4. A regulatory study shall not be conducted at any premises of a test facility unless—
(a)the operator of the test facility is regarded by virtue of regulation 5 or 6 as a member or a prospective member of the United Kingdom good laboratory practice compliance programme (hereafter referred to as “the UK GLP compliance programme"); and
(b)the operator’s membership or prospective membership of that programme is or is partly in respect of those premises,
and if a regulatory study is conducted at any premises in contravention of this regulation, the operator of that test facility shall be guilty of an offence.