Medicines and Medical Devices Act 2021

4 Falsified medicines U.K.

(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.