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 ;

“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, the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 M2 , or the Medical Devices Regulations 2002 M3 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.

Marginal Citations

M1 1968 c. 67.

M2 S.I. 1994/3144 amended by S.I. 1998/3105, 2000/292, 2001/795, 2002/236 and 2002/542.

M3 S.I. 2002/618.

Establishment of the fund U.K.

2.  As from 1st April 2003, for such of the operations of the Department of Health 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.

Source of loans U.K.

3.  The Secretary of State for Health is hereby designated as the source of issues to the fund by way of loan.

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 M4 is hereby revoked.

Marginal Citations

M4 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

25th March 2003

We concur

Jim Fitzpatrick

John Heppell

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

28th March 2003