- Definitions
- Continuation of Council, and its powers and functions
- Constitution of Council
- Disqualification for appointment as member of Council
- Tenure of office of members
- Vacation of office and filling of vacancies
- Chairperson and vice-chairperson
- Meetings of Council
- Disclosure of interest
- Remuneration
- Executive committee
- Veterinary medicines committee
- Other committees
- Restriction of liability
- Financial year and annual report
- Appointment of Registrar of Medicines
- Registers
- Prohibition on sale of medicines, which are subject to registration and are not registered
- Registration of medicines
- Amendment of entries in register
- Transfer of certificate of registration
- Cancellation of registration
- Notification of registration, or cancellation of registration, in the Gazette
- Labels and advertisements
- Prohibition on sale of medicines, which do not comply with prescribed requirements, and furnishing of information regarding medicines to the Council
- Publication or distribution of false advertisements concerning medicines
- Council may authorise sale of unregistered medicine for certain purposes
- Council to cause certain information to be furnished
- Control of medicines and scheduled substances
- Generic substitution
- Licences and permits
- Publication of information relating to medicines, scheduled substances or any other things subject to this Act
- Disposal of undesirable medicines
- Appeal against decisions of Council
- Inspectors
- Powers of inspectors
- Analysts
- Offences
- Penalties
- Presumptions and evidence
- Special defences in case of prosecutions
- Preservation of secrecy and inappropriate use of information
- Delegation of powers, and assignment of duties and functions
- Regulations
- Exemptions
- Transitional provisions
- SCHEDULE
GOVERNMENT GAZETTE
OF THE
REPUBLIC OF NAMIBIA
N$7.80 WINDHOEK - 28 August 2003 No.3051 CONTENTS Page GOVERNMENT NOTICE No. 192 Promulgation of Medicines and Related Substances Control Act, 2003 (Act No. 13 of 2003), of the Parliament .............................................................. _______________ 1 Government Notice
OFFICE OF THE PRIME MINISTER
No. 192 2003
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. 13 of 2003: Medicines and Related Substances Control Act, 2003.
ACT
To provide for the establishment of a Namibia Medicines Regulatory Council; for the registration of medicines intended for human and for animal use; for the control of medicines and scheduled substances; and to provide for incidental matters.
(Signed by the President on 13 August 2003)
ARRANGEMENT OF SECTIONS
Section - Definitions
- Continuation of Council, and its powers and functions
- Constitution of Council
- Disqualification for appointment as member of Council
- Tenure of office of members
- Vacation of office and filling of vacancies
- Chairperson and vice- chairperson
- Meetings of Council
- Disclosure of interest
- Remuneration
- Executive committee
- Veterinary medicines committee
- Other committees
- Restriction of liability
- Financial year and annual report
- Appointment of Registrar of Medicines
- Registers
- Prohibition on sale of medicines, which are subject to registration and are not registered
- Registration of medicines
- Amendment of entries in register
- Transfer of certificate of registration
- Cancellation of registration
- Notification of registration, or cancellation of registration, in the Gazette
- Labels and advertisements
- Prohibition on sale of medicines, which do not comply with prescribed requirements, and furnishing of information regarding medicines to the Council
- Publication or distribution of false advertisements concerning medicines
- Council may authorise sale of unregistered medicines for certain purposes
- Council to cause certain information to be furnished
- Control of medicines and scheduled substances
- Generic substitution
- Licences and permits
- Publication of information relating to medicines, scheduled substances or other things subject to this Act
- Disposal of undesirable medicines
- Appeal against decisions of Council
- Inspectors
- Powers of inspectors
- Analysts
- Offences
- Penalties
- Presumptions and evidence
- Special defences in case of prosecutions
- Preservation of secrecy and inappropriate use of information
- Delegation of powers, and assignment of duties and functions
- Regulations
- Exemptions
- Transitional provisions
- Repeals, amendments and savings
- Short title and commencement
SCHEDULE - LAWS REPEALED OR AMENDED BE IT ENACTED by the Parliament of the Republic of Namibia as follows: Definitions
1. (1) In this Act, unless the context otherwise indicates
“advertisement”, in relation to a medicine or a scheduled substance, means a written, a pictorial, a visual or other descriptive matter or verbal statement or reference - (a)
- appearing in a newspaper, a magazine, a pamphlet or other publication;
- (b)
- broadcast on television or radio;
- (c)
- distributed to members of the public; or
- (d)
- brought to the notice of members of the public in any manner,
which is intended to promote the sale of that medicine or scheduled substance, and
“advertise” has a corresponding meaning;
“analyst” means an analyst to whom authority has been granted under section 37;
“animal” means animal as defined in the Animal Diseases and Parasites Act, 1956 (Act
No. 13 of 1956);
“appeal committee” means the appeal committee referred to in section 34(1);
“authorised prescriber” means a medical practitioner, a dentist, a veterinarian or a person
authorised to prescribe a medicine under section 31(1) or (2);
“certificate of registration” means a certificate of registration issued in terms of section
19(7)(b), 20(4)(b) or 21(4)(c);
“chairperson” means the person elected as chairperson of the Council in terms of section
7(1);
“committee” means a committee established by the Board under this Act;
“complementary medicine” means a substance or a mixture of substances prepared and
used or purported to be suitable for use in - (a)
- the diagnosis, treatment, mitigation, modification, or prevention, of a disease, abnormal physical or mental state, or the symptoms thereof, in humans or animals; or
- (b)
- restoring, correcting or modifying any somatic, psychic or organic function in humans or animals,
in accordance with the principles of any of the following disciplines:
CONTROL ACT, 2003 (i) Homeopathy; (ii) Western herbal medicine; (iii) African traditional medicine; or (iv) Chinese herbal medicine;
“controlled chemical” means a chemical declared to be a controlled chemical under section
44(1)(dd);
“controlled equipment” means equipment declared to be controlled equipment under
section 44(1)(dd);
“Council” means the Namibia Medicines Regulatory Council referred to in section 2;
“dentist” means a dentist as defined in the Medical and Dental Professions Act, 1993
(Act No. 21 of 1993);
“dispense”, in relation to a medicine, means to - (a)
- prepare;
- (b)
- count out, measure or decant from a bulk supply;
- (c)
- mix;
- (d)
- dissolve; or
- (e)
- disperse,
and dispose of, a medicine, for gain or otherwise, for the treatment of a particular person or animal, but does not include the actual administration of the medicine, and “dispensing” has a corresponding meaning;
“emergency medicine” means medicine needed for immediate relief of a symptom or needed for procedures in a practice, but does not include medicine for a patient to take away;
“essential drugs” means medicines listed in the prevailing Namibian Essential Drugs List published by the Ministry responsible for health;
“export” includes to deliver or supply within Namibia for dispatch to a destination outside of Namibia;
“health facility” means a health facility as defined in the Hospitals and Health Facilities Act, 1994 (Act No. 36 of 1994) or in the Veterinary and Para-veterinary Professions Proclamation, 1984 (Proclamation No. AG 14 of 1984);
“hospital” means a hospital as defined in the Hospitals and Health Facilities Act, 1994 (Act No. 36 of 1994);
“immediate container”, in relation to a medicine or a scheduled substance, means a container which is in direct contact with the medicine or the scheduled substance, but is not a package liner;
“importer” means a person who brings a medicine, a scheduled substance, a controlled chemical, controlled equipment or a medical device into Namibia or causes a medicine,
a scheduled substance, a controlled chemical, controlled equipment or a medical device
(in this definition called goods) to be brought into Namibia, and includes a person who (a) owns the goods brought into Namibia; (b) carries the risk for the goods brought into Namibia; (c) represents to be the one who brought the goods into Namibia or who owns those goods; (d) actually brings the goods into Namibia; (e) is beneficially interested in any way in the goods brought into Namibia; or (f) acts on behalf of a person referred to in paragraphs (a) to (e),
and “import” and “importation” have a corresponding meaning;
“inspector” means a person authorised as an inspector under section 35;
“interchangeable multi-source medicine” means medicine that contains the same quantities of the same active substances in the same dosage form and meets comparable standards as another medicine;
“international treaties” means treaties relating to narcotic drugs and psychotropic substances to which Namibia is a party;
“label”, when used as a verb, means brand, mark or otherwise designate or describe, and when used as a noun, means a brand or a written, a pictorial or other descriptive matter appearing on or attached to an article or the package containing an article, and referring to the article;
“legal practitioner” means a legal practitioner as defined in the Legal Practitioners Act, 1995 (Act No. 15 of 1995);
“manufacture” means carry out operations including purchasing of material, processing, packaging, quality control, release and storage of medicinal products and related substances, and “manufacturing” has a corresponding meaning;
“manufacturer”, means a person who manufactures or on whose direction manufacturing takes place;
“medical device” means any instrument, appliance, material, machine, apparatus, implant or diagnostic reagent used or purported to be suitable for use for medical or veterinary purposes, and includes a part or an accessory of a medical device;
“medical practitioner” means a medical practitioner as defined in the Medical and Dental Professions Act, 1993 (Act No. 21 of 1993), or a medical intern as defined in that Act;
“medicinal purpose”, in relation to a scheduled substance, means for the purpose of the treatment or prevention of a disease or some other definite curative or therapeutic purpose, but does not include the satisfaction of a habit, or the relief of a craving for the substance used or for any other such substance, except where the substance is administered or used under a programme approved for this purpose by the Minister;
“medicine” means
(a) a substance or a mixture of substances used or purported to be suitable for use or manufactured or sold for use in - (i)
- the diagnosis, treatment, mitigation, modification or prevention of a disease, abnormal physical or mental state, or the symptoms thereof, in humans or animals; or
- (ii)
- restoring, correcting or modifying any somatic, psychic or organic function in humans or animals;
- (b)
- a veterinary medicine; or
- (c)
- a complementary medicine;
“Minister” means the Minister responsible for health;
“original immediate container” means the immediate container in which the medicine was originally distributed by the manufacturer;
“package” means a container in or by which an original immediate container of a medicine is enclosed, covered, contained or packed, but excludes bulk boxes in which that original immediate container or the package is transported;
“para-veterinary professional” means a person registered to practise a para-veterinary profession under the Veterinary and Para-veterinary Professions Proclamation, 1984 (Proclamation No. AG. 14 of 1984);
“patient” means - (a)
- in the case of a medical practitioner, a dentist, a practitioner or a registered nurse, a person treated by the medical practitioner, the dentist, the practitioner or the registered nurse;
- (b)
- in the case of a veterinarian or a para-veterinary professional, an animal treated by the veterinarian or the para-veterinary professional; and
- (c)
- in the case of a pharmacist, a person, or an animal, treated by the pharmacist;
“Permanent Secretary” means the Permanent Secretary of the Ministry responsible for health; “pharmaceutical technician” means a pharmaceutical technician as defined in the
Pharmacy Profession Act, 1993 (Act No. 23 of 1993);
“pharmacist” means a pharmacist as defined in the Pharmacy Profession Act, 1993 (Act No. 23 of 1993); “pharmacist’s assistant” means a pharmacist’s assistant as defined in the Pharmacy
Profession Act, 1993 (Act No. 23 of 1993);
“pharmacist intern” means a pharmacist intern as defined in the Pharmacy Profession Act, 1993 (Act No. 23 of 1993); “practitioner” means a practitioner as defined in the Allied Health Services Professions
Act, 1993 (Act No. 20 of 1993); “prescribe” means - (a)
- prescribe by regulation under this Act; and
- (b)
- in relation to a medicine, issue a written or oral instruction for a specific patient to receive a medicine specified in that instruction under such conditions as may be specified, and “prescription” has a corresponding meaning;
“public” includes a section of the public concerned with manufacturing, dispensing, selling or administering, or the issue of prescriptions for, medicines or scheduled substances;
“public need and interest” means the health care needs and interests of the greater Namibian community in respect of availability and equitable access to health care services;
“Public Service Act” means the Public Service Act, 1995 (Act No. 13 of 1995);
“register” - (a)
- when used as a noun, means the medicines register or veterinary medicines register or complementary medicines register, or any other register kept in terms of section 17; and
- (b)
- when used as a verb, means enter in a register referred to in paragraph (a);
“registered nurse” means a registered nurse as defined in the Nursing Professions Act, 1993 (Act No. 30 of 1993);
“Registrar” means the Registrar of Medicines appointed in terms of section 6;
“regulation” means a regulation made under this Act;
“scheduled substance” means any medicine or substance classified as a Schedule 1, Schedule 2, Schedule 3, Schedule 4 or Schedule 5 substance in terms of section 29(1);
“sell” means sell by wholesale or retail, and includes import, offer, advertise, keep, expose, transmit, consign, convey or deliver for sale or authorise, direct or allow a sale, or prepare or possess for purposes of sale, and barter or exchange or supply or dispose of to a person, whether for a consideration or otherwise, and “sale” and “sold” have a corresponding meaning;
“staff member” means a staff member as defined in the Public Service Act;
“this Act” includes a regulation made under it;
“unscheduled medicine” means a medicine which is not classified in terms of section 29(1);
“veterinarian” means a person registered as such under the Veterinary and Para-veterinary Professions Proclamation, 1984 (Proclamation No. AG. 14 of 1984);
“veterinary medicines” means a substance or a mixture of substances, other than farm feed as defined in the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act No. 36 of 1947), used or purporting to be suitable for use or manufactured or sold for use in connection with - (a)
- the diagnosis, treatment, prevention or cure of a disease, an infection or other unhealthy condition in animals;
- (b)
- the maintenance or improvement of health, growth, production or working capacity in animals; or
- (c)
- restoring, correcting or modifying a somatic or organic function, or for correcting or modifying behaviour, in animals;
“veterinary medicines committee” means the committee referred to in section 12(1);
“vice-chairperson” means the person elected as vice-chairperson of the Council in terms of section 7(1). - (2)
- Notwithstanding anything contained in any other law, a medicine must be regarded as being the same as any other medicine registered in Namibia, if
- (3)
- In determining whether or not the registration or availability of a medicine is in the public interest, regard must be had to its safety, quality and therapeutic efficacy in relation to its effect on the health of humans or animals, as the case may be.
- (4)
- In the registration of medicines, the registration of essential drugs must receive priority.
(a) its components, physical characteristics, quantity and quality are identical to those of that other medicine; (b) it is manufactured by the same manufacturer; and (c) the label and the information accompanying that medicine is approved by the Council.
Continuation of Council, and its powers and functions
2. (1) The council known as the Medicines Control Council established by the Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965), continues to exist under the name Namibia Medicines Regulatory Council. - (2)
- The Council may exercise the powers conferred, and must perform the functions assigned, to the Council by or under this Act.
- (3)
- Without prejudice to the generality of subsection (2), the functions of the Council are to
- (a)
- advise the Minister and report to the Minister on any matter referred to the Council by the Minister for consideration and arising from the application of this Act; and
- (b)
- register medicines and any other thing that is required or prescribed to be registered.
Constitution of Council
3. (1) The Council consists of the following members appointed by the Minister as follows: - (a)
- Three medical practitioners
- (i)
- one of whom is registered as a medical specialist;
- (ii)
- one of whom is engaged in private medical practice; and
(iii) one of whom is employed by the Ministry responsible for health;
- (b)
- three pharmacists
- (i)
- one of whom is engaged in private pharmaceutical practice;
- (ii)
- one of whom is employed by the Ministry responsible for health; and
- (c)
- two veterinarians, nominated for appointment by the Minister responsible for agriculture
- (i)
- one of whom is engaged in private veterinary practice; and
- (ii)
- one of whom is employed by the Ministry responsible for agriculture;
- (d)
- one legal practitioner nominated for appointment by the Minister responsible for justice;
- (e)
- one registered nurse;
- (f)
- one practitioner who, in the opinion of the Minister, has sufficient knowledge of medicines and related substances; and
- (g)
- one other person.
- (2)
- For the purpose of appointment of members under subsection (1)
- (a)
- the Minister must, in respect of the members referred to in paragraphs (a), (b), (e) and (f) of subsection (1);
- (b)
- the Minister responsible for agriculture, on the written request of the Minister, must in respect of the members referred to in paragraph (c) of subsection (1); and
- (c)
- the Minister responsible for justice, on the written request of the Minister, must in respect of the member referred to paragraph (d) of subsection (1),
Act No. 13, 2003 MEDICINES AND RELATED SUBSTANCES CONTROL ACT, 2003 (iii) any other pharmacist;
publish a notice in the Gazette requesting any interested body to submit to the relevant Minister, within 30 days, the names of suitably qualified persons to be appointed as members of the Council. - (3)
- If the names referred to in subsection (2) are not submitted to the Minister who requested them within the period referred to in that subsection, that Minister must nominate suitably qualified persons for appointment as members of the Council and a person nominated under this subsection holds office as if his or her name was submitted in accordance with the said subsection (2).
- (4)
- The Minister must give notice in the Gazette of the names and dates of appointment of the members of the Council and, in the case of a member appointed to fill a casual vacancy, the period for which he or she is appointed.
Disqualification for appointment as member of Council
4. A person does not qualify for appointment as a member of the Council, if the person - (a)
- is an unrehabilitated insolvent;
- (b)
- is disqualified in terms of any law from carrying on the profession in respect of which he or she is to be appointed as member;
- (c)
- is not a Namibian citizen or a holder of a permanent residence permit; or
(d) has during the period of ten years immediately preceding the date of the intended appointment, been convicted of a criminal offence and sentenced to imprisonment without the option of a fine, irrespective of whether or not that sentence has been suspended, and has not received a free pardon.
Tenure of office of members
5. 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.
Vacation of office and filling of vacancies
6. (1) A member of the Council must vacate his or her office, if he or she - (a)
- becomes subject to a disqualification referred to in section 4;
- (b)
- has been absent from three consecutive meetings of the Council without the permission of the chairperson;
- (c)
- resigns his or her office by written notice to the Minister; or
- (d)
- is removed from office by the Minister under subsection (2).
- (2)
- The Minister may, at the request of, or after consultation with, the Council by notice in writing, and if he or she is satisfied that there are sufficient reasons for doing so, remove a member of the Council from office after giving the member concerned a reasonable opportunity to be heard.
- (3)
- If a member of the Council dies, or his or her office becomes vacant in terms of subsection (1), the Minister must, with due regard to section 3, appoint a person to fill the vacancy for the unexpired portion of the term of office of the member in whose stead he or she is appointed.
Chairperson and vice-chairperson
7. (1) The Council must elect a chairperson and a vice-chairperson from amongst the members of the Council. - (2)
- The chairperson and the vice-chairperson may not hold their offices for more than two consecutive terms of three years.
- (3)
- The chairperson and the vice-chairperson may vacate their offices without terminating their membership of the Council.
Meetings of Council
8. (1) The first meeting of the Council must be held at such time and place as the Minister may determine, and thereafter, subject to subsection (3), meetings of the Council must be held at such times and places as the Council may determine, but the Council must hold at least one meeting every three months.
(2) If the Council has not determined the time and place for its next meeting, the chairperson must determine the time and place. - (3)
- The chairperson
- (a)
- may at any time convene a special meeting of the Council; and
(b) must convene a special meeting of the Council, if the Minister requests, or if at least three members of the Council request, him or her, in writing, to do so. - (4)
- The chairperson must convene a meeting requested in terms of subsection (3)(b) within 14 days after the date of receipt of the request and at such time and place as he or she may determine.
- (5)
- The chairperson, or in his or her absence, the vice-chairperson, or in the absence of both the chairperson and the vice-chairperson, a member of the Council elected by the members present, must preside at a meeting of the Council.
- (6)
- Notwithstanding subsection (8), a majority of the members of the Council constitutes a quorum at a meeting of the Council.
- (7)
- A decision of a majority of the members of the Council present at a meeting of the Council is the decision of the Council and, in the event of an equality of votes, the person presiding has a casting vote in addition to his or her deliberative vote.
- (8)
- Subject to subsection (6), a decision of the Council is not rendered invalid by reason only of a vacancy on the Council or of the fact that a person who is not entitled to sit as a member of the Council did so sit when the decision was taken, if that decision was taken by the requisite majority of the members who were present at the time and entitled to vote.
- (9)
- The chairperson must cause a record to be kept of the proceedings of every meeting of the Council and must cause that record to be submitted to the Minister as soon as is practicable after a meeting of the Council.
Disclosure of interest
9. (1) A member of the Council or of a committee must, within a period of three months from the date of his or her appointment as a member of the Council or of a committee, declare in writing to the Minister or to the Council, as the case may be, his or her commercial interests related to the pharmaceutical or health care industry, which interests include, but are not limited to, any consultancy for, research grants from, or equity holding or directorship in, a pharmaceutical company, or any other payment or benefit in kind. - (2)
- If a member of the Council or of a committee, or his or her spouse, is in any way directly or indirectly interested in a matter, which is the subject of consideration by the Council or a committee and which may cause a conflict of interests in the performance of his or her duties as a member of the Council or as a member of any such committee, he or she must fully disclose the nature of that interest as soon as is practicable after the commencement of the meeting of the Council or of any such committee at which that matter is a subject of consideration and that member of the Council or of any such committee, may not take part in the consideration of, or vote on, a question relating to that matter.
- (3)
- If a member of the Council or of a committee fails to disclose a conflict of interests as required by subsection (2) and is present at a meeting of the Council or of any such committee, or in any way participates in the consideration of, or votes on, a question relating to the matter referred to in that subsection, the proceedings in relation to that matter must, as soon as the non-disclosure is discovered, be rendered invalid and thereafter be reviewed by the Council or any such committee, as the case may be, in the absence of the member of the Council or the member of any such committee.
(4) A person who knowingly fails to comply with subsection (1) or (2) commits an offence and is liable on conviction to a fine not exceeding N$8 000 or to imprisonment for a period not exceeding two years or to both the fine and imprisonment.
Remuneration
10. (1) There must be paid to a member of the Council or of a committee, who is not in the full-time employment of the State, in respect of his or her services as a member of the Council or of any such committee, such remuneration as the Minister, in consultation with the Minister responsible for finance, may determine.
(2) Different amounts of remuneration may be determined under subsection
(1) according to the different offices held on the Council or committee, or the work performed for the Council or committee, by the persons concerned.
Executive committee
11. (1) The Council must establish from amongst its members an executive committee, which consists of the chairperson and not more than four other members of the Council. - (2)
- Subject to the directions of the Council, the executive committee may exercise the powers, and must perform the functions, of the Council during the periods between the meetings of the Council.
- (3)
- Unless specifically empowered by the Council to do so, the executive committee may not set aside or vary a decision of the Council.
- (4)
- An action taken or a decision made by the executive committee is subject to review at the first ensuing meeting of the Council.
Veterinary medicines committee
12. (1) The Council must establish a veterinary medicines committee, which may exercise the powers conferred on, and must perform the functions assigned to, the veterinary medicines committee by this Act. (2) The veterinary medicines committee consists of (a) one veterinarian designated by the Council from amongst its members, who must be the chairperson of the committee; (b) two veterinarians designated by the Minister responsible for agriculture; (c) one veterinarian designated by the Veterinary Association of Namibia; and (d) one pharmacist who is a member of the Council. (3) The veterinary medicines committee may appoint not more than two other
persons to be additional members of the veterinary medicines committee, subject to approval by the Council. - (4)
- Section 6, with the necessary modifications, applies also to those members of the veterinary medicines committee, who are not members of the Council.
- (5)
- The Council or 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, 42(a)(i), 44(1) or 45 with respect to a veterinary medicine, unless the veterinary medicines committee recommends so.
Other committees
13. The Council may - (a)
- from time to time, establish such other committees as it may consider necessary to investigate and report to it on a matter, which is within the purview of the Council in terms of this Act; and
- (b)
- appoint such persons, including persons other than members of the Council, as it may consider fit to be members of a committee established in terms of paragraph (a).
Restriction of liability
14. 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.
Financial year and annual report
15. (1) The financial year of the Council begins on 1 April and ends on 31 March in the following year. - (2)
- The Council must submit a report to the Minister, not later than 30 September in each year, relating to the activities of the Council during the previous financial year.
- (3)
- The Minister must lay the report referred to in subsection (2) on the Table in Parliament within 28 days after the date of the receipt of the report, if Parliament is then in ordinary session, or, if Parliament is not then in ordinary session, within 28 days after the commencement of its next ordinary session.
Appointment of Registrar of Medicines
16. (1) Subject to the Public Service Act and after consultation with the Council, the Minister must appoint a pharmacist to be the Registrar of Medicines.
REPUBLIC OF NAMIBIA
N$7.80 WINDHOEK - 28 August 2003 No.3051 CONTENTS Page GOVERNMENT NOTICE No. 192 Promulgation of Medicines and Related Substances Control Act, 2003 (Act No. 13 of 2003), of the Parliament .............................................................. _______________ 1 Government Notice
OFFICE OF THE PRIME MINISTER
No. 192 2003
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. 13 of 2003: Medicines and Related Substances Control Act, 2003.
ACT
To provide for the establishment of a Namibia Medicines Regulatory Council; for the registration of medicines intended for human and for animal use; for the control of medicines and scheduled substances; and to provide for incidental matters.
(Signed by the President on 13 August 2003)
ARRANGEMENT OF SECTIONS
Section - Definitions
- Continuation of Council, and its powers and functions
- Constitution of Council
- Disqualification for appointment as member of Council
- Tenure of office of members
- Vacation of office and filling of vacancies
- Chairperson and vice- chairperson
- Meetings of Council
- Disclosure of interest
- Remuneration
- Executive committee
- Veterinary medicines committee
- Other committees
- Restriction of liability
- Financial year and annual report
- Appointment of Registrar of Medicines
- Registers
- Prohibition on sale of medicines, which are subject to registration and are not registered
- Registration of medicines
- Amendment of entries in register
- Transfer of certificate of registration
- Cancellation of registration
- Notification of registration, or cancellation of registration, in the Gazette
- Labels and advertisements
- Prohibition on sale of medicines, which do not comply with prescribed requirements, and furnishing of information regarding medicines to the Council
- Publication or distribution of false advertisements concerning medicines
- Council may authorise sale of unregistered medicines for certain purposes
- Council to cause certain information to be furnished
- Control of medicines and scheduled substances
- Generic substitution
- Licences and permits
- Publication of information relating to medicines, scheduled substances or other things subject to this Act
- Disposal of undesirable medicines
- Appeal against decisions of Council
- Inspectors
- Powers of inspectors
- Analysts
- Offences
- Penalties
- Presumptions and evidence
- Special defences in case of prosecutions
- Preservation of secrecy and inappropriate use of information
- Delegation of powers, and assignment of duties and functions
- Regulations
- Exemptions
- Transitional provisions
- Repeals, amendments and savings
- Short title and commencement
SCHEDULE - LAWS REPEALED OR AMENDED BE IT ENACTED by the Parliament of the Republic of Namibia as follows: Definitions
1. (1) In this Act, unless the context otherwise indicates
“advertisement”, in relation to a medicine or a scheduled substance, means a written, a pictorial, a visual or other descriptive matter or verbal statement or reference - (a)
- appearing in a newspaper, a magazine, a pamphlet or other publication;
- (b)
- broadcast on television or radio;
- (c)
- distributed to members of the public; or
- (d)
- brought to the notice of members of the public in any manner,
which is intended to promote the sale of that medicine or scheduled substance, and
“advertise” has a corresponding meaning;
“analyst” means an analyst to whom authority has been granted under section 37;
“animal” means animal as defined in the Animal Diseases and Parasites Act, 1956 (Act
No. 13 of 1956);
“appeal committee” means the appeal committee referred to in section 34(1);
“authorised prescriber” means a medical practitioner, a dentist, a veterinarian or a person
authorised to prescribe a medicine under section 31(1) or (2);
“certificate of registration” means a certificate of registration issued in terms of section
19(7)(b), 20(4)(b) or 21(4)(c);
“chairperson” means the person elected as chairperson of the Council in terms of section
7(1);
“committee” means a committee established by the Board under this Act;
“complementary medicine” means a substance or a mixture of substances prepared and
used or purported to be suitable for use in - (a)
- the diagnosis, treatment, mitigation, modification, or prevention, of a disease, abnormal physical or mental state, or the symptoms thereof, in humans or animals; or
- (b)
- restoring, correcting or modifying any somatic, psychic or organic function in humans or animals,
in accordance with the principles of any of the following disciplines:
CONTROL ACT, 2003 (i) Homeopathy; (ii) Western herbal medicine; (iii) African traditional medicine; or (iv) Chinese herbal medicine;
“controlled chemical” means a chemical declared to be a controlled chemical under section
44(1)(dd);
“controlled equipment” means equipment declared to be controlled equipment under
section 44(1)(dd);
“Council” means the Namibia Medicines Regulatory Council referred to in section 2;
“dentist” means a dentist as defined in the Medical and Dental Professions Act, 1993
(Act No. 21 of 1993);
“dispense”, in relation to a medicine, means to - (a)
- prepare;
- (b)
- count out, measure or decant from a bulk supply;
- (c)
- mix;
- (d)
- dissolve; or
- (e)
- disperse,
and dispose of, a medicine, for gain or otherwise, for the treatment of a particular person or animal, but does not include the actual administration of the medicine, and “dispensing” has a corresponding meaning;
“emergency medicine” means medicine needed for immediate relief of a symptom or needed for procedures in a practice, but does not include medicine for a patient to take away;
“essential drugs” means medicines listed in the prevailing Namibian Essential Drugs List published by the Ministry responsible for health;
“export” includes to deliver or supply within Namibia for dispatch to a destination outside of Namibia;
“health facility” means a health facility as defined in the Hospitals and Health Facilities Act, 1994 (Act No. 36 of 1994) or in the Veterinary and Para-veterinary Professions Proclamation, 1984 (Proclamation No. AG 14 of 1984);
“hospital” means a hospital as defined in the Hospitals and Health Facilities Act, 1994 (Act No. 36 of 1994);
“immediate container”, in relation to a medicine or a scheduled substance, means a container which is in direct contact with the medicine or the scheduled substance, but is not a package liner;
“importer” means a person who brings a medicine, a scheduled substance, a controlled chemical, controlled equipment or a medical device into Namibia or causes a medicine,
a scheduled substance, a controlled chemical, controlled equipment or a medical device
(in this definition called goods) to be brought into Namibia, and includes a person who (a) owns the goods brought into Namibia; (b) carries the risk for the goods brought into Namibia; (c) represents to be the one who brought the goods into Namibia or who owns those goods; (d) actually brings the goods into Namibia; (e) is beneficially interested in any way in the goods brought into Namibia; or (f) acts on behalf of a person referred to in paragraphs (a) to (e),
and “import” and “importation” have a corresponding meaning;
“inspector” means a person authorised as an inspector under section 35;
“interchangeable multi-source medicine” means medicine that contains the same quantities of the same active substances in the same dosage form and meets comparable standards as another medicine;
“international treaties” means treaties relating to narcotic drugs and psychotropic substances to which Namibia is a party;
“label”, when used as a verb, means brand, mark or otherwise designate or describe, and when used as a noun, means a brand or a written, a pictorial or other descriptive matter appearing on or attached to an article or the package containing an article, and referring to the article;
“legal practitioner” means a legal practitioner as defined in the Legal Practitioners Act, 1995 (Act No. 15 of 1995);
“manufacture” means carry out operations including purchasing of material, processing, packaging, quality control, release and storage of medicinal products and related substances, and “manufacturing” has a corresponding meaning;
“manufacturer”, means a person who manufactures or on whose direction manufacturing takes place;
“medical device” means any instrument, appliance, material, machine, apparatus, implant or diagnostic reagent used or purported to be suitable for use for medical or veterinary purposes, and includes a part or an accessory of a medical device;
“medical practitioner” means a medical practitioner as defined in the Medical and Dental Professions Act, 1993 (Act No. 21 of 1993), or a medical intern as defined in that Act;
“medicinal purpose”, in relation to a scheduled substance, means for the purpose of the treatment or prevention of a disease or some other definite curative or therapeutic purpose, but does not include the satisfaction of a habit, or the relief of a craving for the substance used or for any other such substance, except where the substance is administered or used under a programme approved for this purpose by the Minister;
“medicine” means
(a) a substance or a mixture of substances used or purported to be suitable for use or manufactured or sold for use in - (i)
- the diagnosis, treatment, mitigation, modification or prevention of a disease, abnormal physical or mental state, or the symptoms thereof, in humans or animals; or
- (ii)
- restoring, correcting or modifying any somatic, psychic or organic function in humans or animals;
- (b)
- a veterinary medicine; or
- (c)
- a complementary medicine;
“Minister” means the Minister responsible for health;
“original immediate container” means the immediate container in which the medicine was originally distributed by the manufacturer;
“package” means a container in or by which an original immediate container of a medicine is enclosed, covered, contained or packed, but excludes bulk boxes in which that original immediate container or the package is transported;
“para-veterinary professional” means a person registered to practise a para-veterinary profession under the Veterinary and Para-veterinary Professions Proclamation, 1984 (Proclamation No. AG. 14 of 1984);
“patient” means - (a)
- in the case of a medical practitioner, a dentist, a practitioner or a registered nurse, a person treated by the medical practitioner, the dentist, the practitioner or the registered nurse;
- (b)
- in the case of a veterinarian or a para-veterinary professional, an animal treated by the veterinarian or the para-veterinary professional; and
- (c)
- in the case of a pharmacist, a person, or an animal, treated by the pharmacist;
“Permanent Secretary” means the Permanent Secretary of the Ministry responsible for health; “pharmaceutical technician” means a pharmaceutical technician as defined in the
Pharmacy Profession Act, 1993 (Act No. 23 of 1993);
“pharmacist” means a pharmacist as defined in the Pharmacy Profession Act, 1993 (Act No. 23 of 1993); “pharmacist’s assistant” means a pharmacist’s assistant as defined in the Pharmacy
Profession Act, 1993 (Act No. 23 of 1993);
“pharmacist intern” means a pharmacist intern as defined in the Pharmacy Profession Act, 1993 (Act No. 23 of 1993); “practitioner” means a practitioner as defined in the Allied Health Services Professions
Act, 1993 (Act No. 20 of 1993); “prescribe” means - (a)
- prescribe by regulation under this Act; and
- (b)
- in relation to a medicine, issue a written or oral instruction for a specific patient to receive a medicine specified in that instruction under such conditions as may be specified, and “prescription” has a corresponding meaning;
“public” includes a section of the public concerned with manufacturing, dispensing, selling or administering, or the issue of prescriptions for, medicines or scheduled substances;
“public need and interest” means the health care needs and interests of the greater Namibian community in respect of availability and equitable access to health care services;
“Public Service Act” means the Public Service Act, 1995 (Act No. 13 of 1995);
“register” - (a)
- when used as a noun, means the medicines register or veterinary medicines register or complementary medicines register, or any other register kept in terms of section 17; and
- (b)
- when used as a verb, means enter in a register referred to in paragraph (a);
“registered nurse” means a registered nurse as defined in the Nursing Professions Act, 1993 (Act No. 30 of 1993);
“Registrar” means the Registrar of Medicines appointed in terms of section 6;
“regulation” means a regulation made under this Act;
“scheduled substance” means any medicine or substance classified as a Schedule 1, Schedule 2, Schedule 3, Schedule 4 or Schedule 5 substance in terms of section 29(1);
“sell” means sell by wholesale or retail, and includes import, offer, advertise, keep, expose, transmit, consign, convey or deliver for sale or authorise, direct or allow a sale, or prepare or possess for purposes of sale, and barter or exchange or supply or dispose of to a person, whether for a consideration or otherwise, and “sale” and “sold” have a corresponding meaning;
“staff member” means a staff member as defined in the Public Service Act;
“this Act” includes a regulation made under it;
“unscheduled medicine” means a medicine which is not classified in terms of section 29(1);
“veterinarian” means a person registered as such under the Veterinary and Para-veterinary Professions Proclamation, 1984 (Proclamation No. AG. 14 of 1984);
“veterinary medicines” means a substance or a mixture of substances, other than farm feed as defined in the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act No. 36 of 1947), used or purporting to be suitable for use or manufactured or sold for use in connection with - (a)
- the diagnosis, treatment, prevention or cure of a disease, an infection or other unhealthy condition in animals;
- (b)
- the maintenance or improvement of health, growth, production or working capacity in animals; or
- (c)
- restoring, correcting or modifying a somatic or organic function, or for correcting or modifying behaviour, in animals;
“veterinary medicines committee” means the committee referred to in section 12(1);
“vice-chairperson” means the person elected as vice-chairperson of the Council in terms of section 7(1). - (2)
- Notwithstanding anything contained in any other law, a medicine must be regarded as being the same as any other medicine registered in Namibia, if
- (3)
- In determining whether or not the registration or availability of a medicine is in the public interest, regard must be had to its safety, quality and therapeutic efficacy in relation to its effect on the health of humans or animals, as the case may be.
- (4)
- In the registration of medicines, the registration of essential drugs must receive priority.
(a) its components, physical characteristics, quantity and quality are identical to those of that other medicine; (b) it is manufactured by the same manufacturer; and (c) the label and the information accompanying that medicine is approved by the Council.
Continuation of Council, and its powers and functions
2. (1) The council known as the Medicines Control Council established by the Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965), continues to exist under the name Namibia Medicines Regulatory Council. - (2)
- The Council may exercise the powers conferred, and must perform the functions assigned, to the Council by or under this Act.
- (3)
- Without prejudice to the generality of subsection (2), the functions of the Council are to
- (a)
- advise the Minister and report to the Minister on any matter referred to the Council by the Minister for consideration and arising from the application of this Act; and
- (b)
- register medicines and any other thing that is required or prescribed to be registered.
Constitution of Council
3. (1) The Council consists of the following members appointed by the Minister as follows: - (a)
- Three medical practitioners
- (i)
- one of whom is registered as a medical specialist;
- (ii)
- one of whom is engaged in private medical practice; and
(iii) one of whom is employed by the Ministry responsible for health;
- (b)
- three pharmacists
- (i)
- one of whom is engaged in private pharmaceutical practice;
- (ii)
- one of whom is employed by the Ministry responsible for health; and
- (c)
- two veterinarians, nominated for appointment by the Minister responsible for agriculture
- (i)
- one of whom is engaged in private veterinary practice; and
- (ii)
- one of whom is employed by the Ministry responsible for agriculture;
- (d)
- one legal practitioner nominated for appointment by the Minister responsible for justice;
- (e)
- one registered nurse;
- (f)
- one practitioner who, in the opinion of the Minister, has sufficient knowledge of medicines and related substances; and
- (g)
- one other person.
- (2)
- For the purpose of appointment of members under subsection (1)
- (a)
- the Minister must, in respect of the members referred to in paragraphs (a), (b), (e) and (f) of subsection (1);
- (b)
- the Minister responsible for agriculture, on the written request of the Minister, must in respect of the members referred to in paragraph (c) of subsection (1); and
- (c)
- the Minister responsible for justice, on the written request of the Minister, must in respect of the member referred to paragraph (d) of subsection (1),
Act No. 13, 2003 MEDICINES AND RELATED SUBSTANCES CONTROL ACT, 2003 (iii) any other pharmacist;
publish a notice in the Gazette requesting any interested body to submit to the relevant Minister, within 30 days, the names of suitably qualified persons to be appointed as members of the Council. - (3)
- If the names referred to in subsection (2) are not submitted to the Minister who requested them within the period referred to in that subsection, that Minister must nominate suitably qualified persons for appointment as members of the Council and a person nominated under this subsection holds office as if his or her name was submitted in accordance with the said subsection (2).
- (4)
- The Minister must give notice in the Gazette of the names and dates of appointment of the members of the Council and, in the case of a member appointed to fill a casual vacancy, the period for which he or she is appointed.
Disqualification for appointment as member of Council
4. A person does not qualify for appointment as a member of the Council, if the person - (a)
- is an unrehabilitated insolvent;
- (b)
- is disqualified in terms of any law from carrying on the profession in respect of which he or she is to be appointed as member;
- (c)
- is not a Namibian citizen or a holder of a permanent residence permit; or
(d) has during the period of ten years immediately preceding the date of the intended appointment, been convicted of a criminal offence and sentenced to imprisonment without the option of a fine, irrespective of whether or not that sentence has been suspended, and has not received a free pardon.
Tenure of office of members
5. 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.
Vacation of office and filling of vacancies
6. (1) A member of the Council must vacate his or her office, if he or she - (a)
- becomes subject to a disqualification referred to in section 4;
- (b)
- has been absent from three consecutive meetings of the Council without the permission of the chairperson;
- (c)
- resigns his or her office by written notice to the Minister; or
- (d)
- is removed from office by the Minister under subsection (2).
- (2)
- The Minister may, at the request of, or after consultation with, the Council by notice in writing, and if he or she is satisfied that there are sufficient reasons for doing so, remove a member of the Council from office after giving the member concerned a reasonable opportunity to be heard.
- (3)
- If a member of the Council dies, or his or her office becomes vacant in terms of subsection (1), the Minister must, with due regard to section 3, appoint a person to fill the vacancy for the unexpired portion of the term of office of the member in whose stead he or she is appointed.
Chairperson and vice-chairperson
7. (1) The Council must elect a chairperson and a vice-chairperson from amongst the members of the Council. - (2)
- The chairperson and the vice-chairperson may not hold their offices for more than two consecutive terms of three years.
- (3)
- The chairperson and the vice-chairperson may vacate their offices without terminating their membership of the Council.
Meetings of Council
8. (1) The first meeting of the Council must be held at such time and place as the Minister may determine, and thereafter, subject to subsection (3), meetings of the Council must be held at such times and places as the Council may determine, but the Council must hold at least one meeting every three months.
(2) If the Council has not determined the time and place for its next meeting, the chairperson must determine the time and place. - (3)
- The chairperson
- (a)
- may at any time convene a special meeting of the Council; and
(b) must convene a special meeting of the Council, if the Minister requests, or if at least three members of the Council request, him or her, in writing, to do so. - (4)
- The chairperson must convene a meeting requested in terms of subsection (3)(b) within 14 days after the date of receipt of the request and at such time and place as he or she may determine.
- (5)
- The chairperson, or in his or her absence, the vice-chairperson, or in the absence of both the chairperson and the vice-chairperson, a member of the Council elected by the members present, must preside at a meeting of the Council.
- (6)
- Notwithstanding subsection (8), a majority of the members of the Council constitutes a quorum at a meeting of the Council.
- (7)
- A decision of a majority of the members of the Council present at a meeting of the Council is the decision of the Council and, in the event of an equality of votes, the person presiding has a casting vote in addition to his or her deliberative vote.
- (8)
- Subject to subsection (6), a decision of the Council is not rendered invalid by reason only of a vacancy on the Council or of the fact that a person who is not entitled to sit as a member of the Council did so sit when the decision was taken, if that decision was taken by the requisite majority of the members who were present at the time and entitled to vote.
- (9)
- The chairperson must cause a record to be kept of the proceedings of every meeting of the Council and must cause that record to be submitted to the Minister as soon as is practicable after a meeting of the Council.
Disclosure of interest
9. (1) A member of the Council or of a committee must, within a period of three months from the date of his or her appointment as a member of the Council or of a committee, declare in writing to the Minister or to the Council, as the case may be, his or her commercial interests related to the pharmaceutical or health care industry, which interests include, but are not limited to, any consultancy for, research grants from, or equity holding or directorship in, a pharmaceutical company, or any other payment or benefit in kind. - (2)
- If a member of the Council or of a committee, or his or her spouse, is in any way directly or indirectly interested in a matter, which is the subject of consideration by the Council or a committee and which may cause a conflict of interests in the performance of his or her duties as a member of the Council or as a member of any such committee, he or she must fully disclose the nature of that interest as soon as is practicable after the commencement of the meeting of the Council or of any such committee at which that matter is a subject of consideration and that member of the Council or of any such committee, may not take part in the consideration of, or vote on, a question relating to that matter.
- (3)
- If a member of the Council or of a committee fails to disclose a conflict of interests as required by subsection (2) and is present at a meeting of the Council or of any such committee, or in any way participates in the consideration of, or votes on, a question relating to the matter referred to in that subsection, the proceedings in relation to that matter must, as soon as the non-disclosure is discovered, be rendered invalid and thereafter be reviewed by the Council or any such committee, as the case may be, in the absence of the member of the Council or the member of any such committee.
(4) A person who knowingly fails to comply with subsection (1) or (2) commits an offence and is liable on conviction to a fine not exceeding N$8 000 or to imprisonment for a period not exceeding two years or to both the fine and imprisonment.
Remuneration
10. (1) There must be paid to a member of the Council or of a committee, who is not in the full-time employment of the State, in respect of his or her services as a member of the Council or of any such committee, such remuneration as the Minister, in consultation with the Minister responsible for finance, may determine.
(2) Different amounts of remuneration may be determined under subsection
(1) according to the different offices held on the Council or committee, or the work performed for the Council or committee, by the persons concerned.
Executive committee
11. (1) The Council must establish from amongst its members an executive committee, which consists of the chairperson and not more than four other members of the Council. - (2)
- Subject to the directions of the Council, the executive committee may exercise the powers, and must perform the functions, of the Council during the periods between the meetings of the Council.
- (3)
- Unless specifically empowered by the Council to do so, the executive committee may not set aside or vary a decision of the Council.
- (4)
- An action taken or a decision made by the executive committee is subject to review at the first ensuing meeting of the Council.
Veterinary medicines committee
12. (1) The Council must establish a veterinary medicines committee, which may exercise the powers conferred on, and must perform the functions assigned to, the veterinary medicines committee by this Act. (2) The veterinary medicines committee consists of (a) one veterinarian designated by the Council from amongst its members, who must be the chairperson of the committee; (b) two veterinarians designated by the Minister responsible for agriculture; (c) one veterinarian designated by the Veterinary Association of Namibia; and (d) one pharmacist who is a member of the Council. (3) The veterinary medicines committee may appoint not more than two other
persons to be additional members of the veterinary medicines committee, subject to approval by the Council. - (4)
- Section 6, with the necessary modifications, applies also to those members of the veterinary medicines committee, who are not members of the Council.
- (5)
- The Council or 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, 42(a)(i), 44(1) or 45 with respect to a veterinary medicine, unless the veterinary medicines committee recommends so.
Other committees
13. The Council may - (a)
- from time to time, establish such other committees as it may consider necessary to investigate and report to it on a matter, which is within the purview of the Council in terms of this Act; and
- (b)
- appoint such persons, including persons other than members of the Council, as it may consider fit to be members of a committee established in terms of paragraph (a).
Restriction of liability
14. 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.
Financial year and annual report
15. (1) The financial year of the Council begins on 1 April and ends on 31 March in the following year. - (2)
- The Council must submit a report to the Minister, not later than 30 September in each year, relating to the activities of the Council during the previous financial year.
- (3)
- The Minister must lay the report referred to in subsection (2) on the Table in Parliament within 28 days after the date of the receipt of the report, if Parliament is then in ordinary session, or, if Parliament is not then in ordinary session, within 28 days after the commencement of its next ordinary session.
Appointment of Registrar of Medicines
16. (1) Subject to the Public Service Act and after consultation with the Council, the Minister must appoint a pharmacist to be the Registrar of Medicines.
CONTENTS | ||
---|---|---|
Page | ||
GOVERNMENT NOTICE | ||
No. 192 | Promulgation of Medicines and Related Substances Control Act, 2003 (Act No. 13 of 2003), of the Parliament .............................................................. _______________ | 1 |
Government Notice |
OFFICE OF THE PRIME MINISTER
No. 192 2003
PROMULGATION OF ACT 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. 13 of 2003: Medicines and Related Substances Control Act, 2003.
ACT To provide for the establishment of a Namibia Medicines Regulatory Council; for the registration of medicines intended for human and for animal use; for the control of medicines and scheduled substances; and to provide for incidental matters.
(Signed by the President on 13 August 2003)
Section SCHEDULE - LAWS REPEALED OR AMENDED BE IT ENACTED by the Parliament of the Republic of Namibia as follows: Definitions
1. (1) In this Act, unless the context otherwise indicates
“advertisement”, in relation to a medicine or a scheduled substance, means a written, a pictorial, a visual or other descriptive matter or verbal statement or reference which is intended to promote the sale of that medicine or scheduled substance, and No. 13 of 1956); authorised to prescribe a medicine under section 31(1) or (2); “certificate of registration” means a certificate of registration issued in terms of section 7(1); used or purported to be suitable for use in in accordance with the principles of any of the following disciplines: “controlled chemical” means a chemical declared to be a controlled chemical under section 44(1)(dd); “Council” means the Namibia Medicines Regulatory Council referred to in section 2; “dentist” means a dentist as defined in the Medical and Dental Professions Act, 1993 and dispose of, a medicine, for gain or otherwise, for the treatment of a particular person or animal, but does not include the actual administration of the medicine, and “dispensing” has a corresponding meaning;
“emergency medicine” means medicine needed for immediate relief of a symptom or needed for procedures in a practice, but does not include medicine for a patient to take away;
“essential drugs” means medicines listed in the prevailing Namibian Essential Drugs List published by the Ministry responsible for health;
“export” includes to deliver or supply within Namibia for dispatch to a destination outside of Namibia;
“health facility” means a health facility as defined in the Hospitals and Health Facilities Act, 1994 (Act No. 36 of 1994) or in the Veterinary and Para-veterinary Professions Proclamation, 1984 (Proclamation No. AG 14 of 1984);
“hospital” means a hospital as defined in the Hospitals and Health Facilities Act, 1994 (Act No. 36 of 1994);
“immediate container”, in relation to a medicine or a scheduled substance, means a container which is in direct contact with the medicine or the scheduled substance, but is not a package liner;
“importer” means a person who brings a medicine, a scheduled substance, a controlled chemical, controlled equipment or a medical device into Namibia or causes a medicine,
a scheduled substance, a controlled chemical, controlled equipment or a medical device and “import” and “importation” have a corresponding meaning;
“inspector” means a person authorised as an inspector under section 35;
“interchangeable multi-source medicine” means medicine that contains the same quantities of the same active substances in the same dosage form and meets comparable standards as another medicine;
“international treaties” means treaties relating to narcotic drugs and psychotropic substances to which Namibia is a party;
“label”, when used as a verb, means brand, mark or otherwise designate or describe, and when used as a noun, means a brand or a written, a pictorial or other descriptive matter appearing on or attached to an article or the package containing an article, and referring to the article;
“legal practitioner” means a legal practitioner as defined in the Legal Practitioners Act, 1995 (Act No. 15 of 1995);
“manufacture” means carry out operations including purchasing of material, processing, packaging, quality control, release and storage of medicinal products and related substances, and “manufacturing” has a corresponding meaning;
“manufacturer”, means a person who manufactures or on whose direction manufacturing takes place;
“medical device” means any instrument, appliance, material, machine, apparatus, implant or diagnostic reagent used or purported to be suitable for use for medical or veterinary purposes, and includes a part or an accessory of a medical device;
“medical practitioner” means a medical practitioner as defined in the Medical and Dental Professions Act, 1993 (Act No. 21 of 1993), or a medical intern as defined in that Act;
“medicinal purpose”, in relation to a scheduled substance, means for the purpose of the treatment or prevention of a disease or some other definite curative or therapeutic purpose, but does not include the satisfaction of a habit, or the relief of a craving for the substance used or for any other such substance, except where the substance is administered or used under a programme approved for this purpose by the Minister;
“medicine” means
(a) a substance or a mixture of substances used or purported to be suitable for use or manufactured or sold for use in “Minister” means the Minister responsible for health;
“original immediate container” means the immediate container in which the medicine was originally distributed by the manufacturer;
“package” means a container in or by which an original immediate container of a medicine is enclosed, covered, contained or packed, but excludes bulk boxes in which that original immediate container or the package is transported;
“para-veterinary professional” means a person registered to practise a para-veterinary profession under the Veterinary and Para-veterinary Professions Proclamation, 1984 (Proclamation No. AG. 14 of 1984);
“patient” means “Permanent Secretary” means the Permanent Secretary of the Ministry responsible for health; “pharmaceutical technician” means a pharmaceutical technician as defined in the
Pharmacy Profession Act, 1993 (Act No. 23 of 1993);
“pharmacist” means a pharmacist as defined in the Pharmacy Profession Act, 1993 (Act No. 23 of 1993); “pharmacist’s assistant” means a pharmacist’s assistant as defined in the Pharmacy
Profession Act, 1993 (Act No. 23 of 1993);
“pharmacist intern” means a pharmacist intern as defined in the Pharmacy Profession Act, 1993 (Act No. 23 of 1993); “practitioner” means a practitioner as defined in the Allied Health Services Professions
Act, 1993 (Act No. 20 of 1993); “prescribe” means “public” includes a section of the public concerned with manufacturing, dispensing, selling or administering, or the issue of prescriptions for, medicines or scheduled substances;
“public need and interest” means the health care needs and interests of the greater Namibian community in respect of availability and equitable access to health care services;
“Public Service Act” means the Public Service Act, 1995 (Act No. 13 of 1995);
“register” “registered nurse” means a registered nurse as defined in the Nursing Professions Act, 1993 (Act No. 30 of 1993);
“Registrar” means the Registrar of Medicines appointed in terms of section 6;
“regulation” means a regulation made under this Act;
“scheduled substance” means any medicine or substance classified as a Schedule 1, Schedule 2, Schedule 3, Schedule 4 or Schedule 5 substance in terms of section 29(1);
“sell” means sell by wholesale or retail, and includes import, offer, advertise, keep, expose, transmit, consign, convey or deliver for sale or authorise, direct or allow a sale, or prepare or possess for purposes of sale, and barter or exchange or supply or dispose of to a person, whether for a consideration or otherwise, and “sale” and “sold” have a corresponding meaning;
“staff member” means a staff member as defined in the Public Service Act;
“this Act” includes a regulation made under it;
“unscheduled medicine” means a medicine which is not classified in terms of section 29(1);
“veterinarian” means a person registered as such under the Veterinary and Para-veterinary Professions Proclamation, 1984 (Proclamation No. AG. 14 of 1984);
“veterinary medicines” means a substance or a mixture of substances, other than farm feed as defined in the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act No. 36 of 1947), used or purporting to be suitable for use or manufactured or sold for use in connection with “veterinary medicines committee” means the committee referred to in section 12(1); “vice-chairperson” means the person elected as vice-chairperson of the Council in terms of section 7(1). 2. (1) The council known as the Medicines Control Council established by the Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965), continues to exist under the name Namibia Medicines Regulatory Council. 3. (1) The Council consists of the following members appointed by the Minister as follows: publish a notice in the Gazette requesting any interested body to submit to the relevant Minister, within 30 days, the names of suitably qualified persons to be appointed as members of the Council. 4. A person does not qualify for appointment as a member of the Council, if the person (d) has during the period of ten years immediately preceding the date of the intended appointment, been convicted of a criminal offence and sentenced to imprisonment without the option of a fine, irrespective of whether or not that sentence has been suspended, and has not received a free pardon.
5. 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. (1) A member of the Council must vacate his or her office, if he or she 7. (1) The Council must elect a chairperson and a vice-chairperson from amongst the members of the Council. 8. (1) The first meeting of the Council must be held at such time and place as the Minister may determine, and thereafter, subject to subsection (3), meetings of the Council must be held at such times and places as the Council may determine, but the Council must hold at least one meeting every three months.
(2) If the Council has not determined the time and place for its next meeting, the chairperson must determine the time and place. (b) must convene a special meeting of the Council, if the Minister requests, or if at least three members of the Council request, him or her, in writing, to do so. 9. (1) A member of the Council or of a committee must, within a period of three months from the date of his or her appointment as a member of the Council or of a committee, declare in writing to the Minister or to the Council, as the case may be, his or her commercial interests related to the pharmaceutical or health care industry, which interests include, but are not limited to, any consultancy for, research grants from, or equity holding or directorship in, a pharmaceutical company, or any other payment or benefit in kind. (4) A person who knowingly fails to comply with subsection (1) or (2) commits an offence and is liable on conviction to a fine not exceeding N$8 000 or to imprisonment for a period not exceeding two years or to both the fine and imprisonment.
10. (1) There must be paid to a member of the Council or of a committee, who is not in the full-time employment of the State, in respect of his or her services as a member of the Council or of any such committee, such remuneration as the Minister, in consultation with the Minister responsible for finance, may determine.
(2) Different amounts of remuneration may be determined under subsection
(1) according to the different offices held on the Council or committee, or the work performed for the Council or committee, by the persons concerned.
11. (1) The Council must establish from amongst its members an executive committee, which consists of the chairperson and not more than four other members of the Council. 12. (1) The Council must establish a veterinary medicines committee, which may exercise the powers conferred on, and must perform the functions assigned to, the veterinary medicines committee by this Act. persons to be additional members of the veterinary medicines committee, subject to approval by the Council. 13. The Council may 14. 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. (1) The financial year of the Council begins on 1 April and ends on 31 March in the following year. 16. (1) Subject to the Public Service Act and after consultation with the Council, the Minister must appoint a pharmacist to be the Registrar of Medicines.
OF PARLIAMENT
ARRANGEMENT OF SECTIONS
“advertise” has a corresponding meaning;
“analyst” means an analyst to whom authority has been granted under section 37;
“animal” means animal as defined in the Animal Diseases and Parasites Act, 1956 (Act
“appeal committee” means the appeal committee referred to in section 34(1);
“authorised prescriber” means a medical practitioner, a dentist, a veterinarian or a person
19(7)(b), 20(4)(b) or 21(4)(c);
“chairperson” means the person elected as chairperson of the Council in terms of section
“committee” means a committee established by the Board under this Act;
“complementary medicine” means a substance or a mixture of substances prepared and
CONTROL ACT, 2003 (i) Homeopathy; (ii) Western herbal medicine; (iii) African traditional medicine; or (iv) Chinese herbal medicine;
“controlled equipment” means equipment declared to be controlled equipment under
section 44(1)(dd);
(Act No. 21 of 1993);
“dispense”, in relation to a medicine, means to
(in this definition called goods) to be brought into Namibia, and includes a person who
(a) owns the goods brought into Namibia; (b) carries the risk for the goods brought into Namibia; (c) represents to be the one who brought the goods into Namibia or who owns those goods; (d) actually brings the goods into Namibia; (e) is beneficially interested in any way in the goods brought into Namibia; or (f) acts on behalf of a person referred to in paragraphs (a) to (e),
(a) its components, physical characteristics, quantity and quality are identical to those of that other medicine; (b) it is manufactured by the same manufacturer; and (c) the label and the information accompanying that medicine is approved by the Council. Continuation of Council, and its powers and functions
Constitution of Council
(iii) one of whom is employed by the Ministry responsible for health;
Act No. 13, 2003 MEDICINES AND RELATED SUBSTANCES CONTROL ACT, 2003 (iii) any other pharmacist;
Disqualification for appointment as member of Council
Tenure of office of members
Vacation of office and filling of vacancies
Chairperson and vice-chairperson
Meetings of Council
Disclosure of interest
Remuneration
Executive committee
Veterinary medicines committee
(2) The veterinary medicines committee consists of (a) one veterinarian designated by the Council from amongst its members, who must be the chairperson of the committee; (b) two veterinarians designated by the Minister responsible for agriculture; (c) one veterinarian designated by the Veterinary Association of Namibia; and (d) one pharmacist who is a member of the Council. (3) The veterinary medicines committee may appoint not more than two other
Other committees
Restriction of liability
Financial year and annual report
Appointment of Registrar of Medicines