SCHEDULE 34 Amendment of Regulation (EC) No 1223/2009 and related amendments

Amendment of Article 11

11.  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”.