Transparency Regulation – Advance Notification of Studies

From 27th March 2021, all new studies intended to form part of a PPP dossier for approval of new and existing active substances (and representative products) must be notified to EFSA in one submission for each application. EFSA recommends that the “notification of intended studies” for renewal is done at least 5 months before the studies are started “in order to allow for the appropriate consultation to take place”.

This is required to allow the list of studies to form part of a public consultation, increasing the transparency of the approval process.  This change results from the ‘Transparency Regulation’ (Regulation 2019/1381, 20th June 2019), amending the General Food Law (Regulation 178/2002, 28th Jan 2002).  

This new ‘Notification of intended studies’ procedure applies to all studies commissioned after the 27th March 2021.  However, it can also apply to studies started before 27th March for notification in a specific dossier, on a case by case basis if requested by EFSA as part of pre-submission advice to the applicant.

There are legal obligations in this process on all of the following parties:

  • “Business operators” (our clients) – as applicant and the sponsor or owner of the associated studies 
  • “Third parties”, such as regulatory consultants (Staphyt Regulatory) – can notify intended studies on behalf of the business operator.
  • “Laboratories/Test centres” or CROs (Staphyt Agrosciences) – as the party responsible for running the studies will also need to co-notify.

 

Staphyt Regulatory Affairs has registered as a “third party” as part of this process, so that we can act on behalf of clients and notify studies, in our role as a regulatory consultancy.  

Where Staphyt is undertaking studies as a CRO (such as field, laboratory or glasshouse studies, provided through Staphyt Agroscience) our team will also be able to meet their obligations for co-notification.

If you need any support or advice relating to this, or more generally, please do not hesitate to contact Garth Drury on gdrury@staphyt.com.