Last updated: 11 January 2025
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Important note to Product Lifecycle Management Portal PLM Portal users
Due to an identified issue with ingredient data on the PLM Portal, the following medicinal product data will be removed from the Product Lifecycle Management Portal from 13 to 17 January 2025:
- All ingredients and their strengths
- Pharmaceutical products and routes of administration
- Package Items, Package Item Materials, Package Manufactured Items
- ATC codes
This means the above data will be unavailable in Product Management Service Product User Interface and Human Variations electronic Application Form.
- In practice, for PLM Portal web-based eAF users this means that fields containing this information will be empty in the eAFs generated from the PLM Portal during this period.
- The missing data is not expected to impact the users of the eAF for variations for Centrally Authorised Products; and eAFs submitted with empty fields where the data is ‘missing’ due to the data cleansing exercise will not be rejected.
- Users are requested request NOT to report missing data/data issues in the eAF via the EMA Service desk during this period.
- This means that PLM Portal eAF users should be able to continue to use the web-based form during this period unless unexpected issues, that were not found during testing, are found once the data cleansing process starts.
- However, users should note that the interactive pdf eAF is available for use for all variation procedures and applicants may feel more comfortable using the pdf eAF .
From 20 January 2025, the removed data will be re-uploaded in phases:
- All Centrally Authorised Products’ (CAPs) data will be available from 20 January 2025;
- Non-CAPs data will gradually reappear over the following two weeks.
Source: eSubmission
IRIS guide for applicants How to create, submit and manage IRIS applications, for industry and individual applicants
The updated guide Version 3.6 has been published. You can view it here. In this version, there minor updates to sections 11.3, 11.7 and 11.10.
European Shortages Monitoring Platform ESMP pre-launch for MAHs and available training materials
- As of 28 November 2024, the European Shortages Monitoring Platform (ESMP) is officially live for routine shortage reporting by marketing authorisation holders (MAHs).
- MAHs can now submit data to routinely report shortages of centrally authorised medicines (CAPs) to EMA.
- This marks the start of a transition period that will end on 2 February 2025, when the use of the platform becomes mandatory for CAP shortage reporting to EMA.
- National reporting requirements remain applicable.
- The ESMP will enable information exchange for prevention, identification and management of shortages to ensure medicines are available for patients in the EU and EEA
- The full first version of the ESMP will be released by 2 February 2025 and will expand the platform’s functionalities to include supply, demand, and availability reporting during crises and MSSG-led preparedness exercises by MAHs and NCAs.
- Further information, including training materials, user guidance, and ESMP webinar and ESMP training event recordings, are available on EMA’s website to support stakeholders.
- For more details, visit the ESMP webpage and the press release on EMA’s website.
Source: eSubmission