Health Products Act 2007(No. 15 of 2007)
Table of Contents
Long Title
Enacting Formula
Part I PRELIMINARY
1 Short title and commencement
2 Interpretation
3 Purposes of Act
4 Act to apply only to health products specified in First Schedule
5 Act not to apply to supply or use of health products and active ingredients for veterinary purposes
Part II ADMINISTRATION
6 Administration of Act
7 Appointment of enforcement officers
8 Designation of analysts
9 Enforcement officers and analysts deemed to be public officers
10 Advisory Committees
11 Appeal Advisory Committees
Part III MANUFACTURE and import OF HEALTH PRODUCTS
12 Manufacture of health products
13 Import of health products
Part IV SUPPLY OF HEALTH PRODUCTS
14 Wholesaling of health products
15 Prohibition against supply of unregistered health products
16 Prohibition against supply of health products that are adulterated, counterfeits, etc.
17 Supply of health products to be carried out in accordance with prescribed requirements
18 Presentation of health products
Part V ADVERTISEMENT OF HEALTH PRODUCTS
19 Advertisement of health products
20 False or misleading advertisement
21 Further requirements for advertisement of health products
22 Defences
23 Corrective measures in relation to contravening advertisements
Part VI licences
24 Issue and renewal of licences
25 Variation of licence conditions on application by licensee
26 Register of licensees
27 Suspension and revocation of licence and cancellation of approval
28 Appeal
Part VII REGISTRATION OF HEALTH PRODUCTS
29 Health products to be registered according to categories in First Schedule
30 Registration of health products
31 Duration of registration
32 Conditions of registration
33 Evaluation of health products
34 Register of Health Products
35 Re-categorisation or reclassification of health products on application of registrant
36 Power to re-categorise or reclassify health products in absence of application by registrant
37 Suspension and cancellation of registration
38 Appeal
Part VIII DUTIES OF MANUFACTURERS, IMPORTERS, ETC., OF HEALTH PRODUCTS
39 Application of this Part
40 Keeping of records
41 Furnishing of information or document regarding health product
42 Reporting of defects and adverse effects to Authority
43 Verification of quality, safety and efficacy of health product
44 Notification to Authority concerning recall of health product
45 Additional duties under regulations
Part IX REGULATION OF DEALINGS IN ACTIVE INGREDIENTS
46 Active ingredients to which this Part applies
47 Regulation of manufacture, import, supply, etc., of active ingredients
Part X ENFORCEMENT
48 Non-compliant health products and active ingredients
49 Powers of enforcement
50 Unlawful alteration, destruction, etc., of documents
51 Obstructing officers in execution of their duties
Part XI PRESUMPTIONS AND OTHER EVIDENTIARY PROVISIONS FOR PURPOSES OF ENFORCEMENT OF ACT
52 Presumption as to liability of importers and manufacturers
53 Presumption as to identity of advertiser
54 Presumption as to purpose for which health product is manufactured, imported or supplied
55 Presumption as to similarity in properties between health products, etc., found and sample taken therefrom
56 Presumption of person’s intention to supply health product found in his possession
57 Evidence of analyst
Part XII OFFENCES AND PROSECUTION
58 Jurisdiction of court
59 Offences by bodies corporate, etc.
60 Enhanced penalty for corporations
61 Liability for offences by agents or employees
62 Forfeiture
63 Recovery of fees and other expenses incidental to prosecution
64 Non-disclosure of information
65 Composition of offences
Part XIII MISCELLANEOUS
66 Protection of confidential information
67 Service of documents
68 Form and authentication of notices, orders and other documents
69 Inaccuracies in documents
70 Exemption
71 Fees
72 Regulations
Part XIV REGULATION OF SUPPLY AND USE OF HEALTH PRODUCTS and active ingredients FOR VETERINARY PURPOSES
73 Supply and use of health products and active ingredients for veterinary purposes
74 Powers of officers enforcing regulations made under section 73
75 Application of Parts X to XIII
Part XV RELATED AND CONSEQUENTIAL AMENDMENTS TO OTHER WRITTEN LAWS
76 Related amendments to Medicines Act
77 Consequential amendments to Health Sciences Authority Act
78 Consequential amendment to Pharmacists Registration Act