Regulation 3B M1

Capital fees for pre-application meetings

Paragraph (a)

£1,000

£1,012

Paragraph (b)

£1,330

£1,346

Paragraph (c)

£1,670

£1,690

Paragraph (d)

£2,000

£2,024

Regulation 6

Applications for certificates by Exporters of medicinal products

Paragraph (1)(a)

£117

£118

Paragraph (1)(b)

£52

£53

Paragraph (1)(c)(i)

£52

£53

Regulation 10

Renewal of clinical trial certificates

£2,199

£2,225

Regulation 11(1)

Renewals of certain manufacturer’s licences

£125

£127

Part II of Schedule 1 M2

Capital fees for applications for authorizations, licences and certificates

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

Entry 1(a)

£25,835

£25,690

Entry 1(b)

£55,441

£56,106

Entry 1(c)

£79,630

£80,586

Entry 2(a)

£15,392

£15,577

Entry 2(b)

£21,990

£22,254

Entry 3(a)

£5,640

£5,708

Entry 3(b)

£8,063

£8,160

Entry 4

£2,199

£2,225

Entry 5

£1,465

£1,483

Entry 6

£362

£366

Paragraph 1A(1)

£6,480

£6,558

Paragraph 4(4)(b)

£494

£500

Paragraph 5(1)(a)

£140

£142

Paragraph 5(1)(b)

£265

£268

Paragraph 5(1)(c)

£2,415

£2,444

Paragraph 6(1)

£949

£1,402

Paragraph 6(2)

£698

£600

Paragraph 6(4)

£306

£310

Paragraph 7

£17,215

£17,422

Part IIA of Schedule 1 M3

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

Paragraph 2(a)(i)

£33,992

£34,400

Paragraph 2(a)(ii)

£22,328

£22,596

Paragraph 2(b)(i)

£8,748

£8,853

Paragraph 2(b)(ii)

£5,832

£5,902

Paragraph 2(c)(i)

£3,499

£3,541

Paragraph 2(c)(ii)

£2,916

£2,951

Paragraph 2(d)

£2,094

£2,119

Part III of Schedule 1 M4

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

Paragraph 2(a)

£140

£142

Paragraph 2(aa)

£214

£224

Paragraph 2(b)

£494

£590

Paragraph 2(c)

£7,326

£6,672

Paragraph 2(cc)

£21,990

£22,254

Paragraph 2(d)

£6,480

£6,558

Paragraph 3(a)

£220

£222

Paragraph 3(aa)

£334

£442

Paragraph 3(b)

£598

£714

Paragraph 3(c)

£11,432

£11,568

Paragraph 3(d)

£30,738

£31,106

Paragraph 5A(1)

£494

£500

Paragraph 6(a)

£140

£142

Paragraph 6(b)

£6,480

£6,558

Paragraph 6(c)

£292

£296

Paragraph 7(a)

£132

£200

Paragraph 7(b)

£264

£400

Paragraph 8

£132

£200

Paragraph 9

£304

£378

Paragraph 10

£132

£200

Paragraph 11

£216

£218

Paragraph 15(a)(ii)

£494

£500

Paragraph 15(a)(iii)

£247

£250

Paragraph 15(b)(ii)

£247

£250

Part IIIA of Schedule 1 M5

Capital fees for assessment of labels and leaflets

Paragraph 2(a)

£350

£319

Paragraph 2(b)

£270

£273

Part IV of Schedule 1 M6

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)

£7,327

£7,415

Paragraph 1(b)

£598

£605

Paragraph 2(a)(ii)

£598

£605

Paragraph 2(b)(ii)

£299

£303

Schedule 2

Fees for inspections

Paragraph 2(a)(i)

£2,291

£2,481

Paragraph 2(a)(ii)

£4,249

£4,601

Paragraph 2(a)(iii)

£5,132

£5,557

Paragraph 2(a)(iv)

£8,796

£9,525

Paragraph 2(b)(i)

£2,492

£2,698

Paragraph 2(b)(ii)

£5,132

£5,557

Paragraph 2(b)(iii)

£8,061

£8,729

Paragraph 2(b)(iv)

£14,659

£15,873

Paragraph 2(c)(i)

£879

£952

Paragraph 2(c)(ii)

£2,460

£2,664

Paragraph 2(c)(iii)

£3,677

£3,982

Paragraph 2(c)(iv)

£6,888

£7,459

Paragraph 2(cc)(i)

£1,500

£1,518

Paragraph 2(cc)(ii)

£4,000

£4,048

Paragraph 2(cc)(iii)

£7,500

£7,590

Paragraph 2(d)

£166

£168

Paragraph 5(1)

£461

£499

Paragraph 5(1)

£1,011

£1,095

In column 2 of the Table in paragraph 5(3) M7

Entry for “None”

£1,011

£1,023

Entry for “1 to 4”

£1,211

£1,226

Entry for “5 to 20”

£2,011

£2,035

Entry for “21 to 100”

£4,011

£4,059

Entry for “101 to 500”

£9,011

£9,119

Entry for “More than 500”

£16,011

£16,203

Paragraph 5A(a) M8

£3,500

£3,542

Paragraph 5A(b)

£5,000

£5,060

Paragraph 5A(c)

£10,000

£10,120

Part III of Schedule 3

Periodic fees for marketing authorizations and licences

In column 2 of the Table in paragraph 1

Entry 1

£14,241

£14,768

Entry 2(a)

£5,863

£6,080

Entry 2(b)(i)

£1,467

£1,521

Entry 2(b)(ii)

£732

£759

Entry 2(b)(iii)

£238

£247

Entry 2(c)(i)

£642

£666

Entry 2(c)(ii)

£321

£333

Entry 2(c)(iii)

£119

£123

Entry 2(d)(i)

£265

£275

Entry 2(d)(ii)

£132

£137

Entry 2(d)(iii)

£58

£60

Entry 2(e)

£72

£75

Paragraph 2(a)

£326

£338

Paragraph 2(b)

£161

£167

Paragraph 2(c)

£68

£71

Paragraph 3(a)

£5,863

£6,080

Paragraph 3(b)

£3,959

£4,105

Paragraph 7

£293

£304

Paragraph 8(1)

£180

£187

Paragraph 8(2)

£108

£112