Vault includes integrations with the FDA Electronic Submissions Gateway (ESG), the EMA eSubmissions (ESUB) Gateway, and the EMA XEVMPD Gateway. These integrations allow users to send submissions or medicinal product data directly to the relevant Health Authority from Vault and receive gateway responses.
Note: Some gateway profiles are available only in certain RIM Vaults. See Gateway Profiles.
Gateway Profiles
RIM Registrations and RIM Submissions Publishing Vaults come provisioned with the following inactive standard gateway profiles:
- EU EMA ESUB (
eu_ema_esub__v) (Submissions Publishing) - EU EMA XEV (
eu_ema_xev__v) (Registrations) - EU EUDAMED UDI (
eu_eudamed_udi__v) (Registrations) - US FDA Async ESG (
us_fda_async_esg__v) (recommended profile for Submissions Publishing)
In order for users to send submissions or medicinal product data through one of the gateways, you must configure and activate a profile within Vault. Gateway profiles have a specific Vault URL that users must register when setting up an account at the FDA or EMA Health Authority.
Note: As of 24R1, we will no longer support the FDA sync gateway.
For FDA submissions, Veeva recommends the US FSA Async ESG profile, as it allows users to submit larger submissions to the FDA asynchronously.
Copying the Vault URL
You must create an account with the FDA or EMA before configuring a Vault gateway profile. You can find the steps to create an FDA account on the FDA website. To create an EMA account for the ESUB gateway, see the EMA website. To create an EMA account for the XEVMPD gateway, see the EMA website and download a sample registration form.
As part of the account setup, the Health Authority will require the Vault URL. To obtain the URL:
- Navigate to Admin > Settings > Gateway Profiles > [Profile].
- Click the Copy URL button to copy the Vault URL.
Once you obtain the necessary certificates from the Health Authority, you can configure a gateway profile.
Configuring a Gateway Profile
Note: Any changes saved to a EUDAMED gateway profile may prevent Vault from sending unsubmitted UDI submissions, or a submission may be rejected. To avoid regenerating and resending the submission, ensure the gateway profile details are confirmed prior to generating any submission from a registration where the Registration Holder is associated to that profile.
- Navigate to Admin > Settings > Gateway Profiles.
- If you are creating a custom profile, click Create, then select the profile type. Otherwise, click a profile name to open it and then click Edit.
- Optional: Edit or enter the Label and Description for the profile.
- Enter a Sponsor Email Address to be used in the message header.
- Click the Choose button next to Sponsor Certificate to upload a corresponding digital certificate with the PKCS12 (*.pfx or *.p12) format. The FDA and EMA gateway systems both require digital certificates to verify the digital signature of a document received from a specific source. Input the Sponsor Certificate Password. You cannot activate a profile without uploading a certificate.
- Enter the Sponsor ID as provided to the Healthy Authority. This may be your organization’s DUNS number, Routing ID, or SRN.
- Click the Choose button next to Health Authority Certificate to upload a corresponding digital public certificate for the FDA or EMA gateway system. This would have been received from the Health Authority during account setup. The format of this file can be PKCS7 (*.p7b, *.p7c), DER (*.cer, *.der), or PEM (*.cer, *.crt, *.pem). The FDA and EMA systems both require digital certificates to verify the digital signature of a document received from a specific source.
- Edit or enter the Health Authority ID for the profile. This should be the same value used by the FDA, EMA, or European Commission gateway system and provided by the Health Authority during account setup. For EUDAMED, this is the Party ID for your access point.
- Input the Health Authority URL, which is the URL for the FDA, EMA, or European Commission gateway system.
- For UDI profiles only: Input the service access token as the Health Authority Token.
- Optional: Select the Gateway User Required checkbox to use a separate Vault account to manage the gateway profile and then select a Gateway User. Vault sends all submission notification messages to this account. Note that this field is required for some connections.
- Click Save.
- Click Set Active.
You can only activate the profile after you’ve populated all fields and uploaded the appropriate Health Authority Certificate.
About Custom Gateway Profiles
Vault allows you to create custom gateway profiles to support product data submission by multiple applicants. Custom profiles are currently available for XEVMPD and UDI only.
To create a custom gateway profile:
- Create and activate the profile, then navigate to the applicant’s Organization record.
- Click Edit.
- In the Gateway Profile field, select the desired profile(s). You can select one active profile of each type.
- Click Save.
You can also delete any custom profile which is not referenced in the Gateway Profile field on an Organization record.
When you clone a Vault, custom profiles are not included in the clone and must be recreated.
US FDA Gateway
Sending a submission to the Health Authority through the FDA Electronic Submissions Gateway (ESG) is the final step of the submissions publishing process. Vault’s integration with the FDA ESG allows you to set up a gateway profile for users to submit directly from a Submission record and receive gateway responses.
Associated Configuration Options for US FDA ESG
The following configuration items are available in support of this feature:
- Submission Lifecycle User Action: You can configure the Submit to Gateway action to allow users to submit directly from a Submission record. When users select this action, Vault runs a pre-validation to ensure that Application > Lead Market is set to United States. Additionally, Vault validates that the Health Authority Division on the Application object is populated and that the Submission Format, XML Sequence ID, XML Submission ID on the Submission object are populated. Following validation, Vault prompts the user to review the application number, submission number, center, number of files, and the total size of submission before submitting and queuing for transfer to the ESG.
- Prepare Resubmission Record Action: You can activate the Prepare Resubmission action on the Dossier Details object to unlock transmitted submissions, allowing for resubmission to the FDA.
- Picklists: Vault includes picklists entries for corresponding Gateway Profiles and Submission Format controlled vocabulary records.
- Objects: The Health Authority Division object captures the health authority division for each health authority.
- Object Fields: Vault includes various object fields for managing FDA Gateway Integration. See associated object fields for more information.
- Object Type: The Health Authority object type is available on the Constraints object to capture constraints associated with the Region, Country, Health Authority, Health Authority Division, and Submission Format fields.
Associated Object Fields
The following object fields are available in support of the US FDA ESG integration:
| Field | Object | Function |
|---|---|---|
| Health Authority | Constraint, Application | Allows constraints to include the Health Authority. For the Application object, this field captures the corresponding Health Authority. |
| Health Authority Division | Constraint, Application | Allows constraints to include the Health Authority Division. For the Application object, this field captures the corresponding Health Authority Division. |
| Acknowledgment Count | Dossier Details | This field captures the number of acknowledgments received from the Health Authority. |
| Submission Format | Submissions | This field is for the submission format for transmission to the Health Authority |
European Commission Gateway for UDI
Note: Any changes saved to a EUDAMED gateway profile may prevent Vault from sending unsubmitted UDI submissions, or a submission may be rejected. To avoid regenerating and resending the submission, ensure the gateway profile details are confirmed prior to generating any submission from a registration where the Registration Holder is associated to that profile.
Submitting medical device data through the EUDAMED AS4 access point for UDI is the final step of the UDI process. When configured with the UDI Submission Viewer, Vault’s integration with the access point allows you to submit UDI data directly from the viewer and receive responses and acknowledgements.
To do this, configure the standard EU EUDAMED UDI profile included in your Registrations Vault with the recommended information in the table below. Items with an asterisk (*) assume you have already been granted new machine-to-machine access within your EUDAMED account.
You can also create custom profiles as needed if your organization registers devices under multiple legal entities.
| Field | Recommended Value |
|---|---|
| Label | Update the default label to the SRN of the Actor that will use this profile (for example, AB-MF-123456789) |
| Sponsor Certificate | Enter your organization’s PKCS12 certificate (*.p12 or *.pfx) |
| Sponsor ID | Enter the SRN of the Actor that will use this profile (for example, AB-MF-123456789) |
| Health Authority Certificate | Select the appropriate EUDAMED certificate depending on the EUDAMED environment: Playground/Acceptance: eudamed_mdr_acc.pemProduction: eudamed_mdr.pemYou can download these certificates from the EUDAMED onboarding wiki. Contact the EUDAMED Help Desk for access to the wiki. |
| Health Authority ID* | Enter your access point’s Party ID. To find it, log in to your EUDAMED account, navigate to Tasks > Access Point Management, then select the access point. |
| Health Authority URL | Enter the appropriate URL depending on the EUDAMED environment: Playground/Acceptance: https://edelivery-as4-ext-acc.eusfx.ec.europa.eu/?domain=EUDAMEDProduction: https://edelivery-as4-ext.eusfx.ec.europa.eu/?domain=EUDAMED |
| Health Authority Token* | Enter the token for your Party ID for the UDI/Device module. To generate it, log in to your EUDAMED account, navigate to Tasks > Access Point Management, then select the access point. |
| Gateway User | Select the Vault user who will receive notifications in the event the original user who sent the message (and to whom EUDAMED is attempting to respond) cannot be identified. |
| Encryption Algorithm | Select AES128-GCM |
| Signing Algorithm | Select RSA-SHA-256 |
EMA Gateway for eCTD Submissions
Submitting Centralised Procedures through the EMA AS2 eSubmission (ESUB) Gateway is the final step of the eCTD submission process. Vault’s integration with the EMA ESUB Gateway allows you to set up a gateway profile for users to submit eCTDs directly from a Submission record and receive gateway responses.
Associated Configuration Options
This feature is automatically enabled on RIM Submissions Vaults licensed with Submissions Publishing. The following configuration items are available in support of this feature:
- Submission Lifecycle User Action: You can configure the Gateway Submission action to allow users to submit directly from a Submission record. When users select this action, Vault runs a pre-validation to ensure that the Submission contains an XML Delivery File as an attachment. Additionally, Vault validates that the Applicant, Procedure Tracking Number, and XML Submission ID on the Submission object are populated. Following validation, Vault prompts the user to review the application number, submission number, number of files, and the total size of submission before submitting and queuing for transfer to the EMA.
- Prepare Resubmission Record Action: You can activate the Prepare Resubmission action on the Dossier Details object to unlock transmitted submissions, allowing for resubmission to the EMA.
- Picklists: Vault includes picklists entries for corresponding Gateway Profiles controlled vocabulary records.
- Objects: The Health Authority Division object captures the Health Authority division for each Health Authority.
- Object Fields: Vault includes various object fields for managing EMA ESUB Gateway Integration. See associated object fields for more information.
Associated Object Fields
The following object fields are available in support of the EMA ESUB integration:
| Field | Object | Function |
|---|---|---|
| Acknowledgment Count | Dossier Details | This field captures the number of acknowledgments received from the Health Authority. |
| Dossier Status | Submission | This field allows Vault to confirm that the submission is not part of an active transfer to the EMA Gateway. |
| Procedure Type | Submission | This field must be set to Centralised in order for users to submit to the EMA Gateway. |
EMA Gateway for XEVMPD
Submitting medicinal product data through the EMA AS2 Gateway is the final step of the XEVMPD process. Vault’s integration with the EMA Gateway allows you to set up a standard or custom gateway profile for users to submit XEVPRM messages directly from a Product Data Message record and receive responses and acknowledgements. See XEVMPD Configuration for full configuration details.