Amendment of regulation 3 of the principal Regulations

3.  In regulation 3 of the principal Regulations (sponsor of a clinical trial)—

(a)in paragraph (11), in sub-paragraph (a), for “the European Community” substitute “an EEA State”; and

(b)after paragraph (11), insert the following paragraph—

“(12) A person who is a sponsor of a clinical trial in accordance with this regulation may delegate any or all of his functions under these Regulations to any person but any such arrangement shall not affect the responsibility of the sponsor.”.