PART 11Pharmacovigilance
Enforcement
Offences relating to pharmacovigilance obligations under Regulation (EC) No 726/2004210
1
A person is guilty of an offence if the person—
a
commits a breach of a provision of Regulation (EC) No 726/2004 listed in paragraph (3); or
b
provides information which is false or misleading in a material particular to the licensing authority or the EMA pursuant to an obligation in Chapter 3 of Title II of Regulation (EC) No 726/2004.
2
A breach of a provision listed in paragraph (3) includes any—
a
failure to comply with any requirement or obligation contained in any of those provisions;
b
contravention of any prohibition contained in any of those provisions; or
c
failure to comply with any requirement imposed by the licensing authority or the EMA pursuant to any of those provisions.
3
Those provisions are—
a
Article 16(4), second paragraph47;
b
Article 20(8)48;
c
Article 21(1) and (2)49;
d
Article 2250;
e
Article 28(1), (2) and (5)51;
f
Article 28a(3)52; and
g
Article 28b(1)53, except insofar as it imposes an obligation under Article 107n(1), or the first paragraph of Article 107n(3), of the 2001 Directive.
4
Subject to paragraph (5), 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 for a term not exceeding two years or to both.
5
A person guilty of an offence under this regulation in relation to a provision of Regulation (EC) No 726/2004 listed in paragraph (6) is liable—
a
on summary conviction to a fine not exceeding the statutory maximum; or
b
on conviction on indictment to a fine.
6
Those provisions are—
a
Article 16(4), second paragraph;
b
Article 21(1) insofar as it relates to obligations set out in—
i
the second paragraph of Article 104(2) of the 2001 Directive save the obligation regarding preparing and implementing a corrective action plan,
ii
Article 104(3)(a) of the 2001 Directive,
iii
Article 104(3)(b) of the 2001 Directive, or
iv
the second paragraph of Article 104(3) of the 2001 Directive;
c
Article 21(2) insofar as it relates to the obligation to submit a detailed description of a risk management system;
d
Article 28(1) insofar as it relates to obligations set out in—
i
the second paragraph of Article 107(1) of the 2001 Directive,
ii
the first sentence of Article 107(4) of the 2001 Directive, or
iii
Article 107(5) of the 2001 Directive;
e
Article 28(2) insofar as it relates to the obligation set out in the third paragraph of Article 107c(4) of the 2001 Directive; and
f
Article 28b(1) insofar as it relates to prohibitions or obligations set out in—
i
Article 107m(3) to (6) of the 2001 Directive,
ii
the second paragraph of Article 107n(3) of the 2001 Directive, or
iii
the last sentence of Article 107o of the 2001 Directive.
7
This regulation is subject to regulation 212 (transitional arrangements).