PART 5Marketing authorisations
F1Offences relating to the safety features appearing on the packaging of medicinal products
Offences relating to Commission Regulation 2016/16194A
F21
A person who is—
a
the holder of a UKMA(NI), UKMA(UK) or parallel import licence, or
b
a parallel distributor,
is guilty of an offence if the holder 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 33 (uploading of information in the repositories system);
b
Article 40 (products recalled, withdrawn or stolen);
c
Article 41 (products to be supplied as free samples); and
d
Article 42 (removal of unique identifiers from the repositories system).
F33
In this regulation “parallel distributor” means a person who imports into Northern Ireland from an EEA state a product which has been granted a marketing authorisation under Regulation (EC) No 726/2004 and in relation to which that person is not the holder of a UKMA(NI), UKMA(UK), Article 126a authorisation, COR(NI), COR(UK), THR(NI) or THR(UK).
Reg. 94A and cross-heading inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 8 and reg. 94A and cross-heading inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 8