The Medicines and Healthcare Products Regulatory Agency Trading Fund Order 2003

Citation, commencement and interpretation U.K.

1.—(1) This Order may be cited as the Medicines and Healthcare Products Regulatory Agency Trading Fund Order 2003 and shall come into force on 1st April 2003.

(2) In this Order—

“the 1968 Act” means the Medicines Act 1968 M1 ;

[F1 “device evaluation services” means services consisting of or relating to the evaluation of medical devices or similar devices, or the components of such devices, for the purpose of determining—

(i)

the performance of those devices or components,

(ii)

the ease with which they can be used,

(iii)

whether they are suitable for use in different environments or for different purposes, or,

(iv)

how the safety and performance of one device or component compares with that of other devices or components intended for use for the same purpose;]

“the fund” means the fund established by Article 2 of this Order;

“funded operations” means the operations described in Schedule 1 to this Order;

“reference substance” means a chemical or biological reference preparation used in tests or assays in connection with or related to the production of medicinal products or similar products; and

“tissue bank” means any place where human tissue or cells are stored or processed.

(3) In this Order expressions defined in the 1968 Act, [F2 the Human Medicines Regulations 2012], [F3 the Medical Devices Regulations 2002 or the Blood Safety and Quality Regulations 2005] for the purposes of that Act or those Regulations shall have the same meaning as is given for the purposes of that Act or those Regulations.

[F4 (4) In this Order “electronic cigarettes” and “refill containers” have the meaning given to them by article 2 of Directive 2014/40/EU of the European Parliament and the Council on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products.]

Textual Amendments

F1 Words in art. 1(2) inserted (1.9.2005) by The Medicines and Healthcare Products Regulatory Agency Trading Fund (Amendment) Order 2005 (S.I. 2005/2061), arts. 1(1), 2(a)

F2 Words in art. 1(3) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 78 (with Sch. 32)

F3 Words in art. 1(3) substituted (1.9.2005) by The Medicines and Healthcare Products Regulatory Agency Trading Fund (Amendment) Order 2005 (S.I. 2005/2061), arts. 1(1), 2(b)

F4 Art. 1(4) inserted (29.4.2016) by The Medicines and Healthcare Products Regulatory Agency Trading Fund (Amendment) Order 2016 (S.I. 2016/549), arts. 1(1), 2

Marginal Citations

M1 1968 c. 67.

Establishment of the fund U.K.

2.  As from 1st April 2003, for such of the operations of the Department of Health [F5 and Social Care] as are described in Schedule 1 to this Order, there shall be established a trading fund to be known as the Medicines and Healthcare Products Regulatory Agency Trading Fund.

Textual Amendments

F5 Words in art. 2 inserted (11.4.2018) by The Secretaries of State for Health and Social Care and for Housing, Communities and Local Government and Transfer of Functions (Commonhold Land) Order 2018 (S.I. 2018/378), art. 1(2), Sch. para. 20(e) (with art. 14)

Source of loans U.K.

3.  The Secretary of State for Health [F6 and Social Care] is hereby designated as the source of issues to the fund by way of loan.

Textual Amendments

F6 Words in art. 3 inserted (11.4.2018) by The Secretaries of State for Health and Social Care and for Housing, Communities and Local Government and Transfer of Functions (Commonhold Land) Order 2018 (S.I. 2018/378), art. 1(2), Sch. para. 21(h) (with art. 14)

Assets, liabilities, reserves and public dividend capital U.K.

4.—(1) The Crown assets and liabilities set out in Schedule 2 to this Order shall be appropriated as assets and liabilities of the fund.

(2) £16,100,000 of the amount by which the assets of the fund exceed the amounts of the liabilities shall be treated as a revaluation reserve in the accounts of the fund, and the reserve so treated shall be maintained as a revaluation reserve.

(3) £3,900,000 of the amount by which the assets of the fund exceed the amounts of the liabilities shall be treated as a retained surplus reserve in the accounts of the fund, and the reserve so treated shall be maintained as a retained surplus reserve.

(4) 50 per cent of any balance of—

(a) the amount by which the values of the assets exceed the amounts of the liabilities, less

(b) the sum of the amounts to be treated as reserves in accordance with paragraphs (2) and (3),

shall be treated as public dividend capital.

Maximum borrowing etc. U.K.

5.  The aggregate of the following shall not exceed £10,000,000:

(a) the total outstanding at any given time in respect of amounts issued to the fund under section 2B of the 1973 Act (other than as originating debt) and,

(b) the total at that time constituting public dividend capital issued to the fund under section 2A(2A) of that Act.

Revocation U.K.

6.  The Medicines Control Agency Trading Fund Order 1993 M2 is hereby revoked.

Marginal Citations

M2 S.I. 1993/751 as amended by S.I. 1997/805.

One of Her Majesty’s Principal Secretaries of State

Alan Milburn

Secretary of State for Health

We concur

Jim Fitzpatrick

John Heppell

Two of the Lords' Commissioners of Her Majesty’s Treasury