Regulation 171 Amendment to paragraph 17

In paragraph 17 (application for variation to marketing authorisation under national or mutual recognition procedure)—

(a)

in sub-paragraph (1) omit “18, 19 or”;

(b)

for the table substitute—

“

Type of variations Fee (£)

Single variations; one change for each product
Variation – standard 2,895
Unless the variation is—
(a) a change of route of administration, or the addition of a new one, of—
(i) an immunological product, or a pharmaceutical product for a non-food-producing animal 5,390
(ii) a pharmaceutical product for a food-producing animal 7,135
(b) a change of bioavailability 8,415
(c) a change of active substance, where the change is to—
(i) use a different biologically active substance with a slightly different molecular structure 8,415
(ii) modify the vector used to produce the antigen or the source material, including a new master cell bank from a different source 8,415
(d) a change of pharmacokinetics 8,415
Simultaneous application falling within (a) to (d): fee for each additional product in the application 1,465
Variation – reduced 885
Variation - no assessment 455
Grouped variations
Variation – standard led
For the first nine changes 6,280
For each subsequent group of five or fewer changes 2,250
Variation – reduced led:
For the first nine changes 1,770
For each subsequent group of five or fewer changes 2,250

”.

Type of variations			Fee (£)
Single variations; one change for each product
Variation – standard			2,895
	Unless the variation is—
	(a) a change of route of administration, or the addition of a new one, of—
	(i)	an immunological product, or a pharmaceutical product for a non-food-producing animal	5,390
	(ii)	a pharmaceutical product for a food-producing animal	7,135
	(b) a change of bioavailability		8,415
	(c) a change of active substance, where the change is to—
	(i)	use a different biologically active substance with a slightly different molecular structure	8,415
	(ii)	modify the vector used to produce the antigen or the source material, including a new master cell bank from a different source	8,415
	(d) a change of pharmacokinetics		8,415
	Simultaneous application falling within (a) to (d): fee for each additional product in the application		1,465
Variation – reduced			885
Variation - no assessment			455
Grouped variations
Variation – standard led
	For the first nine changes		6,280
	For each subsequent group of five or fewer changes		2,250
Variation – reduced led:
	For the first nine changes		1,770
	For each subsequent group of five or fewer changes		2,250