The Medicines and Healthcare Products Regulatory Agency Trading Fund Order 2003

Article 2

SCHEDULE 1U.K.FUNDED OPERATIONS

1.  All the operations of that part of the Department of Health known from 1st April 2003 as the Medicines and Healthcare Products Regulatory Agency carried out in connection with the following:—U.K.

(a)the functions of the Health Ministers, the Ministers, the appropriate body or the licensing authority under—

(i)the Medicines Acts of 1968 and 1971 M1 and secondary legislation under those Acts, and

(ii)any legislation of the European Communities or their institutions relating to medicinal products, and related implementing legislation;

(b)the functions of the Secretary of State relating to the application of the principles of good laboratory practice and the verification of their application for tests on substances and to the inspection and verification of good laboratory practice as laid down in [F1the European Parliament and Council Directive 2004/10/EC of 11th February 2004 and the European Parliament and Council Directive 2004/9/EC of 11th February 2004] and related implementing legislation, and as arising out of the United Kingdom’s membership of the Organisation for Economic Co-operation and Development;

[F2(bb)the functions of the Secretary of State under—

(i)the Blood Safety and Quality Regulations 2005, and

(ii)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 and related implementing legislation;]

(c)the functions of the Secretary of State—

(i)under the Medical Devices Regulations 2002 M2 and the Medical Devices Directives,

(ii)under the Clinical Thermometers (EEC Requirements) Regulations 1993 M3,

(iii)otherwise in connection with the safe use of medical devices or similar devices;

[F3(cc)the functions of the United Kingdom and its national competent authority under Article 20 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 (electronic cigarettes) and related implementing legislation;]

(d)the functions of the Secretary of State under any legislation of the European Communities or their institutions relating to general product safety, and related implementing legislation in so far as the legislation relates to medicinal products or medical devices or similar products or devices;

(e)the functions of the United Kingdom authorities relating to medicinal products, medical devices or similar products or devices [F4or electronic cigarettes and refill containers] under international obligations or in connection with Association Agreements or Mutual Recognition Agreements or in connection with any activities of the European Communities or any of their institutions;

(f)[F5the provision of services relating to or in connection with public health, standards of quality and safety for human blood and blood components, medicinal products, medical devices or similar products or devices, other than the provision of device evaluation services,] [F6or electronic cigarettes and refill containers] to meet the needs of customers in the United Kingdom, in Europe or world-wide including:

(i)assistance to other regulatory authorities, other Government departments or agencies, or public bodies,

(ii)advisory, information, education or training services,

(iii)the collection, processing, analysis or provision of data,

(iv)the inspection or accreditation of tissue banks,

F7(v). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(vi)the sale of reference substances,

(vii)the sale of publications.

Textual Amendments

Marginal Citations

2.  Any operations carried on in connection with any proposed legislation or the provision and dissemination of information relating to the functions described in paragraph 1.U.K.

3.  Any operations which are incidental, conducive or are otherwise ancillary to the operations described in paragraphs 1 and 2.U.K.

Article 4(1)

SCHEDULE 2U.K.ASSETS AND LIABILITIES APPROPRIATED AS THOSE OF THE FUND

PART I U.K.ASSETS

1.  Plant and equipment (including vehicles and computers) and assets under construction which at 1st April 2003 are used or are allocated for use in the funded operations.U.K.

2.  Data and computer software as at 1st April 2003 used or allocated for use in the funded operations.U.K.

3.  Intangible assets, including intellectual property, arising from the funded operations as carried on up to 1st April 2003.U.K.

4.  Debtors and cash as at 1st April 2003 used or allocated for use in, or arising from, the funded operations.U.K.

PART II U.K.LIABILITIES

1.  Fees paid in advance in respect of services to be rendered on or after 1st April 2003.U.K.

2.  Creditors, accruals and provisions as at 1st April 2003 arising from the funded operations.U.K.