Health Sciences Authority - Singapore Customs

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 

All Rights Reserved 2006 Health Sciences Authority 

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Health Sciences Authority 

Statutory board of the Ministry of Health 

Formed on 1 Apr 2001 

Consist of 6 Centres under 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 nation’s 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, eg Bill 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, eg Ecstasy 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 licences are 

required for each consignment 

• The import licence must accompany the 

consignment at the ICA’s checkpoint 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 PSYs since 1990 

• Objectives: To combat the increasing international 

abuse of PSYs without 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 licence for 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 authorisation from 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 Seng Promenade #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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• 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 licence is issued to the person working for the 

company. If the licensee leaves the company, the 

licence has to be cancelled and another person 

within the company may come forward to apply 

for a new licence 


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• Unless exempted under the Act, a licence would 

be required for import of all poisons, even if in 

small quantity 

• Approved licence will 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 Foong Mei 

(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 RSU’s 

working hours will be processed within the 

first hour of the next working day 


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Working hours 

RSU’s working hours are: 

• Monday to Thursday 

•Friday 

8:30am – 1:00pm; 2:00pm – 6:00pm 

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 generalise the items, eg “drugs for shipping 

vessels” 

• Relevant licence number (if any) to be stated in 

the licence details 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 

• Supplier’s invoice 

• Copy of Controlled Drugs Import Licence 

(if any) 

• Authorisation letter 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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• 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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• Importing injection (eg vaccine 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 

30 

• 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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• A licence holder 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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• 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 licence holder 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 

–Fax 

• (65) 6866 3432 

• (65) 64789035 

– Email 

• hsa_tradenet@hsa.gov.sg 


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Thank you ! 


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FORM E 


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Health Sciences Authority - Singapore Customs

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