Webinar on Nationally Authorised Products (NAPs) release on Product Lifecycle Management (PLM) Portal electronic Application Forms (eAFs)
Table of contents
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 form 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 webinar is intended for business and technical audiences working for industry and national competent authorities that are interested in the use of eAFs for NAPs following the PMS data release in the PLM Portal between the end of Q2 2023 and beginning of Q3 2023.
A video recording will be made available after the event.