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Paragraph 11 Amendment of Article 11

Original text. Later amendments are not shown.

In Article 11 (product information file)—

(a)

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

(b)

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.”;

(c)

for paragraph 4 substitute—

“4.

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