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

Citation, commencement and interpretation U.K.

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 M1 .

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

2.—(1) The Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 M2 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) M3 —

(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) M4 , 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 U.K.

F1 3.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 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))

Amendment of Part IA of the Medicines Fees Regulations U.K.

F1 4.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 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))

Amendment of Part VI of the Medicines Fees Regulations U.K.

F1 5.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 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))

Amendment of Part VII of the Medicines Fees Regulations U.K.

F1 6.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 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))

Amendment of Schedule 1 to the Medicines Fees Regulations U.K.

F1 7.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 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))

Amendment of Schedule 2 to the Medicines Fees Regulations U.K.

F1 8.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 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))

Amendment of Schedule 3 to the Medicines Fees Regulations U.K.

F1 9.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 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))

Amendment of Schedule 6 to the Medicines Fees Regulations U.K.

F1 10.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 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))

Increase in fee amounts prescribed by the Medicines Fees Regulations U.K.

F1 11.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 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))

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

12.—(1) The Medical Devices (Consultation Requirements) (Fees) Regulations 1995 M5 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—

(a)

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,

(b)

Commission Directive 2003/63/EC amending Directive 2001/83/EC,

(c)

Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC,

(d)

Directive 2004/27/EC of the European Parliament and of the Council also amending Directive 2001/83/EC, and

(e)

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—

“Fees for pre-consultation meetings

3A.— (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,

that person or notified body shall pay the fee specified in paragraph (2).

(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—

(a)

discover or verify the effects of such a substance,

(b)

identify any adverse reaction to such a substance, or

(c)

study absorption, distribution, metabolism and excretion of such a substance,

with the object of ascertaining the safety or efficacy of that substance, as required to verify the safety and usefulness of the substance in accordance with paragraph 7.4 of Annex I;

“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—

“Payment and recovery of fees

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 U.K.

13.—(1) The Medical Devices Regulations 2002 M6 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 U.K.

14.  The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007 M7 are hereby revoked.

Marginal Citations

M7 S.I. 2007/610

Signed by authority of the Secretary of State

Hunt

Minister of State

Department of Health

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

L.S.

Andrew McCormick

Permanent Secretary

Department of Health, Social Services and Public Safety

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

L.S.

Pat Toal

Permanent Secretary

Department of Agriculture and Rural Development

We consent,

Dave Watts

Frank Roy

Two of the Lords Commissioners of Her Majesty's Treasury