The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1999

Regulation 4(2)

SCHEDULEU.K.

Column (1)Column (2)Column (3)Column (4)
Provision in the General RegulationsSubject matterOld amountNew amount
Regulation 6Applications for certificates by exporters of medicinal products
Regulation 6(1)(a)£80£85
Regulation 6(1)(c)(ii)£14£15
Regulation 10Renewals of clinical trial certificates£1,500£1,575
Regulation 11(1)Renewals of certain manufacturers’ licences£85£90
Part II of Schedule 1Capital 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 1Capital 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 2Fees 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 3Periodic 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