N$3.60 WINDHOEK -28 December 2007 No. 3968
CONTENTS
Page
GOVERNMENT NOTICE
No. 233 Promulgation of Medicines and Related Substances Control Amendment Act, 2007 (Act No.8 of 2007), of the Parliament 1
No. 233 2007
PROMULGATION OF ACT
OF PARLIAMENT
The following Act which has been passed by the Parliament and signed by the President in terms of the Namibian Constitution is hereby published in terms of Article 56 of that Constitution.
No.8 of 2007: Medicines and Related Substances Control Amendment Act, 2007.
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Act No.8, | 2007 | MEDICINES | AND RELATED | SUBSTANCES | |
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CONTROL | AMENDMENT | ACT, 2007 | |||
EXPLANATORY | NOTE: |
Words underlined with a solid line indicate insertions in existing provisions.
Words in bold type in square brackets indicate omissions from existing provisions.
ACT
To amend the Medicines and Related Substances Control Act, 2003, so as to amend and delete certain definitions; to provide for a period within which the Council must be appointed; to provide for the appointment of chairpersons of committees established by the Council; to amend provisions relating to the classification of medicines and other substances as scheduled substances; to amend provisions relating to the manufacturing, packing and selling of specified Schedule 3 and specified Schedule 4 substances; to delete references to generic substitutions; to substitute references to Schedule 1, Schedule 2, Schedule 3 or Schedule 4 medicines by references to Schedule 1, Schedule 2, Schedule 3 or Schedule 4 substances; to insert provisions relating to the registration of premises engaged in the manufacturing of medicines; to amend provisions relating to offences and penalties; to amend provisions relating to the destruction of forfeited medicines, scheduled substances or other things; to provide for the making of regulations in relation to medicines; to amend provisions relating to the exclusion of medicines from the operation of the Act; to amend the transitional provisions; to amend provisions relating to the repeal and amendment of certain laws; and to provide for matters incidental thereto.
(Signed by the President on 21 December 2007)
BE IT ENACTED by the Parliament of the Republic of Namibia, as follows:
Amendment of section 1 of Act No. 13 of 2003
1. Section 1 of the Medicines and Related Substances Control Act, 2003 (hereinafter referred to as the principal Act) is amended
"'appeal committee' means the appeal committee referred to in section 34(2}[(1»);"; No. 3968 Government Gazette 28 December 2007
Act No.8, 2007 MEDICINES AND RELATED SUBSTANCES CONTROL AMENDMENT ACT, 2007
"'authorised prescriber' means a medical practitioner, a dentist, a veterinarian, [or] a person authorised to prescribe specified Schedule 1, Schedule 2 or Schedule 3 substances under section 31(1)) or a pharmacist authorised to prescribe specified Schedule 2 or Schedule 3 substances under section 31(2) [a medicine under section 31(1) or (2)];";
"'complementary medicine' means a substance or a mixture of substances
prepared and used or purported to be suitable for use or manufactured or
sold for use in
in accordance with the principles of any of the following disciplines:
(iii) African traditional medicine; or
(iv) Chinese herbal medicine,
whether or not administered by or through a medical device;";
"'medical practitioner' means a medical practitioner as defined in the Medical and Dental [Professions] Act, 2004 (Act No. 10 of 2004), [1993 (Act No. 21 of 1993)] or a medical intern as defined in that Act;";
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(i) by the substitution for the definition of "medicine" of the following definition:
'''medicine' means
(a) a substance or a mixture of substances prepared and used or purported to be suitable for use or manufactured or sold for use in
whether or not administered by or through a medical device;
"'pharmacist's assistant' means a pharmacist's assistant as defined in the Pharmacy [Professions] Act, 2004 (Act No. 9 of 2004) [1993 (Act No. 23 of 1993];",
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Act No.8, 2007 MEDICINES AND RELATED SUBSTANCES CONTROL AMENDMENT ACT, 2007
(n) by the substitution for the definition of "pharmacist intern" of the following definition:
"'pharmacist intern' means a pharmacist intern as defmed in the Pharmacy [Professions] Act, 2004 (Act No.9 of 2004) [1993 (Act No. 23 of 1993);";
(0)· by the substitution for the definition of "practitioner" of the following definition:
"-'practitioner' means an allied or complementary health practitioner as defined in the Allied Health [Services] Professions Act, 2004 (Act No.7 of 2004) [1993 (Act No. 20 of 1993)];";
(p) by the substitution for the definition of "register" of the following definition:
"'register'
. (q) by the substitution for the definition of "registered nurse" of the following definition:
"'registered nurse' means a registered nurse as defined in the Nursing [Professions] Act, 2004 (Act No.8 of 2004) [1993 (Act No. 30 of1993)];";
(1) by the substitution for the definition of "Registrar" of the following definition:
'''Registrar' means the Registrar of Medicines appointed in terms of section
16;";
"'veterinary medicine [s]' means a substance or mixture of substances, [other than farm feeds as defined in the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act No. 36 of 1947),] including stock remedies as defined in the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act No. 36 of 1947), prepared and used or purporting to be suitable for use or manufactured or sold for use in connection with
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whether or not administered by or through a medical device;". Amendment of section 3 of Act No. 13 of 2003
2. Section 3 of the principal Act is amended by the substitution for the words preceding paragraph (a) of subsection (1) of the following words:
"The Council consists of the following members to be appointed by the Minister within six months after the date of commencement of this Act as follows:".
Amendment of section 12 of Act No. 13 of 2003
3. Section 12 of the principal Act is amended by the substitution for subsection
(5) of the following subsection:
"(5) The Councilor the Permanent Secretary, as the case may be, may not exercise any powers, take a decision, or perform a function in terms of section 18(2), 19(4) or (11),20(1) or (4),21 (4),22(1) or (3),25(2),27(1) or (3),29(1), (3), (15), (23), (24), (27) or (29), [29(1)], 31(1), (2), (3), (4) or (5),32,33,37, 37B(3), 37C, 37D(2)' (3), (4) and (5), 37E, 42(a)(i), 44(1) or 45 with respectto a veterinary medicine, unless the veterinary medicines committee recommends so.".
Substitution of section 13 of Act No. 13 of 2003
4. The following section is substituted for section 13 of the principal Act: "Other committees
13. The Council may
ill persons other than members of the Council, as it may consider fit to be members of a committee established in terms of paragraph (a);
(ill. the chairperson of such a committee.".
No. 3968 Government Gazette 28 December 2007 7 Act No.8, 2007 MEDICINES AND RELATED SUBSTANCES CONTROL AMENDMENT ACT, 2007 Amendment of section 29 of Act No. 13 of 2003
5. Section 29 of the principal Act is amended
(a) by the substitution for subsection (1) of the following subsection:
"(1) The Minister, on the recommendation of the Council and for the purpose of the control of medicines and other substances
Provided that the Council must recommend only those medicines and other substances, which it considers necessary to be classified.";
"(2) Subject to this section, a person may not sell, have in his or her possession or manufacture a medicine or a scheduled substance, except in accordance with the prescribed conditions.";
(d) by the substitution for paragraph (a) of subsection (15) of the following paragraph:
"(a) the Council may issue a permit in the prescribed form and manner to a person to manufacture, [or] pack and sell a specified Schedule 3 substance;"; and
(e) by the substitution for paragraph (a) of subsection (23) of the following paragraph:
"(a) the Council may issue a permit in the prescribed form and manner to a person to manufacture, [or] pack and sell a specified Schedule 4 substance;".
Amendment of section 30 of Act No. 13 of 2003
6. Section 30 of the principal Act is amended by the substitution for the heading of the following heading:
"Substitution of medicine on prescription with interchangeable multi-source medicine" ·
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Act No.8, 2007 MEDICINES AND RELATED SUBSTANCES CONTROL AMENDMENT ACT, 2007
7. The following section is substituted for section 31 of the principal Act:
31. (1) The Council may issue a licence on application in the prescribed form by a person, who lawfully performs a health service, other than a person referred to in subsection (2) or (3), authorising that person to
specified Schedule 1, Schedule 2 or Schedule 3 substances, [medicines] subject to such conditions as the Council may determine, if the Council is satisfied that granting such a licence is in the public need and interest and that the person possesses the required competence to possess, prescribe, use, or supply those scheduled substances [medicines].
(2) The Council may issue a licence on application in the prescribed form by a pharmacist, authorising that pharmacist to
specified Schedule 2 or Schedule 3 substances, [medicines] subject to such conditions as the Council may determine, if the Council is satisfied that granting such a licence is in the public need and interest and that the pharmacist possesses the required competence to prescribe those scheduled substances [medicines].
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Amendment of section 33 of Act No. 13 of 2003
8. Section 33 of the principal Act is amended by the substitution for subsection
(1) of the following subsection:
"(1) If the Council is of the opinion that it is not in the public interest that a medicine or a scheduled substance be made available to the public, the Council may
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(ii) deliver or send that medicine to any other person designated by the Council." .
Insertions of sections 37A, 37B, 37C, 37D, 37E and 37F in Act No. 13 of 2003
9. The following sections are inserted in the principal Act after section 37: "Premises to be registered
37A. (1) No person may manufacture any medicine on any premises unless
(2) Subsection (1) prevails over any other provision to the contrary contained in any other law, and nothing in any other law is deemed to authorise any person to act in contravention of subsection (1).
Application for registration of premises
37B. (1) A person who wishes to have a premises registered as contemplated in section 37A(1), must submit an application to the Registrar in the prescribed form.
(3) The Registrar must submit, as soon as is practicable after he or she has received the application referred to in subsection (1), the application and the prescribed particulars, if any, to the Council for consideration, and must inform the applicant in writing that the application has been so submitted.
Consideration of application and registration of premises
37C. (1) On receipt of an application referred to in section 37B(1), the Council
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the Registrar must inform the applicant in writing of such intention and the reasons thereof and that the applicant may make, ifhe or she so wishes, within such period, being not more than 14 days, as the Council may specify, written representations in relation to the intention concerned.
Validity and renewal of licences
37D. (1) A licence issued in terms of section 37B(3)(b)(ii) is valid, unless cancelled or suspended, for a period of 24 months and may be renewed before its expiry.
(2) An application for the renewal of a licence must be made to the Registrar, and must be
(a) in the prescribed form;
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Act No.8, 2007 MEDICINES AND RELATED SUBSTANCES CONTROL AMENDMENT ACT, 2007
(3) On receipt of an application for the renewal of a licence the Council may, if itis
the Council must give notice thereof in writing to the applicant concerned.
No. 3968 Government Gazette 28 December 2007 Act No.8, 2007 MEDICINES AND RELATED SUBSTANCES CONTROL AMENDMENT ACT, 2007 Cancellation, suspension, alteration and variation of licences 37E. (1) If the Council is of the opinion that
(iii) alter the purposes for which the licence was issued; or
(iv) vary the conditions subject to which the licence was issued.
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(4) Subject to subsection (5), a decision of the Council contemplated in subsection (3) has immediate effect notwithstanding the lodging of any appeal against the decision of the Council.
such conditions as it may determine, authorise the holder of the licence concerned to continue to operate under the original licence until the appeal is determined or has been abandoned.
Effect of non-renewal or cancellation of licence
37F. 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.".
Amendment of section 38 of Act No. 13 of 2003
10. Section 38 of the principal Act is amended by the insertion after paragraph
(m) of the following paragraph:
"(IDA) contravenes section 37A(1)". Amendment of section 39 of Act No. 13 of 2003
11. Section 39 ofthe principal Act is amended
(a) by the substitution for subsection (2) of the following subsection:
"(2) The court convicting a person of an offence under this Act may
ill declare a medicine or a scheduled substance, or other thing, to which the offence relates, to be forfeited to the State;
ilil in the case of a second or subsequent conviction in respect of a person who is the holder of a licence or pennit issued in terms of this Act, order that such person be disqualified indefinitely from holding a licence or pennit concerned."; and
(b) by the substitution for subsection (3) of the following subsection:
"(3) A medicine or a scheduled substance, or any other thing, forfeited in terms of subsection (2) must be destroyed or dealt with ill in the prescribed manner; or ilil if no regulations have been made which prescribe the manner of
destruction thereof. in such manner as the Permanent Secretary may direct.". Amendment of section 44 of Act No. 13 of 2003
12. Section 44 of the principal Act is amended by the substitution for paragraphs
(s) to (y) of subsection (1) of the following paragraphs:
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Act No.8, 2007 | MEDICINES | AND RELATED | SUBSTANCES | ||
CONTROL | AMENDMENT | ACT, 2007 |
"(s) as to the transshipment or the importation into, or exportation from, Namibia of a scheduled substance or a medicine, and specifying the ports or places at which that substance or medicine may be imported into, or exported from, Namibia;
Substitution of section 45 of Act No. 13 of 2003
13. The following section is substituted for section 45 of the principal Act:
"Exclusions
45. (1) The Minister, after consultation with the Council, may exclude by notice in the Gazette a medicine from the operation of any or all the provisions of this Act, subject to such conditions as he or she may determine.
Amendment of section 46 of Act No. 13 of 2003
14. (1) Section 46 of the principal Act is amended
(a) by the substitution for subsection (1) of the following subsection:
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Act No.8, 2007 MEDICINES AND RELATED SUBSTANCES CONTROL AMENDMENT ACT, 2007
"(1) A person, who was in office as
immediately before the date of commencement of this Act, continues in such office until the day immediately preceding the day on which the Minister appoints the members of the Council as contemplated in section 3( 1) [for the period for which the person was appointed to that office].";
(b) by the insertion of the following subsections after subsection (1):
"(lA) Subject to this Act
(1B) Subsections (1) and (IA) are not so construed as to prohibit the Council from establishing the veterinary medicines committee immediately after the commencement of this Act."; and
(c) by the insertion of the following subsection after subsection (2):
(2A) For purposes of the application of subsection (2)
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(c) | any reference to Schedule 5 or 6 of the Medicines and Related Substances Control Act, 1965 (Act No. 101 of | 1965), | is |
construed as a reference to Schedule 3 of this Act;
Substitution of section 47 of Act No. 13 of 2003
15. The following section is substituted for section 47 of the principal Act: "Repeals, amendments and savings
47. (1) Subject to subsection (2)
(a) the
(iii) Drugs Control Amendment Act, 1970 (Act No. 88 of 1970);
(vii) Health Laws Amendment Act, 1977 (Act No. 36 of 1977);
(viii) Medicines and Related Substances Control Amendment Act, 2000 (Act No. 19 of 20(0),
are repealed;
(b) all amendments to the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act No. 36 of1947), contained in the Schedule are repealed.
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(2) Notwithstanding | subsection | (1) any | notice, | regulation, |
authorisation, order, approval or certificate issued, made or granted or any other thing done in terms of a provision of a law repealed or amended by that subsection is, except in so far as may be otherwise required by this Act,
deemed to have been issued, made, granted or done under the corresponding provision of this Act.".
Short title and commencement
17. This Act is called the Medicines and Related Substances Control Amendment Act, 2007, and comes into operation on a day to be determined by the Minister by notice in the Gazette.