Health Sciences Authority What A Chemical Importer Needs To Know

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All Rights Reserved 2006 Health Sciences Authority

HEALTH SCIENCES AUTHORITY
What a chemical importer needs to know
Ms HUI FOONG MEI
Head (Good Distribution Practice Unit)
MANUFACTURING & QUALITY AUDIT DIVISION
CENTRE FOR DRUG ADMINISTRATION
HEALTH SCIENCES AUTHORITY
Hui_Foong_Mei@hsa.gov.sg
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Health Sciences Authority
Statutory board of the Ministry of Health
Formed on 1 Apr 2001
Consist of 6 Centresunder 3 groupings
- Health Products Regulation Group (HPRG)
- Applied Sciences Group (ASG)
- Health Services Group (HSG)
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Health Sciences Authority
Health Products Regulation Group
Centre for Drug Administration
Centre for Medical Device Regulation
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HSA Mission
To wisely regulate health products
To serve the administration of justice
To secure the nations blood supply
To safeguard public health
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RELEVANT
LEGISLATIONS
ADMINISTERED BY
CDA
Poison Act and Rules
Medicines Act and Regulations
Misuse of Drugs Act and Regulations
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Poisons Act and Rules
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An Act to regulate the importation, possession,
manufacture, compounding, storage, transport and
sale of poisons.
Intended to control the supply of, and access to,
substances that are potentially hazardous, in order
to prevent them from causing harm to the public
through accidents, mishandling or misuse/abuse
Mechanism of control helps to ensure that such
substances are only handled by those people who
are competent to do so
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So what is a Poison?
"poison" means any substance deemed to be a
poison within the meaning of this Act
Or any substance specified in the Poisons List
in the Schedule of the Poisons Act
Generally of pharmaceutical purposes
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Examples of poisons
Specific:
Amoxycillin; its salts; its esters; their salts
Sildenafil; its salts
Phenothiazine, derivatives of only derivatives and not
Phenothiazine itself
General classifications:
Adrenaline; its salts; except when contained in preparations
intended for external application only or in inhalants (except
inhalants in aerosol dispensers), rectal preparations or
preparations intended for use in the eye
Androgenic, oestrogenic and progestational substances, the
following:
Derivatives of stilbene, dibenzyl or naphthalene with
oestrogenic activity; their esters; their ethers; their salts
Steroid compounds with androgenic or oestrogenic or
progestational activity; their esters; their ethers; their
salts
Vaccines, sera, toxoids, antitoxoids, immunoglobulins and
antigens for human administration
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Exemptions (2
nd
Schedule)
Androgenic, oestrogenic and progestational substances, the
following:
Preparations intended for external application only, except
preparations containing more than 4 mg of oestrogenic substance
per hundred grammes of inert substances; feeding stuffs containing
hexoestrol or stilboestrol or both and not containing any other
androgenic, oestrogenic or progestational substance.
Antibiotics, the following, their salts; their esters:
Preparations for animal feeding containing not more than the
equivalent of 5 parts of antibiotic substance in 100 parts of feeding
stuff.
Sensitivity Bio-Discs incorporated with antibiotics for Laboratory use
only.
Media containing antibiotics for storage of organis or tissues to be
transplanted which are not intended for the treatment of human
ailments
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Exemptions
Do remember to check for Schedule 2 of the
Poisons Rules which provides exemptions
Antibiotics presented as sensitivity bio-discs, within
media etc
Lithium carbonate, acetanilide, alkyl acetanilides
other than those intended for treatment of human
ailments (non-medicinal use)
Phenols, sodium nitrite or others below a certain
strength, e.g. preparations less than 1%
Other general exemptions such as adhesives, plastics,
lacquer solvents etc
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Poisons Licence
A person shall need a licence to import,
possess for sale, sell or offer for sale any
poison.
Form A or Form C Poisons Licence
The licence is company and person specific
and is non-transferable
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Obtaining Poisons
Section 8 of the Poisons Act list certain
scenarios whereby a person can legally obtain a
poison without any licence
8(e): the sale of poisons for use by a Government
department;
8(f): the sale of poisons to a person or institution
concerned with scientific education or research,
A Licence would still be required if importing
the materials, or obtaining a poisons for
purpose of re-selling or re-supplying
The company that sells poisons have to ensure
that the buyer is licensed except for those who
are exempted under the legislations
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Labeling of Poisons
The container of the poison must be labelled
with:
the name of the poison;
Strength
with the word Poison or other prescribed
indication of the character of the substance (as
specified in Schedule 10)
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Storage of Poisons
Poisons have to be stored:
kept in a room or cupboard under lock and key
in a container impervious to the poison and
sufficiently stout to prevent leakage from the
container arising from the ordinary risks of
handling and transport
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Record keeping
Form E Records (Schedule 8 of the Poisons Rules)
Signed orders
Provided by the buyer of poisons, stating the intention
and purpose of poisons
Seller must ensure that the transaction is legitimate
Invoices & related delivery orders
Other documents, egBill of Lading/Airway Bills,
Disposal records, etc
To be preserved on the premises for 2 years
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Enforcement
Offences may attract a maximum penalty of
$10,000 and 2 years imprisonment
Multiple charges possible based on number of
transactions
Enforcement work
Routine audit (announced)
Ad-hoc audit (unannounced)
Surveillance
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Controlled Drugs and
Psychotropic Substances
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Controlled Drugs and
Psychotropic Substances
Within the Poisons List, some of the items are
also controlled as a Controlled Drugs (CDs)
or Psychotropic Substances (PSYs)
Singapore is a signatory to International UN Drug
Conventions on the control of CD and PSY
International monitoring on the movement of such
goods
Import, export or re-export of such items would not
be allowed if the dealers/importers do not have the
relevant permits/licences/authorisations.
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Misuse of Drugs Act
and Regulations
Central Narcotics Bureau (CNB) administers the
Misuse of Drugs Act while CDA assist in the
administration of the licensing requirements under
the Misuse of Drugs Regulations
Any substances or products controlled under the
Misuse of Drugs Act and Regulations are known
as Controlled Drugs or CDs
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Examples of Controlled Drugs
Buprenorphine
Cocaine
Fentanyl
Ketamine
Methadone
Metamphetamine
Morphine
Pethidine
Some newer drugs that have been subjected to abuse have
also been classified as CDs, egEcstasy and designer drugs
like Dexamphetamine
Include Diagnostic test kits Conjugates of CD, and
Positive Controls
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Import and export of CDs
Separate import and export licencesare
required for each consignment
The import licence must accompany the
consignment at the ICAscheckpoint before
goods can be cleared
Licence is valid for one consignment only
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Tradenet declarations
for CD import
Individual CD and CD test kits should be
declared under separate rows
Item description should match against the
CD Import Licence
Need ICA officers physical check and
endorsement at Customs Checkpoint
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Psychotropic Substances (PSY)
Singapore acceded to the 1971 United Nation
Convention on PSYssince 1990
Objectives: To combat the increasing international
abuse of PSYswithout unduly restricting their
legitimate use
Examples(mainly benzodiazepines) include
Diazepam (Valium)
Midazolam(Dormicum)
Lorazepam(Ativan)
Alprazolam(Xanax)
Phenobarbitone(Phenobarbital)
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Export of PSY
Under the Medicines (Export Licence for
Psychotropic Substances) Regulations, no person
shall export any consignment of PSY specified in
the Schedule to Regulations, unless:
Possess a valid PSY export licencefor that
consignment (also Form A Poisons Licence under the
Poisons Act)
The export of the PSY is in accordance with the terms
and conditions specified in the licence
International Practice (UN Convention)
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Import of PSY
Some authority would require an Import Permit
before allowing an export
For PSY and other restricted substances (eg
Testosterone)
May apply for an Import authorisationfrom CDA
Need name & qty of materials, name & address of
exporter
Need Form A Poisons Licence
Issued for that consignment only
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Contacts
For details on the control of CD and
Psychotropic Substances:
Dr Chan Wai Yee
(65) 6866 3521
Dr Lai WengFai
(65) 6866 3519
Preferably email or fax
hsa_certification@hsa.gov.sg
(65) 6478 9068
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Obtaining Legislations
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How to obtain the legislations?
Hard copy
SNP Corporation Ltd (Legal Publications)
1 Kim SengPromenade #18-01
Great World City East Tower
Singapore 237994
Tel: 6826 9691 Fax: 6820 3341
email: legalpub@snpcorp.com
Main Act/Rules; amendments sold separately
Online purchase from
http://www.snpcorp.com/webshop
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How to obtain the legislations?
AGC webite(http://statues.agc.gov.sg)
Only the Acts
Lawnet (http://www.lawnet.com.sg)
Look under Legal Workbench Versioned Legislation
Database
Charges for time-based access or via subscription
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Applying for
Form A Poisons Licence
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Applying for licences
A Form A Poisons Licence is required for
importing and selling poisons
Applicant need to be familiar with the legal
requirements and would be responsible for the
transactions
http://www.hsa.gov.sg/fapl
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Applying for licences
Application done on-line, via PRISM
http://www.hsa.gov.sg/fapl (select e-services)
To register with CRIS (one-time setup)
Login with your SINGPASS
Easy to use
Knowledge on internet browsing would be helpful
Cyber-tutor available
Licence number issued (e.g. POFA0700001)
Renewed yearly
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Application Information
Company has to be registered with ACRA
Licensee would have to apply for the licence
online personally
Licensee would be responsible for the handling of
the poisons
Holding a managerial position
Assessed (face-to-face assessment) to be competent
before approval of licence
Need to provide soft copy of the company
registration certificate and store layout plan during
application submission
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Things to note
Licensee may not be a registered
pharmacist. However, the licensee would
not be allowed to deal with controlled drugs
and pharmaceutical medicinal products for
human administration
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Things to note
Prior to approval of licence, the applicant would
have to be assessed on the understanding of the
relevant legislations. For a new company, the
designated storage area would also be audited.
The licenceis issued to the person working for the
company. If the licensee leaves the company, the
licencehas to be cancelled and another person
within the company may come forward to apply
for a new licence
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Things to note
Unless exempted under the Act, a licencewould
be required for import of all poisons, even if in
small quantity
Approved licencewill specify the general category
of poisons that a licensee may deal with, e.g.
Diagnostic kits / Reagents / Standards. No
separate approval required if you intend to deal
with new poison items, as long as the items fall
within the approved category
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Contacts
For details on the control of poisons:
Ms Valerie Gan
(65) 6866 3516
Ms Hui FoongMei
(65) 6866 3511
Preferably email or fax
hsa_gdp@hsa.gov.sg
(65) 6478 9068
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CDA TradeNet
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TradeNet clearance
Handled by Regulatory Support Unit (RSU) of
CDA
On-line processing of permit applications
Other than chemicals, RSU is also responsible for
screening imports for
Medicinal products
Health supplements
CPM products and other
traditional medicines
Veterinary medicaments
Therapeutic chewing gums
Contact lens solutions
Condoms
Snuffs and smokeless
chewing tobaccos
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Timeline
Within 2 hours of applications received on
the same working day
Committed to process (either approve, reject or
query) application within 2 hours of the same
working day
Applications submitted outside RSUs
working hours will be processed within the
first hour of the next working day
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Working hours
RSUsworking hours are:
Monday to Thursday
8:30am 1:00pm; 2:00pm 6:00pm
Friday
8:30am 1:00pm; 2:00pm 5:30pm
Saturday, Sunday and Public holidays
Closed
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TradeNet Permit application
Need the following information
Name and quantity of the product
Do not generalisethe items, egdrugs for shipping
vessels
Relevant licencenumber (if any) to be stated in
the licencedetails field
Name of importer
Chemical compositions / Product formula
Correct HS Code
Ensure that the forwarding agent use the correct HS
code
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TradeNet Permit application
Also need supporting documents
Suppliers invoice
Copy of Controlled Drugs Import Licence
(if any)
Authorisationletter to clear consignment of
controlled drugs (if applicable)
Note: To indicate TradeNet unique reference number
on the top right hand corner before faxing to RSU at
Fax Number 64789035
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Things to note
You would need to know the chemical
composition of the chemicals you are
dealing with. Proprietary name would not
be sufficient. Information is important for
us to decide if approval should be granted.
Do seek such information from your
supplier or any other sources
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Things to note
Importing injection (egvaccine injection) or tablet
or other medicinal products in various dosage
forms for use in laboratory research, the following
statement must be included For use in laboratory
research only. Should be declared under Chapter
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Chemicals in the form of raw materials should not
be declared under Chapter 30 which is meant for
medicinal products of finished dosage form.
Correct HS code could be 29xxxxxx or HS code
28xxxxxx.
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Things to note
A licenceholder may appoint a forwarding agent
to clear the consignment for poisons (including
controlled drugs). During permit application, your
company name shall be reflected as the importer
and you have the ultimate responsibility for the
consignment. Do provide the HS code, licence
number and other information / supporting
document to your freight forwarder
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Things to note
If you are importing a list of laboratory reagents
controlled as a poison, you would not need to
provide chemical composition for every reagents.
Do declare that there is no controlled drugs within
the consignment. With your valid Form A
Poisons Licence number, we would be able to
approve the permit, on the basic understanding
that licenceholder understand the controls of
poisons imported
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Contacts
For TradeNet-related matters, contact RSU at
TradeNet Officer
(65) 6866 3449 (During office hours)
(65) 9431 7740 (Outside office hours only)
TradeNet Supervisor
(65) 6866 3432
Fax
(65) 64789035
Email
hsa_tradenet@hsa.gov.sg
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