Health Products (Clinical Research Materials) Regulations 2016 · As enacted · Part 2 · Exceptions for Manufacture, Import and Supply of Clinical Research Materials
7. Notification of supply of clinical research material by manufacturer
Feedback & supportRegulation 3(3) and (4) applies to a supply of clinical research material by a person who manufactures the material (called in these Regulations a manufacturer) only if the manufacturer gives the Authority notice of the supply before the manufacturer supplies the material.
The notice must be given in the form and manner, and within the time specified, on the Authority’s website.
This regulation does not apply if the manufacture of the clinical research material being supplied comprises solely of the packaging or labelling of the material.
Subregulation 1
Regulation 3(3) and (4) applies to a supply of clinical research material by a person who manufactures the material (called in these Regulations a manufacturer) only if the manufacturer gives the Authority notice of the supply before the manufacturer supplies the material.
Subregulation 2
The notice must be given in the form and manner, and within the time specified, on the Authority’s website.
Subregulation 3
This regulation does not apply if the manufacture of the clinical research material being supplied comprises solely of the packaging or labelling of the material.