False good laboratory practice instruments12
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.