C1PART 12Dealings with medicinal products
CHAPTER 4Miscellaneous provisions, offences and disqualification
Miscellaneous provisions
F1Offences relating to Commission Regulation 2016/161: management of the repository system255C
1
A legal entity established to set up and manage the repositories system pursuant to Article 31 of Commission Regulation 2016/161 is guilty of an offence if the legal entity fails to comply with a requirement or obligation contained in a provision of Commission Regulation 2016/161 listed in paragraph (2).
2
The provisions mentioned in paragraph (1) are—
a
Article 31 (establishment of the repositories system);
b
Article 32 (structure of the repositories system);
c
Article 33 (uploading of information in the repositories system);
d
Article 34 (functioning of the hub);
e
Article 35 (characteristics of the repositories system);
f
Article 36 (operations of the repositories system);
b
Article 37 (obligations of legal entities establishing and managing a repository which is part of the repositories system);
c
Article 38 (data protection and data ownership); and
d
Article 39 (access by national competent authorities).
3
A legal entity guilty of an offence under paragraph (1) is liable on summary conviction, or on conviction on indictment, to a fine.
4
A person guilty of an offence under paragraph (1) by virtue of regulation 338 is liable—
a
on summary conviction to a fine; or
b
on conviction on indictment to a fine, to imprisonment for a term not exceeding two years, or to both.
Pt. 12 modified (E.W.) (1.10.2015) by The Nicotine Inhaling Products (Age of Sale and Proxy Purchasing) Regulations 2015 (S.I. 2015/895), regs. 1(3), 4(2)