concerned member Statemeans an EEA state, the competent authority of which receives an application to obtain recognition, according to the procedure laid down in Articles 28 and 29(1) to (3) of the 2001 Directive, of an EC registration;”
decentralised procedure applicationmeans an application relating to a homoeopathic medicinal product in respect of which at the time of the application— (a) an EC registration has not been granted in any EEA State;
mutual recognition procedure incoming applicationmeans an application relating to a homoeopathic medicinal product in respect of which— (a) an EC registration has already been granted in another EEA State;
set of applicationsmeans— (a) a number of applications to the licensing authority for regulatory assistance in connection with obtaining recognition according to the procedure laid down in Articles 28 and 29(1) to (3) of the 2001 Directive of a single certificate of registration in other EEA States, where those applications to the licensing authority all relate to applications for EC certificates of registration in other EEA States that have the same 90 day assessment period for the purposes of Article 28(4) of the 2001 Directive;
the Homoeopathic Regulationsmeans the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994.
the time allowedmeans the period of twenty-eight days beginning with the date of the relevant notification, or such longer period as the licensing authority may allow in any particular case. 2 Subject to paragraph 4, Part 2 applies to— a any application for the grant of a certificate of registration for a homoeopathic medicinal product except one made pursuant to the procedure in Article 28 of the 2001 Directive;