EMA
- Template or form: CHMP protocol assistance scientific advice briefing document template (updated)
- Newsletter: News bulletin for small and medium-sized enterprises - Issue 58
- Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes / Clean Version (updated)
- Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes / Clean Version (updated)
- Extensions of marketing authorisations: questions and answers (updated)
- Pre-authorisation guidance (updated)
Web-based Human Variations eAF (DADI) - Updated timeline
We are pleased to inform you the updated PLM (Product Lifecycle Management) Portal web-based electronic Application Form (eAF) for Human medicinal products release timeline is available on the PLM portal Forum at the following link. In addition, we invite PLM Portal users' feedback on the Portal and web-based eAFs through a survey you can find below.
Note in particular the following periods:
| June 2023 | Start of data transfer - Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs) for use in eAFs - the first NAPs products will appear in the eAF. This will allow users to start preparing web-based eAFs for NAPs as these products become gradually available on the PLM Portal; |
| August 2023 | Expected completion of data transfer - all CAPs and NAPs available in eAF; |
| November 2023 | User Acceptance Testing (UAT) on the version of the web-based eAF intended to replace the PDF and trigger the transition; |
| Q1 2024 | Confirmation of transition period start date, approximately 2 months in |
| Q2 2024 | Start of 6-months transition to mandatory use of web-based eAF for Human Variations. This is subject to a successful outcome of the UAT. Note that the transition period may start earlier, if feasible, respecting the 2- month advance notice period. |
(Further detailed information on impacts for eAF Users, can be found in the 2nd page of the document link.
Please note:
- Functionalities required for mandatory use are being released incrementally: all required functionalities will be available on the PLM Portal before the start of the UAT.
- The use of the web-based eAF will follow the current process for updating data. Use of structured data will be implemented at a later point.
- The capability to view migrated PMS product data in the Product User Interface on the PLM Portal is under development in parallel - delivery timelines will be announced at a later date.
- Details on how the UAT will be organized will be shared in due course.
Feedback Survey for PLM Portal Users (New Deadline: 8 May 2023)
We kindly ask you to provide your feedback on your experience with the new eAF and the PLM Portal, by responding the survey at the following link: https://ec.europa.eu/eusurvey/runner/Adoption-survey-eAF-HumanVariations
This survey aims to gather your feedback on the level of adoption of the change, including the potential concerns or issues you are facing, in order to enable the eAF product team to envisage appropriate fixing and/or mitigation activities.
Please note that the survey will be anonymous, and the results will not be publicly disclosed. This survey was already shared with PLM portal users in March 2023 and was intended to close on 31 March 2023, but the deadline for responding is now extended to 8 May 2023.
For more insight on eAF, you are invited to consult the following Q&A documents and sessions:
- eAF-PMS FAQs Document (link), including Q&A's on PMS (Product Management Services);
- Training Q&A document (link) addressing questions raised by users during earlier eAF (DADI) trainings;
- Human Variations eAF go-live Q&A session (link);
- Human Variations eAF go-live training session (2 February 2023) (link).
eSubProgofficer@ema.europa.eu or via the PLM Portal Forum.
MHRA