Health Products (Clinical Research Materials) Regulations 2016 - Singapore Statutes Online

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Health Products (Clinical Research Materials) Regulations 2016

Table of Contents

Enacting Formula

Part 1 GENERAL

1 Citation and commencement

2 Definitions

Part 2 EXCEPTIONS FOR MANUFACTURE, IMPORT AND SUPPLY OF CLINICAL RESEARCH MATERIALS

3 Exceptions from Act

4 Notification of import of clinical research material

5 Approval for import of consignments of clinical research materials containing psychotropic substances

6 Approval for export of consignments of certain clinical research materials

7 Notification of supply of clinical research material by manufacturer

Part 3 MANUFACTURE AND IMPORT OF CLINICAL RESEARCH MATERIALS

8 Manufacture and import of clinical research materials

Part 4 SUPPLIES OF CLINICAL RESEARCH MATERIALS

9 Supply only as clinical research material

10 (Deleted)

11 Supply to subject of prescription‑only or pharmacy‑only medicine

12 Supply to subject by administration of prescription‑only medicine

13 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

14 Dealing with clinical research materials

14A Duty to maintain system of traceability for CTGT product

Division 2 — Keeping of records

15 Records of manufacture

16 Records of receipt and supply

17 Records of dealings with clinical research materials

18 Production of and time for keeping of records

Division 3 — Reports to Authority

19 Notifications of unexpected serious adverse drug reactions

19A Duty to report defects

20 Recall of clinical research material

Part 6 MISCELLANEOUS

21 Certificate of manufacturing standard of clinical research materials

22 Certificate of distribution standard of clinical research materials

23 Enforcement requirements

24 Offences

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