Schedule 1 Amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016
United Kingdom
- 1ZAInsertion of new regulation 10A (waiver for advice given to small and medium companies)
- 1Amendment of regulation 19 (capital fees for applications for variations of authorisations)
- 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)
- 3Amendment of regulation 23 (applications for multiple variations)
- 4Insertion of regulation 27A (fee for renewals of a marketing authorisation)
- 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)
- 6Amendment of Schedule 1 (general interpretation provisions)
- 7Amendment of Schedule 2 (capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates)
- 8Amendment of Schedule 4 (periodic fees for licences)
- 8AAmendment of Schedule 6 (time for payment of capital fees: small companies)
- 9Amendment of Schedule 7 (waiver, reduction or refund of capital fees)
- 10Amendment of Schedule 8 (Adjustment, reduction or refund of periodic fees)
- 11Savings