Regulation 25 Amendment of regulation 44

In regulation 44(1) (interpretation), in the definition of “standard variation”—

(a)

in sub-paragraph (o), at the end, omit “or”;

(b)

in sub-paragraph (p), for “authorisation.” substitute “authorisation; or”;

(c)

after sub-paragraph (p), insert—

“(q)

a change to any packaging of the product, including the container or other form of packaging immediately in contact with the medicinal product, any packaging into which the container or other form of packaging immediately in contact with the product is placed, or to a leaflet that accompanies the product and contains information for the user of the product.”.