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PHARMACY LIGISLATIONS
The are 5 types of Malaysian Pharmacy
Legislations.
It consist of 5 Main Acts and several regulation
made under each Act.
Each Act stand by itself and are specific in its own
way and control.
Certain requirement can be different or
overlapping between the Acts but the public have
to satisfy and abide to the requirement of every
Act.
ORDINANCE,
ACT,
REGULATION &
GUIDELINE
ORDINANCE
Laws before Merdeka Day
For Federal they are called
ORDINANCE
For State they are known as
ENACTMENT
ACT (AKTA)
Laws after Merdeka Day
Written Laws
***Federal
Constitution
***Constitution of State
***Act of
Parliament
Common Laws
REGULATION
Subsidiary Legislation
Form a subsidiary to the Act with
the criteria of supervisional
Regulation only need to be
approved by the Minister who will
be empowered by the Parent Act.
Do not go to Parliament for
approval
GUIDELINES
More for the purpose of Administrative
Mostly no legal standing
May have legal implication when the Parent
Act or the regulations have provision for
certain bodies to issues guidelines
***eg.
The DCA who are
promulgated under the Control of Drug
and Cosmetic Regulations is given
power under Regulations 20(1), 22.
ADA
SOALA
N TAK?
AKTA UBAT
(IKLAN DAN PENJUALAN) 1956
MEDICINE
(ADVETISMENT & SALE)
ACT 1956
It is an Act to
prohibit certain
advertisments
relating to medical
matters and to
regulate the sale of
substances
recommended as a
INTERPRETATION &
DEFINITION OF CERTAIN
IMPORTANT WORDS AND
PHRASES
SECTION 2
Advertisment
Definition;
*advertisment includes any notice,
circular, report, comentary, pemphlet,
label, wrapper or other document or
any announcement made orally or by
any means of producing or transmitting
light or sound;
*
the inclusive definition of advertisment
means that it take into consideration the
traditional meaning (as in the dictionaries) of
and advertisment and it include..............
OTHER IMPORTANT
SECTIONS
PRODUCT
Sec. 3
Sec. 4
Sec. 4A
Sec. 4B
Sec. 5
Sec. 6
TREATMENT
SECTION 3
Prohibition of advertisment relating to certain
diseases.
Paragraph 3(1)(a) prohibition of advertisment
relating to diseases in Schedule
Paragraph 3(1)(b) prohibition of advertisment
relating to contraception among human beings
Paragraph 3(1)(c) prohibition of advertisment
relating to improving condition or function of
human kidney, heart, sexual function or sexual
performance of human
Paragraph 3(1)(d) prohibition of advertisment
relating to diagnosis of disease as specified in
schedule
SECTION 4
Prohibition of advertisment relating to
abortion
this section relates to advertisment for article
used for procuring the miscarriage of woman
SECTION 4A
This section prohibit advertisment relating to skill or
service
Paragraph 4A(a) refer to skill or service relating to
treatment, prevention or diagnosis of disease, injury,
infirmity or condition effecting the human body
Paragraph 4A(b) added that the advertisment which is
capable of inducing, contain an invitation to any person
to seek the advive of the advertiser or any person
referred to in the advertisment
Paragraph 4A(aa) is an examption for advertisment of
such nature by pfofessional body
Paragraph 4A(bb) approval from MAB needed for such
advertisment for private hosp., clinic, radiology or lab.
SECTION 4B
Avertisment of medicines to be approved by
the Medicines Advertisment Board (MAB)
established by the Minister
This approval given by the MAB do not
include the advertisment of medicine for the
treatment and prevention the diseases listed
under the Schedule (because those in the
schedule are totaly prohibited for layman
advertisment)
Subsection 4 (2) stated that the advertisment to
be publish have to be submitted to MAB in the
manner as regulated
SECTIONS 6
Disclosure of composition of
medicines
Such information have to be
written in English or national
language and clearly legible
Information includes ingredient,
quantity, poison (as in the
Poison Act 1952 and its
regulations), ..........
SEC. 6A:
SECTION 6B
Power of Officer to
investigate offences under
the Act
Power of officer with the
cooperation of the court to
secure attendance of
witness for the purpose of
investigation
SECTION 6C
Examination of witness
Recording statement of
who ever is acquainted with
the fact and circumstances
of the case
Proviso for caution and the
right of the person
investigated upon
SECTION 6D
Power of officer to enter,
search and examine premises
related with the offence under
the Act
power of officer to inspect,
remove, detain any related
item with the offence under
the Act.
SECTION 6E
Penalty for
obstructing or
impeding an
authorised
officer
SECTION 6F
Sanction by the Public
Prosecutor before a
case under this Act can
be taken to court
Authorised Officer to
conduct prosecution
SEC. 7:
MEDICINE ADVERTISMENT
BOARD REGULATION 1976
ANY
QUESTION?
PREAMBLE
Generally
For over 40 years this Act and its regulations provided
the chief source of law relating to the sale and supply
of medicines and other chemicals.
A Poison Board was created under the Act, to advice
the Health Minister on substances to be controlled
and various restriction to be imposed upon.
The expression Poison was defined as any
substance specified by name in the first column of the
poison list order under the Act.
Regulations
SECTION 2
INTERPRETATION,
DEFINITION
Some important definition
Transportation of Poison
Poisons have to be transported in accordance with
regulation made under this Act (s. 10). The
Poison Regulation set that the poison which are to
be transported have to be;
* pack in such a way to avoid leakage (r.8(1))
* to be labelled with the name of the poison and to
follow all the labelling requirement as being
mention in any of the regulation made under this Act
(r. *(2))
* to be transported on a vehicle separately from food
to avoid contamination (r. 8(3))
Type A Licence
Type B Licence
This licence is issued to any person the Licensing Officer may
consider to be fit and proper person to hold such licence, or
issued to a responsible officer of a company incorperated
under the Companies Act 1965.
This type B licence allows a person to import, store and sell
by wholesale only such poison as may be specified in the
licence.
This licence is restricted only in dealing on specific poisons
excluding the Group A poison.
The Poison Act also have proviso which do not allow this type
B licence to be issued to any person or officer who is engaged
or concern in selling goods by retail.
Type C Licence
The Licensing Officer is issued to listed seller a Type C
Licence when there is no pharmacist in within a local
authority licensed to carry on a business in such area.
This license will allow the listed seller to sell by retail and
store Group F poisons.
As the number of licensed pharmacist increase
tremendously the Poison Board view that they should up
grade all Group F poisons.
Untill 1989 there is no more Group F poison in the Poison
List so there is no more Type C licence issued by the
Licensing Officer.
Type D Licence
This licence is issued to any person whom the
licensing may consider to be fit and proper to hold
such license to store and sell by retail such Part II
Poisons as may be specified(ususlly after an
inspection of the applicant premise by the
enforcement officer to acertain that the applicant
and their premises are fit to handler such poison in
term of storage and safety)
Type E Licence
This licence is for any person who uses Sodium
Hydroxide in the course of his business in a
substantial quantity where this licence allows the
holder to import, store and use.
The enforcement unit of the state will have to ensure
that the person and the premises is fit and proper for
such activity before this licence can be considered
by the Licensing Officer.
General: on license
All the format of licences are prescribed by the Act
Licensing Officer have freedom to instate terms and condition in
every licence where he deem it is fit, proper and which are not
inconsistent with this Act or its Regulations. If the terms and
condition stated in the licence is not aggreable by the applicant,
the applicant can appeal to the minister (s. 26(3) and 26(4)).
All licence is personal to the licensee named in the licence and are
not tranferable.
The person named in the licence have to be responsible for
authorising any sale of the poison and any dealing in such poison
have to be personally supervised by him.
Each licence is specific to the premise where the addresses are stated in the
lic. Any change of add. have to be made by application to the Licensing
Officer and he will amend the address as he see fit (s. 26(6).
Section 26(5) give powers to the Licensing Officer to refuse issuance any
such licence or he may may cancel a licence that had been issued. Anybody
aggrieved by such action may appeal to the Minister. The Minister decision
on the appeal shall be final
All licensed shall be numbered by the State consecutively in respect of each
type and of year in which it was issued and commencing each year with the
number one.
A Register recording all the particular of each lic. and records any event on
cancellation or amendment have to be kept for all licence issued by the
Licensing Officer of every State. This register shall be accepted in any court
case as a prima facie evidence (s. 27).
The Director General of Health shall publish the name of all licence holder in
a Gazette annually in about the month of February each year. This
Government Gazette shall also be prima facie evidence in any court
proceeding (s. 28).
Power to investigate
A DEO is given the power to investigate under
section 31(2). Power in oral examination of any
body acquinted with the fact and circumstances
of the case is also given (s. 31(3)) where it
means that they are given the power to record
statement of witnesses and the acused. Section
31(4), (5), and (6) laid the the caution involve in
taking the statement.
Regulations
Section 35 gives power to the Minister to make
regulations to carry out the purpose of this Act and these
regulations may be in respect or for the purpose related to
poisons such as importation, manufacturing, sale,
storage, transport, labelling, containers, compounding,
dispensing, record, qualification of poison guardian,
providing exemption, prescribing form of licences and
register, the act of dealing in specific poison such as lead
tetraethyl, presccribing penalties for offence againts the
regulations and regulate the control of Psychotropics
substance.
Third Schedule
This Act define Psychotropic Substances as those listed in
Third Schedule of the Act (s. 30(1).
The third Schedule listed out all the Psichotropic
Substances under the control of this Act.
not all psychotropic drugs as classified by way of their
Pharmacological action are listed under this Schedule.
Those listed are those Psychotropic which have abuse
tendencies.
The Minister from time to time can vary the Third Schedule
by way of Gazzett.
Section 30(3) provide that all dealing in Psy. Subst. have to
be in accordence with the regulations made under this Act.
Poisons (Psychotropic
Substances) Regulations 1989
This Regulations regulate the possession,
import, export, sale, supply, purchase,use,
administration, dispensing, compounding,
mixing, manufacturing, storage, disposal
and labelling of Psychotropic Substances.
Possession of Psychotropic
Substance
Administration, Dispensing,
Compounding, Mixing and Mnufacturing
of
Psy.
Substance
Register of Psychotropic
The recording of psychotropic provided in regulations 19,
20, 21, 22 and 23 and can be simplified as follows;
i) Records of sale and supply for the purpose of
treatment (r.19);
a) to keep a register containing
- name strength and quantity sold or supplied
- name and address of patient, name and address of reciepient for
veterinary
ii) Recs of sale & supp other than for the purpose of treat. (r.20);
a) to keep a supply register for Psychotropic, containing
More on register
Any register of Psychotropic Substances should only be
corrected with a marginal note or footnote specifying the
date and the correction (r.22(c)).
All entery have to be made in cronological order (r.22(d))
register have to be in a bound book (r.23) or any other
form approved by the Licensing Officer
registers to be preserved for not less than 2 years from
the date of last entry.
Part I
Part II
Part II consist of prepared Opium and
cannabis resin. These are processed drug
but are still in the raw extract state. The
control are still the same as those in Part I.
Part III
Part III are made up of the longest list of
dangerous drug in the form of chemical
active or in the form of content in any
dosage form. Most of the Pharmaceutical
dosage forms are control under this Part.
Part IV
Part IV listed out ethylmorphin,
propoxyphene and most of the morphine
derivatives in the codiene groups. The
dangerous drugs under this part are also
very common in the pharmaceutical
preparation or dosage form.
Part IV
Part IV is considered to be the lowest
control dangerous. The drug listed in this
Part are pharmaceutical preparations. The
Act regulates that the items in this part do
not need an export authorisation on
exportation (more explanation will be given
on import and export of dangerous drugs in
the coming chapter) .
Manufacturing of Dangerous
Drugs
Storage, Records of DD
Reg. 9 (2),- dengerous drug to be under lock and key and the
authorised person as guardian.
Reg. 15(1) & (2)
15(1)(a) - DD Register, in chronological order for every DD for receive
and supply (day book)
15(1)(b) - Separate book for every DD - purpose of audit
15(1) c - entry on supply to be made on the same day
15(1)(d) - format for cancellation of record
15(1)(e) - call for information by the DG of Health or the authority
Form of DD prescription
Reg. 11(2) - set the format for prescription
Format for Psy. Subst. Is an improved
format from DD prescription.
Dispensing of DD
Reg. 12(1) - validity of prescription
Reg. 12(1)(a) - prescription should comply to format
Reg. 12(1)(b) - to ascertain that the prescription is
genuine
DD Licenses
Reg. 18 - Wholesale license
Reg. 4 - Manufacturing License
Appointment of Drug
Enforcement Officer
Appointment of Drug
Enforcement Officer
25
KUASA PELANTIKAN DI
BAWAH SEK.3
Yang Dipertuan Agung melantik
Analyst[S. 3(1)]
Menteri besar melantik pegawai
berkuasa dan Inspector[S.3(2)]
Menteri Kesihatan diberi kuasa
mengadakan peraturan-peraturan
untuk tugas-tugas analyst, pegawai
berkuasa dan inspector. [S. 3(3)]
KUASA-KUASA PEGAWAI
BERKUASA DAN INSPECTOR DI
BAWAH SEK. 4
Memasuki dan memereksa [S. 4(1)(a)]
Menjalankan kerja-kerja mark, seal,
secure, weigh, count, measure
[S.
4(1)(b)]
merampas drug yang unwholesome atau
deleterious [S. 4(2)(a)]
memusnahkan drug[S. 4(2)(a)]
KAEDAH PENSEMPELAN,
SEKSYEN 5 dan 7
Sample diperolehi
(pembelian)[S.5(1)]
memberitahu pehak dimana sample diperolehi
yamg sample berkenaan adalah untuk dianalisa
[S. 7(1)]
sample dibahagikan kepada 3 bahagian
1 bahagian kepada kepada pehak disample
1 bahagian kepada analyst
1 bahagian disimpan oleh Pegawai atau Inspector
[S. 7(2) dan 7(3)]
SEKSYEN 10 :
OFFENCES AND PENALTIES
1. adultration [ S. 10(1)(a) ]
2. misleading statement [ S. 10(1)(b)]
3. containing prohibited substances [ S. 10(1)(c)]
4. containing greater propotion of certain substance
than is permitted [ S 10(1)(d) ]
5. containing methly alcohol,isopropyl alchohol or
denatured alcohol [S.10(1)(e)]
7. nature of substance not as demanded by purchaser [
S. 10(1)(f) ]
PERATURAN-PERATURAN KAWALAN
DADAH DAN KOSMETIK 1984
Digubal di bawah Akta Jualan Makanan dan
Dadah 1952
Bhg. I; Definasi dan Intepretasi
Bhg. II; Pelantikan Pihak Berkuasa (PBKD)
Bhg. III; Keperluan pendaftaran & lesen
Bhg. IV; Kritiria-kritiria GMP, QC dan QA
Bhg. V; Kuasa-kuasa pegawai, Keperluan rekod,
lapuran kesan adverse, hukuman dan kuasa
Menteri
DEFINASI PRODUCT
[r. 2]
product means a drug in a
pharmaceutical dosage
form, or a cosmetic, having
a singular identity,
composition, characteristics
and origin.
KESALAHAN-KESALAHAN DI BAWAH
PERATURAN-PERATURAN
Ubat-ubat tidak berdaftar [r. 7(1)(a)]
Pengilang, pengimport dan pemborong yang tidak
berlesen [r. 7(1)(b)]
Memberi maklumat palsu kepada PBKD
[r.
8(9)]
Pengilangan tidak mengikut apa yang di gariskan
oleh peraturan ini
Tidak melapurkan kesan adverse ubat [r. 28]
Pemborong tidak merekod transaksi ubat [r.27]
Tidak mengikut arahan Pihak Berkuasa [r. 29]
GMP
QA
QA
GMP
REGISTRATION
OF PHARMACIST
ACT 1951
PREAMBLE
An Act relating to the
establishment of a Pharmacy Board
and the registration of Pharmacist
It set up Pharmacy Board
Registration of Pharmacist as a
person
Registration of Bodies Corporate
DEFINITIONS
SEC. 8:
Application for
registration
To be made in such a manner and
to be accopanied with such
documens, photograph and
particulars as may be prescribed
for the purpose of satisfactory
proof of identity
SEC.9:
Power to refuse
registration
If a person is being guilty of
infamous conduct after due
inquiry by the Board,
admission to the register may
be refused.
SEC.10:
Entry of higher
education into register
Every registered person have the
entitlement to insert, add or
substitute in the register a
higher qualification with prove
of achievement.
SEC.11:
Issue of certificate of
registration
After admission to the register the
Board may issue a certificate of
regitration with a photograph affixed.
If the is any condition as mention in
Sec 6(2)(c), such condition or
restriction will be specified in the
certificate.
SEC.15:Publication of register&
presumptions
15(1) The register consist of name,
address, qualifications anddates of
qualification of pharmacist shall be
published annually in a Gazette and from
time to time if there are changes, the
changes shall also be published in a
Gazette