SCHEDULE

Regulation 4(2)

Column (1)

Column (2)

Column (3)

Column (4)

Provision in the General Regulations

Subject matter

Old amount

New amount

Regulation 6

Applications for certificates by exporters of medicinal products

Regulation 6(1)(a)

£80

£85

Regulation 6(1)(c)(ii)

£14

£15

Regulation 10

Renewals of clinical trial certificates

£1,500

£1,575

Regulation 11(1)

Renewals of certain manufacturers’ licences

£85

£90

Part II of Schedule 1

Capital fees for applications for authorizations, licences and certificates

In column 2 of the table in paragraph 1(1)

Entry 1(a)

£18,000

£18,900

Entry 1(b)

£38,500

£40,425

Entry 1(c)

£55,000

£57,750

Entry 2(a)

£10,500

£11,025

Entry 2(b)

£15,000

£15,750

Entry 3(a)

£3,850

£4,040

Entry 3(b)

£5,500

£5,775

Entry 4

£1,500

£1,575

Entry 5

£1,000

£1,050

Entry 6

£250

£260

Paragraph 5(1)(a)

£95

£100

Paragraph 5(1)(b)

£180

£190

Paragraph 5(1)(c)

£1,650

£1,730

Paragraph 6(1)

£650

£680

Paragraph 6(2)

£475

£500

Paragraph 6(4)

£210

£220

Paragraph 7

£11,600

£12,180

Part III of Schedule 1

Capital fees for applications for variations of authorizations, licences and certificates

Paragraph 2(a)

£150

£155

Paragraph 2(b)

£340

£355

Paragraph 2(c)

£5,000

£5,250

Paragraph 3(a)

£230

£240

Paragraph 3(b)

£410

£430

Paragraph 3(c)

£7,800

£8,190

Paragraph 6(a)

£95

£100

Paragraph 6(b)

£200

£210

Paragraph 7(a)

£90

£95

Paragraph 7(b)

£180

£190

Paragraph 8

£90

£95

Paragraph 9

£210

£220

Paragraph 10

£90

£95

Paragraph 11

£150

£155

Paragraph 12

£75

£80

Schedule 2

Fees for inspections

Paragraph 2(a)(i)

£1,560

£1,640

Paragraph 2(a)(ii)

£2,900

£3,045

Paragraph 2(a)(iii)

£3,500

£3,675

Paragraph 2(a)(iv)

£6,000

£6,300

Paragraph 2(b)(i)

£1,700

£1,785

Paragraph 2(b)(ii)

£3,500

£3,675

Paragraph 2(b)(iii)

£5,500

£5,775

Paragraph 2(b)(iv)

£10,000

£10,500

Paragraph 2(c)(i)

£600

£630

Paragraph 2(c)(ii)

£1,680

£1,764

Paragraph 2(c)(iii)

£2,510

£2,635

Paragraph 2(c)(iv)

£4,700

£4,935

Paragraph 2(d)

£115

£120

Paragraph 5(1)

£315

£330

Paragraph 5(1)

£690

£725

Part III of Schedule 3

Periodic fees for marketing authorizations and licences

In column 2 of the table in paragraph 1

Entry 1

£10,200

£10,710

Entry 2(a)

£4,000

£4,200

Entry 2(b)(i)

£1,000

£1,050

Entry 2(b)(ii)

£500

£525

Entry 2(b)(iii)

£165

£170

Entry 2(c)(i)

£440

£460

Entry 2(c)(ii)

£220

£230

Entry 2(c)(iii)

£80

£85

Entry 2(d)(i)

£180

£190

Entry 2(d)(ii)

£90

£95

Entry 2(d)(iii)

£40

£42

Entry 2(e)

£50

£52

Paragraph 2(a)

£225

£235

Paragraph 2(b)

£110

£115

Paragraph 2(c)

£45

£48

Paragraph 3(a)

£4,000

£4,200

Paragraph 3(b)

£2,700

£2,835

Paragraph 7

£200

£210

Paragraph 8(1)

£125

£130

Paragraph 8(2)

£75

£78