Health Products (Clinical Research Materials) Regulations 2016 · As enacted · Part 4 · Supplies of Clinical Research Materials
9. Supply only as clinical research material
Feedback & supportLast amended by an amending law of 2021.
A person who manufactures, imports or is supplied with any clinical research material under regulation 3(1), (2), (3) or (4) must only supply the material for the purpose of being used in any clinical research in accordance with the protocol for the research.
Despite paragraph (1), the person may supply the clinical research material for a purpose other than that specified in paragraph (1) if the Authority has allowed such supply.
To avoid doubt, as from the time that the Authority has allowed the supply for a purpose other than that specified in paragraph (1) —
the clinical research material in question ceases to be clinical research material; and
nothing in these Regulations prevents the clinical research material which ceases to be such, from being subject to any law relating to therapeutic products or CTGT products.
Subregulation 1
A person who manufactures, imports or is supplied with any clinical research material under regulation 3(1), (2), (3) or (4) must only supply the material for the purpose of being used in any clinical research in accordance with the protocol for the research.
Subregulation 2
Despite paragraph (1), the person may supply the clinical research material for a purpose other than that specified in paragraph (1) if the Authority has allowed such supply.
Subregulation 3
To avoid doubt, as from the time that the Authority has allowed the supply for a purpose other than that specified in paragraph (1) —
the clinical research material in question ceases to be clinical research material; and
nothing in these Regulations prevents the clinical research material which ceases to be such, from being subject to any law relating to therapeutic products or CTGT products.