Posted Tue, 16 May 2023 09:20:18 GMT by Caterina Scarpati

Please note that the event (originally scheduled on 8 June 2023) has been postponed. New date and time will be communicated as soon as available.

EMA is pleased to announce a new public webinar for business and technical audiences working for industry and national competent authorities that are interested in the use of electronic Application Forms (eAFs) for Nationally Authorised Products (NAPs) following the Product Management Service (PMS) data release in the Product Lifecycle Management (PLM) Portal between the end of Q2 2023 and beginning of Q3 2023.

The web-based eAFs will replace PDF eAFs used for regulatory submissions in the new Product Lifecycle Management (PLM) portal. 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 PMS data release the form will support all types of EU variation procedures, CAPs and NAPs.