Production Gateway Profile Setup

Prerequisites

• Previous steps successfully completed.

Procedure

1. Login to the Production Vault and navigate to ADMIN section > Settings > Gateway Profiles > eu_ema_esub_v and click Edit.

2. Details section

   • Description (optional)
   • Sponsor Email Address (email of the person authorised for communication on behalf of the applicant introduced in the registration form)

3. AS2 Profile Configuration section

   • Vault AS2 URL (set by Vault RIM)
   • Sponsor Certificate (user should upload the certificate .pfx or .p12 containing both public and private certificate)
   • Sponsor Certificate Password (password of the your certificate)
   • Sponsor Certificate Expiration Date (automatically calculated based on the attached certificate when the profile is saved)
   • Sponsor ID (routing ID as stated in the document received from EMA eSub Account Request, step 5 for “PRODUCTION” environment):

   

   • Health Authority Certificate (public certificate (for Production) received by EMA)
   • Health Authority Certificate Expiration Date (automatically counted based on the attached certificate when the profile is saved)
   • Health Authority ID: ESUBPROD (as stated in the document received from EMA eSub Account Request, step 4)
   • Health Authority URL: http://pgateway.ema.europa.eu:8080/exchange/ESUBPROD
   • Gateway User Required (automatically selected)
   • Gateway User (user to be selected from the list of active Vault RIM users)
   • Encryption Algorithm (leave blank, not applicable for EMA Gateway connection)
   • Signing Algorithm (leave blank, not applicable for EMA Gateway connection)

   Click Save

4. Click Activate to activate the profile.

5. Open a support ticket with EMA with the following text:

   Provide the following information to the FDA in an email as follows:

   Please activate the PROD connection for EMA Gateway:

   SPONSOR ID defined in the PRODUCTION Gateway

   AS2: copy of the Vault AS2 URL in the PRODUCTION Gateway Profile

   ESUBPROD Environment:: http://pgateway.ema.europa.eu:8080/exchange/ESUBPROD

   The certificate remains unchanged

6. Wait for EMA´s confirmation

• If EMA sends a print screen of their PROD setup, confirm that the Routing ID and URL is the correct one.
• If EMA does not send a print screen of their PROD setup, ask EMA to provide it and make a review.