SCHEDULE 2Adjuvants

7

1

In paragraph 5(c)(i), “literature relating to the adjuvant” means—

a

the labelling of the packaging in which the adjuvant is contained;

b

any leaflet accompanying that package; or

c

any other material in writing produced by, or on behalf of, the applicant describing the adjuvant or how to use it.

2

In paragraph 5(c)(ii), “authorisation” means any authorisation or permission granted, or deemed to be granted, in accordance with Regulation 1107/2009 and in paragraphs 1, 2 and 3(b) “authorised” shall be construed accordingly.