Schedule 1 Amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016

1. 1Amendment of regulation 19 (capital fees for applications for variations of authorisations)
2. 2Insertion of regulations 19A-19F (fees for plasma master files, vaccine antigen master files, post-authorisation safety studies, major safety reviews, periodic safety update reports and batch testing)
3. 3Amendment of regulation 23 (applications for multiple variations)
4. 4Insertion of regulation 27A (fee for renewals of a marketing authorisation)
5. 5Omission of Part 8 (Capital Fees for Regulatory Assistance Given by the United Kingdom Acting as Reference Member State Relating to the Assessment of Applications for the Renewal of Specified Marketing Authorisations)
6. 6Amendment of Schedule 1 (general interpretation provisions)
7. 7Amendment of Schedule 2 (capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates)
8. 8Amendment of Schedule 4 (periodic fees for licences)
9. 9Amendment of Schedule 7 (waiver, reduction or refund of capital fees)
10. 10Amendment of Schedule 8 (Adjustment, reduction or refund of periodic fees)
11. 11Savings