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.”.

(1)

Regulation 345 has been amended by S.I. 2019/775.