The Medicines and Healthcare Products Regulatory Agency Trading Fund (Amendment) (EU Exit) Order 2018

Made: 23rd October 2018

Coming into force in accordance with article 1

In accordance with section 6(2) of the 1973 Act[^f00005], a draft of this Order has been laid before the House of Commons and has been approved by a resolution of that House.

Citation, commencement and interpretation

1

• (1) This Order may be cited as the Medicines and Healthcare Products Regulatory Agency Trading Fund (Amendment) (EU Exit) Order 2018 and comes into force on the day after the day on which it is made.

• (2) In this Order, “the MHRA Trading Fund Order” means the Medicines and Healthcare Products Regulatory Agency Trading Fund Order 2003[^f00006].

Amendment of article 1 of the MHRA Trading Fund Order

2

In article 1 of the MHRA Trading Fund Order (citation, commencement and interpretation)—

• (a) in paragraph (2), omit the definition of “tissue bank” and the “and” preceding it; and

• (b) for paragraph (4), substitute—

(4) In this Order “electronic cigarette” and “refill container” have the meanings given to them by regulation 2(1) of the Tobacco and Related Products Regulations 2016[^f00007].

Substitution of Schedule 1 to the MHRA Trading Fund Order

3

For Schedule 1 to the MHRA Trading Fund Order (funded operations), substitute—

SCHEDULE 1 (1) All the operations of that part of the Department of Health and Social Care known from 1st April 2003 as the Medicines and Healthcare Products Regulatory Agency (the Agency) carried out in connection with the following— (a) the regulation of medicinal products; (b) the regulation of clinical trials of medicinal products; (c) the characterisation, standardisation and control of biological medicinal products; (d) the regulation of medical devices; (e) the regulation of products or devices that are similar to medicinal products or medical devices where this is ancillary to the regulation of medicinal products or medical devices; (f) the regulation of collecting, testing, processing, storage and distribution of human blood and human blood components; (g) the application of the principles of good laboratory practice; (h) the regulation of electronic cigarettes and refill containers; (i) the provision of services (including online services) relating to public health or the matters mentioned at sub-paragraphs (a) to (h). (2) Any operations of the Agency carried on in connection with any proposed legislation relating to the matters mentioned at paragraph 1(a) to (i), including legislative proposals being prepared in connection with the withdrawal of the United Kingdom from the European Union. (3) Any operations of the Agency carried on in connection with the dissemination of information relating to the matters mentioned at paragraph 1(a) to (i). (4) Any operations of the Agency which are incidental, conducive or are otherwise ancillary to the operations described in paragraphs 1 to 3. (5) In this Schedule— - “regulation” does not include— the regulation of prices; the regulation of the availability of products as part of the health service; or in relation to medical devices or devices similar to medical devices, the provision of device evaluation services; - “provision of services” includes (but is not limited to)— assistance to other regulatory authorities, other Government departments or agencies or public bodies; advisory, information, education or training services; the collection, processing, analysis or provision of data and enabling clinical studies based on that data; the sale of reference substances; the sale of publications.

Signed

Signed by authority of the Secretary of State.

O’Shaughnessy — Parliamentary Under-Secretary of State, — Department of Health and Social Care — 18th October 2018

We concur

Rebecca Harris — Paul Maynard — Two of the Lords Commissioners of Her Majesty’s Treasury — 23rd October 2018

Explanatory note

(This note is not part of the Order)

EXPLANATORY NOTE

This Order amends the Medicines and Healthcare Products Regulatory Agency Trading Fund Order 2003 (the Trading Fund Order) in order to remove references to European Union legislation that would no longer be appropriate after the withdrawal of the United Kingdom from the European Union. This Order re-states the operations covered by the Trading Fund Order in a more transparent way but without changing the broad substance of the operations covered.

A full impact assessment has not been prepared for this instrument as no, or no significant, impact on the private, voluntary or public sector is foreseen.

Footnotes

[^f00001]: 1973 c.63. Section 1 was substituted, except in relation to Crown Suppliers, by section 1(1) of the Government Trading Act 1990 (c.30) (the 1990 Act); section 6(1) was substituted, except in relation to Crown Suppliers, by section 2(3) of the 1990 Act. See section 1(7) for the definition of “Minister of the Crown”. See also section 1(2), which provides that a power to make an order under section 1 is only exercisable with Treasury concurrence.

[^f00002]: S.I. 2003/1076; this instrument has been amended by S.I. 2005/2061, 2006/2407, 2011/1043, 2012/1916 and 2014/432.

[^f00003]: Section 2 was substituted by section 1 of the 1990 Act and amended by the Finance Act 1991 (c.31), section 119(3), and the Finance Act 1993 (c.34), Schedule 22, paragraph 2.

[^f00004]: Section 4A was inserted by section 1(2) of the Government Trading Act 1990 (c.30) (the 1990 Act).

[^f00005]: Section 6(2) was substituted by section 2(3) of the 1990 Act.

[^f00006]: S.I. 2003/1076; this instrument has been amended by S.I. 2004/994, 2005/2061, 2006/2407, 2011/1043, 2012/1916, 2014/432, 2016/549 and 2018/378.

[^f00007]: S.I. 2016/507, to which there are amendments not relevant to this Order.