kawalan bahan kimia oleh bahagian perkhidmatan farmasi...

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