Q&As

Want to search for the relevant question and answer in your own language? Change the language in the dropdown menu above.

REACH-IT

Joint submission

One substance, one registration

Under what circumstances can a registrant submit partially or fully separate data from other members of the joint submission?

Registrants must always submit their information within the framework of a joint submission. However, registrants can submit some information separately, if: 

  • it would be disproportionately costly for them to submit some information jointly, or
  • submitting the information jointly would lead to the disclosure of commercially sensitive information that would likely cause substantial commercial detriment, or
  • they disagree with the lead registrant on the selection of information.

Registrants who fall under any of the above circumstances can submit some or all data on their own: these are respectively called partial and full opt-out. Technical implementation of the opt-out is described in Q&A 396.

 

 

 

Categories Display