Related documents
Medicines and Related Substances Control Act, 2003
Act 13 of 2003
- Published in Government Gazette 3051 on 28 August 2003
- Assented to on 13 August 2003
- Commenced on 25 July 2008 by Commencement of Medicines and Related Substances Control Act, 2003
- [This is the version of this document from 1 August 2008 and includes any amendments published up to 13 March 2024.]
- [Amended by Medicines and Related Substances Control Amendment Act, 2007 (Act 8 of 2007) on 1 August 2008]
1. Definitions
2. Continuation of Council, and its powers and functions
3. Constitution of Council
4. Disqualification for appointment as member of Council
A person does not qualify for appointment as a member of the Council, if the person -5. Tenure of office of members
Subject to section 6, a member of the Council holds office for a period of three years from the date of his or her appointment and is eligible for re-appointment.6. Vacation of office and filling of vacancies
7. Chairperson and vice-chairperson
8. Meetings of Council
9. Disclosure of interest
10. Remuneration
11. Executive committee
12. Veterinary medicines committee
13. Other committees
The Council may -14. Restriction of liability
The Council or a committee or a member of the Council or of any such committee is not liable for any loss or damage arising out of, or in connection with, the performance of the Council's or the committee's or the member's duties under this Act, or in respect of any act or thing done in good faith by the Council or any such committee or member in the exercise of the powers or the performance of functions under this Act, unless the loss or damage is due to the Council's, the committee's or the member's willful misconduct, gross negligence or failure to comply with this Act or a direction or decision given under it.15. Financial year and annual report
16. Appointment of Registrar of Medicines
17. Registers
18. Prohibition on sale of medicines, which are subject to registration and are not registered
19. Registration of medicines
20. Amendment of entries in register
21. Transfer of certificate of registration
22. Cancellation of registration
23. Notification of registration, or cancellation of registration, in the Gazette
The Registrar must give notice in the Gazette of the registration, or cancellation of registration, of a medicine in terms of this Act, and must in such notice specify -24. Labels and advertisements
25. Prohibition on sale of medicines, which do not comply with prescribed requirements, and furnishing of information regarding medicines to the Council
26. Publication or distribution of false advertisements concerning medicines
27. Council may authorise sale of unregistered medicine for certain purposes
28. Council to cause certain information to be furnished
The Council must in such manner as it considers most suitable, and as soon as is practicable -29. Control of medicines and scheduled substances
30. Substitution of medicine on prescription with interchangeable multi-source medicine
[heading substituted by Act 8 of 2007]31. Licences and permits
32. Publication of information relating to medicines, scheduled substances or any other things subject to this Act
33. Disposal of undesirable medicines
34. Appeal against decisions of Council
35. Inspectors
36. Powers of inspectors
37. Analysts
The Permanent Secretary, after consultation with the Council, may grant authority to such analysts as he or she may consider necessary to examine or analyse samples of medicines, scheduled substances or of other things, taken by an inspector under section 36(1)(d).37A. Premises to be registered
37B. Application for registration of premises
37C. Consideration of application and registration of premises
37D. Validity and renewal of licences
37E. Cancellation, suspension, alteration and variation of licences
37F. Effect of non-renewal or cancellation of licence
If a licence has not been renewed as contemplated in section 37D(5) or has been cancelled as contemplated in section 37E(3), the registration of the premises lapses.[section 37F inserted by Act 8 of 2007]38. Offences
A person commits an offence if he or she -39. Penalties
40. Presumptions and evidence
41. Special defences in case of prosecutions
It is sufficient defence for a person charged with the sale of a medicine in contravention of section 25, if the person proves that he or she -42. Preservation of secrecy and inappropriate use of information
Subject to section 32, a person may not -43. Delegation of powers, and assignment of duties and functions
44. Regulations
45. Exemptions
46. Transitional provisions
47. Repeals, amendments and savings
48. Short title and commencement
This Act is called the Medicines and Related Substances Control Act, 2003, and comes into operation on a date to be determined by the Minister by notice in the Gazette.History of this document
01 August 2008 this version
25 July 2008
28 August 2003
13 August 2003
Assented to
Subsidiary legislation
Title | Numbered title |
---|---|
Regulations relating to Medicines and Related Substances, 2008 | Government Notice 178 of 2008 |
Cited documents 10
Legislation 10
- Allied Health Professions Act, 2004
- Criminal Procedure Act, 1977
- Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947
- Health Laws Amendment Act, 1977
- Hospitals and Health Facilities Act, 1994
- Legal Practitioners Act, 1995
- Medical and Dental Act, 2004
- Nursing Act, 2004
- Pharmacy Act, 2004
- Public Service Act, 1995
Documents citing this one 146
Discussion Paper 1
Gazette 130
- Namibia Government Gazette dated 2003-08-28 number 3051
- Namibia Government Gazette dated 2004-07-28 number 3249
- Namibia Government Gazette dated 2004-07-29 number 3250
- Namibia Government Gazette dated 2004-07-30 number 3251
- Namibia Government Gazette dated 2004-11-09 number 3317
- Namibia Government Gazette dated 2004-12-24 number 3358
- Namibia Government Gazette dated 2007-12-28 number 3968
- Namibia Government Gazette dated 2008-07-25 number 4088
- Namibia Government Gazette dated 2008-08-18 number 4103
- Namibia Government Gazette dated 2008-10-30 number 4150
- Namibia Government Gazette dated 2008-12-01 number 4174
- Namibia Government Gazette dated 2009-01-02 number 4192
- Namibia Government Gazette dated 2009-01-15 number 4197
- Namibia Government Gazette dated 2009-02-16 number 4210
- Namibia Government Gazette dated 2009-07-24 number 4302
- Namibia Government Gazette dated 2009-10-27 number 4367
- Namibia Government Gazette dated 2010-03-18 number 4444
- Namibia Government Gazette dated 2010-04-30 number 4473
- Namibia Government Gazette dated 2010-06-17 number 4505
- Namibia Government Gazette dated 2010-09-15 number 4561
- Namibia Government Gazette dated 2010-10-07 number 4577
- Namibia Government Gazette dated 2010-12-21 number 4633
- Namibia Government Gazette dated 2011-04-08 number 4683
- Namibia Government Gazette dated 2011-04-21 number 4695
- Namibia Government Gazette dated 2011-06-03 number 4726
- Namibia Government Gazette dated 2011-06-15 number 4736
- Namibia Government Gazette dated 2011-07-13 number 4752
- Namibia Government Gazette dated 2011-07-15 number 4756
- Namibia Government Gazette dated 2011-07-26 number 4761
- Namibia Government Gazette dated 2011-10-14 number 4808
- Namibia Government Gazette dated 2011-10-17 number 4812
- Namibia Government Gazette dated 2011-12-01 number 4843
- Namibia Government Gazette dated 2012-03-30 number 4915
- Namibia Government Gazette dated 2012-06-29 number 4978
- Namibia Government Gazette dated 2012-07-16 number 4996
- Namibia Government Gazette dated 2012-07-31 number 5003
- Namibia Government Gazette dated 2012-08-15 number 5015
- Namibia Government Gazette dated 2012-09-21 number 5042
- Namibia Government Gazette dated 2012-11-15 number 5076
- Namibia Government Gazette dated 2012-12-31 number 5115
- Namibia Government Gazette dated 2013-02-22 number 5139
- Namibia Government Gazette dated 2013-02-26 number 5142
- Namibia Government Gazette dated 2013-05-15 number 5188
- Namibia Government Gazette dated 2013-06-05 number 5218
- Namibia Government Gazette dated 2013-07-15 number 5241
- Namibia Government Gazette dated 2013-08-01 number 5255
- Namibia Government Gazette dated 2013-08-14 number 5263
- Namibia Government Gazette dated 2013-11-01 number 5328
- Namibia Government Gazette dated 2013-12-31 number 5379
- Namibia Government Gazette dated 2013-12-31 number 5380
- Namibia Government Gazette dated 2014-02-27 number 5415
- Namibia Government Gazette dated 2014-03-14 number 5425
- Namibia Government Gazette dated 2014-07-09 number 5502
- Namibia Government Gazette dated 2014-07-09 number 5503
- Namibia Government Gazette dated 2014-07-25 number 5515
- Namibia Government Gazette dated 2014-09-05 number 5550
- Namibia Government Gazette dated 2014-10-06 number 5582
- Namibia Government Gazette dated 2014-10-17 number 5591
- Namibia Government Gazette dated 2014-10-22 number 5596
- Namibia Government Gazette dated 2014-12-01 number 5624
- Namibia Government Gazette dated 2015-02-27 number 5681
- Namibia Government Gazette dated 2015-04-01 number 5703
- Namibia Government Gazette dated 2015-05-15 number 5738
- Namibia Government Gazette dated 2015-05-20 number 5742
- Namibia Government Gazette dated 2015-06-12 number 5758
- Namibia Government Gazette dated 2015-07-15 number 5783
- Namibia Government Gazette dated 2015-09-01 number 5818
- Namibia Government Gazette dated 2015-09-16 number 5831
- Namibia Government Gazette dated 2015-12-31 number 5915
- Namibia Government Gazette dated 2016-05-13 number 6005
- Namibia Government Gazette dated 2016-09-15 number 6125
- Namibia Government Gazette dated 2017-01-16 number 6217
- Namibia Government Gazette dated 2017-02-27 number 6249
- Namibia Government Gazette dated 2017-03-31 number 6277
- Namibia Government Gazette dated 2017-08-15 number 6384
- Namibia Government Gazette dated 2017-09-29 number 6426
- Namibia Government Gazette dated 2017-10-17 number 6444
- Namibia Government Gazette dated 2017-11-01 number 6458
- Namibia Government Gazette dated 2018-02-15 number 6527
- Namibia Government Gazette dated 2018-02-26 number 6534
- Namibia Government Gazette dated 2018-03-20 number 6551
- Namibia Government Gazette dated 2018-03-22 number 6552
- Namibia Government Gazette dated 2018-03-29 number 6556
- Namibia Government Gazette dated 2018-04-10 number 6566
- Namibia Government Gazette dated 2018-04-27 number 6580
- Namibia Government Gazette dated 2018-07-16 number 6649
- Namibia Government Gazette dated 2018-08-29 number 6690
- Namibia Government Gazette dated 2018-09-06 number 6704
- Namibia Government Gazette dated 2018-10-31 number 6749
- Namibia Government Gazette dated 2018-11-28 number 6779
- Namibia Government Gazette dated 2018-12-28 number 6803
- Namibia Government Gazette dated 2018-12-31 number 6816
- Namibia Government Gazette dated 2019-01-30 number 6830
- Namibia Government Gazette dated 2019-02-07 number 6840
- Namibia Government Gazette dated 2019-04-01 number 6868
- Namibia Government Gazette dated 2019-04-15 number 6875
- Namibia Government Gazette dated 2019-04-30 number 6892
- Namibia Government Gazette dated 2019-05-07 number 6901
- Namibia Government Gazette dated 2019-05-21 number 6910
- Namibia Government Gazette dated 2019-07-18 number 6956
- Namibia Government Gazette dated 2019-07-22 number 6958
- Namibia Government Gazette dated 2019-09-16 number 6997
- Namibia Government Gazette dated 2019-09-18 number 6999
- Namibia Government Gazette dated 2019-11-18 number 7052
- Namibia Government Gazette dated 2019-12-06 number 7073
- Namibia Government Gazette dated 2020-08-04 number 7296
- Namibia Government Gazette dated 2020-09-01 number 7321
- Namibia Government Gazette dated 2020-10-06 number 7353
- Namibia Government Gazette dated 2020-11-13 number 7386
- Namibia Government Gazette dated 2020-12-01 number 7402
- Namibia Government Gazette dated 2021-03-09 number 7479
- Namibia Government Gazette dated 2021-04-19 number 7509
- Namibia Government Gazette dated 2021-04-30 number 7522
- Namibia Government Gazette dated 2021-05-06 number 7527
- Namibia Government Gazette dated 2021-06-30 number 7568
- Namibia Government Gazette dated 2021-08-24 number 7608
- Namibia Government Gazette dated 2021-08-30 number 7615
- Namibia Government Gazette dated 2022-01-21 number 7728
- Namibia Government Gazette dated 2022-02-10 number 7744
- Namibia Government Gazette dated 2022-04-27 number 7794
- Namibia Government Gazette dated 2022-05-24 number 7811
- Namibia Government Gazette dated 2022-06-02 number 7819
- Namibia Government Gazette dated 2022-09-30 number 7917
- Namibia Government Gazette dated 2022-10-21 number 7934
- Namibia Government Gazette dated 2022-10-25 number 7936
- Namibia Government Gazette dated 2022-11-15 number 7955
- Namibia Government Gazette dated 2022-12-01 number 7966
- Namibia Government Gazette dated 2023-01-03 number 7999
- Namibia Government Gazette dated 2023-02-09 number 8028
- Namibia Government Gazette dated 2023-03-09 number 8044
Judgment 4
- Medical Association of Namibia and Another v Minister of Health and Social Services and Others (SA 80 of 2013) [2017] NASC 1 (9 February 2017)
- Medical Associaton of Namibia and Another v Minister of Health And Social Services and Others (APPEAL 217 of 2012) [2013] NAHCMD 362 (27 November 2013)
- Minister of Health and Social Services and Others v Medical Association of Namibia Ltd and Another (SA 13 of 2010) [2012] NASC 7 (21 June 2012)
- S v Ismael (CR 14 of 2022) [2022] NAHCNLD 22 (17 March 2022)
Law Reform Report 1
Legislation 10
- Animal Health Regulations, 2013
- Criminal Procedure Act, 2004
- Disaster Risk Management Regulations, 2013
- Medical and Dental Act, 2004
- National Health Act, 2015
- Nursing Act, 2004
- Pharmacy Act, 2004
- Public Health COVID-19 General Regulations
- Regulations relating to Veterinary and Veterinary Para-Professions, 2014
- Veterinary and Veterinary Para-Professions Act, 2013