Paragraph 41 I1

For Article 51 substitute—

“Article 51

Adoption of decisions under dossier evaluation

1

This Article applies where the Agency has notified its draft decision in accordance with Article 40 or 41.

2

If the Agency receives no comments from the registrant or downstream user, the Agency must make its decision in the version notified under paragraph 1.

3

If the Agency receives any comments from the registrant or downstream user, the Agency must—

(a)

take the comments into account, and

(b)

make its decision (whether that is to make the decision in the version notified or vary the decision notified).

4

The Agency must notify the registrant or downstream user and the appropriate authorities of the decision made under paragraph 2 or 3.

5

An appeal may be brought, in accordance with Articles 91, 92 and 93 against a decision made under paragraph 2 or 3.”.