Paragraph 11 Amendment of Article 11I1

in point (e) for “his” substitute “ their ”;

for paragraph 3 substitute—

“3

The responsible person must make the product information file readily accessible to a competent authority in an electronic or other format at the address notified in accordance with Article 13 as the address at which the product information file is kept.”;

for paragraph 4 substitute—

“4

The information contained in the product information file must be in English”.