Health Products (Clinical Research Materials) Regulations 2016 · As enacted · Part 3 · Manufacture and Import of Clinical Research Materials
8. Manufacture and import of clinical research materials
Feedback & supportA manufacturer of any clinical research material, or an importer of such material, must ensure that the material is of the correct identity and conforms with the applicable standards of strength, quality and purity for the material.
Despite paragraph (1), where the manufacturer of the clinical research material only packages or labels the material, the manufacturer need only ensure that the material is of the correct identity.
Subregulation 1
A manufacturer of any clinical research material, or an importer of such material, must ensure that the material is of the correct identity and conforms with the applicable standards of strength, quality and purity for the material.
Subregulation 2
Despite paragraph (1), where the manufacturer of the clinical research material only packages or labels the material, the manufacturer need only ensure that the material is of the correct identity.