How to apply for new uses, voluntary GAP changes and significant formulation changes?

Applicants that wish to make amendments in their Dutch authorization, e.g. because of their wish to harmonize GAPs or formulations across the zone in their renewal dossiers, or to add new uses, are advised to apply for these well in advance of the renewal application via an article 33 or art 40 application. Applications based on the old active substance Endpoints should in principal be finished before the date of Application (DoA) of the active substance renewal; see also Impact active substance renewal on ongoing applications bases on old endpoints.

Once approved, the amendments should be included in the (GAP of the) renewal application. Alternatively these changes can be applied for after the renewal of the PPP, again via art 33 or art 40 PPPR (EC) 1107/2009. It may be possible to start applications for renewal and applications for extensions or other amendments under art 33 in parallel, leading to efficiency gain.Please bear in mind time lines are different.

In case the voluntary label change is considered minor and specific for NL uses, it may be evaluated in advance of the renewal on a national level in an NLWG application under article 45 of  PPPR (EC) 1107/2009. These applications generally have shorter time lines.

While an existing authorization is under renewal, label extensions applied-for with the new List of Endpoints and Guidance in place at the submission date for the PPP renewal application (or later Guidance) may be submitted. If finished before the end of the product renewal, the new uses may be added to the current authorization. As they are considered to be ‘renewal proof’ , the new uses can also be  transferred to the product label upon renewal of the original authorization without the need for an additional evaluation.