kawalan bahan kimia oleh bahagian perkhidmatan farmasi...
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KAWALAN BAHAN KIMIA OLEH BAHAGIAN PERKHIDMATAN
FARMASI: TERKINILATIFAH BINTI HAJI IDRIS
KETUA PENOLONG PENGARAH KANAN
BAHAGIAN PENGUATKUASA FARMASI
KEMENTERIAN KESIHATAN MALAYSIA
AKTA YANG DIKUATKUASAKAN
• Akta Racun 1952 dan Peraturannya
- Peraturan Racun 1952
- Peraturan Racun (Bahan Psikotropik) 1989
• Akta Jualan Dadah 1952 dan Peraturannya
- Peraturan Kawalan Dadah dan Kosmetik 1984
• Akta Pendaftaran Ahli Farmasi 1951 dan Peraturannya
• Akta Ubat(Iklan dan Penjualan) 1956 dan Peraturannya
• Akta Dadah Berbahaya 1952 dan Peraturannya
• Akta Perdagangan Stratergik 2010 dan peraturannya
KAEDAH KAWALAN BAHAN KIMIA PREKURSOR
• Akta Racun 1952 dan Peraturannya
• Arahan Kastam (Larangan Import) 1998
• Arahan Kastam (Larangan Eksport) 1998
• UN Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances 1988
KAWALAN BAHAN KIMIA DI BAWAH AKTA RACUN 1952
• Lesen Jenis A – Ahli Farmasi
• Lesen jenis B – ‘fit and proper’ person
• Senarai racun dalam lesen
• (precursor, arsenic, cynides – Diploma in Science)
• Store requirement
BAHAN PREKURSOR YANG DIKAWAL
TABLE I
N-acetylanthranilic acid
Acetic anhydride
Ephedrine
Ergometrine
Ergotamine
Isosafrole
Lysergic acid
3,4-MDP-2-P
Norephedrine
1-phenyl-2-propanone
Piperonal
Potassium permanganate
Pseudoephedrine
Safrole
Phenylacetic acid (17 Jan 2011)
BAHAN PREKURSOR YAN DIKAWAL
TABLE II
Acetone
Anthranilic acid
Ethyl ether
Hydrochloric acid
Methyl ethyl ketone
Phenylacetic acid (Table I)
Piperidine
Sulphuric acid
Toluene
coca leaf opiumsulphuric acid
coca paste morphine
pot acetic anhydride permanganate
cocaine/heroin
acetone/ethyl ether acetone / methyl ethyl ketone/ ethyl ether toluene
hydrochloric acid hydrochloric acidcocaine/heroine
hydrochloride
SUBSTANCES USE IN ILLICIT MANUFACTURE OF COCAINE AND HEROIN
COMMON METHODS USED IN ILLICIT MANUFACTURE OF
AMPHETAMINE AND METHAMPHETAMINE
Ephedrine/Pseudoephedrine
Amphetamine
Sulphate salt
Methamphetamine
1- Phenyl-2-propanone
Sulphuric acid
Phenylacetic acid
Hydrochloric salt
cathinone
ephedrine
methamphetamine
Mephedrone
(4-methylmethcathinone)
Contoh rampasan di makmal haram
78 x 25 kg thionyl chloride seized in meth lab Semenyih, Malaysia, 2004
Formic acid seized in meth lab Lunas, Malaysia, 2006
Modus Operandi
Misdeclaration/Mislabeling
“Polyvinyl Resin” “Bleaching Powder” “Fish Feed” “Fresh Meat”
JOHOR
Isu simbah asid
• Balas dendam?
• Terlalu marah?
• Niat jenayah?
• Masalah psikosis?
Kedai hardware
• Dilarang menjual racun kecuali mempunyai lesen jenis B
• Penjualan racun secara borong sahaja
• Penjualan racun secara runcit tidak dibenarkan
Syarat lesen Jenis B
• Lysergic acid, 1-phenyl-2-propanone (P2P), potassium permanganate, n-acetylanthranilic acid, 3,4-methylenedioxyphenyl-2-propanone (3,4MDP2P), Safrole, Isosafrole, Anthranilic acid, ethyl ether, phenylacetic acid, piperidine, Sulphuric acid, hydrochloric acid
rekod
Nama racun dan kepekatan (%)…………………….
• Selain dari rekod dalam buku penjualan borong (poisons wholesale sales book)
Tarikh diterima/dibekal
Nama pembekal/pembeli
Alamat pembekal/pembeli
Kuantiti diimport/dibekal/dijual/dibeli
Baki stok
Poisons wholesale sales book(poisons acts sec. 15(3)
Name of purchaser
Address of purchaser
Date of sale
Name of poison sold
Quantity of poison sold
purpose for which required
Signature of purchaser or refer to signed order
Sec.15(3) Poisons Act
• Sale of poisons by wholesale
the seller by wholesale of any poison shall not deliver it until-
a) He has made or caused to be made an entry in a book to be kept for such purpose, in the prescribed form, stating the name and address of the purchaser, the date of the sales, the name and quantity of the poison sold and the purposes for which it is stated by purchaser to be required and..
Cont…
• b) the purchaser has affixed his signature to the entry or has forwarded to the seller a written order in respect of such sale signed by the purchaser and containing the particulars required to be entered under this section. Every such written order shall be retained by the seller and a reference to the file in which such order is retained shall be entered in the book in place of the purchaser’s signature.
Pemeriksaan Audit
• Baki stok awal tahun(a)
• Kuantiti beli(b)
• Kuantiti jual/guna(c)
• Baki stok(d)
• a+b=c+d
• a+b>c+d =penjualan tidak direkod=diversion
• a+b<c+d=pembelian yang tidak direkod
Pemeriksaan audit
• Baki stok dalam rekod semasa audit
• Baki stok fizikal semasa audit
• Perbezaan stok fizikal dan rekod
• Pembelian tidak direkod?
• Penjualan tidak direkod?
• Diversion?
Sec.26(5) Poisons Act
• Licences
The Licensing officer may, in his discretion, refuse to issue any such licence or may cancel any such licence previously issued:…
STRATERGIC TRADE ACT 2010 (STA)
WHY MALAYSIA REQUIRE THE STA?
• As one of the United Nations (UN) members, obliged to set up national export control and adopted the United Nations Security Council Resolution 1540 (UNCSR 1540)
WHY MALAYSIA REQUIRE THE STA? (3) UN SECURITY COUNCIL RESOLUTION
SCR 1540 – OP3(d) requires all States to -
• take and enforce effective measures to establish domestic
controls to prevent the proliferation of nuclear, chemical, or
biological weapons and their means of delivery, including by
establishing appropriate controls over related materials and to this end shall
…establish, develop, review and maintain appropriate effective
national export and trans-shipment controls over such items,
including appropriate laws and regulations to control export,
transit, trans-shipment and re-export…”
WHY MALAYSIA REQUIRE THE STA? (4) INADEQUACY OF DOMESTIC LEGAL
FRAMEWORK
Existing domestic laws
insufficient to cover the
Strategic items
Currently regulated by
international
control
regimes
Sectoral
based
Not designed
to control
strategic items
that can be
used for
WMD
purposes
STATUS OF STA
Cabinet’s approval – 26 March 2010
Parliament – 5 April 2010
Royal Assent – 2 June 2010
Publication in the Gazette – 10 June 2010
Gazette of Regulations and Orders – 31 Dec 2010
export transshipmenttransitbrokeringother
activities
STRATEGIC ITEMStransfer of
technology
FACILITATE:
-design -development -production
OBJECTIVES OF STA
WEAPONS OF MASS DESTRUCTION (WMD) &
DELIVERY SYSTEMS
CONTROL
(CATCH - ALL)
goods
(listed and
unlisted)
PREVAILING LAW
STA
2010
Plant Quarantine
Act 1976
Animals Act 1953
Prevention and Control of Infectious Diseases Act 1988
Atomic Energy Licensing Act
1984
Chemical Weapons
Convention Act 2005Poison Act
1952
Customs Act 1967
Protection of New Plant
Varieties Act 2004
Pesticide Act 1974
conflict or inconsistency : STA shall prevail
Malaysian Communications and
Multimedia Commission Act (1998)
46
• Customs and Policeofficers
• Officers of the Maritime Enforcement Agency
• Officers of MCMC
• Other officers specified by the Controller
Authorisedofficer
• Authority designatedunder the related lawsfor the regulation of thestrategic items, unlisteditems and restrictedactivities, and includesthe Controller.
Relevant Authority
PARTNER AGENCIES
Licensing Ministry /
Agencies:
•Ministry Of International
Trade And Industry
•Malaysian
Communication And
Multimedia Commission
•Atomic Energy Licensing
Board
•Pharmaceutical Division,
Ministry Of Health
Enforcement Agencies:
Royal Malaysian Customs
Royal Malaysian Police
Malaysian Maritime Enforcement Agency
Malaysia Communication and Multimedia Commission
Other officers specified by the Controller
‘dual-use’ items
• Items, including software and technology, which can be used for both civil and military purposes, and shall include all goods which can be used for both non-explosives uses and assisting in any way in the manufacture of nuclear weapons or other nuclear explosives devices (source: definition in Art.2 of the EU-Dual-Use Regulation)
EU DUAL USE LIST
Categories and Numbering Scheme
1 C 1 50
Technical Category Product Group Regime
Origin
Item.
No.
0 Nuclear Materials, Facilities and
Equipment
1 Materials, Chemicals,
“Microorganism” and “Toxins”
2 Material Processing
3 Electronics
4 Computers
5 Telecommunications and
“Information Security”
6 Sensors and Lasers
7 Navigation and Avionics
8 Marine
9 Propulsion Systems, Space
Vehicles and Related Equipment
A Systems,
Equipment,
Components
B Test,
Inspection
and Product
Equipment
C Materials
D Software
E Technology
0: Wassenar
or NSG
Trigger
List
1: MTCR
2: NSG
Dual-Use
List
3: AG
4: CWC
Controlled items are identified by a unique 5-character number
- e.g 1C350
List of ‘Dual-use ‘ (regime origin)
• Wassenaar Arrangement (WA)
• Missile technology control regime(MTCR)
• Nuclear suppliers group (NSG)
• Australia group (AG)
• Chemical weapons convention (CWC)
e.g1C350
Chemicals, which may be used as precursors for toxic chemical agents, as follows, and “chemical mixtures” containing one or more thereof…….(63 listed)
Category code Items description
1C229 Bismuth having both of the following characteristics;· A purity of 99.99% or greater by weight; and· Containing less than 10 parts per million by weight of silver
1C350 Chemicals, which may be used as precursors for toxic chemical agents, as follows, and “chemical mixtures” containing one or more thereof:9. Thionyl Chloride (CAS 7719-09-7)24. Hydrogen Fluoride (CAS 7664-39-3)31. Arsenic Trichloride (CAS 7784-34-1)40. Potassium Cyanide (CAS 151-50-8)43. Sodium Fluoride (CAS 7681-49-4)45. Sodium Cyanide (CAS 143-33-9)
1C450 Toxic chemicals and toxic chemical precursors, as follows, and “chemical mixtures” containing one or more thereof:6. Hydrogen Cyanide (CAS 74-90-8)
PENALTIES
Severity of penalty depends on intent and knowledge
For arms and related materials
•With the intent and knowledge to unlawfully export, tranship or
bring into transit without a permit:
• Where death is the result – a death sentence or
imprisonment for natural life
• In the case of a body corporate a minimum fine of RM 30
million
• In any other case, imprisonment for not less than 10
years or with a fine of not less than RM10 million or both
(body corporate – RM20 million)
• Without the intent and knowledge to unlawfully export,
tranship or bring into transit without a permit:
• Imprisonment of not less than 5 years or fine of not less
than RM5 million or both (body corporate - RM10 million)
For strategic items and unlisted items
•With the intent and knowledge to unlawfully export,
transship or bring into transit without a permit:
• imprisonment for a term of not less than 10 years or
a fine of not less than RM10 million or both (body
corporate – RM20 million)
•Without the intent and knowledge to unlawfully export,
tranship or bring into transit without a permit:
• imprisonment of not less than 5 years or fine of not
less than RM5 million or both (body corporate -
RM10 million)
CONT…
STATE NOT PARTY TO THE CHEMICAL WEAPON CONVENTION (CWC)
• Israel
• Myanmar
• Angola
• Egypt
• North Korea
• Somalia
• Syria
AP requirement(permit)
• Export to states not party to CWC
Arsenic trichloride in mixtures - >10%
• Export to states party
Arsenic trichloride in mixtures - >30%
• Bithmuth of purity 99.99% or greater by weight and containing < 10parts per million by weight of silver
AP requirement
• Mixtures containing one or more of the chemicals specified (thionyl chloride, hydrogen fluoride, potassium cyanide, sodium fluoride, sodium cyanide and hydrogen cyanide) – >30%
Does not control products identified as consumer items packaged for retail sale for personal use or packaged for individual use.
Permit (AP)
• Application to the relevant authority –Bahagian Perkhidmatan Farmasi
• End-use statement and any other additional documents if required
• Registration of brokers
• E-permit/manual
Web-based system for the application and approval
of pre-registration and permits under STA
What is ePermit (STA)?
59
Creates a virtual community for key players in
the trade supply chain - paper-less environment
Designed to meet the specific requirements of
STA for the purposes of products monitoring and standard
Approved permits will be transmitted to Sistem
Maklumat Kastam (SMK) for cross-reference
purposes against Customs declaration
60
Main Components in ePermit (STA)
• Registration of Company Details, End Users (Importers) and Authorized Applicants, which will be approved by MITI
• Registration of STA Products, which will be approved by the respective agencies i.e. MITI, AELB, MCMC, Pharmaceutical Department
• User IDs will be created based on approved Authorized Applicants
• Authorized Applicant will receive a token for digital signature purposes on permits
Pre-registration for STA
• Application of permits for export, transshipment, transit and brokering for strategic items
• Approvals will be made by respective agencies, based on products
• Digital signature by applicant and approver will be used in this process
Permits for STA
Company Registration and Fee
61
Item New DNT UserItem
Existing DNT User
Documents required for registration
Online registration at www.dagangnet.com – Services – Online Registration
Register manually by submitting to DNT the:- Registration form* - Form 9 and Form 49 or Form 13-Letter of Authorization
Registration Fee
- One time fee
RM200 for SME** sector
RM500 for private sector
Waived
Module Access Fee- Yearly Fee
RM200 RM200
Transaction Fee-Per approved transaction
RM5 RM5
Token and Fee
62
Item One time/ ID Yearly renewal/ID
Digital ID per user/ year RM55 RM55
Token RM75 -
Total RM130 RM55
Rgistration of broker/agent
• FORM 7 : Application for Registration/ Renewal Of Registration For Brokers In Strategic Items Under Section 19 Of The Strategic Trade Act 2010
Informasi STA
FORMAT BORANG STA_rin.doc
Conclusion
• The STA is intended to protect Malaysia and Malaysian exporters from being exploited by proliferators and those that profit from their activities without compromising legitimate trade in the strategic items concerned.
TERIMA KASIH