PART 3Amendment of retained direct EU legislation

Amendment of Regulation 378/200566

In Article 4—

a

in each place it which it occurs, for “CRL”, substitute “reference laboratory”;

b

for paragraph 3, substitute—

3

The appropriate authority may, once a year, prescribe adaptations in the amount of the fee mentioned in paragraph 1. The adaptation shall take into account the experience gained during the operation of this Regulation and in particular the possibility of fixing different fees for different types of applications.

c

after paragraph 3, insert—

4

In this Regulation, any rates, fees or charges denominated in euro (“EUR”) are to be read as converted into pounds sterling (“GBP”) using an exchange rate of GBP1 = EUR1.1413.

5

Any power to make regulations under this Article—

a

so far as exercisable by a Minister of the Crown, is exercisable by statutory instrument;

b

so far as exercisable by the Welsh Ministers, is exercisable by statutory instrument;

c

so far as exercisable by the Northern Ireland devolved authority is exercisable by statutory rule for the purposes of the Statutory Rules (Northern Ireland) Order 1979 (SI 1979/1573 (NI 12)) (and not by statutory instrument).

6

For regulations made under this Article by the Scottish Ministers, see also section 27 of the Interpretation and Legislative Reform (Scotland) Act 20108 (Scottish statutory instruments).

7

Any power to make regulations under this Article includes power—

a

to make different provision in relation to different cases or classes of case (including different provision for different areas or different classes of business); and

b

to provide for such exceptions, limitations and conditions, and to make such supplementary, incidental, consequential or transitional provisions, as the appropriate authority considers necessary or expedient.

8

Any statutory instrument, Scottish statutory instrument or statutory rule containing regulations made under this Article is subject to annulment in pursuance of a resolution—

a

in the case of England, of either House of Parliament;

b

in the case of Wales, of the National Assembly for Wales;

c

in the case of Scotland, of the Scottish Parliament;

d

in the case of Northern Ireland, being a negative resolution within the meaning given by section 41(6) of the Interpretation Act (Northern Ireland) 19549.

9

In this Article, any power—

a

of the Secretary of State to make regulations is limited to regulations which apply in relation to England only;

b

of the Welsh Ministers to make regulations is limited to regulations which apply in relation to Wales only;

c

of the Scottish Ministers to make regulations is limited to regulations which apply in relation to Scotland only;

d

of the Northern Ireland devolved authority to make regulations is limited to regulations which apply in relation to Northern Ireland only.