The Medicines (Products for Human Use) (Fees) Regulations 2012

Multiple reclassification variation applications

This section has no associated Explanatory Memorandum

48.  Where more than one reclassification variation application is made at the same time by the same applicant, each relating to medicinal products which have the same active ingredient or combination of ingredients, the fee payable under regulation 18(1)—

(a)if one or more of the applications is an application to which paragraph 37 does not apply—

(i)in connection with the first application to which paragraph 37 does not apply, is the appropriate amount specified in this Part of the Schedule;

(ii)in connection with each other application to which paragraph 37 does not apply, the fee payable is £794; and

(iii)in connection with each other application to which paragraph 37 does apply, the fee payable is £397; and

(b)in any other case—

(i)in connection with the first application, is the appropriate amount specified in this Part of the Schedule; and

(ii)in connection with each other application, the fee payable is £397.