PART 4Requirement for authorisation
Breach of requirement47
1
A person who breaches regulation 46 is guilty of an offence.
2
A person guilty of an offence under this regulation is liable—
a
on summary conviction to a fine not exceeding the statutory maximum; or
b
on conviction on indictment to a fine, to imprisonment not exceeding two years or to both.
3
It is to be presumed for the purposes of regulation 46(3) that, if a person (“P”) knows or has reasonable cause to believe that a medicinal product is intended to be sold or supplied to another person, P knows or has reasonable cause to believe that the other person is within the F1United Kingdom or the European Economic Area.
4
Paragraph (3) does not apply if P proves that P did not know or have reasonable cause to believe that the person was within the F2United Kingdom or the European Economic Area.
5
Where evidence is adduced that is sufficient to raise an issue with respect to the defence in paragraph (4), the court or jury must assume that the defence is satisfied unless the prosecution proves beyond reasonable doubt that it is not.
6
Paragraph (7) applies if the holder of a marketing authorisation, certificate of registration, traditional herbal registration or Article 126a authorisation is charged with an offence under this regulation in respect of anything that—
a
has been manufactured or assembled to the holder's order by another person; and
b
has been so manufactured or assembled as not to comply with the terms of the authorisation, certificate or registration.
7
Where this paragraph applies, it is a defence for the holder to prove that—
a
the holder communicated the terms of the authorisation, certificate or registration to the other person; and
b
the holder did not know and could not by the exercise of reasonable care have known that those terms had not been complied with.