Guidance Notes for the eservice 'Marketing Authorisation & Lifecycle Management of Medicines' Contents

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1 Guidance Notes for the eservice 'Marketing Authorisation & Lifecycle Management of Medicines' Contents Login... 2 No active procedure at the moment... 3 'Active' procedure... 4 New communication (procedure specific)... 5 Reply to a communication... 7 No new communication 'Freiwillige Nachreichung' (= submission of documents without preceding communication of the BASG/AGES MEA) Appendix Translation of field names and options within the dropdown menu L_MEA_VIE_PHIIT_E68_02 Gültig ab: von 12

2 Login To access enter your user name and your password. Click 'Zulassung und Lifecycle ASP' ('Marketing Authorisation & Lifecycle Management of Medicines'). L_MEA_VIE_PHIIT_E68_02 Gültig ab: von 12

3 No active procedure at the moment No procedure number Click No procedure number If you see either of these screens, it means that your procedures have not been activated in the system yet (due to technical reasons procedures which have been migrated from the 'old' system of the BASG/AGES MEA to PHAROS have to be 'activated' first), or none of your procedures are currently pending. L_MEA_VIE_PHIIT_E68_02 Gültig ab: von 12

4 After you have submitted a dossier via CESP or CD/DVD it might take 1-2 days till your procedure is shown in the eservice. The reason is that the procedure is only available in the eservice at the stage of regulatory validation. In case you want to submit product information texts before the procedure has been activated please attach them in a MS-word format (*.doc, *.docx) as working documents to the dossier. 'Active' procedure The procedure has been activated in the eservice Click the blue coloured number(s) in the column 'Verfahrensnummer' ('Procedure Number'). The field 'Communications' then opens. If applicable, procedure-specific documents as provided by the BASG/AGES MEA are shown, such as deficiency letters or corrected product information texts. You can submit documents to the BASG/AGES MEA (e.g. the product information texts for AT) as well. Field for documents (procedure-specific) in this case, no documents available L_MEA_VIE_PHIIT_E68_02 Gültig ab: von 12

5 New communication (procedure-specific) New communication An envelope symbol in the column 'Offene Kommunikationen' ('New Communications') means that you have received a new communication. To open please click the procedure number in the respective row. Click Click the menu arrow that appears at the very left of the row. L_MEA_VIE_PHIIT_E68_02 Gültig ab: von 12

6 Details of the new communication are then shown. To download the file, click the document name. Click Download L_MEA_VIE_PHIIT_E68_02 Gültig ab: von 12

7 Reply to a communication Open the details of the respective communication. First, click the arrow of the menu bar 'Bearbeiten' ('Edit'), then select 'Nachreichung' ('Reply'). In the newly opened field 'Dokument hinzufügen' ('Add Document'), select the respective entries in the drop-down menus: In the menu 'Zu Betrachtungsobjekte(n)' ('Name of the Medicinal Product') select the name of the respective medicinal product. As 'Dokumenttyp' ('Document Type') select 'Fachinformation (FI)' (i.e. translation of the SmPC for AT), 'Gebrauchsinformation (GI)' (i.e. translation of the PIL for AT), or 'Kennzeichnung (KE)' (i.e. translation of the LAB for AT), respectively. L_MEA_VIE_PHIIT_E68_02 Gültig ab: von 12

8 Then click 'Datei auswählen' ('Select File'). Select file The menu opens you can now select a document. After having selected a document click 'Öffnen' ('Open'). L_MEA_VIE_PHIIT_E68_02 Gültig ab: von 12

9 Click The name of the respective document is now shown right of the field 'Datei auswählen' ('Select File'). You can now double-check whether you have selected the intended document. Then click 'Absenden' ('Submit'). If the upload was successful, a confirmation window pops up. Newly uploaded file Your uploaded reply is shown in the row below the respective deficiency letter. L_MEA_VIE_PHIIT_E68_02 Gültig ab: von 12

10 No new communication In case no envelope symbol is shown in the column 'Offene Kommunikation' ('New Communication') of the procedure overview, you have no new communications. L_MEA_VIE_PHIIT_E68_02 Gültig ab: von 12

11 'Freiwillige Nachreichung' (= submission of documents without preceding communication of the BASG/AGES MEA) In case you want to upload procedure-specific documents, without having received a deficiency letter of the BASG/AGES MEA, use the menu item 'Freiwillige Nachreichung' ('Additional Reply') in the communications field of the respective procedure. Then proceed as above ('Reply to a communication'). L_MEA_VIE_PHIIT_E68_02 Gültig ab: von 12

12 Appendix Translation of field names and options within the dropdown menu Field name/option in the dropdown menu 'Abbrechen' 'Absenden' 'Bearbeiten' 'Datei auswählen' 'Dokument hinzufügen' 'Dokumenttyp' 'Fachinformation (FI)' 'Freiwillige Nachreichung' 'Gebrauchsinformation (GI)' 'Kennzeichnung (KE)' 'Nachreichung' 'Offene Kommunikation' 'Öffnen' 'Verfahrensnummer' 'Zu Betrachtungsobjekte(n)' 'Zulassung und Lifecycle ASP' Translation 'Cancel' 'Submit' 'Edit' 'Select File' 'Add Document' 'Document Type' i.e. translation of the SmPC for AT 'Additional Reply' i.e. translation of the PIL for AT i.e. translation of the LAB for AT 'Reply' 'New Communication' 'Open' 'Procedure Number' 'Name of the Medicinal Product' 'Marketing Authorisation & Lifecycle Management of Medicines' L_MEA_VIE_PHIIT_E68_02 Gültig ab: von 12