Regulation 20 Amendment of Schedule 8 (material to accompany an application for a UK marketing authorisation)

Schedule 8^f1 is amended as follows.

In paragraph 12, in the two places where it occurs, for “a member State” substitute “an EEA State”.

For paragraph 23 substitute—

“23.

For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004 or regulation 202A, as the case may be, the symbol and statement “▼ This medicinal product is subject to additional monitoring”. ”