Update on human variations web-based electronic application form implementation on product lifecycle management portal

The web-based electronic Application Forms (eAF) in the new Product Lifecycle Management (PLM) portal will replace the current interactive PDF eAFs used for regulatory submissions. This is a first step towards making the form-filling and submission-handling process more efficient.

The web-based Variations eAF for Human medicinal Centrally Authorised Products (CAPs) was released on 4 November 2022. Following the Product Management Service (PMS) data release, the form will support all types of EU variation procedures, CAPs and Nationally Authorised Products (NAPs).

This is a joint eAF-PMS webinar intended for business and technical audiences working for industry and national competent authorities that are interested in the use of Human Variations web-based eAFs.

The event aims at providing interested parties with comprehensive insights into the implementation progress, challenges, and future prospects of the web-based eAF within the PLM Portal. This session also offers an invaluable opportunity for participants to ask questions on pertinent matters.

One of the highlights of this webinar will be the live demonstration of the features currently under development on the PLM Portal for eAF.

Webinar: Update on Human Variations web-based electronic Application Form implementation on Product Lifecycle Management Portal