Regulation 16 Meaning of “set of applications”
For the purposes of this Part, a “set of applications” means—
a number of applications to the licensing authority for regulatory assistance in connection with obtaining recognition according to the procedure laid down in Title III, Chapter 4 of the 2001 Directive of a single United Kingdom marketing authorisation in other EEA States, but only if all the applications relate to applications for marketing authorisations in other EEA States that have the same 90 day assessment period for the purposes of Article 28(4) of the 2001 Directive; or
a number of applications to competent authorities of other EEA States for marketing authorisations relating to a single United Kingdom marketing authorisation, but only if all the applications have the same 90 day assessment period for the purposes of Article 28(4) of the 2001 Directive.