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Purpose and context
Purpose of this guide
This comprehensive guide explains how applicants can efficiently use the IRIS platform to prepare and submit applications and data for various scientific procedures, including orphan designation applications, scientific advice, ITF briefing meeting requests, marketing status reports, inspections, and veterinary signal management It provides clear instructions to streamline the submission process and ensure compliance with regulatory requirements By following this guide, users can simplify their interactions with the IRIS platform, facilitating effective management of their applications and related activities.
For Parallel Distribution procedures separate user access roles are needed and separate guidance is available on the IRIS home page.
Preliminary requirement
To submit applications in IRIS, you must have an EMA account along with an appropriate role, which can be obtained through a one-time registration This registration enables you to submit various scientific applications now and in the future Please refer to the IRIS registration guide and the quick interactive IRIS registration process guide available on the IRIS homepage for detailed instructions on how to request an EMA account, assign the correct IRIS role, and manage RPI (Research Product Return) requests or transfers.
Supported Browsers
IRIS is accessible on all modern web browsers, including the latest versions of Google Chrome, Internet Explorer 11 and above, Edge (including the new Chromium-based version), Safari 12 and higher, Firefox, Vivaldi, and other popular browsers, ensuring seamless usability across multiple platforms.
Common operations for all scientific submission types
Display and sort submissions
From the IRIS home page, after sign-in, click on any of the options: “Draft Submissions”, “Ongoing
Submissions” or “Completed Submissions” present under “Submissions” Tab;
If you hold an IRIS Industry Manager role, you can view all your created submissions as well as those where you've been added as a contributor As a Contributor, you'll see all submissions to which you're assigned If you have both roles, you'll have access to both your own submissions and those where you're listed as a Contributor In all cases, available submissions include all organizations you are affiliated with in IAM.
Click on any column heading displayed in blue font to sort the table, allowing you to organize the rows in ascending order; clicking again will reverse the order to descending, making it easy to find the information you need.
Search for submissions
You can obtain a restricted subset of your submissions: from the IRIS home page, select first “Draft
Submissions”, “Ongoing Submissions” or “Completed Submissions”;
To find a specific submission, type a relevant string of letters or numbers into the search bar—this identifier may match any of the columns displayed on the screen Using the search function streamlines the process of locating your desired submission efficiently Ensure the entered string accurately corresponds to the submission details for quick retrieval Incorporating search keywords enhances your ability to quickly filter and find relevant entries within the system.
"Submission ID", "Organisation", "Submission Type"); by including an asterisk (*) as first character, the search string will apply to text in any position;
Click on the magnifying glass search symbol or press "Enter" on your keyboard to launch the search;
When you perform a search, a list of relevant results matching your search criteria will be displayed You can easily sort this list based on the options outlined earlier to find the most relevant or recent information quickly This streamlined process enhances your browsing experience and helps you access the desired content efficiently.
In the “Draft submissions” menu, users can access various actions by clicking the down arrow next to a submission, including editing, deleting, and managing contributors and managers Additionally, users can change the “submission contact,” the individual designated to receive all email communications related to the procedure, ensuring efficient management of draft submissions.
Create a new submission (general procedure for all submission types)
From the IRIS home page, click on “Draft submissions” sub-tab present under “Submission” tab;
Click “Create new submission” [a screen with the heading “Portal – New Submissions” opens showing 4 stages The first stage “1 Choose Applicant Type” is highlighted in blue];
From the drop-down arrow on the box below “Are you applying as an individual or on behalf of an organisation?” select the appropriate answer and click “Next”;
Only if you are applying on behalf of an organisation:
To find available organizations, click on the magnifying glass search icon Please note that only organizations affiliated with your user role on the portal will be displayed This feature allows you to easily locate and select the relevant organizations associated with your account.
Pick the right organisation and (there may only be one) and click “Select”;
Use the search symbol to look up the locations available for you to select, pick the right one and click
“Select”; please note that the Regulatory entitlement (Orphan Designation) will be granted to the
6 address of this location and the relevant organisation;
For streamlined management, it is highly recommended to use a single location, typically the organization’s legal seat, for all IRIS submissions, RPIs, and regulatory entitlements Centralizing submissions in IRIS simplifies compliance processes and ensures consistency across regulatory communications Using only one designated location helps avoid errors and enhances efficiency in managing regulatory obligations This approach ensures a clear and organized submission process, making regulatory management more straightforward and effective.
The “Choose Submission Type” section is now highlighted in blue and includes three mandatory fields—“Organisation,” “Location,” and “Submission Type”—with the first two required only when applying on behalf of an organisation Users can use the search icon to find available submission types, select the appropriate option, and then click “Select” to proceed.
When applying on behalf of an organization, it is essential to add at least one Manager with IRIS Industry Manager access, specifically someone affiliated with the selected company and country The system's pop-up list will only display individuals who have been granted this role, ensuring proper role assignment If no Managers have been designated yet, the list will appear empty For effective management and continuity, it is highly recommended to assign at least two Managers to oversee the organization’s responsibilities.
For each IRIS submission, it is recommended to provide at least three important statements to ensure ongoing access This approach safeguards the submission, allowing applicants to retain control and access even if a manager departs or is unavailable for an extended period Implementing this practice enhances the security and continuity of IRIS submissions, preventing potential access issues in the future.
To begin your submission, click “Create and Next,” which generates a new screen displaying a unique reference number (e.g., EMA/XX/0000001234) at the top right of the “Portal – New Submission” page It is recommended to note down this reference number for future reference The page also features a series of tabs (steps) on the left side of the screen, including “Select RPI” and concluding with “Declaration,” guiding you through the submission process.
Figure 2: Example of new submission
Click on “Select RPI” to bring up “Research Product Identifier (RPI)” screen:
Click the magnifying glass search symbol to bring up a list of RPI names;
In the pop-up window, pick an RPI name from the list and click “Select”;
Back in the “Research Product Identifier (RPI)” screen, click “Save and Return” and you are returned to the
If you do not see the RPI for your product in the list:
An RPI (Reference Product Identifier) monitors the development of a medicinal product throughout its lifecycle The RPI remains unchanged even if the substance names within the product are modified or if the development responsibility shifts to a different product If you've already submitted an application to EMA for your medicinal product, it is highly probable that an RPI has been assigned, and it should be utilized in your current submissions.
RPIs are assigned to specific OMS Locations rather than to a parent organization, ensuring precise regulatory tracking When creating submissions for a particular location, only RPIs associated with that location can be selected, emphasizing the importance of proper RPI assignment To streamline compliance and avoid issues, it is highly recommended to assign all RPIs and regulatory entitlements of an organization to a single location, typically the organization's legal seat Proper RPI management ensures accurate regulatory submissions and maintains organizational compliance.
The RPI may already exist but might be owned by a sister company in the same or a different country, a different organization, or a consultant It could also be assigned to a different location within your organization In such cases, the RPI will not appear in the selection list, and you will need to request affiliation to it.
The owner of the Research Product Identifier (RPI) must transfer it to your company, depending on which entity will serve as the sponsor for the orphan designation For the proper transfer process, refer to section 8.3 of the IRIS guide to registration, titled "Transfer a Research Product Identifier (RPI)." Ensuring the correct transfer of the RPI is essential for maintaining accurate registration and sponsorship compliance.
To request an RPI for a medicinal product, follow the IRIS guide to registration section 8.2, “How to request a new RPI,” and submit a separate application through IRIS Once you receive confirmation from EMA that your RPI has been created, you can resume your draft submission and proceed with the next steps.
If your RPI is designed to cover multiple products, methodologies, technologies, or methods rather than a single product, it is essential to contact the EMA ITF Secretariat at ITFSecretariat@ema.europa.eu or Scientific Advice at ScientificAdvice@ema.europa.eu for guidance and support.
If you plan to submit SA or Qualification request you will be requested to complete a specific
Word form and an RPI will be crated and provided you
Applying for ITF BM is streamlined, as most required information is pre-filled in the initial request form submitted to the ITF Secretariat Once your application is received, an RPI (Request for Payment Information) will be generated and provided to you, ensuring efficient processing of your submission.
These ‘special’ RPIs cannot be requested by you via IRIS
Click on “Additional product information/update”:
Make sure that the list of innovation/enabling technologies includes at least one term; if not, choose at least one with the “Add” button;
After completing the RPI data and all mandatory sections, the tabs will change from grey to blue, indicating they are active Users must fill in each section, noting that fields marked with a red asterisk are mandatory It is required to complete each section before saving, but it is not necessary to fill out all sections in a single session, allowing for flexible progress.
Back in the main “Submission Form” Screen, click on “Documents from Applicant”:
You can directly upload documents to your submission on the next screen, with no limit on the number of files or total size, but each file must not exceed 50 MB It is recommended to upload individual files for each document instead of a single Zip file, although multiple files can be uploaded simultaneously If needed, you can merge several PDFs into one using specific software before uploading Zip files should only be used as containers for literature references.
Click “Save and Return” when you have finished uploading documents;
Communication only to the Submission Contact (Portal contact) for a submission
The IRIS communication model designates a single "submission contact" or "portal contact" for each submission, who serves as the primary point of contact for all correspondence While multiple Industry managers and contributors may be associated with a submission, only one person—typically the Industry manager who submits the application—is assigned as the default submission contact This ensures clear and direct communication throughout the submission process.
The "submission contact" role can be reassigned at any time and multiple times by Industry managers involved in the submission However, EMA users of the IRIS system will only communicate with the designated "submission contact" by default, ensuring efficient and secure communication during the submission process.
Applicants can easily nominate additional Industry managers and reassign the "submission contact" role as needed, such as prior to a leave period This process is accessible in IRIS by clicking the V next to the submission and selecting "Manage submission contact," as illustrated in Figure 3.
In addition, applicants may also wish to set up appropriate auto-forwarding rules in the email system of the "submission contact"
IRIS is being built to allow applicants to self-manage their "submission contact" role for each submission
EMA plans to expand this concept to include the self-management of contact persons and contact data for stakeholders assigned to Regulatory Entitlement This upgrade aims to improve efficiency and transparency in regulatory processes In the future, these enhancements may also be applied to the Authorisation sector, streamlining communication and data management for interested parties.
Products Changes will be made by sponsor/marketing authorisation holders directly in the IRIS Industry portal
Figure 3 Changing Submission (Portal) Contact
From the IRIS home page, carry out the following steps (see also Figure 1):
1 Click on "Draft submissions"/”Ongoing submission” sub-tab present under “Submission” tab;
2 Scroll down and find the application you want from the list of your drafts;
3 On the right hand side, click on the drop-down arrow and select “Manage Submission Contact”
4 Click “Change submission contact”, then In the pop-up window, select the name of the person you want to add as portal contact and click on “select” (the list shows all managers associated with that submission)
5 New portal contact will be shown in “Portal contact” field
6 Click on “Save and Return”
Add managers to a draft/ongoing submission
You can add additional managers to a submission after its creation, provided the submission is still in draft or ongoing status This option is not available once the procedure has been completed Additionally, you can only assign new managers to draft applications if you have a “Manager” role; users with a “Contributor” role are not permitted to make such changes.
Managers can edit, submit or withdraw the application From the IRIS home page, carry out the following steps (see also Figure 1):
Click on "Draft submissions"/”Ongoing submission” sub-tab present under “Submission” tab;
Scroll down and find the application you want from the list of your drafts;
On the right hand side, click on the drop-down arrow and select “View/Manage Managers” as Figure 3;
Click “Add”, then In the pop-up window, click the magnifying glass search symbol to bring up a list (and find the name you want to add as a contributor;
To add more maangers to the same application, repeat the steps above
Add contributors to a draft submission
Only users with a "Manager" role can submit or withdraw draft applications; Contributors are limited to editing and cannot perform submission or withdrawal actions.
From the IRIS home page, carry out the following steps (see also Figure 1):
Click on "Draft submissions" sub-tab present under “Submission” tab;
Scroll down and find the application you want from the list of your drafts;
On the right hand side, click on the drop-down arrow and select “View/Manage Contributors”;
Click “Add”, then In the pop-up window, click the magnifying glass search symbol to bring up a list (and find the name you want to add as a contributor;
Click “Continue to submission form”;
To add more contributors to the same application, repeat the steps above.
Delete a draft submission
Only users with a “Manager” role for draft applications can perform certain actions; contributors do not have this permission You cannot delete completed submissions, but ongoing submissions can be withdrawn using a similar procedure.
Click on "Draft submissions" sub-tab present under “Submission” tab;
Find the application you want from the list of your drafts;
On the right hand side, click on the drop-down arrow and select “Delete Draft” and a confirmation message will open up in a new window (see Figure 1);
To delete your draft, click on the "Delete" button to confirm Please note that this action is permanent, as the draft cannot be restored once deleted from IRIS Be sure to confirm before proceeding, since the deletion cannot be undone.
Withdrawal of a Submission
You can only do this for the Ongoing applications for which you have a “Manager” role (not if you are a Contributor) Note: you cannot withdraw a “completed submission”;
Click on "Ongoing submissions" sub-tab present under “Submission” tab;
Find the application you want from the list of your drafts;
To withdraw a submission, click on the drop-down arrow on the right side and select “Edit/View,” which opens the submission in edit mode Then, click the ‘Withdraw Submission’ button at the bottom of the page, and a confirmation window will appear Confirm your withdrawal request to complete the process.
Submission status will be in ‘Withdrawal Requested’ as shown in ‘Ongoing Submission’ Tab;
Once EMA has processed the request, the submission will move to ‘Completed Submission’ Tab;
Automatic deletion of draft submissions
IRIS will automatically scan all submitted entries to detect inactive submissions with no data changes for more than 7 months If an inactive submission is identified, IRIS will notify the submission contact via email about its impending deletion The notification emphasizes that unless a change is made within the next 2 weeks, the submission will be permanently removed This process ensures data relevance and helps maintain an updated and accurate database.
If no modifications are made to the submission within the specified timeframe, it will be permanently deleted from the IRIS system, along with any uploaded documents A final notification email will be sent to the submission contact to inform them of the permanent removal from the system.
Respond to a notification email from EMA requesting changes
On receipt of a notification email from EMA stating for example that “Validation Supplementary
To update or provide the required "Information (VSI)" for your ongoing submission, log into the IRIS portal and follow the necessary steps to submit the missing data or make updates Ensuring these details are complete is essential for maintaining the progress of your submission.
From the IRIS home page, click on “Ongoing submissions” sub-tab present under “Submission” tab;
Locate the submission mentioned in the e-mail by using the sort or search features described in this Guide, or by just scrolling down the list until you find it;
At the end of the row in the list where your submission appears, click on the drop-down arrow and select “View/edit”;
On the “Submission Form” page, click on the specific sections you need to update, such as General Information or Scientific Information, as indicated in the notification received from EMA.
Selected sections will open in edit mode, allowing you to make the necessary modifications Once completed, click on “Save and Return,” and all changes will be saved automatically You will then be redirected back to the “Submission Form” page, ensuring a seamless editing workflow.
If you need to upload updated or new documents, click on “Documents from Applicant” Click on
“Save and Return” when you are done;
Click on the tick box to the left of the declaration statement (that begins with the words: “I confirm…”) to formally declare that you are authorised to submit this request;
Click on the “Declaration and submission” button;
If you are sure you want to submit the application, click” Submit”, then “Ok” and then “Submit”.
Respond to a List of Questions (LoQ) request
Upon receiving a notification email from EMA about a “List of Questions (LoQ)” related to your ongoing submission, you can upload revised or new documents after validation and initiation of the review process However, direct modification of the submission data in the portal is not permitted To update your documents, log into the IRIS portal and follow the necessary steps to upload the required files, ensuring your submission remains compliant with EMA procedures.
From the IRIS home page, click on “Ongoing submissions” sub-tab present under “Submission” tab; Locate the submission mentioned in the e-mail;
At the end of the row in the list where your submission appears, click on the drop-down arrow and select “View/edit”;
Click on “Documents from Applicant”; click on “Save and Return” when you are done;
Click on the tick box to the left of the declaration statement (that begins with the words: “I confirm…”) to formally declare that you are authorised to submit this request;
Click on the “Declaration and submission” button;
If you are sure you want to submit the application, click “Submit”, then “OK” and then “Submit”
Your updated application has been successfully submitted and will now appear in your "Ongoing Submissions" list, ensuring easy tracking of your progress Additionally, you will receive an email confirmation from EMA verifying that your re-submission has been received as requested.
Check the current status of an ongoing Submission in the IRIS Portal
The possible status for the Applicant’s submission (see Figure 5) are shown in the below table
Draft The application is in draft status and can be deleted or submitted (when finalized) Inspection submission cannot be deleted
In Progress Application submitted; case ongoing at EMA
Withdrawal Requested The applicant has requested a withdrawal, which is being assessed at
Completed-Positive Case closed, positive outcome
Completed-Negative Case closed, negative outcome
Completed-Withdrawn Case closed as withdrawn, at the applicant’s request
Completed -Cancelled Inspection request has been cancelled by CHMP/CVMP
Regulatory Entitlements Affiliation
This tab allows you to view a comprehensive list of all regulatory entitlements associated with your affiliated organization(s) You can easily filter these regulatory entitlements by various criteria, including entitlement number, entitlement type, sponsor, product name, EU number, and date of decision, as illustrated in Figure 6.
The tab allows you to view a comprehensive list of all regulatory entitlements granted based on your submissions You can easily filter these results by entitlement number, entitlement type, product name, and decision date for quick and efficient access.
Figure 7: My Individual Regulatory Entitlements
Products - Research Product Identifiers (RPI)
You can view all Research Product Identifiers (RPIs) for which you serve as the sponsor, either individually or through affiliations with one or more companies The platform provides two different views to display these RPIs, enhancing user accessibility and management (see Figure 8).
“My Direct RPIs", which displays all active RPIs for which you are a direct sponsor
“My Organizations RPIs” shows active RPIs for all organization locations you are affiliated to (in any of the locations)
Figure 8: Product- View of RPI's
Orphan submissions
Create an application for orphan designation
When applying for Orphan Designation, it is essential to follow the general submission procedures outlined in Section 2.3, "Create a New Submission," while paying special attention to specific requirements unique to orphan products Ensure all orphan-specific documentation and data are included, and clearly demonstrate the medical need and rarity of the condition Adhering to these additional guidelines helps streamline the review process and increases the likelihood of a successful designation.
The reference number will have “OD” in it (e.g EMA/OD/0000001234) for your draft submission displayed on the upper right-hand side of the “Portal – New Submission” screen (see Figure 9)
Figure 9: Application for orphan designation, main screen
When submitting information, ensure that all mandatory fields marked with a red asterisk “*” in the “General Information” and “Scientific Information” sections are completed After filling out the necessary details, click “Save and Return” to proceed Note that in the prevalence box, you should enter the prevalence per 10,000 persons within the EU population as a single numeric value (typically between 0 and 5.0), not as a ratio Refer to Figure 9 for visual guidance Proper completion of these sections is essential for a successful submission.
Request a Pre-Submission Meeting (for OD)
Before requesting a pre-submission meeting, ensure you prepare a draft of the orphan designation submission as outlined previously This draft should be saved and not yet submitted to allow for review and necessary adjustments Remember to upload all relevant documents within this draft submission to facilitate a smooth review process and streamline your future formal application.
16 orphan designations, not in the pre-submission meeting request The number of the draft request for orphan designation should be referenced in the pre-submission meeting request;
Select “Request for Pre-Submission Meeting” as submission type;
To submit your draft, click “Continue to submission form,” where a unique reference number (e.g., EMA/OD/0000001234) will be displayed in the top right corner of the “Portal – New Submission” screen It is advisable to note this reference number for future tracking and reference purposes.
Back in the Submission Form screen, click on “Submission Details”, enter the information that you want the EMA Orphan Medicines team to know and click “Save and Return”;
Follow steps 13 and 14 from Section 2.3 “Create a new submission (general procedure for all submission types)”above;
Your request for a Pre-Submission Meeting has now been submitted and will appear in your “Ongoing
Request an Appeal (of a COMP Opinion)
In addition to the steps in the general procedure as described in Section 2.3 “Create a new submission (general procedure for all submission types)”, note the following:
As submission type, click on “Appeal” and then click “Select”;
Click “Create and Next” – you will see the message “processing…” for a short while;
Click “Continue to submission form”;
Click on “Start Appeal” and the “View Start Appeal Form” screen appears;
Click on the magnifying glass to select the procedure to be appealed – only cases which have been submitted and are currently in ongoing status are displayed;
Click on one of the procedures listed then click Select” and “Submit”;
To submit your appeal, navigate to the “Submission Form” screen and select the “Ground of Appeal” section Fill out the mandatory “Applicant's Grounds for Appeal” box with relevant information, then click “Save and Return” to complete the process.
Submit an Annual Report for an orphan designation
The process for submitting Annual Reports has been streamlined, with the removal of the previous PDF form from the website Applicants now only need to enter specific data fields within IRIS, simplifying the submission process While uploading supporting documents remains optional, it is no longer mandatory, making compliance easier and more efficient.
In addition to the steps in the general procedure as described in Section 2.3 “Create a new submission (general procedure for all submission types)”, note the following additional points:
As submission type, click on “Annual Report” and then click “Select”;
Click “Create and Next” and then click “Continue to submission form”;
Click on “Regulatory Entitlement” (a generic term for a right granted to a sponsor such as an orphan designation or a transfer of orphan designation);
In the “Regulatory Entitlement” window, click on the magnifying glass symbol to search through the existing orphan designations for your organisation;
Choose the appropriate orphan designation when submitting your Annual Report and click “Save and Return.” If your orphan designation is not listed, please contact the Orphan Medicines Office for assistance.
To complete the scientific content section, click on “Scientific content” and fill in the required data fields, updating prefilled information as needed Ensure all fields marked with an asterisk are filled, as they are mandatory Once all information is entered, click on “Save and Return” to finalize your submission.
To add additional information for the EMA Orphan Medicines team, navigate back to the Submission Form screen and click on “Submission Notes.” Here, you can enter any relevant free-text details you'd like them to know Once you've filled in the information, click “Save and Return” to ensure your notes are recorded and the process is completed smoothly.
Other post-designation procedures for orphan-designated products
All other post-designation procedures for existing orphan designations should be submitted via IRIS, choosing the appropriate procedure type These include:
Submission of a report for the Maintenance of the Designation Criteria at Marketing authorisation (or extensions);
Submission of a report for a Review of the Designation criteria after 5 years;
Request for an Amendment of an existing Orphan designation (to change the condition);
Request to transfer an Orphan Designation;
Request of removal of an Orphan designation from the EC Orphan register;
Change of name and/or address of the Sponsor of an orphan designation
The procedures closely follow the general process outlined in "Create a new submission," applicable to all submission types For comprehensive guidance on these procedures, please refer to the "Activities after orphan designation" webpage on the main EMA website.
How to check if an Orphan Drug Sponsor (Location of an organisation) has associated Regulatory entitlements
Go to https://ec.europa.eu/health/documents/community-register/html/reg_od_act.htm?sort=a and search for EU product e.g EU/3/19/2181
Click on the EU number in the search results to access detailed information The "Sponsor" field will display the organization’s name and location, which indicates its regulatory entitlements This location information can also be selected in IRIS when drafting a form, ensuring accurate and compliant documentation.
Scientific Advice
Create an application for an Initial Scientific Advice (Human)
When initiating a new submission, select “Initial Scientific Advice-Human” as the submission type, following the general procedure outlined in Section 2.3 “Create a new submission (general procedure for all submission types).” It's important to note the additional points specific to this submission type to ensure compliance and accuracy in the process.
The reference number will contain SA (e.g EMA/SA/0000001234) for your draft submission displayed on the upper right-hand side of the “Portal – New Submission” screen;
There is a list of eleven steps (tabs) starting with “Administrative Information” and ending with
“Declaration” relating to the SA Application displayed on the left-hand side of your screen; the two sections
“Administrative Information” and “Select Primary RPI” must be completed, before the other sections (tabs) become available (they turn from grey to blue);
You can optionally select additional (secondary) RPIs to link to your procedure by clicking on “Add
Additional RPIs” (see Figure 10) Note that only RPIs “owned” by the same applicant can be added;
You can include “Submission Notes” in scientific advice forms to provide additional information or explanations This section is essential for detailing reasons for deviation from standard deadlines, such as urgent requests due to COVID-19 Clearly specifying these reasons helps ensure compliance with regulatory requirements and facilitates smoother review processes Including comprehensive submission notes enhances transparency and supports the justification for deadline extensions or special considerations.
Some sections/tabs may not be applicable, e.g “Parallel Consultation EMA/EUnetHTA”; however, at least the mandatory field(s) marked with a red asterisk “*” should be completed
Figure 10: How to include additional RPIs
Create an application for other Scientific Advice procedures
Follow the steps in the general procedure as described in Section 2.3 “Create a new submission (general procedure for all submission types)”, selecting “Initial Scientific Advice-Veterinary” as submission type
Protocol Assistance is Scientific Advice for designated orphan medicinal products In addition to questions on quality, safety and clinical aspects, questions on significant benefit may also be discussed
In addition to the steps in the general procedure as described in Section 2.3 “Create a new submission (general procedure for all submission types)”, note the following additional points:
• The applicant must be the same as the Orphan Designation Sponsor;
When preparing an application for orphan designation, applicants must select an existing orphan designation or positive opinion date related to the same customer's product before proceeding further It is permissible to submit the application after a COMP opinion has been issued but before the European Commission’s formal decision, by choosing the ongoing procedure instead of establishing a new orphan designation However, the final decision must be adopted prior to the commencement of the Protocol Assistance procedure to ensure compliance with regulatory requirements.
Please be aware that certain fields, such as the RPI and the medical condition, will be prepopulated based on the related orphan case and cannot be modified These details must align with the orphan's designation and medical status, as mandated by law, ensuring accurate and compliant data entry.
In addition to the steps in the general procedure as described in Section 2.3 “Create a new submission (general procedure for all submission types)”, note the following additional points:
Select “Initial Qualification Procedure” as submission type
4.2.4 Follow up Scientific Advice – Human
In addition to the steps in the general procedure as described in Section 2.3 “Create a new submission (general procedure for all submission types)”, note the following additional points:
Select “Follow up Scientific Advice-Human” as submission type;
To proceed, you must select a previously completed Scientific Advice procedure from the popup list, which displays all available procedures with their procedure numbers and conditions, regardless of the applicant This selection is made in the “Select Previous Scientific Advice” section.
An RPI is mandatory for compliance; if an RPI was included in the previous Scientific Advice, it will be automatically added to the current record If not, users must select an existing RPI assigned to the same location to ensure accurate tracking and adherence to regulations.
Please note that certain fields, such as the RPI, medical condition, and areas of advice, will be automatically prepopulated from the initial scientific advice case and cannot be modified In follow-up procedures, only previously discussed areas of advice, or a subset thereof, can be included, ensuring consistency and relevance.
4.2.5 Follow up Scientific Advice – Veterinary
In addition to the steps in the general procedure as described in Section 2.3 “Create a new submission (general procedure for all submission types)”, note the following additional points:
• Select “Follow up Scientific Advice-Veterinary” as submission type;
• You will be able to proceed only after selecting a previously completed Scientific Advice – Veterinary procedure;
An RPI is a mandatory component for the process; if an RPI was included in the previous Scientific Advice, it will be automatically added in the current update If not, users must select an existing RPI assigned to the same location to ensure compliance Proper RPI management is essential for accurate and efficient Scientific Advice submissions.
In addition to the steps in the general procedure as described in Section 2.3 “Create a new submission (general procedure for all submission types)”, note the following additional points:
Select “Follow-up Protocol Assistance” as your submission type, ensuring that this option is available even if your previous submission was for Scientific Advice This flexibility allows you to efficiently continue your consultation process without restrictions Properly choosing the correct submission type enhances your application's clarity and aligns with regulatory requirements.
You will be able to proceed only after selecting a previously completed Scientific Advice or Protocol Assistance procedure These appear in the section “Select Previous Scientific Advise” for selection;
When preparing an orphan designation application, applicants must select an existing orphan designation or a positive opinion date for a related product from the same customer before proceeding It is permissible to submit the application after a COMP Opinion has been issued, but prior to the formal decision by the European Commission, by opting for the ongoing procedure instead of an Orphan Designation However, the final decision must be adopted before the initiation of the Protocol Assistance procedure.
Please be aware that certain fields, such as the RPI and the medical condition, will be automatically filled based on the associated orphan case and cannot be modified These prepopulated details must align with the orphan's designated condition as mandated by law Ensuring these fields are accurate is essential for compliance and proper processing.
In addition to the steps in the general procedure as described in Section 2.3 “Create a new submission (general procedure for all submission types)”, note the following additional points:
• Select “Follow up Qualification Procedure” as submission type;
• You will be able to proceed only after selecting a previously completed Qualification procedure These appear in section “Select Previous Scientific Advice” for selection
Owners of Scientific Advice regulatory entitlements (Letters of Advice) can now transfer these entitlements automatically to another owner, similar to the RPI transfer process This new automated transfer process applies exclusively to scientific advice entitlements, facilitating seamless ownership changes It is particularly useful when the applicant for follow-up scientific advice or protocol assistance is different from the initial advice provider, ensuring efficient regulatory management.
In addition to the steps in the general procedure as described in Section 2.3 “Create a new submission (general procedure for all submission types)”, note the following additional points:
Select “Transfer a scientific Advice” as submission type
The reference number will contain SA (e.g EMA/SA/0000001234) for your draft submission displayed on the upper right-hand side of the “Portal – New Submission” screen;
The following four tabs will appear as shown in Figure 11:
1 Select Scientific Advice to be transferred: Click on the tab and a new screen will open Select the desired submission to be transferred, using the search icon option if necessary, and click on “Save and Return”;
2 Transfer details: Click on the tab and a new screen will open Here the current sponsor details will be shown in “read-only” mode and below you can add the “New Sponsor Type” as
Organisation/Individual, then select the “New Organisation” The organisation address will be shown in read-only mode Once all details have been added, click on “Save and Return”
3 Declaration: Click on the tab and a new screen will open Select the checkbox for the declaration and click on “Save and Return”;
4 Submit Application: Once all the above tabs have been filled and green check marks show, the
Once the “Submit Application” button becomes enabled, click on it to open a new confirmation screen Select the checkbox to verify your details, then click the “Submit” button A pop-up window will appear, allowing you to review all entered information before final submission, ensuring accuracy and giving you the opportunity to go back if needed.
Once submitted, the Submission will be shown in “Outgoing” tab and the product will be updated with new sponsor type as mentioned while filling the form
Users can request clarification on a closed Scientific Advice case related to an Initial Scientific Advice or Follow Up Scientific Advice by submitting a request "Clarification on scientific advice" in IRIS
In addition to the steps in the general procedure as described in Section 2.3 “Create a new submission (general procedure for all submission types)”, note the following additional points:
To submit your draft, select “Clarification on Scientific Advice” as the submission type The reference number will include "SA" (e.g., EMA/SA/0000001234) and will be displayed on the top right corner of the “Portal – New Submission” screen, ensuring clear identification of your submission.
The following six tabs will be shown:
1 Select previous Advice: Click on the magnifier of this field, and a new screen will open Select the desired submission Click on “Save and Return”;
2 Grounds for Clarification: Once a previous advice is selected, this tab is enabled for you to add the notes (Figure 12) Once added, click on “Save and Return”;
Figure 12: adding notes for clarification
3 Documents from Applicant: It is possible to add documents under this tab Select that declaration confirming documents have been attached and click on “Save and Return”;
4 Documents from EMA: Can be skipped as part of drafting process;
5 Declaration: Click on this tab, and a new screen appears Select the checkbox for the declaration and click on “Save and Return”;
6 Submit Application: Once all the above tabs have been filled and green check marks show, the
Once the “Submit Application” button is enabled, click on it to open the confirmation screen Check the box confirming your details and then click the “Submit” button A pop-up window will appear, offering a final opportunity to review all entered information or proceed with submission.
Once submitted, the Submission will be shown in “Outgoing” tab and the product will be updated with new sponsor type as mentioned while filling the form
Frequently asked questions related to Scientific Advice can be found in “Forums” tab in IRIS website.
ITF Briefing Meeting Requests
In addition to the steps in the general procedure as described in Section 2.3 “Create a new submission (general procedure for all submission types)”, note the following additional points:
• Select “ITF Briefing Meeting Request” as submission type;
• The section “Documents from applicant” is available to upload any supporting documents;
• The section “Documents from EMA” is where you can find any documents provided by EMA to you, including the minutes from the meeting.
Marketing Status
Marketing Status Notification (Single)
When creating a new submission, select “Marketing Status Notification (Single)” as outlined in the general procedure 2.3 Additionally, be sure to follow any specific requirements associated with this submission type to ensure compliance.
1 Starting with clicking “Select Authorised Product” as the other steps become available after selection of the product (Figure 13);
Figure 13: Marketing Status Single Notification
2 Click on the search icon under “Authorised Product” A list will appear, which includes all products associated to the selected organisation Select one, then click on “Save and Return” 2.7 Once the record is saved, the system will auto-populate details like ’Product Status’, ‘EU number’, ‘Reference number’, ‘Active Substance(s)’, ‘Product Name’, when you revisit the “Select Authorised Product” tab
Once you select an authorized product and click 'Save and Return,' you cannot change the product within that submission To choose a different authorized product, you must start a new submission, which requires deleting the existing draft by following the steps outlined in section 2.7.
3 Click on the section “Register Marketing Status”- all product presentations are shown, for the selected ‘Authorised Product’ Please note if you are doing this for the selected product the first time, you will not see any presentation listed You can add the relevant product presentation(s), member state(s) and Marketing availability by clicking on the ‘Register Marketing Status’ button, as shown in Figure 14
Figure 14: How to add Product Presentations
All fields marked with red asterisk are mandatory to fill This page is divided into 3 sections
Marketing status - The fields present under this section are dynamic and will change based on selection of value in the field “Marketing Status”:
Select the "Marketing Status = 'Marketed'" option to indicate that one or more presentations of the medicinal product are actively marketed in one or more European Union Member States It is essential for the user to specify the relevant details about the marketed presentations to ensure accurate regulatory reporting and compliance with EU pharmaceutical regulations Properly documenting the marketing status helps demonstrate the product's availability and legal distribution within the Union.
‘Date of Marketing Status Change’
Select the "Marketing Status = Temporarily Unavailable" to indicate when one or more presentations are temporarily unavailable in any Member State When this status is chosen, the fields "Date of Marketing Status Change," "Reason of Cessation," "Estimated Date of Reintroduction," and whether the cessation leads to a shortage become mandatory to complete This ensures accurate reporting and communication of temporary market unavailability.
Select the "Marketing Status = 'Not Marketed'" option to indicate that one or more presentations have changed to a permanent cessation or are no longer marketed in one or more Member States Additionally, specify the "Date of Marketing" to accurately document when the product was withdrawn from the market in those regions This ensures proper reporting of market status changes in compliance with regulatory requirements.
Status Change’, ’Reason of cessation’, ‘Does cessation lead to Shortage’ become mandatory and have to be specified by the user to save the details.
Select "Never Marketed" in the marketing status field to indicate that one or more presentations of the medicinal product have never been marketed in any Member State of the European Union This designation is used to accurately report products that have not been distributed or sold within the EU Proper classification of the marketing status is essential for regulatory compliance and ensuring clear communication of a product’s market entry status across member states.
Please refer to regulatory guidance for Notifying-change-marketing-status
Product Presentations - Single or multiple product presentations can be added by clicking on the
‘Add’ button present under ‘Product Presentations’
Member State - presentations can be marketed in different countries, single or multiple countries can be selected here
Figure 15 Adding product presentation, Marketing Status & Member states
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4 Click on ‘View Proposed Marketing Status’ to view the recently added changes in Marketing status pending to be submitted This section will list all the presentations and their marketing status in the countries selected in Section ‘Register Marketing Status’ You can also delete presentation for a specific member state by clicking on the v-shaped arrow as shown in Figure 16: Viewing proposed presentations Figure 16 below Click on ‘Return’ after checking all information;
5 After completing the steps above, click on ‘Declaration’, confirm the declaration, click Save and Return and submit your application in the ‘Submit Application’ section You will receive a confirmation email on the successful submission
6 Your submission is shown in the “Submissions/Ongoing“ sub-tab After the case (procedure) is automatically processed by the IRIS system, the submission will be moved to the
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Marketing Status Notification (Bulk Upload)
To create a new submission, start by following the general procedure outlined in section 2.3 and select “Marketing Status Notification (Bulk Upload).” Additionally, ensure you are aware of and adhere to any specific requirements or instructions associated with this submission type Properly preparing your bulk upload file and verifying data accuracy will help ensure a smooth submission process and compliance with relevant guidelines.
Select the Authorised product in the section “Select Authorised Product”, click ‘Save & Return’
To access the latest product presentations, click on the “Download Current Marketing Status” section A comprehensive table displaying all product presentations associated with the selected product will appear To download these presentations in Excel format, simply click on the designated download button.
‘Download’ button Once the file is downloaded, click on ‘Return’ to go back to the main page
You can update the data in the file according to your requirements, ensuring that unnecessary rows with no changes are deleted Please note that all presentations must correspond to the same authorized product selected in step 0.
Ensure that all column values are provided in a standardized format to prevent validation failures Refer to Figure 17 for the correct formatting guidelines and expected values Maintain the specified order of columns and keep the headers unchanged to ensure data integrity and compliance with submission standards.
Figure 17 Format/Values for Fields in csv
Data columns format and allowed values
Not marketed Temporarily unavailable Never marketed
Excel will apply local time and date format to the Excel file with current marketing status
Reason for Cessation 01 Safety - Medicinal product is harmful (Articles 116 and 117)
02 Efficacy - Medicinal product lacks therapeutic efficacy (Articles 116 and 117)
03 Benefit/risk - risk-benefit balance is not favourable (Articles 116 and 117)
04 Quality - Quantitative and qualitative composition of the medicinal product is not as declared (Articles 116 and 117)
05 Quality - Controls of the medicinal product and/or on the ingredients and the controls at an intermediate stage of the manufacturing process have not been carried out or some other requirement or obligation related to the grant of the marketing authorisation have not been fulfilled (Article 117)
06 Particulars supporting the application as provided for in Articles 8,
10, 10a, 10b, 10c or 11 are incorrect or have not been amended in accordance with Article 23 (obligation to keep dossier up to date) (Article 116)
07 Any conditions referred to in Articles 21a, 22 or 22a have not been fulfilled (PAES, PASS, PV obligations, obligations under exceptional circumstances) (Article 116)
08 Commercial reasons (excluding any ground of art 116 or 117)
Data columns format and allowed values
This article provides a comprehensive overview of European countries, including Austria (AT), Belgium (BE), Bulgaria (BG), Croatia (HR), Cyprus (CY), Czech Republic (CZ), Denmark (DK), Estonia (EE), Greece (EL), Finland (FI), France (FR), Germany (DE), Hungary (HU), Iceland (IS), Ireland (IE), Italy (IT), Latvia (LV), Liechtenstein (LI), Lithuania (LT), Luxembourg (LU), Malta (MT), Netherlands (NL), Norway (NO), Poland (PL), Portugal (PT), Romania (RO), Slovakia (SK), Slovenia (SI), Spain (ES), Sweden (SE), and several other countries Understanding these nations' unique profiles is essential for multi-national engagement, policy development, and regional cooperation Incorporating SEO keywords related to European geography, culture, and economy ensures maximum visibility and relevance in digital content Highlighting each country's contributions and characteristics offers valuable insights for businesses, travelers, and policymakers interested in Europe's diverse landscape.
The ‘Upload Proposed Marketing Status’ feature now allows users to upload Excel files specifically downloaded as instructed in this section, ensuring compatibility and correct formatting Users should avoid using Excel files from the Marketing Status Report, as they have a different format To upload, click the ‘Notification’ button for detailed instructions, then select the file using the ‘Choose file’ button, and finally click ‘Save and Return’ to complete the process.
The “View Proposed Marketing Status” section will be blank at the time of submission Data is added to the view once EMA has processed the case
After completing the steps above, confirm the declaration and submit your application in the ‘Submit
Application’ section You will receive a confirmation email on the successful submission
Your submission is shown in the “Submissions/Ongoing “sub-tab
If the system detects errors in your uploaded file, you will receive an email notification Your submission will be moved back to the “Draft Submissions” section for correction To resume editing, log in to the IRIS portal, locate your submission, and click the ‘V’ shaped button at the right end corner of the record, then select “edit draft” to make the necessary changes.
Figure 20: Opening the submission in edit mode
Click on the ‘Upload Proposed Marketing Status’ section Errors will be shown under section ‘Input File
Validation’ as shown in Figure 22
Figure 22: Showing Validation errors and required corrections
Download the file again by clicking on ‘Download’, correct the data and make a new submission.
Marketing Status Withdrawal Notification
To withdraw the marketing status of a product, follow the standard submission procedure outlined in section 2.3, which includes creating a new submission When submitting, select “Marketing Status Withdrawal” as the submission type It is important to note additional key points, such as ensuring all required documentation is complete and accurate, adhering to specific regulatory guidelines, and confirming the withdrawal request aligns with applicable laws Properly executing these steps guarantees a smooth and compliant withdrawal process, maintaining transparency and regulatory compliance throughout.
1 Select the Authorised product in section “Select Authorised Product”, click ‘Next’, and select one of the options to proceed further Please note if you select ‘No’ as option, then the system will provide a relevant message on proceeding further (Figure 23).You have to delete this draft submission yourself (2.7 Delete a draft submission);
Figure 23: Withdrawal of one or more presentations
If you have selected ‘Yes’, the system will proceed to next step after clicking on ‘Save and Return’ button
Figure 24: Withdrawal of all presentations
To withdraw a product, navigate to the “Reasons for Product Withdrawal” section and select an appropriate option from the list displayed in Figure 25 Enter the required details based on your selected reason, ensuring all fields are accurately filled out After completing the data entry, click on ‘Save and Return’ to finalize the withdrawal process efficiently.
Figure 25: Adding Reason for withdrawal
2 After completing the steps above, confirm the declaration and submit your application in the ‘Submit
Application’ section You will receive a confirmation email on the successful submission
3 Your submission is shown in the “Submissions/Ongoing “sub-tab After the case (procedure) is completed by EMA, the submission will be moved to the “Submissions/Completed’ tab You will receive a confirmation email of the completion of the procedure.
Marketing Status Report
The Marketing Status Report is accessible via the IRIS Portal under the “Products” Tab, providing users with a comprehensive overview of relevant marketing data Users can view only the products they are authorized to see, specifically those linked to their affiliated organization, ensuring tailored access for industry professionals The report offers filtering and search options based on data columns displayed in Figure 26, allowing users to efficiently navigate the registry Searches can be performed using wildcard entries (e.g., */1/00/129/*) or by selecting specific values from dropdown menus, enhancing search flexibility and precision.
Once the search criteria have been selected, click on the ‘Apply’ Button The report is generated with all presentations as per the selected criteria
Users can easily download the data displayed in the table as an Excel file by clicking the ‘Download’ button, ensuring quick access and offline analysis To start fresh or make new selections, simply click the ‘Reset’ button, allowing for a seamless user experience.
To view the forecasted Marketing Status for all Authorized Products and Presentations across all countries on a future date, select the ‘Report Date’ accordingly in the Marketing Status Report page Please note that when this feature is active, the ‘Download’ button will be disabled to ensure accurate data retrieval.
System allows to reset the report date to see Marketing Status for all Authorised Products, all
Presentations for all Countries on current date
Inspections
GMP inspections
These inspections are requested by the Committee for Medicinal Products for Human Use and/or the
Committee for Medicinal Products for Veterinary Use to verify compliance with Good Manufacturing
Practice (GMP) of sites responsible for the manufacture of centrally authorised products
Detailed information about each inspection conducted by the Committee, including contact details of the inspection service personnel involved, is available on the IRIS Industry portal.
A "submission" record is generated for each organization involved in an inspection, differentiating from the standard IRIS process where an application is initiated by the applicant In the conventional workflow, the EMA procedure is only established at the time of submission, making this record creation a unique aspect of the inspection process.
Please promptly notify EMA by replying to the email address that received the inspection request if any of your provided information has changed or contains inaccuracies The inspectors will then contact you to confirm the final inspection dates and detailed arrangements.
Once the GMP inspection request is adopted by the CHMP or CVMP, the applicant will receive a notification from EMA confirming that the inspection has been officially requested by the relevant committee.
It is recommended to use a personal email address, such as john.doe@pharma.com, rather than a general company email like pharma.product@company.com, when submitting CVMP applications for your products This ensures clear communication and facilitates smooth correspondence throughout the regulatory process Using a personal email helps maintain consistency and reduces the risk of missed updates or important notifications related to the product dossier.
At that point, you must update the submission with the necessary information (e.g Purchase Order number) and submit it via the IRIS Portal, within 10 working days of the inspection announcement
Please follow the steps below to submit the required information
1 Login into IRIS Portal with EMA credentials and access ‘My Draft Submissions’ present under
2 You should have a Submission starting with ‘EMA/IN/00000XXXXX’ and a submission type as ‘GMP
Inspection’ Open the submission in edit mode by clicking on the ‘V’ icon present on the right-hand side of the screen as shown below (Figure 27);
2 The notified user is the existing Product Contact as already notified to EMA (integrated from SIAMED2); this user becomes the Portal Contact (a.k.a
Submission Contact) for the ongoing submission To change the product contact, use the existing procedure
3 Click on the ‘Inspection Overview’ section as shown in Figure 28 Inspection related information will be shown: ‘Inspection Sub Type’, Site Name & address, Reporting date, Lead Inspectorate,
Supporting Inspectorate and Contacts click on ‘Return’ to go back to the main menu;
4 Click on the ‘Inspection Details’ section to view the information on Authorised Products
Under the ‘Authorised Products’ section, all authorised products are listed You must add the Purchase Order Number for one of the products to submit the submission
Figure 29: To Edit Purchase Order and fees
To edit a purchase order, click on the "Edit" button as shown in Figure 29 and enter the PO number If you do not have a PO number, add 'N/A' since this field is mandatory for submission Purchase order details will be reflected on the inspection invoice, and the EMA will not accept payment delays due to missing PO references After updating the information, click the ‘Submit’ button to return to the inspection details screen You can also add remarks in the ‘General Comments’ section For questions related to the inspection, contact the EMA inspection coordinator via reply to the IRIS notification, making sure not to change the email subject to ensure proper routing.
Click on ‘Save and Return’ to save the details;
Figure 30: Adding Purchase Order Number
5 Documents from Applicant: It is possible to add documents under this tab Select the declaration confirming that documents have been attached and click on “Save and Return”;
6 Documents from EMA: Can be skipped as part of the drafting process (this tab is used to check if any documents have been made available by EMA);
7 Declare and Submit changes: Once all the above tabs have been filled and the green check marks show, the “Declare and Submit changes” button becomes enabled Click on it and a new screen will open, select the checkbox asking for confirmation and click on the “Submit Application” button box
A pop-up window will prompt you to review your application details, offering a final opportunity to verify accuracy (“Review Application”) before submitting After confirming and submitting your application, it will be displayed under the “Ongoing Submissions” tab for easy tracking.
GCP Inspections
Good clinical practice (GCP) is a global ethical and scientific standard ensuring the proper design, recording, and reporting of clinical trials involving human participants Adhering to GCP guarantees that the rights, safety, and well-being of trial subjects are protected, while also maintaining the credibility and integrity of clinical trial data This compliance provides public assurance of ethical conduct and high-quality research in clinical trials.
GCP inspections, conducted by the CHMP or CVMP, are essential for ensuring compliance with Good Clinical Practice standards These inspections can be routine or initiated in response to issues identified during dossier assessment They are typically requested during the initial review of a marketing authorization application but may also be carried out post-authorization following regulatory submissions to verify ongoing compliance.
When a GCP inspection is adopted, users receive an email notification from EMA confirming that the relevant committee (CHMP or CVMP) has approved the inspection request for their product It is crucial to update the submission with the required information—such as the Purchase Order number and requested documents—within 10 working days of receiving the inspection notification to ensure compliance and smooth processing.
39 otherwise agreed with the Reporting Inspector and submit it via the IRIS Portal Please follow the steps below to submit the required information
1 Login into IRIS Portal with EMA credentials and access ‘My Draft Submissions’ present under
2 You should have a Submission starting with ‘EMA/IN/00000XXXXX’ and a submission type as
‘GCP Inspection’ Open the submission in edit mode by clicking on the ‘V’ icon present on the right-hand side of the screen (Figure 31)
A submission form will open with the following sections: ‘Inspection Overview’, ‘Inspection Details’, ‘Documents from Applicant’, ‘Documents from EMA’ and ‘Declare and Submit the changes’ (Figure 32)
3 Click on the ‘Inspection Overview’ section Inspection related information will be shown: Product Name, Inspection Sub Type, Reporting deadline, Reporting Inspectorate, Supporting Inspectorates and Contacts Click on ‘Return’ to go back to the main menu
4 Click on the ‘Inspection Details’ section to view the information on trials and sites to be inspected At the end of the page, you must add the Purchase Order Number in order to submit (Figure 33)
Please include ‘N/A’ in the PO number field if you do not have a PO number, as this is mandatory for submission Purchase order details will be included on the invoice issued after the inspection Note that the EMA does not accept payment delays due to missing PO reference numbers You can add remarks in the ‘General Comments’ section or contact the EMA inspection coordinator by replying to the IRIS notification for any questions related to the inspection case Ensure you do not change the email subject when replying to maintain correct routing After making updates, click ‘Save and return’ to return to the Inspection details screen.
5 Documents from Applicant: It is possible to add documents under this tab Select the declaration confirming that documents have been attached and click on “Save and Return”
6 Documents from EMA: This tab is used to check if any documents have been made available by
EMA (e.g the Integrated Inspection Report at the end of the process (if applicable))
7 Declare and Submit changes: Once all the above tabs have been filled and the green check marks show, the “Declare and Submit changes” button becomes enabled Click on it and a new screen will open, select the checkbox asking for confirmation that you have read this guidance
To submit your application, navigate to section 41 and follow the instructions in the ‘Guidance for applicants and MAHs involved in GMP and GCP inspections coordinated by EMA’ Click the “Submit Application” button, which will prompt a pop-up window offering a final review—either to revisit and verify all entered details (“Review Application”) or to proceed with submission Once you submit, your application will appear under the “Ongoing Submissions” tab for tracking.
GVP Inspections
GVP inspections are essential to ensure compliance with safety monitoring requirements for medicines These inspections are carried out by national competent authorities, which hold the primary responsibility Additionally, the EMA coordinates GVP inspections upon request from the Committee for Medicinal Products for Human Use and the Committee for Medicinal Products for Veterinary Use, ensuring a consistent approach to medicine safety oversight.
When a GVP inspection is adopted, the QPPV responsible for the pharmacovigilance system will receive an email notification from EMA confirming the inspection request approved by the CHMP or CVMP Inspection details can be accessed by logging into the IRIS portal It is essential to update the submission within 10 working days—providing the Purchase Order number and requested documents—or as otherwise agreed with the Reporting Inspector, and then submit the information via the IRIS portal.
Please follow the steps below to submit the required information:
1 Login into IRIS Portal with EMA credentials and access ‘My Draft Submissions’ present under
2 You should have a Submission starting with ‘EMA/IN/00000XXXXX’ and a submission type as ‘GVP
Inspection’ Open the submission in edit mode by clicking on the ‘V’ icon present on the right-hand side of the screen (Figure 31)
3 Click on the ‘Inspection Overview’ section Inspection related information will be shown: PSMF Code, Inspection Sub Type, Reporting deadline, Reporting Inspectorate, Supporting Inspectorates and Contacts Click on ‘Return’ to go back to the main menu
4 Click on the ‘Inspection Details’ (Figure 34) section to view the information on the sites to be inspected and products covered by the inspections At the end of the page, you must add the Purchase Order Number in order to submit
If you do not have a PO number, include ‘N/A’ in the mandatory purchase order field to proceed with submission Purchase order details will be reflected on the inspection invoice EMA does not accept payment delays due to missing PO reference numbers After updating, click ‘Save and return’ to return to the Inspection details screen.
5 Documents from Applicant: It is possible to add documents under this tab Select the declaration confirming that documents have been attached and click on “Save and Return”
6 Documents from EMA: This tab is used to check if any documents have been made available by
EMA (e.g the Integrated Inspection Report at the end of the process (if applicable)
7 Declare and Submit changes: Once all the above tabs have been filled and the green check marks show, the “Declare and Submit changes” button becomes enabled Click on it and a new screen will open, select the checkbox asking for confirmation that you have read this guidance and the
This guidance is intended for applicants and Marketing Authorization Holders (MAHs) involved in GMP, GCP, and GVP inspections coordinated by EMA To submit your application, click on the “Submit Application” button; a pop-up window will then appear, allowing you to review and confirm that all entered details are correct before final submission.
Application”), or continue and submit Once submitted, the submission will be shown in the