EMA
- Regulatory and procedural guideline: Good practices for industry for the prevention of human medicinal product shortages
- Template or form: QRD Appendix V - Adverse-drug-reaction reporting details(updated)
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.0.1.8 released to production on the 16th of May 2023 are now available on PLM Portal Forum and on the PLM Portal eAF web page.
eAF-PMS Newsletter Issue 3
We are pleased to announce the third edition of the eAF-PMS newsletter is now available at the following link.
This newsletter, available to pharmaceutical companies and National Competent Authorities (NCAs), offers updates on the progress of eAF and PMS, presenting an overview of past and future activities.
In particular, we would like to highlight the following topics:
Upcoming webinars (more details on single events are available in the newsletter):
- Product Lifecycle Management (PLM) Portal Access Management Training Session (25 May 2023, 11:00 - 12:30 Central European Summer Time (CEST)): registration link
- Product Management Service (PMS) Progress Webinar (30 May 2023, 10:00 - 11:30 CEST): registration link
- eAF-PMS Joint Webinar on Nationally Authorised Products (NAPs) Data Release on PLM Portal eAF (8 June 2023, 10:00 - 11:30 CEST): registration link
Updated documents:
- Joint eAF (DADI)-PMS general Q&A document
- Human Variations eAF-PMS Frequently Asked Questions (FAQs) document
Please send any questions to eSubProgofficer@ema.europa.eu or via the PLM Portal Forum.
MHRA
