Regulation 16 Amendment of regulation 277I1

In regulation 277 (interpretation), in paragraph (1), at the appropriate place insert—

““holder of a temporary authorisation” means, where there is in force in relation to a medicinal product an authorisation by the licensing authority on a temporary basis under regulation 174 (but not an authorisation, certificate or registration as mentioned in regulation 279(a) or (b) to (d)), the person who is responsible for placing that product on the market in the United Kingdom;”.