Medicines and Allied Substances Act 2013.pmd
THE MEDICINES AND ALLIED SUBSTANCES
ACT, 2013
ARRANGEMENT OF SECTIONS
PART I
PRELIMINARY
Section
1. Short title
2. Interpretation
PART II
THE ZAMBIA MEDICINES REGULATORY AUTHORITY
3. Continuation and re-naming of Pharmaceutical Regulatory
Authority
4. Seal of Authority
5. Functions of Authority
6. Powers of Authority
7. Constitution of Board of Authority
8. Functions of Board
9. Expert Advisory Committee
10. Committees
11. Delegation of functions of Board
12. Director-General
13. Immunity
PART III
REGISTRATION AND REGULATION OF PHARMACIES, HEALTH SHOPS AND
AGRO-VETERINARY SHOPS
14. Prohibition of operation of unregistered pharmacy, health
shop or agro-veterinary shop
15. Application for certificate of registration
16. Issue of certificate of registration
17. Rejection of application
18. Display of certificate of registration
19. Annual return
20. Surrender of certificate of registration
21. Transfer of certificate of registration
22. Amendment of certificate of registration
23. Suspension or cancellation of certificate of registration
24. Closure of pharmacy
Medicines and Allied Substances [No. 3 of 2013 47
25. Loss of certificate of registration
26. Management of hospital pharmacies
27. Standard of pharmacy practice
28. Dispensing certificate
29. Agro-veterinary shop permit
30. Health shop permit
31. Register of Pharmacies, Agro-veterinary Shops and
Health Shops
32. Publication of registered pharmacies, agro-veterinary
shops and health shop
PART IV
LICENCIES, IMPORT AND EXPORT PERMIT
33. Prohibition of manufacture, distribution, etc. medicine or
allied substance without pharmaceutical licence
34. Pharmaceutical licence
35. Import permit
36. Export permit
37. Additional requirements for import or export for narcotic
drugs, psychotropic substances and precursors
38. Register of Licences and Permits
PART V
REGISTRATION OF MEDICINES AND ALLIED SUBSTANCES
39. Marketing authorisation
40. Categories of medicine
41. Medicines list
42. Prohibition of sale of prescription only medicines without
prescription
43. Labelling of medicine
44. Sale of medicine, etc.
45. Advertising of medicines
46. Recall of medicine, etc. from circulation
47. Monitoring medicine and allied substance
48. Register of Marketing Authorisations
PART VI
REGULATION OF CLINICAL TRIALS
49. Prohibition of conducting clinical trial without certificate
50. Application for clinical trial certificate
48 No. 3 of 2013] Medicines and Allied Substances
Single copies of this Act may be obtained from the Government Printer,
P.O. Box 30136, 10101 Lusaka, Price K 23.00 each.
51. Grant of certificate
52. Inspection of clinical trial sites
53. Register of Clinical Trial Certificate
PART VII
THE NATIONAL DRUG QUALITY CONTROL LABORATORY
54. National Drug Quality Control Laboratory
PART VIII
INSPECTIONS
55. Inspectors
PART IX
GENERAL PROVISIONS
56. Appeals
57. Authority to manufacture patented medicine
58. General offences
59. Prohibition of manufacture, import, export, etc of sub-
standard, counterfeit or adulterated medicine or allied
substances
60. Prohibition of supply of expired medicine
61. Prohibition of deceptive act
62. Prohibition of sale, etc of harmful cosmetics
63. Sale and preparation of cosmetics under insanitary
conditions
64. Standards of cosmetics
65. Prohibition of sale of harmful devices
66. General penalty
67. Offence by body corporate or unincorporate body
68. Guidelines
69. Regulations
70. Repeal of Act No. 14 of 2004
FIRST SCHEDULE
SECOND SCHEDULE
Medicines and Allied Substances [No. 3 of 2013 49
GOVERNMENT OF ZAMBIA
ACT
No. 3 of 2013
Date of Assent:21st March, 2013
An Act to continue the existence of the Pharmaceutical
Regulatory Authority and re-name it as the Zambia
Medicines Regulatory Authority; provide for the functions
and powers of the Authority; provide for the registration
and regulation of pharmacies, health shops and agro-
veterinary shops; provide for the registration and
regulation of medicines and allied substances; provide
for the regulation of the manufacture, importation,
exportation, possession, storage, distribution, supply,
promotion, advertising, sale and use of medicines and
allied substances; provide for the regulation and control
of clinical trials; repeal and replace the Pharmaceutical
Act, 2004; and provide for matters connected with, or
incidental to, the foregoing.
ENACTED by the Parliament of Zambia.
PART I
PRELIMINARY
1. This Act may be cited as the Medicines and Allied
Substances Act, 2013.
2. In this Act, unless the context otherwise requires—
“ administer ” means to give a substance to a human being or
animal orally, by injection or by introduction into the body
in any other way or by external application, whether by
direct contact with the body or not;
“ adulterated medicine ” means any medicine—
(a) consisting in whole or in part of any filthy, putrid,
decomposed, deleterious or foreign substance;
(b) that is prepared or stored under unsanitary conditions;
(c) whose container is composed of any poisons or
deleterious substance;
(d) that contains a colouring agent that is not prescribed;
or
(e) that contains any harmful or toxic substance;
“ agro-veterinary shop ” means a place or premises permitted
to sell prescribed veterinary medicinal products and allied
substances under the control of a relevant veterinary
professional as determined by the Authority;
Medicines and Allied Substances [No. 3 of 2013 51
Enactment
Short title
Interpretation
[22nd March, 2013
“ allied substances ” include acaricides, cosmetics,
disinfectants, food supplements, feed additives and
supplements, medical and surgical sundries, medical devices
and condoms;
“ animal ” has the meaning assigned to it in the Animal Health
Act, 2010;
“ animal health facility ” has the meaning assigned to it in the
Veterinary and Veterinary Para-Professions Act, 2010;
“ assemble ” in relation to a medicine, means enclosing the
medicine or allied substance of the same description in a
container before the medicine or allied substance is sold or
supplied;
“ Authority ” means the Zambia Medicines Regulatory
Authority provided for under section three;
“ biological product ” includes vaccine, immune sera, anti-
toxin, anti-venom, toxoid, blood and blood components,
allergy products used in the prevention, treatment or cure
of disease or condition in human beings and animals
synthesised from living organisms or other product;
“ Board ” means the Board of the Authority constituted under
section seven;
“ certificate of registration ” means the certificate of
registration of a pharmacy;
“ Chairperson ” means the person appointed as Chairperson
of the Board under section seven;
“ clinical trial ” means the systematic study involving human
participants or animal subjects that serves to answer the
efficacy of a medicine, biological products or method of
prevention or treatment;
“ committee ” means a committee of the Board established
under section ten;
“ cosmetic ” means any substance manufactured or sold for
use in cleansing, beautifying or altering the hair, eyes, teeth
or nails, or complexion of the skin, and includes deodorants
and perfumes;
“ counterfeit medicine or allied substance ” means a medicine
or allied substance which is deliberately or fraudulently
mislabeled or misrepresented with respect to identity or
source, or a medicine or allied substance which—
(a) has wrong ingredients;
(b) contains active ingredients or not;
(c) has insufficient or excess active ingredients; or
(d) has fake packaging;
52 No. 3 of 2013] Medicines and Allied Substances
Act No. 27 of
2010
Act No. 45 of
2010
“ deal ” means to sell or offer for sale or trade by wholesale;
“ dental surgeon ” means a person registered as such under
the Health Professions Act, 2009;
“ Director-General ” means the person appointed as Director-
General under section twelve;
“ dispense ” means to count, measure or decant a medicine
from a bulk supply or to prepare, mix, dissolve or supply a
medicine for the treatment of a person or animal, but does
not include the administration of medicine;
“distribute ” means the division and movement of
pharmaceutical products from the premises of the
manufacturer of the products or from another central point
or to an intermediate point or to the end user by means of
any method of transport;
“ Expert Advisory Committee ” means the Expert Advisory
Committee established under section nine;
“ former Authority ” means the Pharmaceutical Regulatory
Authority established under the repealed Act;
“ health facility ” has the meaning assigned to it in the Health
Professions Act, 2009;
“ health shop ” means a place or premises permitted to sell a
prescribed list of medicine by the Authority, under the
control of an authorised person as determined by the
Authority;
“hospital” has the meaning assigned to it in the Health
Professions Act, 2009;
“ hospital pharmacy” means a pharmacy which is part of a
health facility;
“ ingredient ” in relation to the manufacture or preparation of
a substance, includes anything which is the sole active or
inactive ingredient of that substance;
“ inspector” means a person appointed as an inspector under
section fifty-five;
“ label ” means to affix to, or otherwise display on, a container
or package, a notice describing the ingredients and contents
thereof;
“ Laboratory ” means the National Drug Quality Control
Laboratory established under section fifty-four;
“ manufacture ” in relation to a medicine or allied substance,
includes any process carried out in the course of making
that medicine or allied substance, but does not include the
process of—
Medicines and Allied Substances [No. 3 of 2013 53
Act No. 24 of
2009
Act No. 14 of
2004
Act No. 24 of
2009
Act No. 24 of
2009
(a) dissolving or dispensing a product in, or diluting or
mixing it with, some other substance for purposes
of administering it; or
(b) the incorporation of a medicine in any animal feed;
“ marketing authorisation ” means the authorisation granted,
under section thirty-nine, for the placement of a medicine
or allied substance on the market;
“ medical device ” includes an instrument, apparatus,
component, part or accessory manufactured or sold for
use in the diagnosis, treatment, mitigation or prevention of
a disease, disorder or abnormal physical state or the
symptoms of the disease, or abnormal physical state in
human beings or animals;
“ medical doctor ” means a person registered as a medical
doctor under the Health Professions Act, 2009;
“ medicine ” means human medicine, veterinary medicine,
medicinal product, herbal medicine or any substance or
mixture of substances for human or veterinary use intended
to be used or manufactured for use for its therapeutic
efficacy or for its pharmacological purpose in the diagnosis,
treatment, alleviation, modification or prevention of disease
or abnormal physical or mental state or the symptoms of
disease in a person or animal;
“ medicinal product ” means any substance or combination
of substances which may be administered to human beings
or animals in order to make a medical diagnosis or to
restore, correct or modify the physiological functions in
human beings or animals;
“ member ” means a person appointed as a member of the
Board under section seven;
“ midwife ” means a person registered as a midwife under
the Nurses and Midwives Act, 1997;
“ nurse ” means a person registered as a nurse under the
Nurses and Midwives Act, 1997;
“ package ” means anything in or by which any medicine,
herbal medicine, therapeutic substance or allied substance
is enclosed, covered or contained, and includes primary
and secondary packaging;
“ pharmaceutical licence ” means the licence issued, under
section thirty-four, to a person to manufacture, distribute
or deal in a medicine or allied substance;
“ pharmacist” means a person registered as a pharmacist
54 No. 3 of 2013] Medicines and Allied Substances
Act No. 24
of 2009
Act No. 31
of 1997
Act No. 31 of
1997
under the Health Professions Act, 2009;
“ pharmacy ” means a drugstore, druggist, chemist or any
business or premises registered as such under section
sixteen;
“ prescription ” means a written direction given by an
authorised prescriber directing that a stated amount of a
medicine specified in the direction be dispensed for the
person or animal named in the direction;
“ prescription only medicine ” means a medicine dispensed
only on prescription;
“ Register ” means, in relation to—
(a) pharmacies, health shops and agro-veterinary shops,
the Register provided for under section thirty-one;
(b)licences and permits, the Register of Licences and
Permits provided for under section thirty-eight;
(c) marketing authorisation, the Register of Marketing
Authorisations provided for under section forty-
eight; and
(d) clinical trial certificates, the Register of Clinical Trial
Certificates provided for under section fifty-three;
“ repealed Act ” means the Pharmaceutical Act, 2004;
“ sell ” means to offer for sale, expose for sale, have in
possession for sale, and supply, whether the supply is made
for consideration or not;
“ substance ” means any natural or artificial material, whether
in the form of solid, liquid, gas, vapour or any active or
inactive substance or pharmaceutical ingredient;
“ sub-standard medicine ” means a product whose composition
and ingredients do not meet the approved quality
specifications and which may be consequently ineffective
and often dangerous to the patient;
“ veterinary surgeon ” means a person registered as a
veterinary surgeon under the Veterinary and Veterinary
Para-Professions Act, 2010; and
“ Vice-Chairperson ” means the person elected as Vice-
Chairperson under section seven.
PART II
THE ZAMBIA MEDICINES REGULATORY AUTHORITY
3. (1) The Pharmaceutical Regulatory Authority established
under the repealed Act shall continue to exist as if established under
Medicines and Allied Substances [No. 3 of 2013 55
Act No. 24 of
2009
Act No. 14 of
2004
Act No. 45 of
2010
this Act and is hereby renamed the Zambia Medicines Regulatory
Authority.
(2) The Authority shall be a body corporate with perpetual
succession and a common seal, capable of suing and of being sued
in its corporate name, and with power, subject to the provisions of
this Act, to do all such acts and things as a body corporate may, by
law, do or perform.
(3) The provisions of the First Schedule apply to the Authority.
4. (1) The seal of the Authority shall be such device as may be
determined by the Authority and shall be kept by the Director-
General.
(2) The affixing of the seal shall be authenticated by the
Chairperson or the Vice Chairperson and the Director-General or
any other person authorised in that behalf by a resolution of the
Board.
(3) Any contract or instrument which if entered into or executed
by a person not being a body corporate, would not be required to
be under seal, may be entered into or executed without seal on
behalf of the Authority by the Director-General or any other person
generally or specifically authorised by the Board in that behalf.
(4) Any document purporting to be a document under the seal
of the Authority or issued on behalf of the Authority shall be received
in evidence and shall be deemed to be so executed or issued, as the
case may be, without further proof, unless the contrary is proved.
5. The functions of the Authority are to—
(a) grant pharmaceutical licences and marketing
authorisations;
(b) inspect any premises used for the purpose of
manufacturing, distribution, sale, importation or
exportation of medicines or allied substances or for any
other purposes regulated under this Act;
(c) regulate and control the manufacture, importation,
exportation, distribution and sale of medicines and allied
substances;
(d) regulate and control the advertising and promotion of
medicines and allied substances;
(e) register and regulate pharmacies, health shops and agro-
veterinary shops;
(f) in consultation with the relevant professional bodies,
establish, maintain and develop standards for the
operation of pharmacies, health shops and agro-
10 No. of 2013] Medicines and Allied Substances
Continuation
and re-naming
of
Pharmaceutical
Regulatory
Authority
Act No. 14 of
2004
Seal of
Authority
Functions of
Authority
veterinary shops;
(g) serve and protect the public interest in all matters relating
to the sale of medicines and allied substances;
(h) regulate and monitor the conduct of clinical trials;
(i) establish, maintain and enforce standards relating to the
manufacture, importation, exportation, distribution and
sale of medicines and allied substances;
(j) conduct post-marketing surveillance;
(k) establish, maintain and enforce standards for drug quality
control laboratories;
(l) advise the Minister on policies relating to the regulation
and control of medicines and allied substances;
(m) collaborate with corresponding medicines regulatory
authorities in other countries;
(n) in consultation with relevant research institutions,
determine national priorities in pharmaceutical research;
and
(o) do all such things as are connected with, or incidental to,
the functions of the Authority under this Act.
6. The Authority may—
(a) direct any pharmacy, health shop or agro-veterinary shop
or any person providing services relating to the
manufacture, importation, exportation, distribution and
sale of medicines and allied substances to deliver the
services in such manner as to ensure compliance with
this Act;
(b) require any pharmacy, health shop or agro-veterinary shop,
manufacturer, wholesale dealer, distributor, importer,
exporter or person to submit such information and records
as may be necessary to enable the Authority to monitor
the performance of the pharmacy, health shop, agro-
veterinary shop, manufacturer, wholesale dealer,
distributor, importer or exporter;
(c) consider any matter relating to the manufacture,
importation, exportation, distribution and sale of
medicines and allied substances and make
representations thereon to the Minister;
(d) declare certain substances as medicine; and
(e) determine the method of sale of medicines.
7. (1) There is hereby constituted a Board of the Authority
which shall consist of the following part-time members appointed
by the Minister:
Medicines and Allied Substances [No. of 2013 11
Powers of
Authority
(a) a representative of the Pharmaceutical Society of Zambia;
(b) a representative of the Medical Association of Zambia;
(c) a representative of the Health Professions Council of
Zambia;
(d) a representative of the department of pharmacy of a higher
education institution;
(e) a representative of the School of Veterinary Medicine of
a higher education institution;
(f) a representative of the pharmaceutical industry;
(g) a representative of the Ministry responsible for health;
(h) a representative of the Ministry responsible for commerce;
(i) a representative of the Ministry responsible for veterinary
services;
(j) a representative of the Ministry responsible for community
development;
(k) a representative of the Veterinary Association of Zambia;
(l) a representative of the Attorney-General; and
(m) two other persons.
(2) The members referred to in subsection (1) shall be
recommended by their respective institutions.
(3) The Minister shall appoint the Chairperson of the Board from
amongst the members.
(4) The members shall elect the Vice-Chairperson of the Board
from amongst themselves.
(5) A person shall not be nominated or appointed as a member
of the Board if the person—
(a) is an undischarged bankrupt;
(b) has been convicted of an offence involving fraud or
dishonesty;
(c) has been convicted of an offence under any written law
and sentenced to imprisonment for a period exceeding
six months without the option of a fine;
(d) has been found guilty of professional misconduct; or
(e) is an employee of the Authority.
8. The Board shall, subject to the provisions of this Act, perform
the following functions:
12 No. of 2013] Medicines and Allied Substances
Constitution
of Board of
Authority
(a) review the policy and strategic plan of the Authority;
(b) oversee the implementation and successful operation of
the policy and functions of the Authority;
(c) approve the annual budget and plans of the Authority;
(d) monitor and evaluate the performance of the Authority
against budgets and plans;
(e) establish and issue guidelines and standards for purposes
of this Act;
(f)establish and approve rules and procedures for the
appointment,discipline, termination and terms and
conditions of service of the staff of the Authority;
(g) make recommendations to the Minister for amendments
to this Act or the issuance of regulations under this Act;
and
(h) perform any other function conferred or imposed on the
Board by, or under, this Act.
9. (1) The Board shall constitute an Expert Advisory Committee
which shall consist of experts in human medicine, veterinary
medicine and allied substances.
(2) The Expert Advisory Committee constituted under subsection
(1) shall—
(a) advise the Board on—
(i) licensing of medicines and allied substances;
(ii) monitoring the advertisements on medicines and
allied substances;
(iii) monitoring the standards relating to medicines and
allied substances; and
(iv) monitoring the conduct of clinical trials;
(b) provide technical and scientific advice on any aspect of
medicines and allied substances;
(c) review risk assessment and risk management measures
relating to medicines and allied substances;
(d) recommend containment measures, reporting mechanisms,
remedial measures monitoring procedures and other
appropriate conditions for medicines or allied substances;
(e) make policy recommendations to the Board; and
(f) perform any other function conferred on the Expert
Advisory Committee by the Board for purposes of this
Act.
Medicines and Allied Substances [No. of 2013 13
Functions of
Board
Expert
Advisory
Committee
(3) Subject to any specific or general directive of the Board, the
Expert Advisory Committee may regulate its own procedure.
(4) The members of the Expert Advisory Committee shall elect
a Chairperson and Vice-Chairperson from among themselves.
(5) The Minister may, by statutory instrument, make regulations
to provide for the composition, tenure and procedure of the Expert
Advisory Committee.
10. (1) The Board may, for the purpose of performing its
functions under this Act, constitute such committees as it considers
necessary and may delegate to the committee such of its functions
as it considers fit.
(2) The Board may appoint as members of a committee, persons
who are, or are not, members of the Board, except that at least one
member of a committee shall be a member of the Board.
(3) A person serving as a member of a committee shall hold
office for such period as the Board may determine.
(4) Subject to any specific or general direction of the Board, a
committee may regulate its own procedure.
11. Subject to this Act, the Board may, by direction, in writing,
and subject to any terms and conditions as it considers necessary,
delegate to the Director-General any of its functions under this
Act.
12. (1) The Board shall, with the approval of the Minister,
appoint a Director-General on such terms and conditions as it may
determine.
(2) The Director-General shall be the chief executive officer of
the Authority and shall, subject to the control of the Board, be
responsible for the day-to-day administration of the Authority.
(3) A person shall not be appointed as Director-General unless
the person is a pharmacist.
(4) The Director-General may attend meetings of the Board
and of any committee and may address such meetings, but shall
have no vote.
(5) The Board shall appoint a Board Secretary on such terms
and conditions as it may determine.
(6) The Board may, whenever the Director-General is for any
reason unable to discharge the functions of the Director-General’s
14 No. of 2013] Medicines and Allied Substances
Committees
Delegation of
functions of
Board
Director-
General
office, appoint an acting Director-General to discharge the Director-
General’s functions.
(7) The Board may appoint on such terms and conditions as it
may determine, such other staff of the Authority as it considers
necessary for the performance of its functions under this Act.
13. An action or other proceeding shall not lie or be instituted
against the Director-General or a member of staff of the Authority
for, or in respect of, any act or thing done in good faith in the exercise
of, or performance of or purported exercise of, or performance of,
any of the powers, functions or duties conferred under this Act.
PART III
REGISTRATION AND REGULATION OF PHARMACIES, HEALTH SHOPS AND
AGRO-VETERINARY SHOPS
14. (1) A person shall not—
(a) operate, either on that person’s own behalf or on behalf of
another person, a pharmacy that is not registered under
this Act or a health shop or agro-veterinary shop without
a permit issued by the Authority; or
(b) assume, take, exhibit or in any way make use of any title,
emblem, description or addition reasonably calculated
to suggest that a pharmacy is registered, or the health
shop or agro-veterinary shop has a permit.
(2) A person who contravenes subsection (1) commits an
offence and is liable, upon conviction, to a fine not exceeding three
million penalty units or to imprisonment for a period not exceeding
five years, or to both.
15. (1) A person who intends to operate a pharmacy shall apply
to the Authority for a certificate of registration in the prescribed
manner and form upon payment of the prescribed fee.
(2) A separate application shall be made in respect of each
premises to be operated as a pharmacy.
(3)The Authority may—
(a) request an applicant to furnish any other information in
relation to an application, within such period as it may
determine; and
(b) inspect the premises in respect of which an application is
made before the issuance of the certificate of
registration.
Medicines and Allied Substances [No. of 2013 15
Immunity
Prohibition
of operation
of
unregistered
pharmacy,
health shop
or agro-
veterinary
shop
Application
for certificate
of
registration
16. (1) The Authority shall, within sixty days of receipt of an
application made under section fifteen, issue the applicant with a
certificate of registration if—
(a) the application meets the requirements of this Act;
(b) the premises to be used are suitable for conducting
pharmacy business;
(c) the pharmacy is under the management and control of a
registered pharmacist at all times; and
(d) the activity or business to be carried out does not contravene
any other written law.
(2) Where a person applies for a certificate of registration under
section fifteen and the certificate is not granted within sixty days of
the filing of the application, the certificate shall be deemed to have
been granted.
(3) Subject to the other provisions of this Act, a certificate of
registration issued under this section shall be subject to such terms
and conditions as the Authority may determine.
17. (1) The Authority shall reject an application for a certificate
of registration if—
(a) the activity or business to be carried out contravenes any
law in force;
(b) the premises in respect of which the application is made
are not suitable for pharmacy business and do not comply
with prescribed standards of pharmacy practice;
(c) the certificate of registration previously held by the applicant
was cancelled by the Authority; or
(d) the applicant submits false information in relation to the
application.
(2) The Authority shall, where it rejects an application under
subsection (1), inform the applicant, in writing, and give the reasons
for the rejection.
18. A holder of a certificate of registration shall display the
certificate in a conspicuous manner and place at the place of
business.
19. (1) A holder of a certificate of registration shall submit to
the Authority an annual return or no-change return in the prescribed
manner and form upon payment of the prescribed fee.
16 No. of 2013] Medicines and Allied Substances
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application
Issue of
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registration
Display of
certificate of
registration
(2) A holder of a certificate of registration shall, where the
status of a pharmacy required to file a return under this section has
not changed, file a no-change return indicating the financial year in
which the return is filed and containing a general statement that
there has been no change in any given particulars in the return
from the filling of the previous return.
(3) Notwithstanding the filing of a no-change return, the
Director-General may cause to be inspected any records of the
person which the Director-General considers necessary for the
better carrying out of this Act.
(4) A person who fails to submit an annual return or a no-
change return on, or before, the prescribed date is liable to pay the
Authority a fine of ten thousand penalty units and a further fine of
two thousand eight hundred penalty units for each day during which
the default continues.
20. (1) Where the holder of a certificate of registration decides
not to continue with the business to which the certificate relates,
the holder shall notify the Authority, in writing, and shall agree with
the Authority on the terms and conditions of the surrender of the
certificate.
(2) Where a certificate of registration is surrendered under
subsection (1), the certificate shall lapse and subject to section
twenty-three, be cancelled.
21. (1) A certificate of registration shall not be transferred to
a third party without the prior approval of the Authority.
(2) An application for approval to transfer a certificate of
registration shall be made to the Authority in the prescribed manner
and form.
(3) The Authority may, within fourteen days of receipt of an
application to transfer a certificate of registration, determine the
application in accordance with this Act.
22. (1) A holder of a certificate of registration shall, where a
change is made or occurs in any of the following registered
particulars:
(a) the business name;
(b) the physical address of the pharmacy;
(c) the structure of the place of business; or
Medicines and Allied Substances [No. of 2013 17
Annual return
Surrender of
certificate of
registration
Transfer of
certificate
of
registration
Amendment
of certificate
of
registration
(d) the name of the pharmacist designated as the manager of
the pharmacy;
notify the Authority, in the prescribed manner and form, within
fourteen days of the change.
(2) The Authority shall, upon receipt of the notice referred to
in subsection (1), amend the certificate of registration accordingly.
(3) The Authority shall, where it identifies an error on the
Register relating to any particulars of a certificate of registration,
inform the holder of the certificate and amend the certificate
accordingly.
(4) A person who contravenes subsection (1) commits an offence
and is liable, upon conviction, to a fine not exceeding two thousand
eight hundred penalty units for each day during which the default
continues.
23. (1) Subject to the other provisions of this Act, the Authority
may suspend or cancel a certificate of registration if—
(a) the holder obtained the certificate by fraud or deliberate
or negligent submission of false information or
statements;
(b) the holder operates the pharmacy under unsanitary
conditions;
(c) the pharmacist or responsible person obtains medicines
and allied substances from unauthorised suppliers or deals
in unauthorised products;
(d) the pharmacy in respect of which it was issued is not
compliant with prescribed standards of pharmacy
practice or is not managed or controlled by a registered
pharmacist or authorised person determined by the
Authority;
(e) the pharmacist fails to maintain the required records on
medicines and allied substances;
(f) the holder fails to submit an annual return in accordance
with this Act; or
(g) the holder contravenes the terms and conditions of the
certificate of registration, this Act or any other relevant
law.
(2) The Authority shall, before suspending or cancelling a
certificate of registration in accordance with subsection (1), give
written notice to the holder thereof of its intention to suspend or
18 No. of 2013] Medicines and Allied Substances
Suspension
or
cancellation
of certificate
of
registration
cancel the certificate and shall give the reasons for the intended
suspension or cancellation and require the holder to show cause,
within a period of not more than thirty days, why the certificate
should not be suspended or cancelled.
(3) The Authority shall not suspend or cancel a certificate of
registration under this section if the holder takes remedial measures
to the satisfaction of the Authority within the period referred to in
subsection (2).
(4) Where a holder who is notified under subsection (2) fails to
show cause to the satisfaction of the Authority, or does not take
any remedial measures to the satisfaction of the Authority within
the time specified in that subsection, the Authority shall suspend
or cancel the certificate of registration.
(5) Where a certificate of registration is cancelled, the holder of
the certificate shall return it to the Authority and the Authority shall
cancel the name and the particulars relating to the pharmacy from
the Register.
(6) Subject to subsection (7), a person whose certificate of
registration is cancelled may re-apply for registration in the
prescribed manner and form, if that person takes remedial measures
to the satisfaction of the Authority.
(7) An application for re-registration may be made after one
year from the date of the cancellation of the registraton.
24. (1) The Authority may order the closure of a pharmacy
where—
(a) the pharmacy contravenes the terms and conditions of
registration in a manner that presents danger or
imminent harm to members of the public;
(b) the pharmacy is not registered under this Act; or
(c) the pharmacy contravenes the provisions of this Act or
any other relevant law.
(2) The Authority shall, where it receives an inspection report
indicating that a pharmacy is not compliant with the requirements
of this Act or its certificate of registration, or is offering services in
Medicines and Allied Substances [No. of 2013 19
Closure of
pharmacy
excess of those permitted to the pharmacy, give the pharmacy
written notice of the violation.
(3) A pharmacy shall, where it receives a notice under
subsection (2), within fourteen days of service of the notice, provide
the Director-General with a written plan of correction of the
violation, indicating a schedule of dates by which corrective action
shall be taken.
(4) A pharmacy shall, where the plan of correction submitted
by the pharmacy under subsection (3) is accepted by the Director-
General, meet the schedule contained in the plan.
(5) The Authority shall, where the plan of correction submitted
by a pharmacy is rejected by the Director-General, revoke the
certificate of registration and order the closure of the pharmacy.
25. (1) A holder of a certificate of registration who loses the
certificate may apply to the Authority for a duplicate certificate of
registration in the prescribed manner and form upon payment of
the prescribed fee.
(2) The Authority shall, within fourteen days of the receipt of
an application under subsection (1), issue a duplicate certificate of
registration if the applicant meets the requirements of this Act.
26. (1) Subject to subsection (2), a hospital pharmacy shall be
managed by a pharmacist.
(2) The Minister may, on the recommendation of the Authority,
by statutory instrument, provide for circumstances under which a
hospital pharmacy may be operated by a pharmacy technologist or
such other person as the Authority may determine, under the
supervision of a pharmacist.
(3) In this section, “ pharmacy technologist ” means a person
registered as a pharmacy technologist under the Health Professions
Act, 2009.
27. For the purposes of this Part, the Minister may, on the
recommendation of the Authority, by statutory instrument, provide
for standards for the practice of pharmacy in pharmacies and hospital
pharmacies.
28. (1) The Authority may, upon application by a person, issue
a dispensing certificate to the person to dispense medicines and
allied substances to patients under their care in a health facility.
20 No. of 2013] Medicines and Allied Substances
Loss of
certificate of
registration
Management
of hospital
pharmacies
Act No. 24 of
2009
Standards of
pharmacy
practice
(2) A person who dispenses any medicine or allied substance
without a dispensing certificate to a patient in a health facility
commits an offence and is liable, upon conviction, to a fine not
exceeding two million penalty units or to imprisonment for a period
not exceeding four years, or to both.
(3) The Minister may, on the recommendation of the Authority,
by statutory instrument, provide for—
(a) the criteria and procedure for applying for a dispensing
certificate and the grant, amendment, renewal, transfer
and revocation of a dispensing certificate;
(b) the terms and conditions attaching to an application, grant,
amendment, refusal, renewal, transfer or revocation of
a dispensing certificate;
(c) the exemption of certain categories of persons from any
provision of this section; and
(d) any other matters that are necessary or incidental to the
effective regulation of dispensing certificates under this
Act.
29. (1) The Authority may, upon application by a person, issue
an agro-veterinary shop permit to the person to sell a prescribed
list of veterinary medicinal products, under the control and
management of such persons as the Authority may authorise.
(2) The Minister may, on the recommendation of the Authority,
by statutory instrument, provide for—
(a) the criteria and procedure for applying for an agro-
veterinary shop permit and the grant, amendment,
renewal, transfer and revocation of an agro-veterinary
shop permit;
(b) the terms and conditions attaching to an application, grant,
amendment, refusal, renewal, transfer or revocation of
an agro-veterinary shop permit; and
(c) any other matters that are necessary or incidental to the
effective regulation of agro-veterinary shop permits
under this Act.
30. (1) The Authority may, upon application by a person, issue
a health shop permit to the person to handle a prescribed list of
medicines and allied substances in designated areas under the
Medicines and Allied Substances [No. of 2013 21
Dispensing
certificate
Agro-
veterinary
shop permit
control and management of such persons as the Authority may
authorise.
(2) The Minister may, on the recommendation of the Authority,
by statutory instrument, provide for—
(a) the criteria and procedure for applying for a health shop
permit and the grant, amendment, renewal, transfer and
revocation of a health shop permit;
(b) the terms and conditions attaching to an application, grant,
amendment, refusal, renewal, transfer or revocation of
a health shop permit; and
(c) any other matters that are necessary or incidental to the
effective regulation of health shop permits under this
Act.
31. (1) The Authority shall keep and maintain a Register of
the pharmacies, agro-veterinary shops and health shops registered
under this Act in which shall be entered the names and other details
relating to the pharmacies, agro-veterinary shops and health shops.
(2) The Register referred to in subsection (1) shall be kept at
the offices of the Authority and shall be open to inspection by the
public at such times and on such conditions, including the payment
of a fee for inspection, as the Board may determine.
(3) A person may, upon payment of the prescribed fee, require a
copy of the certificate of registration, dispensing certificate or permit
of any person or a copy or extract of any other particulars from the
Register to be certified by the Director-General.
(4) Any document purporting to be an extract or copy of any
entry in the Register and duly certified to be a true copy or extract
under the hand of the Director-General shall be received in evidence
as to the matters stated therein in any legal proceedings.
32. The Authority shall publish, annually, the names of all the
pharmacies, agro-veterinary shops and health shops registered
under this Act in a daily newspaper of general circulation in Zambia.
PART IV
LICENCES, IMPORT AND EXPORT PERMITS
22 No. of 2013] Medicines and Allied Substances
Health shop
permit
Register of
Pharmacies,
Agro-
Veterinary
Shops and
Health Shops
Publication of
registered
pharmacies,
agro-
veterinary
shops and
health shops
33. (1) A person shall not manufacture, distribute or deal in
any medicine or allied substance without a pharmaceutical licence.
(2) A person who contravenes subsection (1) commits an
offence and is liable, upon conviction, to a fine not exceeding two
million penalty units or to imprisonment for a period not exceeding
four years, or to both.
34. (1) A person who intends to manufacture, distribute or deal
in any medicine or allied substance shall apply to the Authority for
a pharmaceutical licence in the prescribed manner and form upon
payment of the prescribed fee.
(2) The Authority shall, within ninety days of the receipt of an
application under subsection (1), issue a pharmaceutical licence to
the applicant if the applicant meets the requirements of this Act.
(3) The Authority shall reject an application which does not
meet the requirements of this Act and inform the applicant of the
reasons for the rejection.
(4) The Minister may, on the recommendation of the Authority,
by statutory instrument, provide for—
(a) the criteria for the licensing of persons under subsection
(1);
(b) the procedure for applying for a pharmaceutical licence
and the grant, amendment, renewal, transfer and
revocation of a pharmaceutical licence;
(c) the terms and conditions attaching to an application, grant,
amendment, refusal, renewal, transfer or revocation of
a pharmaceutical licence; and
(d) such other matters as are necessary or incidental to the
effective regulation of licences under this Part.
(5) The Minister may, on the recommendation of the Authority,
and for the purposes of facilitating the effective implementation
and enforcement of this Act—
(a) exempt certain categories of persons from the application
of some or all of the provisions of this section; and
(b) provide that some or all of the provisions of this section
shall not apply in certain circumstances.
35. (1) A person shall not import any medicine or allied
substance without an import permit.
(2) This section does not apply to any medicine or allied substance
imported by a traveller entering Zambia for the traveller’s use as
Medicines and Allied Substances [No. of 2013 23
Prohibition
of
manufacture,
distribution,
etc. of
medicine or
allied
substance
without
pharmaceutical
licence
Pharmaceutical
licence
Import
permit
may be prescribed.
(3) A person who contravenes subsection (1) commits an offence
and is liable, upon conviction, to a fine not exceeding one million
penalty units or to imprisonment for a period not exceeding three
years, or to both.
(4) The Minister may, on the recommendation of the Authority,
by statutory instrument, provide for—
(a) the criteria for the regulation of persons under subsection
(1);
(b) the procedure for applying for an import permit and the
grant, amendment, renewal, transfer, suspension and
revocation of an import permit;
(c) the terms and conditions attaching to an application, grant,
amendment,refusal, renewal, transfer, suspension or
revocation of an import permit; and
(d) such other matters as are necessary or incidental to the
effective regulation of import permits under this Part.
36. (1) A person shall not export any medicine or allied substance
without an export permit.
(2) A person who contravenes subsection (1) commits an offence
and is liable, upon conviction, to a fine not exceeding one million
penalty units or to imprisonment for a period not exceeding three
years, or to both.
(3) The Minister may, on the recommendation of the Authority,
by statutory instrument, provide for—
(a) the criteria for the regulation of persons under subsection
(1);
(b) the procedure for applying for an export permit and the
grant, amendment, renewal, transfer, suspension and
revocation of an export permit;
(c) the terms and conditions attaching to an application, grant,
amendment, refusal, renewal, transfer, suspension or
revocation of an export permit; and
(d) such other matters as are necessary or incidental to the
effective regulation of export permits under this Part.
37. Where a person intends to import or export a narcotic drug,
psychotropic substance or precursor for medical or scientific use,
24 No. of 2013] Medicines and Allied Substances
Export permit
the person shall—
(a) in addition to obtaining an import or export permit, obtain
additional authorisation from the Authority; and
(b) comply with additional requirements as may be provided
for under the Dangerous Drugs Act and Narcotic Drugs
and Psychotropic Substances Act and any other written
law.
38. The Authority shall maintain a Register of Licences and
Permits, in the prescribed form, which shall contain such particulars
as the Authority may consider necessary for purposes of this Act.
PART V
REGULATION OF MEDICINES AND ALLIED SUBSTANCES
39. (1) A person shall not place on the market, advertise,
market, manufacture, sell, import, supply, administer or deal in any
manner with any medicine or allied substance without a marketing
authorisation issued by the Authority.
(2) A person who intends to place on the market, advertise,
market, manufacture, sell, import, supply, administer or deal in any
manner with any medicine or allied substance shall apply to the
Authority for a marketing authorisation in the prescribed manner
and form.
(3) A person who contravenes subsection (1) commits an offence
and is liable, upon conviction, to a fine not exceeding two million
penalty units or to imprisonment for a period not exceeding four
years, or to both.
(4) This section does not apply to—
(a) donated medicines;
(b) a person importing medicine for that person’s use or for
the use of that person’s relative, if the quantity of the
imported medicine is based on the prescription;
(c) a physician, dentist or veterinary surgeon importing
medicine on the physician’s, dentist’s or veterinary
surgeon’s order for administration to a person or animal,
if the quantity of the imported medicine is based on a
prescription;
(d) medicine manufactured under the supervision of a
pharmacist or by a pharmacist—
(i) for sale in the pharmacist’s own pharmacy; or
(ii) in a hospital for its use;
Medicines and Allied Substances [No. of 2013 25
Cap. 95
Cap. 96
Additional
requirements
for import or
export of
narcotic drugs,
psychotropic
substances
and
precursors
Marketing
authorisation
Register of
Licences and
Permits
(e)medicine imported or exported in response to a declared
health emergency;
(f)medicine imported by an authorised institution for
administration to patients under its care; and
(g) any medicine or allied substance used for purposes of a
clinical trial.
(5) The Minister may, on the recommendation of the Authority,
by statutory instrument, provide for—
(a) the criteria for the regulation of persons under subsection
(1);
(b) the procedure for applying for a marketing authorisation
and the grant, amendment, renewal, transfer and
revocation of a marketing authorisation;
(c) the terms and conditions attaching to an application, grant,
amendment, refusal, renewal, transfer or revocation of
a marketing authorisation; and
(d) such other matters as are necessary or incidental to the
effective regulation of marketing authorisations under
this Part.
(7) A holder of a marketing authorisation shall pay such annual
retention fee as the Minister may prescribe.
40. (1) The categories of medicines to which this Part applies
are—
(a) prescription only medicine;
(b) pharmacy medicine; and
(c) general sale medicine.
(2) Medicines shall be dispensed in accordance with the
respective requirements applicable to the categories specified in
subsection (1) and as shall be prescribed by statutory instrument.
41. The Minister may, on the recommendation of the Authority,
by statutory instrument, provide for a list of substances to be
considered as medicines.
42. (1) A person shall not sell or supply medicine which is
required to be sold by prescription only to any person without a
prescription.
(2) For the purposes of this section, an authorised prescriber
shall prescribe medicines which under this Act are required to be
dispensed only under a prescription by issuing a prescription in the
26 No. of 2013] Medicines and Allied Substances
Categories of
medicines
Medicines
list
Prohibition
of sale of
prescription
only
medicines
without
prescription
prescribed form.
(3) Unless otherwise provided, all prescriptions shall specify the
medicine to be administered by reference to the generic name of
that medicine.
(4) Subject to subsection (5), a prescription signed by an
authorised prescriber authorising the sale or supply of a medicine
shall not be dispensed on more than one occasion, except that if
the prescription expressly directs that it may be dispensed on a
specified number of occasions or at specified intervals in a specific
period, it may be dispensed in accordance with that direction.
(5) Notwithstanding subsection (4), insulin and medicines for
the treatment of asthma or other such diseases as the Minister
may, on the advice of the Authority, by statutory instrument specify,
may be sold or supplied any number of times under an initial
prescription of a medical doctor or veterinary surgeon.
(6) In this section, “ authorised prescriber ” means a medical
doctor, a dental surgeon, a veterinary surgeon or such other person
as the Minister may, on the advice of the Authority, by statutory
instrument, designate.
(7) Where a generic medicine is prescribed under subsection
(3), a pharmacist or any person acting under the supervision of the
pharmacist, or a veterinary surgeon to whom the prescription is
presented, shall dispense the generic medicine specified in that
prescription, unless such generic medicine is not available.
(8) A person who contravenes subsection (1) commits an offence
and is liable, upon conviction, to a fine not exceeding two million
penalty units.
(9) The Minister may, for the purpose of preventing the improper
use of prescription only medicines, on the recommendation of the
Authority, by statutory instrument—
(a) provide for the control of the importation, exportation,
sale, possession, distribution, use and labelling of
prescription only medicines;
(b) exclude any prescription only medicine or preparation of
such medicine from the operation of this Part;
(c) prohibit, regulate or restrict the manufacture of prescription
only medicine; and
(d) regulate the use by any medical doctor, dental surgeon or
veterinary surgeon of preparations containing a
prescription only medicine and the dispensing of the
preparations.
43. Medicines shall be labelled in such manner as the Minister
may, on the recommendation of the Authority, provide by statutory
Medicines and Allied Substances [No. of 2013 27
instrument.
44. (1) A person shall not sell by retail or otherwise supply
medicine in a place other than a pharmacy, health facility or an
animal health facility, except with the written approval of the
Authority.
(2) Any medicine sold in a place other than a pharmacy, health
facility or animal health facility shall be sold in the original package
labelled by the manufacturer with—
(a) full instructions for use;
(b) indications, contra indications, warnings and precautions;
and
(c) any other information as the Minister may provide, by
statutory instrument, on the recommendation of the
Authority.
(3) A medical doctor, dental surgeon or any other authorised
prescriber shall not sell any medicine to any person unless it is in a
package for an individual patient’s use only.
(4) A wholesaler, manufacturer or importer shall not sell any
medicine to any person unless that person is duly authorised to
handle medicines and allied substances under this Act.
45. (1) An advertisement of any medicine or allied
substance shall conform to the information relating to the medicine
or allied substance approved by the Authority and as specified in
the marketing authorisation.
(2) A medicine or allied substance which is sold by prescription
only shall not be advertised to the general public without the prior
written approval of the Authority.
(3) In this section, “ advertisement ” means any representation
by any means whatsoever for the purpose of promoting, directly or
indirectly, the sale or disposal of any medicine or allied substance.
(4) A person who contravenes subsection (1) or (2) commits an
offence and is liable, upon conviction, to a fine not exceeding one
million penalty units or to imprisonment for a period not exceeding
three years, or to both.
(5) Where a person has been charged with an offence under
this section, it shall be a defence for that person to prove—
(a) that the person’s business is to publish or arrange for the
publication of advertisements;
28 No. of 2013] Medicines and Allied Substances
Labelling of
medicines
Sale of
medicine
Advertising of
medicines or
allied
substances
(b) that the advertisement was received in the ordinary course
of business and the person charged had no reason to
suspect that its publication would amount to an offence
under this Act; and
(c) that the advertisement was commissioned by a third party.
46. (1) The Authority may, where it determines that it is not in
the public interest that any medicine or allied substance should be
made available to the public, by notice, in writing, served on any
person or in the Gazette, direct that person to return the medicine
or allied substance which the person has in that person’s possession
to—
(a) the manufacturer of the medicine or allied substance;
(b) in the case of any imported medicine or allied substance,
to the importer concerned;
(c) deliver it or send it to the Authority or such other person
as the Authority may designate.
(2) The Authority may, by notice, in writing, direct the
manufacturer or importer of the medicine or allied substance
referred to in subsection (1) or the person referred to in paragraph
(c) of subsection (1), who has in their possession any quantity of
the medicine or allied substance, including the returned quantity to
deal with or dispose of that quantity in such manner as the Authority
may determine.
(3) A person shall not sell any medicine or allied substance which
is the subject of a notice under subsection (1).
(4) A person who contravenes subsection (3) commits an offence
and is liable, upon conviction, to a fine not exceeding one million
penalty units or to imprisonment for a period not exceeding three
years, or to both.
47. The Minister may, on the recommendation of the Authority,
by statutory instrument, make regulations for monitoring the safety
of medicines and allied substances.
48. (1) The Authority shall keep and maintain a Register of
Marketing Authorisations issued under this Act.
(2) The Register referred to in subsection (1) shall be kept at the
offices of the Authority and shall be open to inspection by the public
at such times and on such conditions, including the payment of a
fee for inspection as the Board may determine.
PART VI
REGULATION OF CLINICAL TRIALS
Medicines and Allied Substances [No. of 2013 29
Recall of
medicine,
etc. from
circulation
Monitoring
medicine and
allied
substance
Register of
Marketing
Authorisations
49. (1) A person shall not conduct a clinical trial involving a
medicine or allied substance without a clinical trial certificate.
(2) A person who contravenes subsection (1) commits an offence
and is liable, upon conviction, to a fine not exceeding three million
penalty units or imprisonment for a period not exceeding five years,
or to both.
50. (1) A person who intends to conduct a clinical trial shall
apply to the Authority for a clinical trial certificate in the prescribed
manner and form upon payment of the prescribed fee.
(2) The Authority shall reject an application for a clinical trial
certificate if—
(a) the application does not meet the requirements of this
Act;
(b) the activity to be carried out contravenes any law in force;
(c) the clinical trial certificate previously held by the applicant
has been revoked by the Authority;
(d) the applicant submits false information in relation to the
requirements for the application;
(e) the premises to be used for the clinical trials is not suitable
for the intended purpose; or
(f) there is some risk to the health or well-being of a participant
and the potential benefit of the clinical trial does not
significantly outweigh that risk.
(3) The Authority shall, where it rejects an application under
subsection (1), inform the applicant accordingly and give the reasons
therefor.
(4) The Minister may, on the recommendation of the Authority,
by statutory instrument, provide for—
(a) the criteria for the regulation of persons under subsection
(1);
(b) the procedure for applying for a clinical trial certificate
and the grant, amendment, renewal, transfer and
revocation of a clinical trial certificate;
(c) the terms and conditions attaching to an application, grant,
amendment, refusal, renewal, transfer or revocation of
a clinical trial certificate; and
(d) such other matters as are necessary or incidental to the
effective regulation of clinical trials under this Part.
51. (1) The Authority shall, within ninety days of receipt of an
application under section fifty, issue the applicant with a clinical
30 No. of 2013] Medicines and Allied Substances
Application
for clinical
trial
certificate
Prohibition
of
conducting
clinical trial
without
certificate
trial certificate if—
(a) the application meets the requirements of this Act;
(b) the clinical trial does not contravene any other written
law;
(c) appropriately qualified persons are available to handle the
medicine or allied substance for purposes of the clinical
trial; and
(d) the premises on which the applicant proposes to conduct
the clinical trials are suitable for the intended purpose.
(2) A certificate granted under this section shall be valid for
such period as shall be specified in the certificate.
52. The Authority shall inspect clinical trial sites during the
course of the trial and at such intervals as it may determine.
53. (1) The Authority shall keep and maintain a Register of
Clinical Trial Certificates issued under this Act in which it shall
enter the names and other details relating to clinical trials.
(2) The Register referred to in subsection (1) shall be kept at
the offices of the Authority and shall be open to inspection by the
public at such times and on such conditions, including the payment
of a fee for inspection, as the Board may determine.
PART VII
THE NATIONAL DRUG QUALITY CONTROL LABORATORY
54. (1) There is hereby established the National Drug Quality
Control Laboratory which shall be managed by the Authority and
shall facilitate the regulation of medicines and allied substances
under this Act.
(2) The Authority shall use the Laboratory to—
(a) verify the safety, quality and efficacy of medicines and
allied substances which are manufactured or imported
into the country by persons who are authorised or
licenced under this Act;
(b) examine, analyse and conduct research on medicine and
allied substances;
(c) provide laboratory services to the general public;
(d) provide practical training for personnel in the analysis of
medicines and allied substances; and
(e) perform such other functions relating to the analysis of
medicines and allied substances as it considers
necessary.
(3) The Authority shall charge such fees for the analysis of
medicines and services provided by the Laboratory as it may
Medicines and Allied Substances [No. of 2013 31
Grant of
clinical trial
certificate
Inspection of
clinical trial
sites
Register of
Clinical Trial
Certificates
National
Drug Quality
Control
Laboratory
determine.
(4) The Board shall appoint a Director for the Laboratory on
such terms and conditions as it may determine, who shall be
responsible for the day-to-day administration of the Laboratory.
(5) The Board shall appoint such number of pharmaceutical
analysts as it may consider necessary for purposes of performing
its functions under this section.
(6) A pharmaceutical analyst shall, as soon as is practicable,
analyse or examine medicines or allied substances sent to the
laboratory and issue a certificate of analysis in such form as may
be prescribed.
(7) The Authority may use any approved laboratory to verify
the quality, efficacy and safety of medicines and allied substances
and the laboratory shall, upon analysis or examination of the
medicines or allied substances, issue a certificate of analysis.
(8) A certificate of analysis issued under this section shall be
received in evidence and shall be deemed to be so issued as the
case may be, without further proof, unless the contrary is proved.
PART VIII
INSPECTIONS
55. (1) The Board may appoint any suitably qualified person to
be an inspector for the purposes of ensuring compliance with this
Act, on such terms and conditions as it may determine.
(2) The Authority shall provide an inspector with an identification
card, in the prescribed form, which shall be prima facie evidence
of the inspector’s appointment as such.
(3) An inspector shall, in performing any function under this
Act—
(a) be in possession of the identification card referred to in
subsection (2); and
(b) show the identification card to any person who requests
to see it or is subject to an inspection or investigation
under this Act.
(4) An inspector may, for the purpose of enforcing the provisions
of this Act, at any reasonable time, and on the authority of a warrant,
enter any premises, pharmacy, health shop, agro-veterinary shop,
container, vessel, vehicle, aircraft or other conveyance that the
inspector has reasonable grounds to believe is used for the
commission of an offence or purposes contrary to the provisions of
this Act, and—
(a) search the pharmacy, health shop, agro-veterinary shop,
container, vessel, vehicle, aircraft or other conveyance,
32 No. of 2013] Medicines and Allied Substances
Inspectors
or the premises of a manufacturer, importer, exporter,
seller or distributor of any medicine or allied substance
or any person licensed or regulated under this Act,
including a private dwelling, where information or
documents which may be relevant to an inspection
may be kept or which are being used for the commission
of an offence under this Act;
(b) search any person on the premises if the inspector has
reasonable grounds to believe that the person has
possession of an article, document, record, medicine
or allied substance that has a bearing on an
investigation, except that a person shall only be
searched by a person of the same sex;
(c) examine any document, record, book, article, medicine
or allied substance found on the premises that has a
bearing on an inspection or investigation;
(d) require information to be given about any document,
record, book, article, medicine or allied substance in
any premises by—
(i) the owner of the premises;
(ii) the person in control of the premises;
(iii) any person who has control of the document,
record, book, article, medicine or allied
substance; or
(iv) any other person who may have the information;
(e) seize any document, book, record, article, computer or
other electronic storage device, medicine or allied
substance that has a bearing on an inspection or
investigation or is used for purposes contrary to the
provisions of this Act;
(f) take samples of any medicine or allied substance as may
be necessary for the purposes of testing, examination
or analysis;
(g) take extracts from, or make copies of, any book, record
or document found on the premises that has a bearing
on an inspection or investigation;
(h) use any computer system or any other electronic device
on the premises, or require the assistance of any
person on the premises to use that computer system
or electronic device, to—
(i) search any data contained in, or available to the
Medicines and Allied Substances [No. of 2013 33
computer system or electronic device;
(ii) reproduce any record from the data; or
(iii) seize any output from the computer or electronic
device for examination and copying; and
(i) attach and, if necessary, remove from the premises for
examination and safeguarding any document, record,
book or article that has a bearing on an inspection or
investigation.
(5) An inspector who removes any document, book, record or
article from any premises under subsection (4) shall—
(a) issue a receipt for the document, book, record or article to
the owner of, or person in control of, the premises; and
(b) return the document, book, record or article as soon as
practicable after achieving the purpose for which it was
removed.
(6) A person who—
(a) delays, assaults, threatens or obstructs an inspector in the
performance of the inspector’s functions;
(b) refuses to give an inspector such reasonable assistance
as the inspector may require for the purpose of
exercising the inspector’s powers;
(c) gives an inspector false or misleading information in answer
to an inquiry made by the inspector; or
(d) impersonates an inspector or presents oneself to be an
inspector;
commits an offence and is liable, upon conviction, to a fine not
exceeding five hundred thousand penalty units or to imprisonment
for a period not exceeding two years, or to both.
(7) An inspector shall furnish the Authority with a written report
and any other information relating to an inspection, as the Authority
may require.
(8) Nothing in this section requires a person to disclose or produce
information or a document, if the person would in an action in a
court be entitled to refuse to disclose or produce the information or
document.
34 No. of 2013] Medicines and Allied Substances
PART IX
GENERAL PROVISIONS
56. (1) A person aggrieved with a decision of the Authority
may appeal to the Minister within thirty days from the date of
service of the decision.
(2) The Minister shall make a decision on the appeal lodged
under subsection (1) within ninety days of receiving the appeal.
(3) A person aggrieved with the decision of the Minister under
subsection (2) may appeal to the High Court within thirty days
from the date of service of the decision.
57. (1) Notwithstanding the provisions of the Patents Act or
any other written law, where—
(a) the Minister declares a national health emergency or state
of extreme urgency;
(b) the public interest so requires; or
(c) any medicine or allied sustance is required for public non-
commercial use;
the Authority may authorise the manufacture locally, or importation,
of a generic formulation of a medicine or allied substance, not
withstanding that a patent in respect of that medicine has been
issued in Zambia.
(2) The Authority shall not grant authorisation to a person to the
exclusion of the patent holder.
(3) The grant of an authorisation under subsection (1), shall be
subject to review by a court.
58. (1) A person who fraudulently obtains a licence, permit,
authorisation or registration under this Act or makes any false or
misleading statement in connection with any medicine or allied
substance commits an offence and is liable, upon conviction, to a
fine not exceeding one million penalty units or to imprisonment for
a period not exceeding three years, or to both.
(2) A person who—
(a) deals in unregistered medicines or allied substances;
(b) tampers with any sample taken for purposes of this Act;
(c) obtains medicines or allied substances from unauthorised
suppliers; or
(d) fails to maintain records for medicines or allied substances
registered under this Act;
Medicines and Allied Substances [No. of 2013 35
Appeals
Authority to
manufacture
patented
medicine
Cap. 400
General
offences
commits an offence and is liable, upon conviction, to a fine not
exceeding four million penalty units or to imprisonment for a period
not exceeding seven years, or to both.
(3) In addition to the penalty provided in subsection (1) and (2),
the court before which a person is convicted of an offence under
this section may order—
(a) that any medicines or allied substances in respect of which
the offence is committed be forfeited to the State and
be disposed of as the court may determine;
(b) that the costs for disposal of any medicine or allied
substance be borne by the offender; or
(c) the cancellation of any licence permit, certificate or
authorisation issued to that person under this Act.
59 (1) A person shall not manufacture, import, export, distribute,
sell, store or deal in any manner with sub-standard, counterfeit,
adulterated or misbranded medicines or allied substances.
(2) A person who contravenes subsection (1) commits an
offence and is liable, upon conviction, to a fine not exceeding two
million penalty units or to imprisonment for a period not exceeding
four years, or to both.
(3) In addition to the penalty provided in subsection (2), the
court before which a person is convicted of an offence under this
section may order that any medicines or allied substances in respect
of which the offence is committed be forfeited to the State to be
destroyed.
60. (1) A person shall not supply or sell an expired medicine or
allied substance.
(2) A person who contravenes subsection (1) commits an
offence and is liable, upon conviction, to a fine not exceeding one
million penalty units or to imprisonment for a period not exceeding
three years, or to both.
(3) In addition to the penalty provided for in subsection (2), the
court before which a person is convicted of an offence under this
section may order that the medicines or allied substances in respect
of which the offence is committed be forfeited to the State to be
destroyed.
61. (1) A person shall not label, package, treat, process, sell or
advertise any medicine or allied substance in a manner that is false,
misleading or deceptive in respect of its character, constitution, value,
potency, quality, composition, merit or safety or in contravention of
any provision of this Act.
36 No. of 2013] Medicines and Allied Substances
Prohibition
of
manufacture,
import,
export, etc.
of sub-
standard,
counterfeit
or
adulterated
medicines or
allied
substances
Prohibition
of supply of
expired
medicines
Prohibition
of deceptive
acts
(2) A person who contravenes subsection (1) commits an offence
and is liable, upon conviction, to a fine not exceeding one million
penalty units or to imprisonment for a period not exceeding three
years, or to both.
62. (1) A person shall not sell any cosmetic that—
(a) has in or upon it any substance that is likely to cause
injury to the health of the user when the cosmetic is
used—
(i) according to the direction on the label of, or
accompanying, such cosmetic; or
(ii) for such purposes and by such methods of use as
are customary or usual; or
(b) consists in whole or in part of any filthy, rotten,
decomposed or diseased substance or of any injurious
foreign matter.
(2) A person shall not manufacture, import, export, sell or
supply any cosmetic that does not meet the prescribed standards
of quality.
(3) A person who contravenes subsection (1) or (2) commits an
offence and is liable, upon conviction, to a fine not exceeding one
million penalty units or to imprisonment for a period not exceeding
three years, or to both.
63. A person who sells, prepares, packages or stores for sale
any cosmetic under insanitary conditions commits an offence.
64. Where a standard has been prescribed for a cosmetic, any
person who labels, packages, sells or advertises any article in such
a manner that it is likely to be mistaken for a cosmetic of the
prescribed standard commits an offence, unless the article complies
with the prescribed standard.
65. (1) A person shall not sell any medical device that may
cause injury to the health of the user when the medical device is
used—
(a) according to the direction on the label of, or accompanying,
that medical device; or
(b) for such purposes and by such methods of use as are
customary or usual.
Medicines and Allied Substances [No. of 2013 37
Prohibition
of
manufacture,
sale, etc of
harmful
cosmetics
Sale and
preparation
of cosmetics
under
insanitary
conditions
Standards of
cosmetics
Prohibition
of sale of
harmful
medical
devices
(2) A person shall not manufacture, import, sell or supply any
medical device that does not meet the prescribed standards of quality.
(3) A person who contravenes subsection (1) or (2) commits an
offence and is liable, upon conviction, to a fine not exceeding two
million penalty units or to imprisonment for a period not exceeding
four years, or to both.
66. A person who contravenes a provision of this Act for
which a specific penalty is not provided for under this Act, commits
an offence and is liable, upon conviction, to a fine not exceeding
one million penalty units or to imprisonment for a period not exceeding
three years, or to both.
67. Where an offence under this Act is committed by a body
corporate or an unincorporate body, every director or manager of
the corporate or unincorporate body is liable, upon conviction, as if
the director or manager had personally committed the offence, unless
the director or manager proves to the satisfaction of the court that
the act constituting the offence was done without the knowledge,
consent or connivance of the director or manager or that the director
or manager took reasonable steps to prevent the commission of the
offence.
68. (1) The Authority may make guidelines for the better
carrying out of the provisions of this Act.
(2) The guidelines referred to in subsection (1) shall, upon
publication in a daily newspaper of general circulation in Zambia,
be binding on all persons regulated under this Act.
69. (1) The Minister may, by statutory instrument, make
regulations for the better carrying out of the provisions of this Act.
(2) Without prejudice to the generality of subsection (1), regulations
under that subsection may make provision for—
(a) the prohibition, regulation or restriction of the manufacture
or importation of pharmaceutical preparations and
prescription only medicines;
(b) the required standards for pharmacies, agro-veterinary
shops and health shops, including their operation and the
maintenance, space, equipment and facilities required
for pharmacies, agro-veterinary shops and health shops;
(c) the required standards for the manufacture, supply,
dispensing and the distribution of medicines and allied
substances;
38 No. of 2013] Medicines and Allied Substances
General
penalty
Offence by
body
corporate or
unincorporate
body
Guidelines
Regulations
(d) the compounding of prescriptions and the dispensing of
medicines or allied substances by medical doctors, dental
surgeons, veterinary surgeons and the conditions under
which the compounding and dispensing of medicines may
be earned out;
(e) the records to be kept by pharmacies, health shops and
agro-veterinary shops;
(f)the advertising, promotion and labelling of medicines and
allied substances;
(g) the recall or withdrawal of medicines and allied substances
that do not meet the prescribed standards of quality,
efficacy and safety;
(h)the handling of donated medicines;
(i) the disposal of obsolete, expired or unwanted medicines or
allied substances, in consultation with the Zambia
Environmental Management Agency;
(j)the storage and standards for medicines and allied
substances;
(k) the period for which any books or registers required to be
kept for the purposes of this Act are to be preserved;
(l) the fees to be paid for certificates, permits, authorisations
and licences under this Act;
(m) the restriction of the number and location of entry points
through which medicines, herbal medicines or allied
substances may be imported or exported;
(n) the categorisation of methods of sale for medicines and
allied substances; and
(o) generally the carrying into effect of the purposes of this
Act.
70. (1) The Pharmaceutical Act, 2004, is hereby repealed.
(2) Notwithstanding subsection (1), the provisions of the Second
Schedule apply in respect of the matters specified therein.
(3) Notwithstanding subsection (1), a person who immediately
before the commencement of this Act held office as a member of
the Board of the former Authority shall hold office as a member of
the Board for a period of three months after which the Minister
shall appoint the members of the Board in accordance with the
provisions of this Act.
(4) Notwithstanding subsection (1), a licence or certificate issued
under the repealed Act shall continue to be valid for six months,
after which the holder of the licence or certificate shall apply for a
licence, permit, authorisation or certificate in accordance with the
provisions of this Act.
Medicines and Allied Substances [No. of 2013 39
Repeal of Act
No. 14 of 2004
Act No. 14 of
2004
FIRST SCHEDULE
(Section 3(3))
THE ZAMBIA MEDICINES REGULATORY AUTHORITY
PART I
ADMINISTRATION OF AUTHORITY
1. (1) Subject to the other provisions of this Act, a member of
the Board shall hold office for a period of three years and may be
re appointed for one further period of three years.
(2) A member may resign upon giving one month’s notice, in
writing, to the Minister.
(3) The office of a member shall become vacant—
(a) if the member is absent, without reasonable excuse, from
three consecutive meetings of the Board of which the
member has had notice;
(b) if the member is adjudged bankrupt;
(c) if the member is convicted of an offence under this Act or
any other written law and sentenced to imprisonment
for a period exceeding six months;
(d) if the member ceases to be a representative or member of
the institution which recommended the member;
(e) if the member is found guilty of professional misconduct;
(f)if the member becomes mentally or physically incapable of
performing the duties of a member; or
(g) upon the member’s death.
(4) On the expiration of the period for which a member is
appointed the member shall continue to hold office until a successor
has been appointed but in no case shall the further period exceed
four months.
2. The Minister may, where the office of a member becomes
vacant before the expiry of the term of office, appoint another
member in place of the member who vacates office but that member
shall hold office only for the unexpired part of the term.
3. (1) Subject to the other provisions of this Act, the Board may
regulate its own procedure.
(2) The Board shall meet for the transaction of business at least
once in every three months at such places and times as the Board
may determine.
40 No. of 2013] Medicines and Allied Substances
Tenure of
office and
vacancy
Filling of
casual
vacancy
Proceedings
of Board
(3) A meeting of the Board may be called by the Chairperson,
upon giving notice of not less than fourteen days, and shall be
called by the Chairperson if not less than one-third of the members
so request in writing,except that if the urgency of any particular
matter does not permit the giving of the notice, a special meeting
may be called upon giving a shorter notice.
(4) The Chairperson, or in the absence of the Chairperson, the
Vice-Chairperson, with six other members shall constitute a
quorum at any meeting of the Board.
(5) There shall preside at any meeting of the Board—
(a) the Chairperson;
(b) in the absence of the Chairperson, the Vice-Chairperson;
and
(c) in the absence of the Chairperson and the Vice-
Chairperson, such other member as the members
present may elect for the purpose of that meeting.
(6) A decision of the Board on any question shall be by a majority
of the members present and voting at the meeting and in the event
of an equality of votes, the person presiding at the meeting shall
have a casting vote in addition to that person’s deliberative vote.
(7) The Board may invite any person, whose presence is in its
opinion desirable, to attend and to participate in the deliberations
of the meeting of the Board, but that person shall not have any
vote.
(8) Where a member is for any reason unable to attend a meeting
of the Board, the member may, in writing, nominate another person
from the same organisation to attend the meeting in that member’s
stead and that person shall be deemed to be a member for the
purpose of that meeting.
(9) The validity of any proceedings, acts or decisions of the
Board shall not be affected by any vacancy in the membership of
the Board or by any defect in the appointment of any member or
by reason that any person not entitled to do so, took part in the
proceedings.
4. There shall be paid to a member of the Board or a committee
of the Board such allowances as the Minister may determine.
5. (1) If any person is present at a meeting of the Board or
any committee of the Board at which any matter is the subject of
consideration, and in which matter that person or that persons
relative is directly or indirectly interested in a private capacity, that
Medicines and Allied Substances [No. of 2013 41
Allowances
of member
Disclosure of
interest
person shall, as soon as is practicable after the commencement of
the meeting, declare that interest and shall not, unless the Board or
the committee otherwise directs, take part in any consideration or
discussion of, or vote on, any question relating to that matter.
(2) A declaration of interest made under subparagraph (1) shall
be recorded in the minutes of the meeting at which it is made.
(3) In this paragraph, “ relative ” in relation to a person means—
(a)a parent, son, daughter, brother, sister, niece, uncle, auntie,
grandparent or cousin of the person or that person’s
spouse; and
(b) a spouse of that person.
6. (1) A person shall not, without the consent in writing given
by, or on behalf of, the Authority, publish or disclose to any
unauthorised person, otherwise than in the course of duties of that
person, the contents of any document, communication, or
information whatsoever, which relates to or which has come to the
knowledge of that person in the course of that person’s duties under
this Act.
(2) A person who contravenes subparagraph (1) commits an
offence and is liable, upon conviction, to a fine not exceeding five
hundred thousand penalty units or to imprisonment for a period not
exceeding two years, or to both.
(3) A person who, having any information which to the knowledge
of that person has been published or disclosed in contravention of
subparagraph (1), unlawfully publishes or communicates the
information to any other person, commits an offence and is liable,
upon conviction, to a fine not exceeding five hundred thousand
penalty units or to imprisonment for a period not exceeding two
years, or to both.
7. An action or other proceeding shall not lie or be instituted
against a member of the Board or a member of a committee of the
Board for, or in respect of, any act or thing done or omitted to be
done in good faith in the exercise or performance of, or purported
exercise or performance of any of the powers, functions or duties
conferred under this Act.
PART II
FINANCIAL PROVISIONS
8. (1) The funds of the Authority shall consist of such moneys
as may—
42 No. of 2013] Medicines and Allied Substances
Prohibition
of
publication
or disclosure
of
information
to
unauthorised
persons
Immunity
Funds of
Authority
(a) be appropriated to the Authority by Parliament for the
purposes of the Authority;
(b) be paid to the Authority by way of fees, grants or donations;
and
(c) otherwise vest in or accrue to the Authority.
(2) The Authority may, subject to the approval of the Minister—
(a) accept moneys by way of grants or donations from any
source within or outside Zambia; and
(b) raise by way of loans or otherwise, such moneys as it
may require for the discharge of its functions.
(3) There shall be paid from the funds of the Authority—
(a) the salaries, allowances, loans, gratuities and pensions of
members of staff of the Authority;
(b) such reasonable travelling and other allowances for the
members of the Board and of any committee of the
Board when engaged on the business of the Authority,
at such rates as the Minister may determine; and
(c) any other expenses incurred by the Authority in the
performance of its functions under this Act.
(4) The Authority may, subject to the approval of the Minister,
invest in such manner as it considers appropriate such funds of the
Authority which it does not immediately require for the discharge
of its functions.
9. The financial year of the Authority shall be a period of
twelve months ending on 31st December in each year.
10. (1) The Authority shall cause to be kept proper books of
account and other records relating to its accounts.
(2) The Authority shall, within ninety days of expiry of financial
year, submit to the Minister a report concerning its activities during
the financial year.
(3) The report referred to in subparagraph (2) shall include
statements of income and expenditure and a statement of affairs
or balance sheet.
(4) The accounts of the Authority shall be audited annually or
whenever necessary by the Auditor-General.
11. (1) As soon as practicable, but not later than six months
after the end of the financial year, the Authority shall submit to the
Minister a report concerning its activities during that financial year.
Medicines and Allied Substances [No. of 2013 43
Financial
year
Accounts and
audit
Annual
report
(2) The report referred to in subparagraph (1) shall include
information on the financial affairs of the Authority and there shall
be appended to that report—
(a) an audited balance sheet;
(b) an audited statement of income and expenditure; and
(c) such other information as the Minister may require.
(3) The Minister shall, not later than seven days after the first
sitting of the National Assembly next after receipt of the report
referred to in subparagraph (1), lay the report before the National
Assembly.
SECOND SCHEDULE
(Section 68(2))
SAVINGS AND TRANSITIONAL PROVISIONS
1. (1) For the avoidance of doubt, a person who, before the
commencement of this Act, was an officer or employee of the
former Authority, shall continue to be an officer or employee of the
Authority, as the case may be, as if appointed or employed under
this Act.
(2) The service of the persons referred to in subparagraph (1)
shall be treated as continuous service.
(3) Nothing in this Act affects the rights and liabilities of any
person employed or appointed by the former Authority before the
commencement of this Act.
2. (1) On or after the commencement of this Act, there shall
be transferred to, vest in and subsist against the Authority by virtue
of this Act and without further assurance, all assets, rights and
obligations which immediately before that date were the assets,
rights, liabilities and obligations of the former Authority.
(2) Subject to sub-paragraph (1), every deed,bond and agreement,
other than an agreement for personnel service, to which the former
Authority was a party immediately before the commencement of
this Act whether or not of such a nature that rights, liabilities and
obligations could be assigned, shall, unless its subject matter or terms
make it impossible that it should have effect as modified, as provided
under this paragraph, have effect as if—
(a) the Authority had been party to it;
(b) for any reference to the former Authority there was
substituted, with respect to anything required to be done
on or after the commencement of this Act, a reference
to the Authority; or
44 No. of 2013] Medicines and Allied Substances
Staff of
Authority
Transfer of
assets and
liabilities
(c) for any reference to any officer of the former Authority,
not being a party to it and beneficially interested, there
were substituted, with respect to anything required to
be done on or after the commencement of this Act, a
reference to such officer of the Authority as it shall
designate.
(3) Where under this Act, any assets, rights, liabilities and
obligations of the former Authority are deemed to be transferred to
the Authority in respect of which transfer a written law provides
for registration, the Authority shall make an application, in writing,
to the appropriate registration authority for registration of the
transfer.
(4) The registration authority, referred to in subparagraph (2),
shall make such entries in the appropriate register as shall give
effect to the transfer and, where applicable, issue to the transferee
concerned a certificate of title in respect of the property or make
necessary amendments to the register and shall endorse the deeds
relating to the title, right or obligation concerned and no registration
fees or other duties shall be payable in respect of the transaction.
3. (1) Any legal proceedings or application of the former
Authority pending immediately before the commencement of this
Act by or against the former Authority may be continued by or
against the Authority.
(2) After the commencement of this Act, proceedings in
respect of any right, liability or obligation which was vested in,
held, enjoyed, incurred or suffered by the former Authority, may be
instituted by or against the Authority.
Medicines and Allied Substances [No. of 2013 45
Legal
proceedings
