CMDh: Adjustments to the Guide for Electronic Submissions (eAF)

Recommendation

17/18 September 2024

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A new version of the "Module 1: Administrative information Application form - User guide for the electronic application form for a Marketing Authorisation" was prepared in December 2021 and has now been published on the HMA (Heads of Medicines Agencies) website. This document is intended to serve as a supporting guide for the preparation of the electronic application form for the submission of medicinal products for human use and for the registration of traditional herbal medicinal products.

Only minor formal updates have been made to Chapter 1 "Type of application", so this section remains largely as it was before in the latest version of the User Guide from July 2018.

The second chapter, "Marketing Authorisation Application particulars", however, contains editorial adjustments as well as several changes and innovations in its subsections, which are presented in the following list:

• 2.2.4. Medical devices
  - 2.2.4.1. Device (s) identifaction and classification
  - 2.2.4.2. Manufacturer of the device
  - 2.2.4.3. Documentation to confirm compliance to the Medical Device Regulation (EU n°2017/745)
  - 2.2.4.4. Notified Body
  
  
• 2.2.5. Companion diagnostic
  - 2.2.5.1. Is the medicinal product to be used with a companion diagnostic within the meaning of Article 2(7) of Regulation (EU) n°2017/746?
  - 2.2.5.2. Name, description and intended purpose of the device
  - 2.2.5.3. When is the Notified Body consultation on the suitability of the companion diagnostic with the medicinal product planned with the Competent Authority?
  - 2.2.5.4. Notified Body contact details

Subsection 2.2.5. "Companion diagnostic" has been newly created and assigned to section 2.2.

Chapter 3 "Scientific Advice" and Chapter 4 "Other Marketing Authorisation Applications" do not contain any updates in the new version of the User Guide and remain valid in their original versions.

Here you can find the new version of the new "Module 1: Administrative information Application form - User guide for the electronic application form for a Marketing Authorisation" and the recently published documents on the HMA website.