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.