This document is intended to be used as a checklist to guide customers in the setup of the EMA eSubmissions Gateway Connection for Veeva RIM Publishing. It is meant to be used in conjunction with the following EMA information:
Prerequisites
- Access to the following website: https://esubregistration.ema.europa.eu/registration/
- Existing personal certificate
Procedure
Open the EMA’s eSubmission Registration.
Complete Step 1 of eSubmission Registration. Customer must fill in all fields and click Next.
If no existing products, introduce “None” in the Product (invented) name(s) field
If the form states that the Organization name is already registered, introduce i.e. “AS2” at the end of the organization name
Complete Step 2 of eSubmission Registration
Organisation Routing Id in Test:
- Identifier of your choice using at least 3 and up to a maximum of 10 UPPER CASE latin characters and numerics
Organisation Routing Id in Production:
Identifier of your choice using at least 3 and up to a maximum of 10 UPPER CASE latin characters and numerics
Might be same as Organisation Routing Id in Test
Register to: Gateway AS/2
| TESTING | PRODUCTION | |
|---|---|---|
| AS/2 IP Address | N/A | N/A |
| AS/2 Hostname | Example: https://SBX-NAME.veevavault.com | Example: https://PROD-NAME.veevavault.com |
| Receive Port | 4080 | 4080 |
| Transmit Port | 8080 | 8080 |
| Exchange Point | gateway/inboundV2/eu_ema_esub | gateway/inboundV2/eu_ema_esub |
| AS/2 Id | same value as Routing Id identified in Organisation Routing Id in Test field | same value as Routing Id identified in Organisation Routing Id in Production field |
Certificates
- Upload a zip file containing the public personal certificate for both Test and Production (can be the same)
Type in the letters from the controlling picture
Click on Submit
EMA will confirm the receipt of your registration (Please check your email spam folder regularly):
Email contains the following attachments:
- Information for establishing connection in our Vault
- The public certificates for Sandbox and Production
When processed, the EMA will send you an email informing about the activation of the account
