Paragraph
| Item | Type of examination | Amount |
|---|---|---|
A | In approval/extension application cases (Note 1): | |
(1) | Preliminary examination (Note 2) | £125 |
(2) | Basic examination of— | |
(a) | an Administrative Only application (Note 3) | £30 |
(b) | an Administrative application (Note 4) | £50 |
(c) | a Fast application (Note 5) | £1,060 (Note A) |
(d) | a Mutual Recognition application (Note 6) | £1,060 (Note A)(Note B) |
(e) | an Experimental application (Note 7) | £1,085 (Note A)(Note B) |
(f) | an Off-label application (Note 8) | £470 (Note A) |
(g) | a Normal application (Note 9) | £1,535 (Note A)(Note B) |
(h) | a Departmental application (Note 10) | £7,185 (Note A) |
(3) | Examination of a routine additional matter (Note 11) in an Administrative application (Note 4) | £20 per matter |
(4) | Further examination (Note 12) comprising: | |
(a) | Assessment, in a Mutual Recognition application (Note 6), in relation to one or more of the following risk assessment criteria: | £300 per criterion |
(i) | efficacy (Note 13) | |
(ii) | operator exposure (Note 14) | |
(iii) | consumer exposure (Note 15) | |
(iv) | fate and behaviour in the environment (Note 16) | |
(v) | ecotoxicology (Note 17) | |
(b) | Label check in any application | £425 |
(c) | Examination in any application which is not a Mutual Recognition application (Note 6), of any of the following: | |
(i) | product/active chemistry data (Note 18) | £425 |
(ii) | crop safety data (minor) (Note 19) | £425 |
(iii) | parallel import verification (Note 20) | £425 |
(iv) | text without data seeking to justify a new approval or a change to the conditions of an approval | £425 |
(v) | data relating to consumer exposure (Note 15) | £750 |
(vi) | toxicology data (Note 21) | £750 |
(vii) | data relating to operator exposure (Note 14) | £750 |
(viii) | data relating to ecotoxicology (Note 17) | £750 |
(ix) | data relating to fate and behaviour in the environment (Note 16) | £750 |
(x) | effectiveness data (Note 22) | £750 |
(xi) | crop safety data (major) (Note 19) | £750 |
(xii) | any other material which falls within or is related to material falling within Annex II or III of the 1991 Directive | £750 |
(d) | Examination in any Departmental application (Note 10), of any matter covered by any of items A(4)(c)(iv) to (xii) | In addition to the item fee, £1,475 for each such matter |
B | In Annex I application cases (Note 23): | |
(1) | Preliminary examination (Note 2) of an initial application | £4,700 (Note C) |
(2) | Subseqeunt examination of an initial application comprising— | |
(a) | processing and evaluation where application contains a full data package (Note 24) | £90,000 (Note C) |
(b) | processing and evaluation in respect of an active substance which is either a biocontrol agent or pheromone | £40,000 (Note C) (Note D) |
(3) | Examination of a resubmitted application (Note 25) comprising— | |
(a) | preliminary examination (Note 2), processing and evaluation where application contains a very small data package (Note 26) | £26,000 (Note C) (Note E) |
(b) | preliminary examination (Note 2), processing and evaluation where application contains less than 25% of a full data package (Note 24) but more than a very small data package (Note 26) | £35,000 (Note C) (Note E) |
(c) | preliminary examination (Note 2), processing and evaluation where application contains 25–50% of a full data package (Note 24) | £53,000 (Note C) (Note E) |
(d) | preliminary examination (Note 2), processing and evaluation where application contains more than 50% but less than 75% of a full data package (Note 24) | £71,000 (Note C) (Note E) |
(e) | preliminary examination (Note 2), processing and evaluation where application contains 75–100% of a full data package (Note 24) | £90,000 (Note C) (Note E) |
(f) | preliminary examination (Note 2), processing and evaluation in respect of an active substance which is either a biocontrol agent or pheromone | £20,000 (Note C) (Note D) (Note E) |
C | Preliminary examination (Note 2) and evaluation of an application for the official recognition of a test facility or organisation (Note 27): | |
(1) | in connection with the application and inspection for initial official recognition of the test facility | £1,120 (Note A) |
(2) | in connection with the application and inspection for renewed recognition of the test facility | £840 (Note A) |