12.—(1) A person who—
(a)makes a false good laboratory practice instrument; or
(b)makes a copy of an instrument which is, and which he knows or believes to be, a false good laboratory practice instrument,
with the intention that he or another shall use it to induce a regulatory authority to accept it as a genuine good laboratory practice instrument or a copy of a genuine good laboratory practice instrument shall be guilty of an offence.
(2) A person who has in his possession—
(a)a false good laboratory practice instrument which he knows or believes to be a false good laboratory practice instrument;
(b)a copy of an instrument which he knows or believes to be a false good laboratory practice instrument,
with the intention that he or another shall supply it to a regulatory authority with the intention of inducing the regulatory authority to accept it as a genuine good laboratory practice instrument or a copy of a genuine good laboratory practice instrument shall be guilty of an offence.
(3) A person who supplies to a regulatory authority—
(a)a false good laboratory practice instrument which he knows or believes to be a false good laboratory practice instrument;
(b)a copy of an instrument which he knows or believes to be a false good laboratory practice instrument,
with the intention of inducing the regulatory authority to accept it as a genuine good laboratory practice instrument or a copy of a genuine good laboratory practice instrument shall be guilty of an offence.
(4) A good laboratory practice instrument is “false” for the purposes of this regulation if—
(a)it is not that which it purports to be for any reason including where—
(i)it purports to have been made by a person who did not make it,
(ii)it purports to have been made in the form in which it is made by a person who did not in fact make it in that form,
(iii)it purports to have been altered in any respect on the authority of a person who did not in fact authorise the alteration in that respect; or
(b)it includes information which is false or misleading in a material particular,
and a person shall be treated for the purposes of this regulation as making a false good laboratory practice instrument if he alters a good laboratory practice instrument so as to make it false in any respect (whether or not it is false in some other respect apart from that alteration).
(5) A person may be guilty of an offence—
(a)under paragraph (1) or (2) if the regulatory authority is outside the United Kingdom;
(b)under paragraph (3) if the supply is from outside the United Kingdom to a United Kingdom regulatory authority or from within the United Kingdom to a regulatory authority outside the United Kingdom.