Paragraph 6 I1

Northern Ireland

In paragraph 4(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.

Annotations