Regulation 29 Amendment of regulation 345I1

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;”;

in sub-paragraph (c), for “paragraph (a) or (b); or” substitute “ sub-paragraph (a), (aa) or (b); ”;

insert “ ; or ” at the end of sub-paragraph (d); and

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.”.