The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007

Made: 12th March 2007

Laid before Parliament: 16th March 2007

Coming into force

The Secretary of State for Health, the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development, acting jointly, make the following Regulations in exercise of the powers conferred on them by section 1(1) and (2) of the Medicines Act 1971 or, as the case may be, the powers conferred by those provisions and now vested in them .

In so far as these Regulations are not made under section 1(1) and (2) of the Medicines Act 1971, the Secretary of State makes these Regulations in exercise of the powers conferred on her by section 2(2) of the European Communities Act 1972 and section 56(1) and (2) of the Finance Act 1973 . The Secretary of State has been designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to medicinal products and medical devices .

The Treasury has consented to the making of these Regulations as required by section 1(1) of the Medicines Act 1971 and section 56(1) of the Finance Act 1973.

In accordance with section 129(6) of the Medicines Act 1968 , the Secretary of State for Health, the Department of Health, Social Services and Public Safety Development and the Department of Agriculture and Rural Development have consulted with such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations.

Citation, commencement and interpretation

1

• (1) These Regulations may be cited as the Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007 and shall come into force—

• (a) for the purposes of regulation 14, on 13th March 2007; and

• (b) for all other purposes, on 1st April 2007.

• (2) In these Regulations, “the Medicines Fees Regulations” means the Medicines (Products for Human Use—Fees) Regulations 1995 .

Amendment of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994

2

• (1) The Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 are amended as follows.

• (2) In regulation 14 (fees for variations of certificates)—

• (a) in paragraph (2)(a), for “£226” substitute “£237”;

• (b) in paragraph (2)(b)(i), for “£226” substitute “£237”;

• (c) in paragraph (2)(b)(ii), for “£226” substitute “£237”;

• (d) in paragraph (2)(b)(iii), for “£114” substitute “£120”; and

• (e) in paragraph (2)(b)(iv), for “£57” substitute “£60”.

• (3) In regulation 15 (fees payable by holders of certificates), in paragraph (1), for “£15” substitute “ £19 ”.

• (4) In the table in Schedule 2 (fees for applications for the grant of certificates of registration) —

• (a) in column (2) (fees for applications in respect of products prepared from not more than 5 homoeopathic stocks)—

• (i) for “£148” substitute “ £155 ”,

• (ii) for “£444” substitute “ £466 ”,

• (iii) in paragraph 3, for “£465” substitute “ £488 ”, and

• (iv) for “£734” substitute “ £770 ”; and

• (b) in column (3) (fees for other applications)—

• (i) for “£365” substitute “ £383 ”,

• (ii) for “£654” substitute “ £686 ”,

• (iii) in paragraph 3, for “£608” substitute “ £622 ”, and

• (iv) for “£960” substitute “ £1,007 ”.

• (5) In Schedule 2A (fees for assistance in obtaining certificates of registration in other EEA States) , in paragraph 2—

• (a) in sub-paragraph (a), for “£266” substitute “ £279 ”; and

• (b) in sub-paragraph (b), for “£348” substitute “£365”.

Amendment of Part I of the Medicines Fees Regulations

3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of Part IA of the Medicines Fees Regulations

4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of Part VI of the Medicines Fees Regulations

5

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of Part VII of the Medicines Fees Regulations

6

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of Schedule 1 to the Medicines Fees Regulations

7

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of Schedule 2 to the Medicines Fees Regulations

8

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of Schedule 3 to the Medicines Fees Regulations

9

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of Schedule 6 to the Medicines Fees Regulations

10

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Increase in fee amounts prescribed by the Medicines Fees Regulations

11

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of the Medical Devices (Consultation Requirements) (Fees) Regulations 1995

12

• (1) The Medical Devices (Consultation Requirements) (Fees) Regulations 1995 are amended as follows.

• (2) In regulation 1 (citation, commencement and interpretation), in paragraph (2)—

• (a) for the definitions of “Annex II” and “Annex III” substitute the following definitions—

“Annex I”, “Annex II” and “Annex III” mean respectively Annex I, Annex II and Annex III to the Directive;

• (b) in the definition of “competent body”, for the words from “Directive 2001/83/EC” to the end substitute “ the 2001 Directive ”;

• (c) after the definition of “the Directive” insert the following definition—

“the 2001 Directive” means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use, as amended by— 1. Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components, 2. Commission Directive 2003/63/EC amending Directive 2001/83/EC, 3. Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC, 4. Directive 2004/27/EC of the European Parliament and of the Council also amending Directive 2001/83/EC, and 5. Regulation (EC) No. 1901/2006 of the European Parliament and of the Council on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004;

• (d) omit the definition of “fee”;

• (e) in the definition of “manufacturing authorisation”, for the words from “Directive 2001/83/EC” to the end substitute “ the 2001 Directive ”; and

• (f) in the definition of “medicinal substance”, for the words from “Directive 2001/83/EC” to the end substitute “ the 2001 Directive ”.

• (3) In regulation 2 (circumstances in which a fee is payable), in paragraph (1), after “pay a fee” insert “ specified by, or determined under, regulation 3 ”.

• (4) In regulation 3 (fees)—

• (a) in paragraph (1)—

• (i) in sub-paragraph (a), for “£3,948” substitute “£4,141”, and

• (ii) in sub-paragraph (b), for “£9,202” substitute “£9,653”;

• (b) in paragraph (2)—

• (i) in sub-paragraph (a), for “£781” substitute “ £819 ”, and

• (ii) in sub-paragraph (b), for “£2,184” substitute “£2,291”;

• (c) in paragraph (3)—

• (i) in sub-paragraph (a), for “£3,948” substitute “£4,141”, and

• (ii) in sub-paragraph (b), for “£9,262” substitute “£9,653”;

• (d) in paragraph (4)—

• (i) in sub-paragraph (a), for “£781” substitute “ £819 ”, and

• (ii) in sub-paragraph (b), for “£2,184” substitute “£2,291”; and

• (e) in paragraph (5)—

• (i) in sub-paragraph (a), for “£40,374” substitute “£42,352”, and

• (ii) in sub-paragraph (b), for “£10,024” substitute “£10,515”.

• (5) After regulation 3 insert the following regulation—

(3A) that person or notified body shall pay the fee specified in paragraph (2). (1) Where the Department of Health holds a meeting— (a) with a person other than a notified body for the purpose of providing scientific advice to that person with a view to him making an application for an EC examination certificate in relation to a medical device incorporating a medicinal substance, or (b) with a notified body for the purpose of providing scientific advice to that body with a view to that body consulting the Department in relation to an application for an EC examination certificate in relation to a medical device incorporating a medicinal substance, (2) The fee payable shall be— (a) if the advice provided at that meeting consists of advice in connection with— (i) quality development only, or (i) safety development only, £750; (b) if the advice provided at that meeting consists of advice in connection with— (i) quality and safety development only, or (i) clinical development only, £950; (c) if the advice provided at that meeting consists of advice in connection with— (i) quality and clinical development only, or (i) safety and clinical development only, £1,300; (a) if the advice provided at that meeting consists of advice in connection with quality, safety and clinical development, £1,650. (3) In this regulation— - “clinical development” means the conduct of studies of a medicinal substance in human subjects in order to— 1. discover or verify the effects of such a substance, 2. identify any adverse reaction to such a substance, or 3. study absorption, distribution, metabolism and excretion of such a substance, - “quality development” means the chemical, pharmaceutical and biological testing required in order to verify the quality of a medicinal substance in accordance with paragraph 7.4 of Annex I; - “safety development” means the toxicological and pharmacological testing required in order to verify the safety of a medicinal substance in accordance with paragraph 7.4 of Annex I; and - “scientific advice” means advice in connection with the quality, safety or clinical development for a medicinal substance incorporated, or to be incorporated, in a medical device.

• (6) For regulation 4 (payment and recovery of fees) substitute the following regulation—

(4) (1) Any fee payable in accordance with regulations 2 and 3 shall be paid to the Secretary of State not later than the day on which a notified body consults the competent body. (2) Any fee payable in accordance with regulation 3A shall become payable within 14 days following written notice from the Department of Health requiring payment of that fee. (3) All unpaid sums due on account of any fee payable under these Regulations shall be recoverable as debts due to the Crown.

Amendment of the Medical Devices Regulations 2002

13

• (1) The Medical Devices Regulations 2002 shall be amended as follows.

• (2) In regulation 54 (fees payable in connection with the designation etc of UK notified bodies)—

• (a) in paragraph (1)—

• (i) in sub-paragraph (a), for “£650” substitute “ £850 ”, and

• (ii) in sub-paragraph (b), for “£2,600” substitute “£3,400”;

• (b) in paragraph (2), for “£1,300” substitute “£1,700”;

• (c) in paragraph (3), for sub-paragraphs (a) to (c) substitute the following sub-paragraphs—

(a) in respect of an initial inspection pursuant to regulation 45(7)(a), a fee of £4,200 plus the amounts specified in paragraph (3A); (b) in respect of an inspection pursuant to regulation 45(7)(a), other than an initial inspection— (i) if the inspection is for the purposes of deciding whether or not the body is one in respect of which the criteria set out in all three of the Annexes referred to in this paragraph are met, a fee of £6,800, (ii) if the inspection is for the purpose of deciding whether or not the body is one in respect of which the criteria set out in only two of the three Annexes referred to in this paragraph are met, a fee of £5,100, or (iii) if the inspection is for the purposes of deciding whether or not the body is one in respect of which the criteria set out in only one of the Annexes referred to in this paragraph are met, or for the purposes of deciding whether or not a body is capable of fulfilling the functions of an importing Party arising out of the Mutual Recognition Agreements which it needs to be able to fulfil, a fee of £3,400, plus the amounts specified in paragraph (3A); and (c) in respect of an inspection pursuant to regulation 45(7)(b), a fee of £3,400 plus the amounts specified in paragraph (3A).

; and

• (d) after paragraph (3), insert the following paragraphs—

(3A) Subject to paragraph (3B), the additional amounts payable in respect of an inspection referred to in paragraph (3) shall be— (a) an amount for time spent by a member of staff undertaking a site visit at a rate— (i) for the time spent on site, of £240 per half day (periods of less than a half day counting as a half day) up to a maximum of two half days on any one date, and (ii) for the time spent travelling to and from the site, of £67.10 per hour; (b) the actual costs of travel, accommodation and subsistence; and (c) out of pocket expenses. (3B) Where the Secretary of State conducts an inspection referred to in paragraph (3)(a) on the same date and at the same premises as an inspection pursuant to regulation 48(7)(a)— (a) the amount referred to in paragraph (3A)(3) shall include an amount for any time spent on site by a member of staff which is attributable to the conduct of the inspection pursuant to regulation 48(7)(a), at the rate referred to paragraph (3A)(a)(i); and (b) the costs and expenses referred to in paragraph (3A)(b) and (c) shall include any additional costs and expenses attributable to the conduct of the inspection pursuant to regulation 48(7)(a).

• (3) In regulation 55 (fees payable in connection with the designation etc of EC conformity assessment bodies)—

• (a) in paragraph (1)—

• (i) in sub-paragraph (a), for “£650” substitute “ £850 ”, and

• (ii) in sub-paragraph (b), for “£2,600” substitute “£3,400”;

• (b) in paragraph (2), for “£1,300” substitute “£1,700”;

• (c) in paragraph (3)—

• (i) at the beginning insert “ Subject to paragraphs (3A) to (3C) ”, and

• (ii) for paragraphs (a) to (c) substitute the following sub-paragraphs—

(a) in respect of an initial inspection pursuant to regulation 48(7)(a), other than an inspection referred to in sub-paragraph (c), fee of £4,200 plus the amounts specified in paragraph (3D); (b) in respect of any other inspection pursuant to regulation 48(7)(a), other than an inspection referred to in sub-paragraph (c), a fee of £3,400 plus the amounts specified in paragraph (3D); (c) in respect of an inspection pursuant to regulation 48(7)(a) conducted on the same date and at the same premises as an inspection pursuant to regulation 45(7), a fee of £1,700; (d) in respect of an inspection pursuant to regulation 48(7)(b), a fee of £3,400 plus the amounts specified in paragraph (3D).

; and

• (d) after paragraph (3), insert the following paragraphs—

(3A) Where the Secretary of State conducts two or more inspections pursuant to regulation 48(7)(a) on the same date and at the same premises, other than inspections referred to in paragraph (3)(c), and one of the inspections is an initial inspection, the fee payable shall be £4,200 plus— (a) £1,700 for each additional inspection; and (b) the amounts specified in paragraph (3D). (3B) Where the Secretary of State conducts two or more inspections pursuant to regulation 48(7)(a) on the same date and at the same premises, other than inspections referred to in paragraph (3)(c), and none of the inspections is an initial inspection, the fee payable shall be £3,400 plus— (a) £1,700 for each additional inspection; and (b) the amounts specified in paragraph (3D) (3C) Where the Secretary of State conducts two or more inspections referred to in paragraph (3)(c) on the same date and at the same premises, the fee payable for the inspections pursuant to regulation 48(7)(a) shall be £1,700 for each inspection. (3D) The additional amounts payable in respect of an inspection referred to in paragraphs (3) to (3B) shall be— (a) an amount for time spent by a member of staff undertaking a site visit at a rate— (i) for the time spent on site, of £240 per half day (periods of less than a half day counting as a half day) up to a maximum of two half days on any one date, and (ii) for the time spent travelling to and from the site, of £67.10 per hour; (b) the actual costs of travel, accommodation and subsistence, and (c) out of pocket expenses.

• (4) In regulation 56 (fees payable in relation to clinical investigations), in paragraph (1)—

• (a) in sub-paragraph (a)—

• (i) in sub-paragraph (i), for “£1,600” substitute “£1,800”, and

• (ii) in sub-paragraph (ii), for “£2,100” substitute “£2,400”; and

• (b) in sub-paragraph (b)—

• (i) in sub-paragraph (i), for “£2,200” substitute “£2,700”, and

• (ii) in sub-paragraph (ii), for “£3,000” substitute “£3,800”.

Revocation of regulations

14

The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007 are hereby revoked.

SCHEDULE

Column (1) Provision in the Medicines Fees Regulations	Column (2) Subject Matter	Column (3) Old Amount	Column (4) New Amount
Regulation 3B	Capital fees for pre-application meetings
Paragraph (a)		£1,118	£2,108
Paragraph (c)		£1,866	£3,474
Paragraph (d)		£2,235	£4,300
Regulation 3BA	Capital fees for advertising advice meetings	£1,486	£2,108
Regulation 3BB	Capital fees for pharmacovigilance meetings
Paragraph (a)		£1,866	£3,474
Paragraph (b)		£1,486	£2,934
Regulation 3BC	Capital fees for advice meetings concerning labelling and leaflets	£1,118	£2,108
Regulation 3BD	Capital fees for post authorisation regulatory advice meetings	£1,486	£2,648
Part II of Schedule 1	Capital fees for applications for authorizations, licences and certificates
Paragraph 1A(1)		£7,824	£8,206
Paragraph 4(4)(b)		£594	£738
In Column (2) of the table in paragraph 4A
Entry 1		£480	£503
Entry 2		£752	£788
Entry 3		£1,010	£1,060
In Column (3) of the table in paragraph 4A
Entry 1		£680	£713
Entry 2		£942	£988
Entry 3		£1,219	£1,278
Paragraph 4A(5)		£2,000	£2,098
Paragraph 4A(6)		£6,672	£6,998
Paragraph 4A(7)		£590	£618
In Column 2 of the table in paragraph 7
Entry 1		£674	£707
Entry 2		£2,982	£3,128
Entry 3		£2,485	£2,607
Entry 4		£155	£163
Paragraph 7(3)		£100	£105
Paragraph 7(4)		£140	£147
In Column 2 of the table in paragraph 8(1)
Entry 1(a)		£4,500	£4,720
Entry 1(b)		£6,750	£7,081
Entry 2(a)		£2,250	£2,360
Entry 2(b)		£3,375	£3,540
Entry 3(a)		£750	£787
Entry 3(b)		£1,125	£1,180
Entry 4(a)		£500	£525
Entry 4(b)		£750	£787
Entry 5		£366	£384
Paragraph 8(3)(a)		£1,000	£1,049
Paragraph 8(3)(b)		£2,000	£2,098
Paragraph 8(4)		£6,672	£6,999
Paragraph 8(5)		£590	£622
Paragraph 8(6)		£2,000	£2,098
Part IIA of Schedule 1[^f00032]	Capital fees for assistance in obtaining marketing authorizations in other EEA states
Paragraph 2(a)(i)		£37,989	£39,850
Paragraph 2(a)(ii)		£24,953	£26,176
Paragraph 2(b)(i)		£9,777	£10,256
Paragraph 2(b)(ii)		£6,518	£6,837
Paragraph 2(c)(i)		£3,910	£4,102
Paragraph 2(c)(ii)		£3,259	£3,419
Paragraph 2(d)		£2,340	£2,455
Part III of Schedule 1	Capital fees for applications for variations of authorizations, licences and certificates
Paragraph 5A(1)		£594	£738
Paragraph 5B(a)		£218	£237
Paragraph 5B(b)		£350	£367
Paragraph 5B(c)		£110	£120
Paragraph 6(a)		£158	£166
Paragraph 6(b)		£7,824	£8,206
Paragraph 6(c)		£326	£342
Paragraph 11(1)(a)		£110	£115
Paragraph 11(1)(b)		£220	£231
Paragraph 11(1)(c)		£330	£346
Paragraph 11A(a)		£224	£234
Paragraph 11A(b)		£590	£618
Paragraph 11A(c)		£6,672	£6,998
Paragraph 11A(d)		£142	£148
Paragraph 15(a)(ii)		£594	£738
Paragraph 15(a)(iii)		£297	£369
Paragraph 15(b)(ii)		£297	£369
Part IIIA of Schedule 1[^f00033]	Capital fees for assessment of labels and leaflets
Paragraph 2(a)		£472	£496
Paragraph 2(b)		£300	£314
Part IV of Schedule 1[^f00034]	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)		£8,847	£9,281
Paragraph 1(b)		£722	£756
Paragraph 2(a)(ii)		£722	£756
Paragraph 2(b)(ii)		£361	£378
Schedule 2	Fees for inspections
Paragraph 2(a)(i)		£3,618	£3,795
Paragraph 2(a)(ii)		£6,645	£6,971
Paragraph 2(a)(iii)		£8,010	£8,402
Paragraph 2(a)(iv)		£13,676	£14,346
Paragraph 2(b)(i)		£3,928	£4,120
Paragraph 2(b)(ii)		£8,010	£8,402
Paragraph 2(b)(iii)		£12,539	£13,153
Paragraph 2(b)(iv)		£22,740	£23,854
Paragraph 2(c)(i)		£1,563	£1,640
Paragraph 2(c)(ii)		£3,879	£4,069
Paragraph 2(c)(iii)		£5,761	£6,043
Paragraph 2(c)(iv)		£10,726	£11,252
Paragraph 2(cc)(i)		£2,243	£2,353
Paragraph 2(cc)(ii)		£5,856	£6,143
Paragraph 2(cc)(iii)		£10,914	£11,449
Paragraph 2(d)		£240	£252
Paragraph 2A(a)		£2,534	£3,795
Paragraph 2A(b)		£4,654	£6,971
Paragraph 2A(c)		£5,610	£8,402
Paragraph 2A(d)		£9,578	£14, 346
Paragraph 4A(1)(a)		£2,000	£2,996
Paragraph 4A(1)(b)		£4,284	£4,494
Paragraph 4A(1)(c)		£5,712	£5,992
Paragraph 4A(2)(a)		£500	£750
Paragraph 4A(2)(b)		£1,250	£1,875
Paragraph 4A(2)(c)		£2,000	£3,000
Paragraph 5(1)		£712	£747
Paragraph 5(1)		£1,563	£1,640
Paragraph 5A(a)		£5,057	£6,068
Paragraph 5A(b)		£7,225	£8,670
Paragraph 5A(c)		£14,450	£17,340
Paragraph 5B(1) (a)		£800	£839
Paragraph 5B(1)(b)		£1,300	£1,364
Paragraph 5B(1)(c)		£1,300	£1,364
Paragraph 5C(1)(a)		£600	£629
Paragraph 5C(1)(b)		£1,100	£1,154
Paragraph 5C(1)(c)		£1,100	£1,154
Paragraph 5D(1)(a)		£800	£839
Paragraph 5D(1)(b)		£1,300	£1,364
Paragraph 5D(1)(c)		£1,300	£1,364
Paragraph 7(4)(a)		£4,284	£5,141
Paragraph 7(4)(b)		£7,139	£8,567
Paragraph 7(4)(c)		£14,279	£17,135
Paragraph 7(4)(d)		£21,418	£25,702
Paragraph 7(4)		£4,284	£5,141
Part III of Schedule 3	Periodic fees for marketing authorizations and licences
In column 2 of the Table in paragraph 1
Entry 1		£17,278	£18,573
Entry 2(a)		£7,114	£7,648
Entry 2(b)(i)		£1,780	£1,913
Entry 2(b)(ii)		£888	£955
Entry 2(b)(iii)		£289	£310
Entry 2(c)(i)		£779	£837
Entry 2(c)(ii)		£390	£419
Entry 2(c)(iii)		£144	£155
Entry 2(d)(i)		£322	£346
Entry 2(d)(ii)		£160	£172
Entry 2(d)(iii)		£70	£75
Entry 2(e)		£88	£95
Entry 2(g)		£63	£68
Paragraph 2(a)		£395	£425
Paragraph 2(b)		£195	£210
Paragraph 2(c)		£83	£89
Paragraph 3(a)		£7,114	£7,648
Paragraph 3(b)		£4,803	£5,163
Paragraph 7(a)		£356	£383
Paragraph 7(b)		£356	£383
Paragraph 8(1)		£219	£235
Paragraph 8(2)		£131	£141
Paragraph 10		£234	£252
Paragraph 11		£75	£80

Signed

Signed by authority of the Secretary of State

Hunt — Minister of State — 2007-03-08

Sealed with the Official Seal of the Department of Health, Social Services and Public Safety

Andrew McCormick — Permanent Secretary — 2007-03-08

Sealed with the Official Seal of the Department of Agriculture and Rural Development

Pat Toal — Permanent Secretary — 2007-03-08

We consent,

Dave Watts — Frank Roy — Two of the Lords Commissioners of Her Majesty's Treasury — 2007-03-12

Explanatory note

(This note is not part of the Regulations)

Footnotes

[^f00001]: 1971 c.69; as amended by section 21 of the Health and Medicines Act 1988 (c.49). By virtue of section 1(3) of the 1971 Act, expressions used in that section have the same meaning as in the Medicines Act 1968 (c.67) as amended by S.I. 1969/388; see therefore section 1(1) of the 1968 Act, as amended by Schedule 1 to S.I. 1969/388, which contains a definition of “the Ministers” which is relevant to the powers being exercised in the making of these Regulations. See also regulation 9(12) of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (S.I. 1994/3144), by virtue of which the references in section 1(1) and (2)(b) of the 1971 Act to a licence under Part II of the 1968 Act include reference to a marketing authorization under the 1994 Regulations.

[^f00002]: In the case of the Secretary of State, by virtue of article 2(1) of S.I. 1999/3142 and article 3(1)(c) and (7) of S.I. 2002/794. In the case of the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development, by virtue of the powers vested in the Ministers in charge of those Departments by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c.47), which may now be exercised by the Department by virtue of section 1(8) of, and paragraph 4(1)(b) of the Schedule to, the Northern Ireland Act 2000 (c.1); the Departments were renamed by virtue of Article 3(4) and (6) of S.I. 1999/283 (N.I. 1).

[^f00003]: 1972 c.68.

[^f00004]: 1973 c.51.

[^f00005]: S.I. 1972/181.

[^f00006]: The Secretary of State was designated in relation to measures relating to active implantable medical devices in S.I. 1991/2289, and in relation to measures relating to medical devices other than active implantable medical devices in S.I. 1993/2661.

[^f00007]: 1968 c.67; section 129(6) was extended by section 1(3)(b) of the Medicines Act 1971.

[^f00008]: S.I. 1995/1116, as amended by S.I. 1996/683, 1998/574, 1999/566, 2000/592 and 3031, 2001/795, 2002/236 and 542, 2003/625 and 2321, 2004/666 and 1157, 2005/1124 and 2979, and 2006/494 and 2125.

[^f00009]: S.I. 1994/105; relevant amending instruments are S.I. 1996/482, 2005/2753 and 2006/494.

[^f00010]: Schedule 2 was substituted by S.I. 1996/482; the table was substituted by S.I. 2005/2753 and amended by S.I. 2006/494.

[^f00011]: Schedule 2A was inserted by S.I. 2005/2753.

[^f00012]: OJ No. L311, 28.11.2001, p.67.

[^f00013]: OJ No. L33, 8.2.2003, p.30.

[^f00014]: OJ No. L159, 27.6.2003, p.46.

[^f00015]: OJ No. L136, 30.4.2004, p.85.

[^f00016]: OJ No. L136, 30.4.2004, p.34.

[^f00017]: OJ No. L378, 27.12.2006, p.1.

[^f00018]: See regulation 2(1) of the Medicines Fees Regulations for the definition of “the 1994 Regulations”.

[^f00019]: S.I. 2005/2789.

[^f00020]: Part IA was inserted by S.I. 2003/625 and amended by S.I. 2003/2321, 2004/666, 2005/2979 and 2006/494.

[^f00021]: OJ No. L169, 12.7.93, p.1; there are other amendments to the Directive but none are relevant.

[^f00022]: OJ No. L313, 13.2.2000, p.22.

[^f00023]: S.I. 2004/2011; the relevant amending instrument is S.I. 2006/1928.

[^f00024]: Regulation 14A was inserted by S.I. 2004/1157 and amended by S.I. 2005/2979.

[^f00025]: The definition was amended by S.I. 2002/542, 2004/666 and 2005/2979.

[^f00026]: OJ No. L159, 27.6.2003, p.1.

[^f00027]: Volume 2B of “The Rules Governing Medicinal Products in the European Union” is available at http://ec.europa.eu/enterprise/pharmaceuticals/index_en.htm.

[^f00028]: The MHRA Portal may be accessed at http://portal.mhra.gov.uk.

[^f00029]: S.I. 1995/449; relevant amending instrument is S.I. 2006/494.

[^f00030]: S.I. 2002/618, to which there are amendments not relevant to this instrument.

[^f00031]: S.I. 2007/610

[^f00032]: Part IIA was inserted by regulation 6 of S.I. 2000/2031.

[^f00033]: Part IIIA of Schedule 1 was inserted by regulation 4(1) and (6) of S.I. 2003/625.

[^f00034]: Part IV of Schedule 1 was inserted by regulation 5(7) of S.I. 2002/542.

[^f00035]: OJ No. L297, 13.10.92, p.8.

[^f00036]: See articles 1(5), 13 to 16, 53, 68, 69, 85, 100, 119 and 124; relevant amendments to Directive 2001/83/EC were made by Directive 2004/27/EC.

[^f00037]: OJ No. L169, 12.7.93, p.1; relevant amendments are made by Directive 2000/70/EC of the Council and of the Parliament amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivatives of human blood or human plasma.

[^f00038]: OJ No. L189, 20.7.90, p.17.

[^f00039]: OJ No. L331, 7.12.98, p.1.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Editorial notes

[^c18358501]: 1971 c.69; as amended by section 21 of the Health and Medicines Act 1988 (c.49). By virtue of section 1(3) of the 1971 Act, expressions used in that section have the same meaning as in the Medicines Act 1968 (c.67) as amended by S.I. 1969/388; see therefore section 1(1) of the 1968 Act, as amended by Schedule 1 to S.I. 1969/388, which contains a definition of “the Ministers” which is relevant to the powers being exercised in the making of these Regulations. See also regulation 9(12) of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (S.I. 1994/3144), by virtue of which the references in section 1(1) and (2)(b) of the 1971 Act to a licence under Part II of the 1968 Act include reference to a marketing authorization under the 1994 Regulations.

[^c18358511]: In the case of the Secretary of State, by virtue of article 2(1) of S.I. 1999/3142 and article 3(1)(c) and (7) of S.I. 2002/794. In the case of the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development, by virtue of the powers vested in the Ministers in charge of those Departments by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c.47), which may now be exercised by the Department by virtue of section 1(8) of, and paragraph 4(1)(b) of the Schedule to, the Northern Ireland Act 2000 (c.1); the Departments were renamed by virtue of Article 3(4) and (6) of S.I. 1999/283 (N.I. 1).

[^c18358521]: 1972 c.68.

[^c18358531]: 1973 c.51.

[^c18358541]: S.I. 1972/181.

[^c18358551]: The Secretary of State was designated in relation to measures relating to active implantable medical devices in S.I. 1991/2289, and in relation to measures relating to medical devices other than active implantable medical devices in S.I. 1993/2661.

[^c18358561]: 1968 c.67; section 129(6) was extended by section 1(3)(b) of the Medicines Act 1971.

[^c18358571]: S.I. 1995/1116, as amended by S.I. 1996/683, 1998/574, 1999/566, 2000/592 and 3031, 2001/795, 2002/236 and 542, 2003/625 and 2321, 2004/666 and 1157, 2005/1124 and 2979, and 2006/494 and 2125.

[^c18358581]: S.I. 1994/105; relevant amending instruments are S.I. 1996/482, 2005/2753 and 2006/494.

[^c18358591]: Schedule 2 was substituted by S.I. 1996/482; the table was substituted by S.I. 2005/2753 and amended by S.I. 2006/494.

[^c18358601]: Schedule 2A was inserted by S.I. 2005/2753.

[^c18358781]: S.I. 1995/449; relevant amending instrument is S.I. 2006/494.

[^c18358791]: S.I. 2002/618, to which there are amendments not relevant to this instrument.

[^c18358801]: S.I. 2007/610

[^c18358841]: OJ No. L297, 13.10.92, p.8.

[^c18358851]: See articles 1(5), 13 to 16, 53, 68, 69, 85, 100, 119 and 124; relevant amendments to Directive 2001/83/EC were made by Directive 2004/27/EC.

[^c18358861]: OJ No. L169, 12.7.93, p.1; relevant amendments are made by Directive 2000/70/EC of the Council and of the Parliament amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivatives of human blood or human plasma.

[^c18358871]: OJ No. L189, 20.7.90, p.17.

[^c18358881]: OJ No. L331, 7.12.98, p.1.

[^key-46c51bf9ac98749ea5d3a5c861e84dd7]: Regs. 3-11 revoked (1.4.2008) by The Medicines (Products for Human Use-Fees) Regulations 2008 (S.I. 2008/552), regs. 1, 48(1), Sch. 7 (with reg. 48(2))