PART 2

Human medicines
CHAPTER 1

Regulations

Falsified medicines
4
1
Regulations under section 2(1) may make provision about—
a
the prevention of the supply of falsified human medicines, or
b
the use, retention and disclosure, for any purpose to do with human medicines, of information collected for the purpose of preventing the supply of falsified human medicines.
2
Provision made in reliance on subsection (1)(a) may (among other things) make provision—
a
for human medicines that are subjects of a marketing authorisation to be supplied in packs that—
i
carry unique identifiers associated with the products, and
ii
are protected with anti-tamper devices,
b
for checks to be carried out in relation to packs that have or should have such a unique identifier,
c
about the infrastructure, systems and processes required for the allocation and checking of unique identifiers, including provision about—
i
who is to set up the infrastructure, systems and processes,
ii
who is to maintain them, and
iii
who is to pay for them.
3
In making regulations in reliance on subsection (1), the appropriate authority must have regard to the importance of ensuring that information is retained securely.