Deadline for old endpoints following substance renewal
New endpoints are established for the renewal of an active substance, and this has implications for all current applications for products based on these substances. The Ctgb is not permitted to provide any more authorisations that are assessed based on the old endpoints as of the date of application stated in the EU renewal regulation for the substance. Applicants should take this into account and submit applications for products based on substances subject to renewal on time.
Ctgb is currently developing procedures and guidelines for the various types of application to prevent problems in this area. The EU is also working on harmonised solutions.
For Concerned Member State (CMS) applications, some leeway has been created in the new version of the EU Guidance Document Art. 43 PPP renewals (SANCO /2010/13170 rev. 14 dated 7 October 2016), which enters into force on 1 January 2017. CMS Member States may authorise CMS applications based on the old endpoints within three months of the date of application of the renewal regulation, if the Core is completed by the zonal rapporteur Member State (zRMS) based on old endpoints. For such a new product authorisation, the authorisation holder must apply to renew authorisation of the product, directly and no later than three months after the substance renewal comes into force. The Ctgb will make use of this leeway for the completion of CMS applications where necessary, but considers it an extension only. It is therefore not possible to take these three months into account in the planning for new CMS applications.
If the Ctgb expects to encounter difficulties in new applications regarding the deadline for the use of old endpoints, it will contact the applicant to discuss the risks and possible alternatives. It is the responsibility of the applicant to submit applications on time.
Authorisation holders will be informed as soon as we have more information about the Ctbg guidelines for ‘tight deadline cases’. The update of the EU Guidance Document Art. 43 PPP renewals will be added to the Ctgb website information in the coming months. Authorisation holders will be informed through the Ctgb e-zine if there are any significant changes.