EFSA’s website has now been updated to include the template for the new format of health claim applications. The new format was first revealed in the recent revision to the “Scientific & technical guidance for the preparation and presentation of a health claim application” [EFSA Journal 2017;15(1):4680] and so the provision of the template is a welcome next step.
This template provides the basic structure of the new dossier (12 pages only) and includes the major headings and sub-headings for the new dossier format. New health claim applicants must follow the basic structure and use these main headings & sub-headings as currently defined by EFSA. There is however some discretion to add further sub-headings to present the necessary data (if required).
The template can be found under the administrative guidance section of EFSA’s website and also accessed through the following link:
Steve Morrison commented “The template itself is welcome addition to the recently updated guidance from EFSA but, viewed in isolation, it doesn’t help applicants to understand the level of information that is necessary for making a successful submission. Applicants must work with all the relevant guidance notes and also take note of past NDA Panel opinions, in order to continue to get a better understanding of what is needed. P2F Ventures Limited is working with several clients targeting claim submissions in the next 12 months and will continue to develop an “added –value” template based on our first-hand experience of successful past applications”.