- MEDICINES ACT (CHAPTER 176)
- Table of Contents
- PART I—PRELIMINARY
- PART II—LICENCES AND CERTIFICATES RELATING TO MEDICINAL PRODUCTS
- Licensing authority
- General provisions as to dealing with medicinal products
- Provisions as to manufacture and wholesale dealing
- Exemptions for pharmacists and practitioners
- Exemption in respect of herbal remedies.
- General exemptions
- Register of medicinal products and import licence
- Application for licence
- Factors relevant to determination of application for licence
- Whether medicinal product subject to patent
- Grant or refusal of licence
- Duration and renewal of licence
- Provisional licences
- General power to suspend, revoke or vary licences
- Variation of licence on application of holder
- Clinical trials and medicinal tests on animals
- Provision of information to licensing authority
- Protection of confidential supporting information about innovative medicinal product
- Circumstances where protection under section 19A does not apply
- Licensing authority may publish information on applications
- No product licence to be granted on basis of previous grant
- Offences under this Part
- Special defences under section 20
- Certificates for exporters of medicinal products
- PART III—FURTHER PROVISIONS RELATING TO DEALINGS WITH MEDICINAL PRODUCTS
- General sale list
- Sale or supply of medicinal products not on general sale list
- Sale or supply of medicinal products on general sale list
- Prohibition of sale of medicinal products from automatic machines
- Exemptions for doctors, dentists and veterinary surgeons and in respect of herbal remedies
- Power to extend or modify exemptions
- Medicinal products on prescription only
- Prohibition of sale, supply or importation of medicinal products of specified description or of animal feeding stuffs incorporating such products
- Adulteration of medicinal products
- Protection of purchasers of medicinal products
- Compliance with standards specified in monographs in certain publications
- Further powers to regulate dealings with medicinal products
- Offences under this Part
- General provisions
- Registration of premises
- Supplementary provisions as to registration of premises
- Restrictions on use of titles, descriptions and emblems
- Minister may modify restrictions under section 39
- Power for licensing authority to disqualify and direct removal from register
- Appeal relating to disqualification
- Offences under this Part
- PART IV—PHARMACIES
- PART V—CONTAINERS, PACKAGES AND IDENTIFICATION OF MEDICINAL PRODUCTS
- Scope of this Part
- False or misleading advertisements and representations
- Prohibition of certain medical advertisements
- Powers to regulate advertisements and representations
- Power of licensing authority to require copies of advertisements
- Application of this Act to certain articles and substances
- Application of this Act to certain articles and substances
- Application of this Act to certain articles and substances
- Application of this Act to certain articles and substances
- Application of this Act to certain other substances which are not medicinal products
- Rights of entry
- Power to inspect, take samples and seize goods and documents
- Supplementary provisions as to rights of entry and related rights
- Seizure or detention of goods subject to prohibition or restriction
- Forfeiture of goods seized
- Disposal of goods forfeited
- Restrictions on disclosure of information
- Protection for officers
- Contravention due to default of other person
- Warranty as defence
- Offences in relation to warranties
- Offences by bodies corporate
- Certificate of analysis
- Presumptions
- Service of documents
- Jurisdiction of District and Magistrate's Courts
- Composition of offences
- Fees, charges, etc., collected by licensing authority to be paid to appropriate Authority
- Advisory committees
- Regulations
- Application of other written law not affected
- Repeal and consequential amendments
- Act not to apply to products categorised and regulated as health products under Health Products Act 2007
- PART VI—PROMOTION OF SALES OF MEDICINAL PRODUCTS AND MEDICAL ADVERTISEMENTS
- PART VII—MISCELLANEOUS AND SUPPLEMENTARY PROVISIONS
- FIRST SCHEDULE—DISEASES AND CONDITIONS
- SECOND SCHEDULE—AMENDMENTS TO THE POISONS ACT (CHAPTER 234)
MEDICINES ACT
(CHAPTER 176)
History Act 52 of 1975 -> 1985
REVISED EDITION
An Act to make provisions with respect to medicinal products and medical advertisements and matters connected therewith; and to make consequential amendments to the Poisons Act (Chapter 234).
[Parts I and II: 24th June 1977; Part III, sections 30, 31, 34, 35: 24th June 1977; Part V: 24th June 1977; Part VII, sections 54 to 75: 24th June 1977; Part VI: 15th November 1977; Part IV: 16th January 1981; Sections 23-29, 32, 33, Section 76: (Not in force); Part III, with the exception of sections 30, 31, 34 and 35 wef 3 May 93 vide S156/93]
Arrangement of Provisions
PART I
PRELIMINARY
1 Short title and commencement.
2 Interpretation.
3 Meaning of “medicinal product” and related expressions.
PART II
LICENCES AND CERTIFICATES RELATING TO MEDICINAL PRODUCTS
4 Licensing authority.
5 General provisions as to dealing with medicinal products.
6 Provisions as to manufacture and wholesale dealing.
7 Exemptions for pharmacists and practitioners.
8 Exemption in respect of herbal remedies.
9 General exemptions.
10 Register of medicinal products and import licence.
11 Application for licence.
12 Factors relevant to determination of application for licence.
12A Whether medicinal product subject to patent
13 Grant or refusal of licence.
14 Duration and renewal of licence.
15 Provisional licences.
16 General power to suspend, revoke or vary licences.
17 Variation of licence on application of holder.
18 Clinical trials and medicinal tests on animals.
19 Provision of information to licensing authority.
19A Protection of confidential supporting information about innovative medicinal product
19B Circumstances where protection under section 19A does not apply
19C Licensing authority may publish information on applications
19D No product licence to be granted on basis of previous grant
20 Offences under this Part.
21 Special defences under section 20.
22 Certificates for exporters of medicinal products.
PART III
FURTHER PROVISIONS RELATING TO DEALINGS WITH MEDICINAL PRODUCTS
23* General sale list.
24* Sale or supply of medicinal products not on general sale list.
25* Sale or supply of medicinal products on general sale list.
26* Prohibition of sale of medicinal products from automatic machines.
27* Exemptions for doctors, dentists and veterinary surgeons and in respect of herbal remedies.
28* Power to extend or modify exemptions.
29* Medicinal products on prescription only.
30 Prohibition of sale, supply or importation of medicinal products of specified description or of animal feeding stuffs incorporating such products.
31 Adulteration of medicinal products.
32* Protection of purchasers of medicinal products.
33* Compliance with standards specified in monographs in certain publications.
34 Further powers to regulate dealings with medicinal products.
35 Offences under this Part.
PART IV
PHARMACIES
36 General provisions.
37 Registration of premises.
38 Supplementary provisions as to registration of premises.
39 Restrictions on use of titles, descriptions and emblems.
40 Minister may modify restrictions under section 39.
41 Power for licensing authority to disqualify and direct removal from register.
42 Appeal relating to disqualification.
43 Offences under this Part.
PART V
CONTAINERS, PACKAGES AND IDENTIFICATION OF MEDICINAL PRODUCTS
44 Labelling and marking of containers and packages.
45 Leaflets.
46 Requirements as to containers.
47 Distinctive colours, shapes and markings of medicinal products.
48 Offences under this Part and supplementary provisions.
PART VI
PROMOTION OF SALES OF MEDICINAL PRODUCTS AND MEDICAL ADVERTISEMENTS
49 Scope of this Part.
50 False or misleading advertisements and representations.
51 Prohibition of certain medical advertisements.
52 Powers to regulate advertisements and representations.
53 Power of licensing authority to require copies of advertisements.
PART VII
MISCELLANEOUS AND SUPPLEMENTARY PROVISIONS
54 Application of this Act to certain articles and substances.
55 Application of this Act to certain other substances which are not medicinal products.
56 Rights of entry.
57 Power to inspect, take samples and seize goods and documents.
58 Supplementary provisions as to rights of entry and related rights.
59 Seizure or detention of goods subject to prohibition or restriction.
60 Forfeiture of goods seized.
61 Disposal of goods forfeited
62 Restrictions on disclosure of information.
63 Protection for officers.
64 Contravention due to default of other person.
65 Warranty as defence.
66 Offences in relation to warranties.
67 Offences by bodies corporate.
68 Certificate of analysis.
69 Presumptions.
70 Service of documents.
71 Jurisdiction of District and Magistrate’s Courts.
72 Composition of offences.
72A Fees, charges, etc., collected by licensing authority to be paid to appropriate Authority
73 Advisory committees
74 Regulations