Paragraph 15 Marketing authorizations
Subject to paragraphs 17 to 19 and 26 to 28, the fee payable under regulation 18(1) in connection with an application for a variation of a marketing authorization of a kind described in column 1 of the following table is—
(a)
if the application is an eCTD format application, the fee specified in the corresponding entry in column 2 of that table;
(b)
if the application is not an eCTD format application, the fee specified in the corresponding entry in column 3 of that table.
Fees for applications for variations of marketing authorizations
Column 1 Kind of application | Column 2 Fee payable if in eCTD format | Column 3 Fee payable for application not in eCTD format | |
|---|---|---|---|
| 1. Application where, for the purposes of Commission Regulation (EC) No. 1084/2003, the United Kingdom is the reference Member State as defined in Article 3.4 of that Regulation | |||
| (a) | Type IA Application | £278 | £292 |
| (b) | Type IB Application | £556 | £583 |
| (c) | Type II Application | £900 | £944 |
| (d) | Type II Complex Variation Application | £14,586 | £15,298 |
| (e) | Extended Type II Complex Variation Application | £36,290 | £38,062 |
| 2. Other variation applications | |||
| (a) | BROMI Self Certification Application | £176 | £178 |
| (b) | Type IA Application | £180 | £188 |
| (c) | BROMI Type 1A Application | £180 | £188 |
| (d) | Type 1B Application | £280 | £296 |
| (e) | BROMI Type 1B Application | £280 | £296 |
| (f) | Type II Application | £744 | £778 |
| (g) | Type II Complex Variation Application | £8,412 | £8,824 |
| (h) | Extended Type II Complex Variation Application | £25,962 | £27,228 |
| (i) | Reclassification variation Application | £8,264 | £8,666 |