The European Medicines Agency (EMA) has revised the “IRIS guide for applicants (How to create and submit scientific applications, for industry and individual applicants)”. The bold text below denotes new additions in the most recent revision of the guidance.
7.1. GMP inspections
Please let EMA know immediately, by replying to the email e-mail address from which the notification of the inspection request has been received, if any of the information given has changed or is incorrect. The inspectors will contact you to finalise the dates and detailed arrangements.
Upon adoption of a GMP inspection request by the CHMP or CVMP, the user2 will receive a notification from EMA indicating that an inspection request has been adopted by the relevant committee (CHMP or CVMP) for one of their products. It is recommended that the e-mail address linked to the user is a personal e-mail address instead of a general e-mail address (e.g. john.doe@pharma.com instead of pharma.product@company.com).
(…) Click on edit as shown in Figure 29: To Edit Purchase Order and fees, enter the PO number. If you do not have a PO number, please add the text ‘N/A’, since this field is mandatory to proceed with the submission. Purchase order information will be quoted on the invoice issued for the inspection carried out. Please note that the EMA will not accept delays on payments based on missing purchase order (PO) reference number information. (…)
- 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 appear, giving you a final opportunity to go back and check that all the details have been entered correctly (“Review Application”), or continue and submit. Once submitted, the submission will be shown in the “Ongoing Submissions” tab.
7.2. GCP inspections
(…) Upon adoption of a GCP inspection, the user will receive an e-mail notification from EMA indicating that an inspection request has been adopted by the relevant committee (CHMP or CVMP) for one of their products.
- 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). (…) 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).
Once submitted, the submission will be shown in the “Ongoing Submissions” tab.
7.3. GVP Inspections
GVP inspections are conducted to ensure that requirements for monitoring the safety of medicines are met. The responsibility for carrying out the inspections rests with the national competent authorities. EMA is co-ordinating GVP inspections requested by the Committee for Medicinal Products for Human Use and the Committee for Medicinal Products for Veterinary Use.
Upon adoption of a GVP inspection, the QPPV for the pharmacovigilance system subject to the inspection will receive an e-mail notification from EMA indicating that an inspection request has been adopted by the relevant committee (CHMP or CVMP). Details of an inspection can be viewed by logging into the IRIS portal. At that point, you must update the submission with the necessary information (i.e. Purchase Order number and requested documents) within 10 working days of the inspection announcement or otherwise agreed with the Reporting Inspector and submit it via the IRIS Portal.
Please follow the steps below to submit the required information:
- Login into IRIS Portal with EMA credentials and access ‘My Draft Submissions’ present under ‘Submissions’ tab.
- 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).
- 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.
- 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, please add the text ‘N/A’, since this field is mandatory to proceed with the submission. Purchase order information will be quoted on the invoice issued for the inspection carried out. Please note that the EMA will not accept delays on payments based on missing purchase order (PO) reference number information. Once updated, click on the ‘Save and return’ Button and you will be taken back to the Inspection details screen.
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”.
- 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).
- 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 ‘Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections co-ordinated by EMA’ and click on the “Submit Application” button box. A pop-up window will appear, giving you a final opportunity to go back and check that all the details have been entered correctly (“Review Application”), or continue and submit. Once submitted, the submission will be shown in the “Ongoing Submissions” tab.
The document version 2.11 is available here.