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
”
.