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Regulation 28 Amendment of Schedule 27

Original text. Later amendments are not shown.

(1)

Schedule 27 (package leaflets) is amended as follows.

(2)

In paragraph 13 omit the word “safety”.

(3)

For paragraph 14 substitute—

“14.

A standardised text relating to adverse event reporting in accordance with the third sub-paragraph of Article 59(1) of the 2001 Directive.”