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.