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

SCHEDULE 1FUNDED OPERATIONS

Article 2

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—

  1. a

     the regulation of prices;

  2. b

     the regulation of the availability of products as part of the health service; or

  3. c

     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)—

  1. a

     assistance to other regulatory authorities, other Government departments or agencies or public bodies;

  2. b

     advisory, information, education or training services;

  3. c

     the collection, processing, analysis or provision of data and enabling clinical studies based on that data;

  4. d

     the sale of reference substances;

  5. e

     the sale of publications.