PART 4Amendment and revocation of retained direct EU legislation

Commission Regulation (EU) 2018/782I110

1

Commission Regulation (EU) 2018/782 establishing the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009 is amended as follows.

2

In Article 1—

a

for “Agency” substitute “ appropriate authority ”;

b

for “preparing opinions on the” substitute “ producing an assessment report in respect of ”.

3

After Article 3, omit the words from “This Regulation” to “Member States”.

4

In Annex 1—

a

in paragraph 1.1, for the words from “provisions related” to “Council” substitute “ the Good Laboratory Practice Regulations 1999 M1 ”;

b

in paragraph 1.2, for “Directive 2010/63/EU of the European Parliament and of the Council” substitute “ the Animals (Scientific Procedures) Act 1986 M2 ”;

c

in paragraph 1.7, in the second subparagraph—

i

for “European Medicines Agency (‘Agency’)” substitute “ appropriate authority ”;

ii

for “the Agency” substitute “ the appropriate authority ”;

d

in paragraph 1.8, for the words from “the Agency's” to the end substitute “ guidance issued by the appropriate authority ”;

e

in paragraph 2.4.2(l), omit “Agency and other”;

f

in paragraph 2.4.2(m), for “Directive 2010/63/EU” substitute “ the Animals (Scientific Procedures) Act 1986 ”;

g

in paragraph 2.6.1.3, for “Agency” substitute “ appropriate authority ”;

h

in paragraph 3.2.2(j), omit “Agency and other”;

i

in paragraph 3.2.2(k), for “Directive 2010/63/EU” substitute “ the Animals (Scientific Procedures) Act 1986 ”;

j

in paragraph 3.5.5—

i

for “Agency” substitute “ appropriate authority ”;

ii

for “European Reference Laboratory” substitute “ relevant national reference laboratories ”;

k

in paragraph 3.5.6—

i

for “Agency's” substitute “appropriate authority's”;

ii

omit “other EU and”;

l

in paragraph 3.6.3 for “Agency's” substitute “the appropriate authority's”.

5

In Annex 2—

a

in paragraph 2.1—

i

in the second sentence, for the words from “the Agency's” to the end substitute “ guidance issued by the appropriate authority ”;

ii

in the third sentence, omit the words from “as defined” to the end;

b

in paragraph 2.7.2, in the first sentence, for “Agency” substitute “ appropriate authority ”.