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HP Laws Flashcards

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1
Q

Subsets of HP under HPA

A
  1. Medical devices (MD)
  2. Cosmetics (CP)
  3. Therapeutic Product (TP)
  4. Oral Dental Gums
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2
Q

For a heart rate monitoring Watch, explain which act is it governed under.

A

HPA, under HP(MD)r

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3
Q

Johann wishes to manufacture a cordyceps preparation which is officially listed in the Chinese Pharmacopeia.

He has built the manufacturing plant in Singapore, and has signed contract to supply the preparation to various Chinese Medical Halls run by registered TM practitioners.

Explain if Johann requires any license, and explain which act does his manufacturing falls under?

A

CPMs are controlled under MedA (CPM, since it is official preparation in Chinese pharmacopeia)

Licenses Required: Mf under MedA ONLY

  • No need Whs Lc since sale is by Johann himself, who is the Mfer of the product
  • No need Import Lc since Johann is not manufacturing and bringing product from another country
  • CPM does not require a product license
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4
Q

Benny is the head of a pharmaceutical company in Singapore that imports various antibiotics preparation to be supplied to hospitals.

Recently, Benny has been planning to import some Ma Huang (Ephedra) Preparation that is listed in the official Chinese Pharmacopeia, to supply to Traditional Chinese Medical halls run by registered TCM practitioners.

Benny is currently holding the following licenses:

  • Retail Pharmacy License
  • Importer license under PoA
  • Mf Lc under HPA
  • Ipt Lc under HPA
  • Whs Lc under HPA

Explain whether Benny requires any additional license for him to import the Ephedra preparations into Singapore, and to be sold to TCM halls.

A
  • Product in Qn: CPM
  • Lc required: Ipt Lc + Whs Lc under MedA

CPM is governed under MedA. Since Benny is only licensed under HPA, he is only licensed to deal with “western” pharm product only. If he wants to handle CPM, he requires a separate license under MedA to do so.

Since he is not Mfing, he does not need Mfers license

CPM also does not require product license

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5
Q

Dr. Nikki is a registered medicinal practitioner that runs her own private clinic. She is planning to expand her premises by moving the pharmacy to a neighbouring unit beside her clinic to accommodate more waiting patients.

The Pharmacy is planned to supply various western-type therapeutic products to her patients under the instruction of her prescription. Only her patients will access the Pharmacy after consultation with her.

Explain whether Nikki, or her pharmaceutical officer (who is registered) requires additional Lc before the Pharmacy commence its operation

A

No. Since the pharmacy to be opened will only be fore her patients, her pharmacy is not a “retail pharmacy” and does not require additional licensing

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6
Q

What is the broad definition of “retail”?

A

Any form of supply that is NOT wholesale activity

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7
Q

Peter is a fully-registered Pharmacist who is the in-store pharmaceutical officer of XX retail pharmacy. Assume that the retail pharmacy is licensed to conduct retail pharmacy business

Today, Peter received a prescription request from a Doctor of a nearby private clinic to prepare an extemporaneous preparation of Fluconazole suspension from its tablet.

However, Peter has ran out of Fluconazole tablets. Hence, he called the Manufacturer for a supply of Fluconazole tablets. He then made the suspension and instructed his Pharmacy intern (who is not registered under PRA) to deliver the preparation to the clinic.

Describe any form of Lc that may be involved in this case, and explain whether any contraventions has been made.

A
  1. Extempt prep: Form of Mf
    - Exempted from Mf Lc when compounding in licensed retail pharm (under HPA)
  2. Supplier of tablets: Form of Whs
    - Whs of products by Mfers themsevles are EXEMPTED from Whs Lc
    - Mfer require Mf license under HPA
  3. Pharmacy intern delivering compounded product: No need Lc
    - Form of Whs, Lc exempted for Pharm to private clinic
  4. Non-registered pharmacist delivering compounded product to private clinic
    - Grey area??
    - Probably lawful as long as records and documentation is done by Peter himself, who is an frP that can carry out Pharm Prac under PRA
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8
Q

Exporting is considered as which type of dealing?

A

Wholesaling (by export)

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9
Q

Pam is a head of a company of a local firm in Singapore. Her firm is a storage firm. Many exporters outside of Singapore would export western type products to her firm for storage, and to be exported out of Singapore to other countries again.

Recently, Pam received a request from a local school in Singapore. The school has requested for a supply of some western-type therapeutic products with the intention to create a museum of medications for their students to learn. Pam is unsure whether she can do so lawfully.

Suggest the license that Pam is holding. Explain whether Pam can supply therapeutic products to the school lawfully

A
  1. Holding Ipt Lc under HPA
    - No need Whs Lc: exempted when Lc Ipt imports solely for Export
  2. Yes, Pam can, Although act of supplying to school is an act of Whs
    - HP(TP)r57: exempted from Whs Lc since purpose is to schools for education purpose (non-clinical) and it is not to the public
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10
Q

Under HP(MD)r, MD are classified according to…?

A
  1. Invasiveness

2. Active/powered VS non-powered

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11
Q

Aoba is planning to import a newly-created facial cream product that does not contain any API into Singapore.

When the cream arrives in Singapore, he will either be selling directly to the public, or supplying to other suppliers.

Describe Lc requirements (if any), and the pre-market controls that Aoba is subjected to.

A

Lc requirements: None

  • Product in question is CP
  • Ipt, Wholesale and retail of CP are all exempted from Lc

Pre-market controls:

  • Notify (NOT register) HSA before supplying
  • ANNUAL notification to HSA so long as CP in market
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12
Q

Distinguish between the criteria to obtain product license between the Medicines Act and the HPA

A
  • MedA: Safety, Efficacy, Quality

- HP(TP)r: Benefits > Risk

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13
Q

Wendy is an owner of a private hospital in Singapore. Recently, she is interested in getting a supply of wheelchairs to be sold at her hospital. She plans to import the Wheelchairs from a company ran by her friend in Canada, to be sold to the public (patients, and anyone else who may require it)

The wheelchair has not been imported and used in Singapore before. It is a newly created non-electric wheelchair that is ergonomic with cushions designed to be comfortable for users. It complies with GMP and ISO

Currently, Wendy does not posses any forms of import Lc.

Explain whether Wendy requires any Lc, and suggest whether the wheelchair needs product registration under the HPA

A
  • Product: Wheelchair, a MD
    1. Requires Ipt Lc under HP(MD)r
  1. Wheelchair: probably class A under HP(MD)r
    - Class A does not require pre-market registration
    - Hence there is no need for product Lc for the wheelchair

(note for MD, only class B-D require pre-market registration)

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14
Q

Eren is an owner of a local firm who is planning to set-up their first few vending machines named “Titan Machine”

In the Machine, Eren wishes to sell products such as paracetamol and Loratadine .

Does Eren require any licensing or documents of any form to sell those products in a vending machine? Does he need to meet any requirements to do so?

A

Products are GSL under HP(TP)r. No need Lc and Documents

  • Requirements: Vending machine has suitable storage conditions, and products has proper packaging and labelling to them

HP(TP)r15

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15
Q

When a TP is registered under HPA< who is the “registrant”?

A

The product license holders, i.e. held by theperson who registered the product

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16
Q

The laws that govern pre-market controls

A

MedA and HPA

None under SadA, PoA, M(as)A

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17
Q

Roles of HSA under HPA in managing the registered products

s32

A
  1. Maintains list of registered products

2. Can attach conditions to products registrations

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18
Q

Donald is in-charged of a pharmaceutical company in Singapore which sell various western type TP by importing and way of wholesale under HPA. He is in-charged of getting each TP registered.

Recently, his company plans to import and sell some Ginseng preparation which is a preparation that can be found in the official Chinese Pharmacopeia and has not been in Singapore’s market before. Donald is aware that each therapeutic product must be registered.

Currently, his company holds the following license:

  • Importing and Wholesale license under MedA
  • Importing and Wholesale license under HPA
  • Importing and Wholesale license under HP(MD)r
  • Importing and Wholesale license under PoA

Explain whether:

  1. Donald’s company require additional license to import and sell the preparation
  2. Donald needs a product license for the Ginseng preparation before commencing supply
A
  1. No need additional Lc
  2. CPM: NO NEED pdt Lc
    - Rq submission to Lcing authorities for Safety and Quality assessment (no need efficacy)
    - The pdt is then listed
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19
Q

Describe the nature of the product which require market control

A

POTENT pdt intended to tx SERIOUS conditions which require PRO intervention, hence NOT for self-medication and require Control

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20
Q

Main act that prescribes Market Control of products

A

HPA, under HP(TP)r

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21
Q

A nurse in a licensed private hospital is instructed by a registered Medical Doctor to administer drug X to a patient in the hospital. Drug X is classified as “P” under HP(TP)r. The Doctor has yet to write a prescription for drug X, but told the nurse to administer the drug without the Rx to avoid missing a dose for too long.

State whether is it lawful for the nurse to administer drug X to the patient and explain your answer.

A

Yes, it is lawful

  • P only: No need valid Rx
  • Under a (i) practitioner’s instruction in (ii) Lced HCI, drugs can be supplied to OWN patients
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22
Q

You received a call from Hugahuga who is the captain of the ship SS Doodoocaca. Hugahuga has a sick crew on board of his ship and has no medical doctors on board. He is calling you to get advise on what medications to give his crew for the condition

After you assessed the condition and the availability of medical supplies in the ship, you recommended a drug that is classified as POM TP under HP(TP)r.

Is it lawful for Hugahuga to give the drug to his crew?

A

Yes it is lawful
- Master of ship w/o doctor as crew can supply to crew

Third Schedule HP(TP)r

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23
Q

Macque is a fully registered Pharmacist under the PRA and is an in-store pharmaceutical officer at a retail pharmacy. He received an order by the Aviation authority to supply an aircraft with various drugs that are non-controlled.

Can Macque do so lawfully?

A

Yes

  • Supplying to aircraft is a form of wholesale, which may require Whs Lc
  • Pharmacies exempted from Lc when supplying to aircraft under instructions by law
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24
Q

Mike is a fully registered Pharmacist under the PRA and is an in-store pharmaceutical officer of outlet X of a chain of pharmacy called ‘Best Retail Pharmacy’. He is the superintendent pharmacist of outlet X.

Recently, Mike’s manager is very impressed at his work attitude and quality, and offered him a pay raise to also be in charged of a nearby outlet Y. Since he may not be handle two outlets at one time, Mike suggested to get Bertha, who is a pharmacy technician in outlet X (not registered Pcist) to take charge of outlet X whenever Mike is absent.

Explain whether Mike’s manager, as well as Mike’s suggestion, is lawful or not

A

No, BOTH manager and Mike’s ideas are NOT lawful

  1. Manager suggest Mike to be in-charged of 2 outlets
    - A retail pharmacy requires management of qualified Pcist AT ALL TIMES
    - Hence this suggest that Pcist can only be IC at ONE outlet at a time, and cannot leave the outlet without another qualified Pcist managing
  2. Mike’s suggestion for Bertha to take charge
    - Bertha is not a registered Pcist, and cannot take charge of outlet X when Mike is absent
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25
Q

What is a written order (aka signed order), and what information must it contain

r10

A

For Whs supply, an order before or at time of supply to ensure recipient, or the buyer has a legitimate purpose of buying such product, applies to products in HP(TP)r, 2nd Schedule

Information:

  • Recipient NAME, ADDRESS
  • Recipient trade/business/profession (i.e. PURPOSE)
  • Name and Qty ss of TP
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26
Q

How long must records on manufacturing a TP be kept for?

r31

A

The longer of either:

  • 1y after expiry
  • 5y after date Manufactured
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27
Q

How long must registrants and Lc holders keep the records of receipt and supply of TPs? What are the details to be recorded? (note this relates to Whs SUPPLY only, not retail supply)

r32

A

Keep 2y after date ss

Information:

  1. Pdt NAME
  2. Date And qty ss
  3. Name and Address of EITHER buyer or seller
  4. ID no. of product (E.g. BN)
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28
Q

For RETAIL suppliers of TP, every supply must be recorded. What are the details to be recorded?

r16

A
  1. Date ss
  2. Name and address of practitioner
  3. Name, ID and contact of PATIENT
  4. Name of product and total ss

(name of pdt: can be proprietary or generic)
(similar to Rx requirements)

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29
Q

For RETAIL suppliers of P medicines, every supply must be recorded. What are the details to be recorded?

r13(2)

A
  1. Date ss
  2. Name, ID and contact of PATIENT
  3. Name, strength and total ss
  4. Dose, frequency and purpose of tx

(name of pdt: can be proprietary or generic)
(similar to TP supply, except no need practitioner)

30
Q

For retail suppliers of medicines, what type of medicines must have a dispensing records of supply? What are some rules on recording and keeping it?

A

For Rx TP and P medicines

  • Kept at premises where ss
  • Made on day (or next day) of ss
  • Kept ≥2y AFTER date of ss
31
Q

How long must records on manufacturing AND supply of MD be kept for?

r38

A

The longer of either:

  • Projected useful life-span of device
  • 2y after date that device is ss to another person

(quite different from TP: got separate requirements for Mf and supply, as well as no “useful” lifespan, but expiry date)

32
Q

For SUPPLY of MD, what are the details to be recorded by registrants, Mfers, Ipts and Whs?

r39

A
  1. Name OR description of MD
  2. Date and Qty ss
  3. Name and address of RECIPIENT
  4. ID no. of MD (e.g. BN)

(note: number 3 is different from TP: TP can be either buyer or seller)

33
Q

There are some devices listed in the Fifth Schedule of HP(MD)r. What is the requirement for their documentation and records?

r40

A

For qualified practitioners, keep records of patient implanted with “implantable MD”.

MD in 5th Schedule are subject to that record

34
Q

What are the documentation and records requirement for CP, by the person that placed the CP in the market?

r10

A
  1. Keep records of ss of pdt

2. Keep for ≥2y after date ss

35
Q

What are the details of supply records for CP?

r10

A
  1. Name and NOTIFICATION no. of CP
  2. Date and Qty ss
  3. Name and address of RECIPIENT
  4. ID no. of CP ss (e.g. BN)

(note: MOST SIMILAR TO MD, except, instead of “or DESCRIPTION”, it is ‘AND NOTIFICATION’ (i.e. for CP both must need))

36
Q

Company X has registered a drug called “Norunnamase” with the purpose to relieve allergic runny nose. The drug is classified as GSL. They have proposed to announce the following in a video, on televisions islandwide:

‘Norunnamase! Great for your allergy of any form! Relieves sore throat, sore eyes and runny nose as fast as 30 minutes, and be symptom free for up to 24 hours, and kills any potential viruses and bacteria! Norunnamase, for your comfort, for your happiness’

Will this advertisement be approved? Explain your answer

A

No. It is registered for allergic runny nose only, not as antivirus or antibacteria

37
Q

A brand new toothpaste has been invented by company A. While advertising, the company says it is a “recommended brand by dentists Worldwide”.

Is this advertisement lawful?

A

Y

- Toothpaste is not considered a HP

38
Q

Company B has invented this novel anti-diabetic medication called “reversiK”. The product information leaflet for healthcare providers cited research on reversiK stating that there is a chance that the drug can reverse diabetes. The studies are fully cited in PIL

Is such citation lawful?

s21

A

Yes

  • PIL is technically a form of advertisement
  • Can relate to certain disease and conditions, if only providing the information to healthcare professionals
39
Q

Juno suggested to advertise her company’s non-medicated facial cream as follows:

‘Facial cream! Begone all pimples! Begone all acne! Begone all fungus and bacteria! The best facial cream in town. Get one now!’

Is this advertisement lawful?

A

No: Facial cream is CP and should not mention to any therapeutic uses

40
Q

Honda operates a company which specialises in handling drugs that are in its raw powder form. Describe the labelling information that must be present in the powder (e.g. the container) when being sold

s6(2)

A
  1. Name of Po
  2. “Poison” word
  3. Proportion of Po
  4. Name and Address of SELLER
  5. Special precautions (e.g. NTBT)
41
Q

What kind of products do M(as)A cover?

A

“Substance recommended as medicines”

E.g. Supplements, quasi medicines, in ads and promos

(coz CPM under Meds, TP under HPA, Po under PoA)

42
Q

Labelling requirements stated in M(as)A

A
  1. Disclose Composition
  2. Quantitative particulars

(note: very similar to PoA)

43
Q

The two broad details that is required on a label for a medicine under the MedA

r3(2)

A
  1. Administrative stuff (E.g. product name, BN, name and add)
  2. Drug stuff (E.g. dosage, indication, CI)
44
Q

Special thing to take note about CPM under labelling of CPM

r9, r6

A
  1. Self-declaratory statement (that it is cpm)

2. Prohibit claims related to First Schedule of MedA

45
Q

Richie wants to put up a drug for sale. The drug is a western type TP classified as GSL. Richie has Whs license under the HPA.

He is wondering what information must he put on the box that he is going to sell the drug in.

List the information required

r20(1)

A

Info are Key pdt info under HP(TP)r

  1. Name (Proprietary AND generic)
  2. Quantitative info on API
  3. Exp Date
  4. Ctrl no. (E.g. BN)
  5. Product Reg no.

(compare with dispensed pdt: Name just need either prop or generic, no need exp date

46
Q

The western type, GSL product contains the following on its product packaging

“Endorsed by MOH Chief pharmacist!”

Is this legal?

A

This is not legal:

  • Cannot suggest endorsement by health authorities
  • That itself is also false/misleading info which is prohibited

(similar for other products)

47
Q

Under HP(TP)r the Fourth Schedule, what are the three specified additives and preservatives that must have cautionary labelling?

A
  1. Tartrazine
  2. Benzoic Acid
  3. Sodium Benzoate

(just memorise)

48
Q

Under HP(TP)r the Fifth Schedule, what are the two categories of products that must have cautionary labelling, and what is the label?

A
  1. Aspirin products (not for <16yo)

2. Pdts that may cause drowsiness

49
Q

Company X has manufactured a new BP monitor and has packaged it into a container. What information must be in the container?

r15

A
  1. Trade/Brand name
  2. Contents
  3. Expiry date (if applicable)
  4. Control no. (e.g. serial)
  5. Name, address, phone, email of pdt OWNER (NAPE)

(very similar to TP except 5)

50
Q

What are the prohibitions against labelling under HP(MD)r?

r14

A
  1. False/misleading trade descriptions
  2. Change/modify presentation of device

(different from TP!!)

51
Q

Key product information of CP

r7

A
  1. Name
  2. Product function and instructions ofr use
  3. List of ingredients in CP
  4. Qty of product in container
  5. Mf BN
  6. Name and address of person who placed pdt in SG
  7. Country of Mf
  8. Precautions when using
  9. Exp date (if <30 months) or Mf date
52
Q

Mackie’s company is intending to sell a facial cream in the market. The following are the details Mackie has put on the product packaging which expires in May 2021:

  • Name: “Twice o’ day Facial Whitening Cream!”
  • List of ingredients (full)
  • 30g per jar
  • BN1337
  • Mackie’s Co, Hooga drive 30 #03-41, S234567
  • Mf in Singapore
  • “Do not swallow the product or rub into eyes”
  • Date of Mf: 26 May 2020

State whether Mackie has missed out any details for his CP

A

Mackie MUST put the expiry date as CP expires in < 30 months.
- In this case, Mf date is optional

(note: name is self-explanatory in terms of functions and instructions for use)

53
Q

A CPM called “Power-0-Crack’o nut” was tested and found to have contained the following metals:

  • Zn: 250ppm
  • As: 0.4ppm
  • Cu: 50ppm
  • Pb: 9.9ppm
  • Hg: 0.4ppm
  • Ca 7500ppm
  • Mg 1100ppm
  • Na 2200ppm
  • Li 0.2ppm
  • Al 0.1ppm
  • Cd 0.4ppm

State whether this product is prohibited from sale by law

A

Yes it is prohibited.

Limits for 4 THMS: Cd 0.3, Hg 0.5, As 5, Pb10

Product: Cd 0.4ppm, exceeds limits hence prohibited under M(PSSI)o

M(PSSI)o, First Schedule

54
Q

A Traditional Javanese balm, intended to be used as an antiseptic on the skin for wound cleaning, has been found to contain trace amounts of Mercury Oxide. Can this balm be handled by dealers?

p3(1A)

A

No

any topical antiseptics, containing Hg of any form = cannot

55
Q

A liquid oral Preparation of CPM hass been found to contain the following micro-organisms:

  • Mould 20 per mL
  • S.aureus 1 per mL

Is it lawful to sell the CPM?

A

No

- Should not contain Salmonella, S.aureus or E.coli in 1mL (or 1g)

56
Q

An external CPM preparation (herbal cream) has been found to contain the following micro-organisms:

  • E.coli 550 per g
  • Total aerobic microbes 100 per g

Is it lawful to sell the CPM?

p4

A

Yes it is lawful to sell product

  • External prep: Forbids S.aureus and P.aeruginosa
  • Aerobic microbe count limit: 1000
  • No mention E.coli
57
Q

A preparation of Fentanyl patches was found to contain 20µg of morphine. Under the HPA. Is its dealings prohibited? What kind of product is this?

A

Dealing is prohbited

- Adulterated product (substance not supposed to be there is added inside)

58
Q

On the market, there is this GSL product named “JunkieXL” which contains Loratadine 50mg. One product named “JunkleXL” was submitted for registration as a GSL product. It was found to contain Loratadine 50mg and Sildenafil 25mg, and had the exact same tablet appearance as “JunkieXL”

Under the HPA, the sale of “JunkleXL” is of course prohibited. What kind of product is JunkleXL?

A

Product is:

  • Counterfeit
  • Adulterated

(can be etiher one since it was not specified on what kind of API it was registered with)

59
Q

A bottle of Omeprazole capsules (20mg +/- 1%) was found to contain an average of 17mg of Omeprazole per capsule.

Under the HPA, the sale of of this bottle is of course prohibited. What kind of product is this?

A

UNWHOLESOME product (does not conform to Mfers’ specifications)

60
Q

A shop attempts to sell a packet of paracetamol tablets that has expired. that paracetamol tablet is considered _____ under the HPA

A

Unwholesome (past expiry date)

61
Q

A Mfer forgot to put down an ingredient for his traditional chinese medicine product. What type of product is this classified under the MedA?

A

SUBSTANDARD medicinal product

unlike HPA which is “unwholesome” product

62
Q

Margret realises that a body cream that her company is selling is causing rashes in a lot of users. Under the HPA, what must she do?

r11

A

Inform HSA (within 7d), then within 8d (or depending on severity), submit a detailed report to HSA

63
Q

Jane is a manager of a company that sells western type products. Within the past few days of being registered and sold in the market, a few hospitals has reported to Jane that one of her company’s products called “X-ses” has been reported to cause a severe by transient drop in blood pressure (lasts about 5 minutes) when taken by patients.

As a product license holder for “X-ses”, describe Jane’s responsibilities in this scenario. Should she intend to withdraw X-ses from the market, what must she do?

A

Record the blood pressure drop as an AE and report to HSA within specified period (2wk-30d for less serious)

  • If Jane intends to recall product, inform HSA and update them on progress of recall
  • If HSA demands, Jane must investigate the details and report it to HSA
64
Q

What are the laws that do NOT govern post-market duties?

A

SadA, PoA, M(as)A

65
Q

Key difference between HPA and MedA in governing post-market duties

A
  • MedA: Duties within Std Lc Provision and conditions. Meaning products which does not require license DO NOT need to comply (non-Lc pdt)
  • HPA: Mandatory PMD imposed on dealers SEPARATE from Lc, hence PMD is imposed REGARDLESS of Lc
66
Q

Chica is a product license holder for a Blood pressure Machine called “Zeus”. Shortly after marketing the product, the Mfer for Zeus informed Chica that the measurement for blood pressure is not accurate (an average of 15mmHg higher than actual BP).

Besides keeping records of the defect anrd reporting it to HSA, what else must Chica do under PMD?

r46, r47

A
  • Inform HSA of any intended “field safety corrective action”
  • Report to HSA on progres and outcome of “field safety corrective action”

(THIS IS SPECIAL THING OF MD, TPs don’t have this)

67
Q

What is the difference between the definition of Whs in MedA vs HPA

A
  • MedA’s definition of Whs DOES NOT INCLUDE sale by Mfers

- HPA: Does include, but exempts Mfers from Whs Lc

68
Q

Which acts does NOT have controls of dealers?

A

SadA, M(as)A

69
Q

What control does PoA has in terms of dealings

A

Mf, Ipt, Whs, Rts

70
Q

An exemption in import under MedA that is NOT FOUND in HPA?

A

Ipt solely for re-export

71
Q

What are the products that does not have specific market control under any acts

A
  1. CPM
  2. Subsets of Medicinal Products
  3. CP
72
Q

Which acts do not have any laws on Market Control?

A

SadA, M(as)A

Pharm Law (5 decks)

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