value to FDA eMDR and FDA MedWatch 3500A reports.

## Add Substances {#substance-records}

Configure substance information to map information to _Cases_ for E2B export as follows:

* **E2B(R3)**: Section G.k.2.3.r Substance / Specified Substance Identifier and Strength
* **E2B(R2)**: Data element B.4.k.2.2 Substance / Specified Substance Name

When a _Case_ contains a _Case Product_ linked to a company _Product_ with preconfigured _Substances_, Vault maps each _Substance_ to create _Case Product Substances_. <a href="/en/lr/01283/">PSUR aggregate reports</a> can leverage _Substances_ to filter _Cases_ to include in the report tabulations. Other aggregate reports do not leverage _Substances_.

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: We recommend that you link a <em>Substance</em> at the <em>Product</em> level instead of adding a <em>Substance</em> to a <em>Study Product</em>. You should only add a <em>Substance</em> at the <em>Study Product</em> level when you need the <em>Strength</em> fields to appear. If a <em>Study Product Substance</em> exists, it will supersede any <em>Product Substances</em> on the <em>Case</em>.</p>
    </div>
  </div>
</div>



### Add a Substance to a Product {#add-substance-to-product}

To add a _Substance_ to a _Product_:

1. Expand the **Substances** section, then select **Add**.
2. From the _Search: Substance_ window, use either of the following methods to add a _Substance_:
    * To select existing _Substances_ from the library: 
        1. Optional: Use the search bar or filters to refine your search.
        2. Select the applicable _Substances_.
        3. Select **OK**.
    * To create a new _Substance_:
        1. Select **Create**. 
        2. On the _Create Substance_ page, complete the applicable [fields][16].
        3. Select **Save**.
3. Select **OK**.

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: You can also add a <em>Substance</em> to a <em>Product</em> from <strong>Business Admin &gt; Objects &gt; Substances</strong>. Create or select a <em>Substance</em>, and then expand the <strong>Products</strong> section and select <strong>Add</strong>.</p>
    </div>
  </div>
</div>



Whenever you add or remove a _Substance_ from a _Product_ within a _Product Family_, Vault maps all updated _Substances_ across all _Products_ to the [unknown formulation _Product_][10] on the _Product Family_. You can run the [_Sync Substances_][17] action to update all _Product Substances_ associated with a _Product Family_.

#### Product Substance Fields {#product-substance-fields}

The following fields may be available:
<table>
    <thead>
        <tr>
            <th>Field</th>
            <th>Description</th>
        </tr>
    </thead>
    <tbody>
      <tr>
         <td><em>Substance Name</em></td>
         <td><p>Enter the name of the substance. Vault references the substance using the name that you enter in this field.</p>
            <p>Vault maps this field to the Case Product Substance and is used in report generation for <a href="/en/lr/01288/#ich-e2b-r2">E2B(R2)</a> and <a href="/en/lr/01288/#ich-e2b-r3">E2B(R3)</a> formats.</p>
            <p>This field supports up to 128 characters. If your Admin has configured your Vault for 250-character Substance Names, this field may be unavailable and have a different field name.</p></td>
      </tr>
      <tr>
         <td><em>Substance Name</em></td>
         <td><p>Enter the name of the substance. Vault references the substance using the name that you enter in this field.</p>
            <p>Vault maps this field to the Case Product Substance and is used in report generation for <a href="/en/lr/01288/#ich-e2b-r2">E2B(R2)</a> and <a href="/en/lr/01288/#ich-e2b-r3">E2B(R3)</a> formats.</p>
            <p>This field supports up to 250 characters. Your Admin must <a href="/en/lr/01353/">enable this field</a> in your Vault.</p></td>
      </tr>
      <tr>
         <td><em>Organization</em></td>
         <td>Select the organization or use the binoculars icon to search for the organization associated with the substance.</td>
      </tr>
      <tr>
         <td><em>Substance ID</em></td>
         <td><p>Enter the unique identifier for the substance.</p>
             <p>This field is for reference only.</p></td>
      </tr>
      <tr>
         <td><em>Term ID</em></td>
         <td><p>Enter the substance TermID.</p>
            <p>Vault maps this field to the Case Product Substance and is used in report generation for <a href="/en/lr/01288/">E2B(R3)</a> formats.</p></td>
      </tr>
      <tr>
         <td><em>Term ID Version</em></td>
         <td><p>Enter the version date or number for the TermID.</p>
            <p>Vault maps this field to the Case Product Substance and is used in report generation for <a href="/en/lr/01288/">E2B(R3)</a> formats.</p></td>
      </tr>
      <tr>
         <td><em>Description</em></td>
         <td><p>Enter a description for the substance.</p>
             <p>This field is for reference only.</p></td>
      </tr>
   </tbody>
</table>

### Sync Product Substances {#sync}

You can run the _Sync Substances_ action to update all _Substances_ for all _Products_ in a _Product Family_. You can run the action on individual _Product Family_ records and on multiple records in bulk. To run as a <a href="/en/lr/33725/">bulk object record action</a>:

1. Navigate to **Products > Product Families**.
2. Optional: Apply filters to narrow down the list of _Product Families_ you want to synchronize with substance details.
3. From the **All Actions** menu, select the option to perform a bulk action on all records.
4. On the _Refine Selection_ page, review the list of selected records and clear the checkboxes of any _Product Families_ for which you do not want to update.
5. Select **Next**.
6. On the _Choose Action (Step 2)_ page, select **Record Actions** in the _Manage Records_ section.
7. Click **Next**.
8. On the _Choose Record Action (Step 3)_ page, select **Sync Substances (bulk)**. 
9. Select **Next**.
10. On the _Confirmation_ page, review the summary of changes and select **Finish**.

When the action completes, you'll receive an email and a Vault notification letting you know if the action was successful or if there were any errors.

## Create Product and Substance Aliases {#alias}

During E2B or JSON import, Vault attempts to match the _Case Product_ with the relevant _Product_ in your library. You can set up <a href="/en/lr/01145/#product-substance-alias-match">_Product_ matching using _Product_ and _Substance Aliases_</a>. If Vault cannot find a match for the _Case Product_ using non-Study matching, it will attempt to use aliases you set up in the library.

### Add a Product Alias {#product-alias}

To add a _Product Alias_:

1. Navigate to **Business Admin > Objects > Product Aliases**.
2. Select **Create**.
3. Complete the following information: 
    * **Alias**: Enter the alias name.
    * **Product**: Select the _Product_ the alias is associated with.
    * **Default Alias**: <a id="default-alias-field"></a>To make this _Product Alias_ a default, select **Yes**. 
4. Select **Save**.

Now, Vault can match any _Case Product_ with this alias to the associated _Product_ in your library. Vault adds the _Generic_ and _Localized_ names from the _Product_ record as aliases. 

#### About Product Alias Matching



The _Product Alias_ matching logic uses the _Organization_ field and the following _Product_ fields on _Inbox Items_ for additional matching:
* _Country Obtained_
* _Dose Form_
* _Patient ROA_
* _Dosage_
* _Dose Strength and Unit_

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: If the imported product contains more than one <em>Dosage</em> record, Vault uses the existing logic for <em>Product</em> matching. Instead of using these additional <em>Product</em> fields, Vault will use only the <em>Product Alias</em> name.</p>
    </div>
  </div>
</div>





If the imported product still matches with more than one library _Product Alias_, Vault checks if either of them is set as the [_Default Alias_][6] and selects this library _Product Alias_ for auto-coding. Vault also looks for the _Default Alias_ if no _Inbox Item Product_ fields match between the imported product and the library _Product Alias_. If there is no _Default Alias_, Vault does not code the product. If multiple _Default Aliases_ are configured, Vault uses the one with the latest modified date.

### Add a Substance Alias

Consider adding _Substance Aliases_ for _Cases_ where users mistakenly enter a _Substance Name_ as the _Product_. To add a _Substance Alias_:

1. Navigate to **Business Admin > Objects > Substance Aliases**.
2. Select **Create**.
3. Complete the following information:
    * **Substance**: Select the **+** the alias is associated with.
    * **Alias**: Enter the alias name.
4. Select **Save**.

 Now, Vault can match any _Case Product_ with this _Substance_ alias to the associated _Substance_ and, subsequently, to the associated _Product_. Vault adds the _Localized Substance Name_ as an alias. 

### Bulk Import Product and Substance Aliases Using Vault Loader

You can use <a href="/en/lr/26607/#prepare">Vault Loader</a> to load _Product_ and _Substance Aliases_ in bulk from a _Company Product_ in the library. You must repeat the instructions below to upload two different CSV input files for _Product Aliases_ and _Substance Aliases_. To bulk import _Product_ and _Substance_ aliases:

1. [Prepare the CSV input file][2]
2. [Load aliases into Your Vault][3]

#### Prepare the CSV Input File {#prepare-the-csv-input-files}

You can prepare CSV input files for [_Product_][4] and [_Substance_][5] aliases.

##### Prepare the Import File for Product Aliases {#product-aliases}

1. Use <a href="/en/lr/26607/#prepare">Vault Loader</a>  to extract the _Product Aliases_ fields. Keep only the _Field Names_, which will serve as the column headers for the import file.
2. Use Vault Loader to extract the following _Product_ (`product__v`) fields:
    * _Product Name_ (`name__v`)
    * _Organization_ (`organization__v`)
    * _Generic Name_ (`generic_name__v`)
3. Copy the extracted fields into the import file under the respective column. The following table displays the field mapping between the extracted file and the import file columns:<br/>
    <table>
        <tr>
            <th>FIELD LABEL</th>
            <th>EXTRACTED FIELD NAME</th>
            <th>IMPORT FIELD NAME</th>
        </tr>
        <tr>
            <td>Product Name</td>
            <td><code>name__v</code></td>
            <td><code>product__v</code></td>
        </tr>
        <tr>
            <td>Organization</td>
            <td><code>organization__v</code></td>
            <td><code>organization__v</code></td>
        </tr>
        <tr>
            <td>Generic Name</td>
            <td><code>generic_name__v</code></td>
            <td><code>alias__v</code></td>
        </tr>
    </table>
4. Use Vault Loader to extract the following _Localized Product_ (`localized_product__v`) fields.
    * _Name_ (`name__v`)
    * _Product_ (`product__v`)
    * _Organization_ (`organization__v`)
5. Copy the extracted fields into the import file under the respective column. The following table displays the field mapping between the extracted file and the import file columns:<br/>
    <table>
        <tr>
            <th>FIELD LABEL</th>
            <th>EXTRACTED FIELD NAME</th>
            <th>IMPORT FIELD NAME</th>
        </tr>
        <tr>
            <td>Name</td>
            <td><code>name__v</code></td>
            <td><code>alias__v</code></td>
        </tr>
        <tr>
            <td>Product</td>
            <td><code>product__v</code></td>
            <td><code>product__v</code></td>
        </tr>
        <tr>
            <td>Organization</td>
            <td><code>organization__v</code></td>
            <td><code>organization__v</code></td>
        </tr>
6. In the import file, perform the following steps:
    * Capitalize the fields under the _Alias_ (`alias__v`) column.
    * Go through the aliases and remove any duplicates.

##### <a id="substance-aliases"></a>Prepare the Import File for Substance Aliases

1. Use <a href="/en/lr/26607/#prepare">Vault Loader</a> to extract the _Substance Aliases_ fields. Keep only the _Field Names_, which will serve as the column headers for the import file.
2. Use Vault Loader to extract the following _Substance_ (`substance__v`) fields:
    * _Substance Name_ (`name__v`)
    * _Organization_ (`organization__v`)
3. Copy the extracted fields into the import file under the respective column. The following table displays the field mapping between the extracted file and the import file columns:<br/>
    <table>
        <tr>
            <th>FIELD LABEL</th>
            <th>EXTRACTED FIELD NAME</th>
            <th>IMPORT FIELD NAME</th>
        </tr>
        <tr>
            <td>Substance Name</td>
            <td><code>name__v</code></td>
            <td><code>substance__v</code></td>
        </tr>
        <tr>
            <td>Organization</td>
            <td><code>organization__v</code></td>
            <td><code>organization__v</code></td>
        </tr>
    </table>
4. Use Vault Loader to extract the following Localized _Substance_ (`localized_substance__v`) fields.
    * _Name_ (`name__v`)
    * _Substance_ (`substance__v`)
    * _Organization_ (`organization__v`)
5. Copy the extracted fields into the import file under the respective column. The following table displays the field mapping between the extracted file and the import file columns:<br/>
    <table>
        <tr>
            <th>FIELD LABEL</th>
            <th>EXTRACTED FIELD NAME</th>
            <th>IMPORT FIELD NAME</th>
        </tr>
        <tr>
            <td>Name</td>
            <td><code>name__v</code></td>
            <td><code>alias__v</code></td>
        </tr>
        <tr>
            <td>Substance</td>
            <td><code>substance__v</code></td>
            <td><code>substance__v</code></td>
        </tr>
        <tr>
            <td>Organization</td>
            <td><code>organization__v</code></td>
            <td><code>organization__v</code></td>
        </tr>
    </table>
6. In the import file, perform the following steps:
    * Capitalize the fields under the _Alias_ (`alias__v`) column.
    * Go through the aliases and remove any duplicates.

#### <a id="load-aliases-into-your-vault"></a>Load Aliases into Your Vault 

Use <a href="/en/lr/26607/#load">Vault Loader</a> to upload object records to your Vault. When loading records:

* In the **Action Type** dropdown menu, select **Upsert**.
* In the **Key Field** dropdown menu, select **Alias**.

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: When uploading <em>Products</em> to your Vault, if the <em>Generic Name</em> for a <em>Product</em> exists on another <em>Product</em>, Vault creates a new <em>Product</em> with populated <em>Product Name</em> and <em>Generic Name</em> fields, but does not create a <em>Product Alias</em>.</p>
    </div>
  </div>
</div>



## Create Inactive Ingredients

Add an _Inactive Ingredient_ for each _Inactive Ingredient_ for which you will process _Cases_.

### Add Inactive Ingredients

1. Navigate to **Business Admin > Objects > Inactive Ingredients**.
2. On the _Inactive Ingredients_ page, select **Create**
3. Complete the following fields:
    * **Name**: Enter a name for the record.
    * **Organization**: Select the _Organization_ to which the ingredient belongs.
    * **Inactive Ingredient Name**: Enter a name for the ingredient.
4. Select **Save**.

### Add Inactive Ingredient Registrations

Add _Inactive Ingredient Registrations_ for each country the _Inactive Ingredient_ is registered in. Vault links _Inactive Ingredient Registrations_ to _Product Registrations_ and _Inactive Ingredients_.

1. Navigate to the _Inactive Ingredient_ or _Product Registration_.
    * Find _Inactive Ingredient_ records on the **Business Admin > Objects > Inactive Ingredients** page.
    * Find _Product Registration_ records on the **Business Admin > Objects > Product** page, under _Product Registrations_.
2. Under _Inactive Ingredient Registrations_, select **Create**.
3. Complete the following fields:
    * **Name**: Enter a name for the record.
    * **Organization**: This is populated with the _Organization_ name from the parent record.
    * **Inactive Ingredient**: Select the **Inactive Ingredient**. If you access this page through the _Inactive Ingredient_ record, this field is prepopulated.
    * **Product Registration**: Select the associated **Product Registration**. If you access this page through the _Product Registration_ record, this field is prepopulated.
4. Select **Save**.

## Inactivate Products and Product Registrations {#inactive}

You can set _Product_ and _Product Registration_ records to the _Deprecated_ state so that the Safety Rule Engine no longer considers them when determining the reportability of a _Case_. Depending on your configuration, when you deprecate a _Product_, Vault sets all of the related _Product Registration_ records to the _Deprecated_ state as well. For existing _Inbox Items_ and _Cases_ that include the _Product_, a _Deprecated_ tag appears next to the applicable product field. _Products_ and _Product Registrations_ in the _Deprecated_ state remain available for follow-up scenarios.

To manage _Products_ and _Product Registrations_, navigate to **Business Admin > Objects > Products**.

### <a id="deprecate-a-product"></a>Deprecate Products

To deprecate a _Product_:

1. Navigate to the applicable _Product_.
2. Select **State** and select **Deprecated** from the picklist.
3. In the _Change Object Status_ dialog, select **Yes**.

To reactivate the record, update the **State** field to **Active**.

### <a id="pr-inactive"></a>Deprecate a Product Registration

To deprecate a _Product Registration_:

1. Navigate to the associated _Product_ record.
2. Expand the **Registrations** section and select the **Product Registration**.
3. Select **State** and select **Deprecated** from the picklist.
4. In the _Change Object Status_ dialog, select **Yes**.

To reactivate the record, update the **State** field to **Active**.

[1]: #substance-records
[2]: #prepare-the-csv-input-file
[3]: #load-aliases-into-your-vault
[4]: #product-aliases
[5]: #substance-aliases
[6]: #default-alias-field
[7]: #deprecate-a-product
[8]: #pr-inactive
[9]: #add-substance-to-product
[10]: #unknown-formulation-products
[11]: #product-family-fields
[12]: #add-a-product
[13]: #product-fields
[14]: #create-unknown-formulation-products
[15]: #unknown-formulation-field
[16]: #product-substance-fields
[17]: #sync
[18]: #inactive
[19]: #product-alias
