SCHEDULE

Regulation 2(1)

Column (1)

Column (2)

Column (3)

Column (4)

Provision in the General Fees Regulations

Subject Matter

Old Amount

New Amount

Regulation 3B15

Capital fees for pre-application meetings

Paragraph (a)

£1,012

£1,118

Paragraph (b)

£1,346

£1,486

Paragraph (c)

£1,690

£1,866

Paragraph (d)

£2,024

£2,235

Regulation 3BA16

Capital fees for advertising advice meetings

£1,346

£1,486

Regulation 3BB17

Capital fees for pharmacovigilance advice meeting

Paragraph (a)

£1,690

£1,866

Paragraph (b)

£1,346

£1,486

Regulation 3BC18

Capital fees for advice meetings concerning labelling and leaflets

£1,012

£1,118

Regulation 3BD19

Capital fees for post authorisation regulatory advice meetings

£1,346

£1,486

Regulation 6

Applications for certificates by exporters of medicinal products

Paragraph (1)(a)

£118

£130

Paragraph (1)(b)

£53

£58

Paragraph (1)(c)(i)

£53

£58

Paragraph (1)(c)(ii)

£26

£29

Regulation 11

Renewal of certain manufacturer’s licences

£127

£152

Part II of Schedule 1

Capital fees for applications for authorizations, licences and certificates

In Column 2 of the Table in paragraph 120

Entry 1(a)

£25,802

£28,494

Entry 1(b)

£56,218

£61,959

Entry 1(c)

£56,218

£61,959

Entry 1(d)

£80,698

£88,993

Entry 1(e)

£115,098

£126,982

Entry 1(f)

£80,698

£88,993

Entry 2(a)

£15,689

£17,202

Entry 2(b)

£15,689

£17,202

Entry 2(c)

£22,366

£24,576

Entry 2(d)

£31,219

£34,353

Entry 2(e)

£22,366

£24,576

Entry 3(a)

£5,820

£6,304

Entry 3(b)

£5,820

£6,304

Entry 3(c)

£8,272

£9,011

Entry 3(d)

£11,813

£12,921

Entry 3(e)

£8,272

£9,011

Entry 4(a)

£2,337

£2,457

Entry 4(b)

£2,337

£2,457

Entry 5

£1,493

£1,638

Entry 6

£366

£404

Paragraph 1A(1)

£6,558

£7,824

Paragraph 4(4)(b)

£500

£594

Paragraph 5(1)(a)

£142

£156

Paragraph 5(1)(b)

£268

£295

Paragraph 5(1)(c)

£2,444

£2,688

Paragraph 6(1)

£1,402

£1,542

Paragraph 6(2)

£600

£660

Paragraph 6(4)

£310

£341

In Column 2 of the Table in paragraph 721

Entry 1

£610

£674

Entry 2

£2,700

£2,982

Entry 3

£2,250

£2,485

Entry 4

£140

£155

Part IIA of Schedule 122

Capital fees for assistance in obtaining marketing authorizations in other EEA States

Paragraph 2(a)(i)

£34,400

£37,989

Paragraph 2(a)(ii)

£22,596

£24,953

Paragraph 2(b)(i)

£8,853

£9,777

Paragraph 2(b)(ii)

£5,902

£6,518

Paragraph 2(c)(i)

£3,541

£3,910

Paragraph 2(c)(ii)

£2,951

£3,259

Paragraph 2(d)

£2,119

£2,340

Part III of Schedule 1

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

Paragraph 2(a)

£142

£170

Paragraph 2(aa)

£224

£266

Paragraph 2(b)

£590

£704

Paragraph 2(c)

£6,672

£7,964

Paragraph 2(cc)

£22,254

£24,576

Paragraph 2(d)

£6,558

£7,824

Paragraph 3(a)

£222

£264

Paragraph 3(aa)

£442

£526

Paragraph 3(b)

£714

£852

Paragraph 3(c)

£11,568

£13,808

Paragraph 3(d)

£31,106

£34,353

Paragraph 5A(1)

£500

£594

Paragraph 6(a)

£142

£158

Paragraph 6(b)

£6,558

£7,824

Paragraph 6(c)

£296

£326

Paragraph 7(a)

£200

£220

Paragraph 7(b)

£400

£440

Paragraph 8

£200

£220

Paragraph 9

£378

£416

Paragraph 10

£200

£220

Paragraph 11(1)(a)

£100

£110

Paragraph 11(1)(b)

£200

£220

Paragraph 11(1)(c)

£300

£330

Paragraph 15(a)(ii)

£500

£594

Paragraph 15(a)(iii)

£250

£297

Paragraph 15(b)(ii)

£250

£297

Part IIIA of Schedule 123

Capital fees for assessment of labels and leaflets

Paragraph 2(a)

£430

£472

Paragraph 2(b)

£273

£300

Part IV of Schedule 124

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 authorizations

Paragraph 1(a)

£7,415

£8,847

Paragraph 1(b)

£605

£722

Paragraph 2(a)(ii)

£605

£722

Paragraph 2(b)(ii)

£303

£361

Schedule 2

Fees for inspections

Paragraph 2(a)(i)

£2,534

£3,618

Paragraph 2(a)(ii)

£4,654

£6,645

Paragraph 2(a)(iii)

£5,610

£8,010

Paragraph 2(a)(iv)

£9,578

£13,676

Paragraph 2(b)(i)

£2,751

£3,928

Paragraph 2(b)(ii)

£5,610

£8010

Paragraph 2(b)(iii)

£8,782

£12,539

Paragraph 2(b)(iv)

£15,926

£22,740

Paragraph 2(c)(i)

£1,005

£1,563

Paragraph 2(c)(ii)

£2,717

£3,879

Paragraph 2(c)(iii)

£4,035

£5,761

Paragraph 2(c)(iv)

£7,512

£10,726

Paragraph 2(cc)(i)

£1,518

£2,243

Paragraph 2(cc)(ii)

£4,048

£5,856

Paragraph 2(cc)(iii)

£7,590

£10,914

Paragraph 2(d)

£221

£240

In column 2 in the Table in paragraph 2(f)25

Entry for “none”

£1,023

£1,461

Entry for “1 to 4”

£1,226

£1,751

Entry for “5 to 20”

£2,035

£2,906

Entry for “21 to 100”

£4,059

£5,796

Entry for “101 to 500”

£9,119

£9,484

Entry for “more than 500”

£16,203

£16,850

Paragraph 4A(1)(b)

£3,000

£4,284

Paragraph 4A(1)(c)

£4,000

£5,712

Paragraph 5(1)

£499

£712

Paragraph 5(1)

£1,095

£1,563

In column 2 in the Table in paragraph 5(3)26

Entry for “none”

£1,023

£1,461

Entry for “1 to 4”

£1,226

£1,751

Entry for “5 to 20”

£2,035

£2,906

Entry for “21 to 100”

£4,059

£5,796

Entry for “101 to 500”

£9,119

£9,484

Entry for “more than 500”

£16,203

£16,850

Paragraph 5A(a)27

£3,542

£5,057

Paragraph 5A(b)

£5,060

£7,225

Paragraph 5A(c)

£10,120

£14,450

Paragraph 5D(1)(a)28

£600

£800

Paragraph 5D(1)(b)

£1,100

£1,300

Paragraph 5D(1)(c)

£1,100

£1,300

Paragraph 7(4)(a)29

£3,000

£4,284

Paragraph 7(4)(b)

£5,000

£7,139

Paragraph 7(4)(c)

£10,000

£14,279

Paragraph 7(4)(d)

£15,000

£21,418

Paragraph 7(4)

£3,000

£4,284

Part III of Schedule 3

Periodic fees for marketing authorizations and licences

In column 2 of the Table in paragraph 1

Entry 1

£14,768

£17,278

Entry 2(a)

£6,080

£7,114

Entry 2(b)(i)

£1,521

£1,780

Entry 2(b)(ii)

£759

£888

Entry 2(b)(iii)

£247

£289

Entry 2(c)(i)

£666

£779

Entry 2(c)(ii)

£333

£390

Entry 2(c)(iii)

£123

£144

Entry 2(d)(i)

£275

£322

Entry 2(d)(ii)

£137

£160

Entry 2(d)(iii)

£60

£70

Entry 2(e)

£75

£88

Paragraph 2(a)

£338

£395

Paragraph 2(b)

£167

£195

Paragraph 2(c)

£71

£83

Paragraph 3(a)

£6,080

£7,114

Paragraph 3(b)

£4,105

£4,803

Paragraph 7(2)

£304

£356

Paragraph 8(1)

£187

£219

Paragraph 8(2)

£112

£131

Paragraph 1030

£200

£234