Medicines (Medicinal Products as Clinical Research Materials) Regulations 2016
Table of Contents
Enacting Formula
Part 1 GENERAL
1 Citation and commencement
2 Definitions
Part 2 EXEMPTIONS FOR CLINICAL RESEARCH MATERIALS
3 Exemptions from Act
Part 3 MANUFACTURE, ASSEMBLY AND IMPORT OF CLINICAL RESEARCH MATERIALS
4 Manufacture, assembly and import of clinical research materials
Part 4 SUPPLIES, ETC., OF CLINICAL RESEARCH MATERIALS
5 Supply only as clinical research material
6 Supply of clinical research material properly labelled
Part 5 DUTIES RELATING TO CLINICAL RESEARCH MATERIALS
Division 1 — Use and disposal, etc., of clinical research materials
7 Dealing with clinical research materials
Division 2 — Keeping of records
8 Records of manufacture
9 Records of receipt and supply
10 Records of dealings with clinical research materials
11 Production of and time for keeping of records
Division 3 — Reports to Authority
12 Notifications of unexpected serious adverse drug reactions
13 Recall of clinical research material
Part 6 MISCELLANEOUS
14 Offences