Transition of post-authorisation to IRIS overview + request to register in EMA IAM by Oct 2024

Please find attached a brief transition overview presentation including: 

• the detailed roadmap for post-authorisation procedures transition to IRIS; 

• key changes for Industry users & what stays the same; 

• general process flow for regulatory procedures in IRIS; 

• summary of key actions & engagement activities for Industry users this year. 

Important: Submission of all regulatory procedures of the product lifecycle will still be performed via the current systems (i.e. Gateway and PSUR repository) 

As part of the transition, we require all Marketing Authorisation Holders (MAHs) product contact points to register in the EMA Account Management System by 31 October 2024. This is essential to ensure seamless email communication, access to case information, and document management. 

Important instructions for you: 

1. Use of personal mailboxes as product contacts: 

• Due to security reasons, IRIS will no longer accept generic mailboxes as contact points for regulatory procedure application submissions. 
• If your products currently list generic mailboxes, please update all product contacts to personal mailboxes associated with responsible individuals within your organisation: 
  a. Submit the updated form using the following template: template_letter-change_contact_person_en.doc (live.com). 
  b. Instructions to submit the form are available here: 
      - Human-use products: Contacting EMA: post-authorisation | European Medicines Agency (europa.eu)
      - Veterinary-use products: Notifying EMA of changes to contact persons (veterinary medicines) | European Medicines Agency (europa.eu) 

1. Register all contacts in EMA Account Management System (IAM) by 31 October 2024 (or as soon as possible if your products are already transitioned to IRIS): 

• Request access via the EMA Account Management System for all affiliated roles. Detailed instructions are available in the IRIS guide to registration and RPIs. 
• Ensure the access is requested for the relevant organisations affiliated with the products you are contact for (Request Access · EMA Account Management (europa.eu)). 

If you have already an IRIS Account that complies with the above guidelines, please ignore this request.

Transition overview: 

• The first transition of Regulatory Procedure Management (RPM) for Product Lifecycle Management (PLM) to IRIS took place on 23 January 2024, onboarding variations*, Article 61.3 notifications**, and marketing authorisation (MA) transfer procedures for a subset of 67 human and 45 veterinary centrally authorised medicinal products (CAPs) with low regulatory complexity. 

• A second transition took place in July 2024: 37 human and 16 veterinary products were migrated to IRIS for the procedures listed above. 

• In 2024, we continue developing further regulatory procedures in IRIS: Periodic Safety Update Reports, Post-Authorisation Measures, Line Extensions, Renewals, Annual Reassessments, Post-Authorisation Safety Studies, and Referrals. These procedures will transition to IRIS for all CAPs (and, consequently, for all MAHs with CAPs) in January 2025. 

Further information

If you would like to stay up to date on planned RPM engagement activities, we encourage you to subscribe to the quarterly Product Lifecycle Management (PLM) Newsletter. 

We also encourage you to fill in this survey after you have reviewed the information in this email and presentation to share your awareness and readiness for the 2025 IRIS transition.

Good morning,
How is the MAH notified that its CAP product has been migrated to IRIS?
Thank you

We directly contacted the MAHs whose CAPs have already been migrated to IRIS.
The products from other MAHs should be migrated when the transition of all post-authorisation procedures takes place on IRIS, i.e. 1 January 2025.
 

Good morning,
How we can see which mailboxes are set as product contacts?
Thank you.

Good morning, 

Do Scientific service contact point (eAF MAA section 2.4.5) and Contact person in the EEA for product defects and recalls (eAF MAA section 2.5.1.1) also need to have EMA account and request access to IRIS? 

Thank you. 

Hello,

Do the following contact persons also need to be registered in EMA IRIS Portal , as some have already received reminders emails ? (That was actually not announced/ understood previously) ? 
Can we keep the generic emails for those , as there is a higher risk of missing urgent/ legal emails (especially for QPPV and MAH Contact for CD) ?

• Contact person at the MAH address (referred to in section 2.4.1 of the application form)
• Qualified person in the European Economic Area (EEA) for pharmacovigilance (referred to in section 2.4.4 of the application form).
• Scientific service of the MAH in the EEA as referred to in Article 98 of Directive 2001/83/EC (referred to in section 2.4.5 of the application form)
• Contact person in the EEA for product defects and recalls, as defined in Article 79 of Directive 2001/83/EC (referred to in section 2.5.1.1 of the application form)

Thank you.
 

In addition,

1. It is not clear how/ from which time point the Contact person authorised for communication between the MAH and the competent authorities (referred to in sections 2.4.3 of the application form) has been assigned - as in some cases old contact person has recieved the EMA reminder email (although change contact form has been submitted previously and acknowledged by EMA) ?
    
2. How those contact persons will be maintained ? change of contact in IRIS is flexible per submission. However, when we want to change a whole product contact person, do we still need to submit the contact change form via Service Now  to EMA ? 
3. How will this person be or not be assigned to all previously related product procedures ?

Thank you.

Dear All, I would like to follow-up on my previous questions please here above. BR, Isha

Dear Requestor, 

It is important that anyone communicating with EMA will have an IRIS account since IRIS will be the main platform from which EMA will be communicating with the MAHs (and IRIS has embedded email functionality, hence Outlook will be less used in the future).

if not already done so, you are kindly requested to register all contacts in EMA Account Management System by 30 November 2024 (or as soon as possible if your products are already transitioned to IRIS):
· Request access via the EMA Account Management System for all affiliated roles. Detailed instructions are available in the IRIS guide to registration and RPIs.
· Ensure the access is requested for the relevant organisations affiliated with the products you are contact for.

The roles applicable are:
IRIS Industry Manager: can create new applications, and edit, submit and withdraw the created applications or any other where the user has been specifically added as Industry
Manager.
IRIS Industry Contributor (this role is automatically assigned also to IRIS Industry Managers): can edit submissions where he/she has been added as a Contributor by a
Manager. An Industry Contributor cannot create, submit or withdraw a submission.

For users not directly involved in the procedure management, the IRIS Industry Contributor role is advised, however please note that it has some limitations (see above).

If you wish to change also your product's contact name:
a) Submit the updated form using the specific template
b) Instructions to submit the form are available at the following links: 
· Human-use products
· Veterinary-use products