Regulation 7 Chapter 5

(1)

Chapter 5 is amended as follows.

(2)

In Article 59—

(a)

in paragraph 1—

(i)

in the second subparagraph, in the words before point (a)—

(aa)

omit “, adjuvants”;

(bb)

for “Member State” substitute “competent authority”;

(ii)

in the third subparagraph—

(aa)

for “the Member State which received it” substitute “any competent authority”;

(bb)

omit “and adjuvants”;

(iii)

in the fourth subparagraph, for “first authorisation in that Member State” substitute “the first authorisation by a competent authority in the United Kingdom in relation to which the report is submitted”;

(iv)

in the fifth subparagraph, for “in that Member State” substitute “described in the fourth subparagraph”;

(b)

in paragraph 3—

(i)

omit “, adjuvant”;

(ii)

for “Member State” substitute “competent authority”.

(3)

In Article 60—

(a)

in paragraph 1—

(i)

for “and adjuvant, rapporteur Member States” substitute “, the assessing competent authority”;

(ii)

for “Member States and the Commission” substitute “other competent authorities”;

(b)

in paragraph 2—

(i)

in the words before point (a), for “Member States” substitute “a competent authority”;

(ii)

in point (a), omit “, adjuvant”;

(c)

after paragraph 3 insert—

“4.

In paragraph 1, “assessing competent authority” has the same meaning as in Subsection 2 of Section 1 of Chapter 2.”.

(4)

In Article 61—

(a)

in paragraph 1, in the first subparagraph—

(i)

in the first sentence, omit “or for an adjuvant”;

(ii)

in the second sentence, for “The competent authority” substitute “A competent authority”;

(b)

in paragraph 2, for “The competent authority of the Member State” substitute “A competent authority”.

(5)

In Article 62—

(a)

in paragraph 2—

(i)

for “Member States” substitute “A competent authority”;

(ii)

for “Annex II to Directive 1999/45/EC” substitute “Part 3 of Annex 1 to Regulation (EC) No 1272/2008 of the European Parliament and of the Council”;

(b)

in paragraph 4—

(i)

in the first subparagraph—

(aa)

omit “, or of adjuvants”;

(bb)

omit “of the Member State”;

(ii)

in the second subparagraph, omit “of that Member State”;

(c)

in paragraph 6—

(i)

in the second sentence—

(aa)

omit “of the Member State”;

(bb)

omit “administered under national law”;

(ii)

in the third sentence, omit “of the Member States”;

(iii)

in the fourth sentence, for “in the courts of the Member States” substitute “as a civil debt”.