Amendment of regulation 345
29. In regulation 345(1) (immunity from civil liability), in paragraph (3)—
(a)after sub-paragraph (a) insert—
“(aa)if there is no holder of an authorisation for the product but the sale or supply of the product is authorised by the licensing authority on a temporary basis under regulation 174, the person responsible for placing the product on the market in the United Kingdom;”;
(b)in sub-paragraph (c), for “paragraph (a) or (b); or” substitute “sub-paragraph (a), (aa) or (b);”;
(c)insert “; or” at the end of sub-paragraph (d); and
(d)after sub-paragraph (d) insert—
“(e)any person, not being a health care professional, who administers the product in accordance with a protocol of the type mentioned in regulation 247A.”.
Regulation 345 has been amended by S.I. 2019/775.