Cristina Pepato

This message is to inform all IRIS Industry users about the need to check the “Affiliation” field in the EMA Account Management system, to keep track of their company affiliations and perform updates upon need.  
 
Below, some instructions on how to proceed.  
Users with the "IRIS Industry User Admin" role for an Organisation should: 
 

1. run periodical checks on the list of users that are affiliated to their Organisation, and their roles; 

2. promptly remove outdated affiliations in case, for example, an employee or affiliated person leaves her/his position, or if an external consultant should not be allowed access anymore.  

This can be done via the EMA Account Management – Manage Access page, that allows to list, export and revoke access for all the users of the Organisation the IRIS User Admin is affiliated to, as shown in the figure attached to this thread. 

We kindly remind you that EMA does not check the affiliation status of users to Organisations, as this responsibility rests with each Organisation.  
Furthermore, we encourage Organisations to implement a standard policy of affiliation removal in their check-out procedures for leavers.  
 
In case of any questions or issues, please raise a ticket via ServiceNow. If any questions remain, please contact ServiceNow@ema.europa.eu

Per Regulation (EU) No 2022/123, the EMA Emergency Task Force (ETF) is mandated to provide scientific advice (SA) on the development of medicinal products targeting declared or potential public health emergencies. Currently COVID-19 and Monkeypox are declared public health emergencies of international concern. The pathogens with potential to cause a public health emergency are for example Zika virus, Ebola virus, Chikungunya virus, other Coronaviruses or Pandemic influenza viruses. In addition, ETF together with the Clinical Trial Coordination Group (CTCG) and the MSs facilitate the approval and conduct of clinical trials for medicinal products targeting public health emergencies by providing scientific advice on trial protocols and support on aspects related to clinical trial authorisation.

The SA submission forms, namely the “Administrative Information” section for the initial and follow up SA applications, have been updated with additional questions to distinguish between the standard SAs and the SAs related to declared or potential public health emergencies (refer to section 4.2 in the IRIS guide for applicants).

EMA is pleased to announce that parallel distribution notification forms in IRIS have been updated with pre-filled Customer account number. This information is populated by the system for the fee-incurring parallel distribution procedures in the first stages of the submission process after users have selected the organisation and the location (corresponding to the legal address) on behalf of which they are making the submission. 
 

As before, Customer account number must be provided in the section ‘Parallel Distributor Information’ of the submission form. 

• If the location (LOC-ID) has a customer account number associated to it in Organisation Management System (OMS), it will appear in the field ‘Customer account number’ submission form.  

• If the pre-populated customer account number is incorrect or it is missing, you are kindly requested to provide the correct account number and to request change of your organisation data in OMS by logging a Service Desk ticket.  

More information is available within the updated IRIS user guide for parallel distributors. 

For technical support, please log a ticket in Service Desk; for general enquiries, please send us a question or post a new thread in the IRIS Forum “General Discussion and Self-Help”. 

Thank you for your questions. Please note the Agency is taking into consideration recommendations coming from Industry. As per the established process, these recommendations are provided through EU Industry Trade Associations or in forums such as the Industry Volunteer Groups whose members are nominated by EU Industry Trade Associations. For specific issues, kindly report them directly by raising a ticket through the EMA ServiceDesk Portal.

Marketing authorisation holders for all authorised medicines in the EU are required to appoint a so-called industry single point of contact (i-SPOC) who can provide information directly to EMA about the supply and availability of critical medicines identified in the context of a major event or a public health emergency. This applies to products authorised via any procedure, whether centrally via EMA, or using national, mutual recognition or decetralised procedures.

They need to register an i-SPOC by 2 September 2022.

For more information, please read the announcement on the EMA Corporate website.

Registering an i-SPOC

Marketing authorisation holders need to identify their i-SPOC via EMA's IRIS platform.

They can log in to IRIS using their EMA account credentials.

Guidance on how to register an i-SPOC is available in the demo video on the EMA Corporate website, and in the user guide on the IRIS platform. Marketing authorisation holders who do not have an EMA account need to create one first via EMA's Account Management portal. This could take 5-10 working days. For technical support, they should contact the EMA Service Desk.

Thank you for your question. Kindly note Section 6 of the document (Marketing Status), in particular par. 6.2, was updated.

Thank you for your questions.

With respect to Question 1):
&nbsp;Yes, there is no limitation, more information can be found in the&nbsp;<a href="https://register.ema.europa.eu/identityiq/help/useradmin.html">User Administrator Guide · EMA Account Management (europa.eu)</a>.<br>
As regards Question 2):<br> - the same User can request his/her access to be removed: <a href="https://register.ema.europa.eu/identityiq/help/requestaccess.html#removeaccess">Request Access · EMA Account Management (europa.eu)</a><br> - or another User Admin can remove the access of the administrator that left the company using the IRIS Role Admin tab in EMA Account Management, more information can be found in the&nbsp;<a href="https://register.ema.europa.eu/identityiq/help/useradmin.html#useradminremoveaccess">User Administrator Guide · EMA Account Management (europa.eu)</a><br> <br> In general, <a href="https://register.ema.europa.eu/identityiq/home.html">Home · EMA Account Management (europa.eu)</a> offers documentation on how to manage users and roles at EMA.<br> &nbsp;

The Agency is aware that some MAHs are experiencing a delay in the time that it takes for the Marketing Status bulk notifications to be processed and closed. The validation is performed automatically by the system with no manual intervention and we are experiencing some unexpectedly long processing time. We are actively working to solve the issue. We want to reassure all MAHs that baseline notifications are accepted even if the formal deadline has past.

Equally, it has been identified that a few newly authorized products/product presentations are not visible in IRIS. A new routine for data integration is expected to be deployed within the next couple of weeks to improve data integration between the systems. If the absence of a product/presentation is preventing you from reporting the Marketing Status, please raise a ticket through the EMA ServiceDesk Portal.
Your ticket will be responded to once the issue is sorted so that you can proceed with the reporting. In case of a technical issue preventing any MAH from reporting the Marketing Status, the baseline can still be reported within 2 weeks after the EMA Service Desk ticket being solved.

 

This update is to communicate the Agency is working on further improving the submission process of Marketing Status reports for marketed CAPs through IRIS, as well as addressing the issue of the newly authorised products and product presentations not being visible on the portal. Part of the issues are linked to wrong format of the data in the uploaded Excel files. A set of improved validation rules are implemented on the content of the Excel file uploaded by MAHs in the section ‘Uploaded proposed marketing status’.
In relation to the reported issue of new products/product presentations, a new routine for data integration is expected to be deployed within the next couple of weeks.


Actions taken by EMA
Please find below a summary of steps taken recently by the Marketing Status team:

• A release of a major fix which is aimed to address most of the validation issues in the key columns of the file (Country, Marketing Status, Date of Marketing Status Change, Reason for Cessation, Estimated Date of Reintroduction, Does Cessation lead to Shortage?).
• Validation error email is sent when the data in the key columns of the file could not be validated.
• The required corrections are listed in ‘Upload proposed marketing status’ section of the submission form.
• Date format is set to the local date and time.
• Updated Q&A published on the IRIS Forum with more practical information.

Actions to be taken by MAHs
Please consult the updated Q&A available from the IRIS Forum (Questions and answers on Marketing Status reporting submissions · IRIS (europa.eu)) listing the actions which are expected to facilitate the submission process and avoid validation errors, as well as the steps to follow when receiving validation errors emails.
Currently the deadline for the baseline submissions remains 30 April 2022.

For any technical query related to a specific IRIS Marketing Status submission, please do not hesitate to contact the Agency through the EMA ServiceDesk Portal.

For more information follow the links below:

• IRIS guide to applicants (scientific applications)
• Notifying a change of marketing status | European Medicines Agency (europa.eu)

EMA is pleased to announce the launch of the GCP Inspections feature in the IRIS platform. With the implementation of this new feature, Marketing Authorisation Applicants/Holders as well as EU/EEA inspectorates will be able to interact with EMA via a single portal for the exchange of documents and information on GCP Inspections procedures.
This is expected to streamline the Inspection co-ordination process, ensure more secure information exchanges, and increase data quality through integration with other EMA master data systems (e.g. SPOR).

For more information please check the updated IRIS guide for applicants or the Guidance for applicants/MAHs involved in GMP and GCP inspections co-ordinated by EMA.
Kindly note a recording from the training session on GMP and GCP for Industry users is available from the IRIS portal section “Additional guidance & training videos”.

If you have general questions with regard to the IRIS feature on GCP Inspections, please post a new thread in the IRIS Forum “General Discussion and Self-Help”. If you have technical questions or issues please raise a ticket via the EMA ServiceDesk.