Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021
Table of Contents
Enacting Formula
Part 1 PRELIMINARY
1 Citation and commencement
2 Definitions
3 Clinical research CTGT products excluded
Part 2 CTGT PRODUCT MANUFACTURE — LICENSING AND EXCEPTIONS
Division 1 Exceptions to need for licence
4 Manufacturing minimally manipulated CTGT products
5 Manufacturing other CTGT products for research or non‑clinical purposes
Division 2 Licences
6 Requirements for manufacturer’s licence for CTGT products
Part 3 CTGT PRODUCT IMPORT — LICENSING AND EXCEPTIONS
7 Importing minimally manipulated CTGT products
8 Importing to manufacture CTGT products
9 Requirements for importer’s licence for CTGT products
Part 4 CTGT PRODUCT SUPPLY — LICENSING AND EXCEPTIONS
10 Supplying minimally manipulated CTGT products by wholesale
11 Wholesale supply of other CTGT products for research or non‑clinical purposes
12 Class 2 CTGT products transferred by healthcare service licensees
13 Wholesale supply of CTGT products imported solely for export
14 Wholesale supply of self‑manufactured CTGT products
Division 2 Supply of CTGT products without registration
15 Prescribed exceptions
16 Supply of Class 1 CTGT products
17 Duty to obtain consent and provide information for supply of unregistered Class 2 CTGT products in certain circumstances
18 Supply of CTGT products manufactured under agreement with licensed or known manufacturer
Division 3 Licences
19 Requirements for wholesaler’s licence for CTGT products
Part 5 SUPPLY REQUIREMENTS
20 Wholesale supply of Class 2 CTGT products
21 Supply by retail sale of CTGT products
22 Supply by administration of CTGT products
23 Records of supply of prescribed CTGT products
Part 6 PRESENTATION OF CTGT PRODUCTS
24 Trade descriptions
25 Information to be provided with CTGT products
26 Supply by dispensing CTGT products
27 Re‑labelling of unregistered Class 2 CTGT products without manufacturer’s licence
28 Corrective measures in relation to contravening trade descriptions or failure to provide prescribed information
Part 7 REGISTRATION OF CTGT PRODUCTS
29 Requirements for registration
29A Prescribed time for cancellation of registration of CTGT product for non-payment of retention fee
30 Disclosure of information on applications for registration
Part 8 DUTIES AND OBLIGATIONS OF MANUFACTURERS, IMPORTERS, ETC., OF CTGT PRODUCTS
Division 1 General duties
31 Routine inspections, etc.
32 Duty to maintain records of manufacture
33 Duty to maintain records of receipt and supply
34 Duty to maintain system of traceability
35 Duty to maintain records of defects and adverse effects
36 Duty to report defects and adverse effects
37 Duty to notify Authority concerning recall
38 Duty of supplier of unregistered Class 1 CTGT product to provide information
Division 2 Duties specific to licensed and known manufacturers, importers and wholesalers
39 Duty of licensed or known manufacturer
40 Duty of licensed or known importer
41 Duty of licensed or known wholesaler
42 Duty of known manufacturer, importer or wholesaler to provide information
43 Responsible person
44 Offence for contravention of duties
45 Changes affecting licences
46 Changes affecting notices
47 False notice
Division 3 Duties specific to registrants
48 Changes concerning registered CTGT products
49 Information on validity of data submitted to or considered by Authority
50 Submission of benefit-risk evaluation reports
51 Duty to carry out risk management plan
Part 9 CERTIFICATION
52 Certification of CTGT products intended for export
53 Certificate of manufacturing standard of CTGT products
54 Certificate of distribution standard of CTGT products
55 Other certificates or documents
Part 10 GENERAL PROVISIONS
56 Product quality surveillances
57 Non-compliant CTGT products
58 Confidential information
59 (Deleted)
60 Saving and transitional provisions