The Medicines (Products for Human Use) (Fees) Regulations 2016 No. 190

SCHEDULES

SCHEDULE 2 U.K. Capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates

PART 1 U.K. General: interpretation and categories of applications and variations

Complex variation application U.K.

7.  A complex variation application is an application by a traditional herbal registration holder to vary a traditional herbal registration which relates to a change in the formulation of a medicinal product comprising one or more of the following changes—

(a) a change in that product's active ingredients which involves the addition of one or more active ingredients which are active ingredients from a new source;

(b) a change in that product's excipients which involves the addition of one or more TSE risk excipients from a new source; or

(c) a change which involves the addition of one or more vitamins or minerals which are vitamins or minerals from a new source where no European Pharmacopoeia certificate of suitability covering those vitamins or minerals has been submitted with the application.