SCHEDULE

Regulation 5(9)

Annotations:
Marginal Citations
M1

Part IIA was inserted by regulation 6 of S.I. 2000/3031.

Column (1) Provision in the General Regulations

Column (2) Subject matter

Column (3) Old amount

Column (4) New amount

Regulation 6

Applications for certificates by exports of medicinal products

Paragraph (1)(a)

£100

£108

Paragraph (1)(b)

£44

£48

Paragraph (1)(c)(i)

£44

£48

Paragraph (1)(c)(ii)

£22

£24

Regulation 10

Renewal of clinical trial certificates

£1,885

£2,036

Regulation 11(1)

Renewals of certain manufacturer’s licences

£107

£116

Part II of Schedule I

Capital fees for applications for authorizations, licences and certificates

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

Entry 1(a)

£22,622

£24,431

Entry 1(b)

£48,389

£52,260

Entry 1(c)

£69,127

£74,657

Entry 2(a)

£13,196

£14,252

Entry 2(b)

£18,853

£20,361

Entry 3(a)

£4,835

£5,222

Entry 3(b)

£6,913

£7,466

Entry 4

£1,885

£2,036

Entry 5

£1,256

£1,356

Entry 6

£310

£335

Paragraph 5(1)(a)

£120

£130

Paragraph 5(1)(b)

£227

£245

Paragraph 5(1)(c)

£2,070

£2,236

Paragraph 6(1)

£814

£879

Paragraph 6(2)

£598

£646

Paragraph 6(4)

£262

£283

Paragraph 7

£14,579

£15,940

Part IIA of Schedule 1 M1

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

Paragraph 2(a)(i)

£30,000

£32,400

Paragraph 2(a)(ii)

£20,000

£21,600

Paragraph 2(b)(i)

£7,500

£8,100

Paragraph 2(b)(ii)

£5,000

£5,400

Paragraph 2(c)(i)

£3,000

£3,240

Paragraph 2(c)(ii)

£2,500

£2,700

Paragraph 2(d)

£1,795

£1,939

Part III of Schedule 1

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

Paragraph 2(a)

£184

£198

Paragraph 2(b)

£424

£458

Paragraph 2(c)

£6,282

£6,784

Paragraph 3(a)

£288

£310

Paragraph 3(b)

£514

£554

Paragraph 3(c)

£9,802

£10,586

Paragraph 6(a)

£120

£130

Paragraph 7(a)

£113

£122

Paragraph 7(b)

£227

£245

Paragraph 8

£113

£122

Paragraph 9

£262

£282

Paragraph 10

£113

£122

Paragraph 11

£185

£200

Paragraph 12

£95

£103

Schedule 2

Fees for inspections

Paragraph 2(a)(i)

£1,964

£2,121

Paragraph 2(a)(ii)

£3,643

£3,934

Paragraph 2(a)(iii)

£4,400

£4,752

Paragraph 2(a)(iv)

£7,541

£8,144

Paragraph 2(b)(i)

£2,136

£2,307

Paragraph 2(b)(ii)

£4,400

£4,752

Paragraph 2(b)(iii)

£6,911

£7,464

Paragraph 2(b)(iv)

£12,568

£13,573

Paragraph 2(c)(i)

£754

£814

Paragraph 2(c)(ii)

£2,110

£2,278

Paragraph 2(c)(iii)

£3,153

£3,405

Paragraph 2(c)(iv)

£5,906

£6,378

Paragraph 2(d)

£143

£154

Paragraph 5(1)

£395

£427

Paragraph 5(1)

£867

£936

Part III of Schedule 3

Periodic fees for marketing authorizations and licences

In column 2 of the Table in paragraph 1

Entry 1

£12,209

£13,186

Entry 2(a)

£5,027

£5,429

Entry 2(b)(i)

£1,257

£1,358

Entry 2(b)(ii)

£628

£678

Entry 2(b)(iii)

£204

£220

Entry 2(c)(i)

£550

£594

Entry 2(c)(ii)

£275

£297

Entry 2(c)(iii)

£102

£110

Entry 2(d)(i)

£227

£245

Entry 2(d)(ii)

£113

£122

Entry 2(d)(iii)

£50

£54

Entry 2(e)

£62

£67

Paragraph 2(a)

£280

£302

Paragraph 2(b)

£138

£149

Paragraph 2(c)

£58

£63

Paragraph 3(a)

£5,027

£5,429

Paragraph 3(b)

£3,394

£3,666

Paragraph 7

£251

£271

Paragraph 8(1)

£155

£167

Paragraph 8(2)

£93

£100