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PL > 3a_Controls on Manufacturers and Importers > Flashcards

3a_Controls on Manufacturers and Importers Flashcards

1
Q

Which controls have no specific controls on the control of manufacturers?

A
  • Sales of Drugs Act
  • Medicines (Advertisement and Sale) Act
  • Poisons Act
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2
Q

Who are exempted from controls on manufacturing under Medicines Act?

A
  • manufactures of “herbal remedies” -s8
  • manufacturers from Medicines (Traditional Medicines, Homoeopathic Medicines and Other Substances) (Exemption) Order -p3
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3
Q

Who must have a manufacturer’s license under the Med Act?

A
  • CPM manufacturers only -r3(4)

- Western pharm med would be regulated as therapeutic products under HPA, not in Med Act

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4
Q

Who are exempted from controls on manufacturing under HPA?

A

Cosmetic products manufacturers

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5
Q

Who must have a manufacturer license under HPA?

A
  • medical devices
  • therapeutic products
  • CTGT
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6
Q

When is a manufacturer’s license issued for therapeutic product?

A
  • provide and maintain staff, premises, equipment and facilities for manufacture, handling and storage of products
  • ensure products are of correct identity, and conform w strength, qly and purity
  • comply w GMP
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7
Q

When is a manufacturer’s license issued for medical CTGT?

A
  • provide and maintain staff, premises, equipment and facilities for manufacture, handling and storage of products
  • ensure products are of correct identity, and conform w strength, qly and purity
  • comply w GMP
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8
Q

When is a manufacturer’s license issued for medical medical devices?

A
  • provide and maintain staff, premises, equipment and facilities for manufacture, handling and storage of products
  • ensure devices not wrongly labelled
  • comply with requirements of ISO 13485
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9
Q

When are there exemptions of manufacturer’s license for therapeutic products?
HP (Therapeutic Products) Regulation

A
  • “private hospitals” “medical clinics” when compounding therapeutic products - r46
  • “licensed retail pharmacies” when compounding therapeutic products -r48
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10
Q

When are there exemptions of manufacturer’s license for medical devices?
HP (Medical Devices) Regulation

A
  • private hospitals medical clinics manufacture “custom-made medical devices” for own pts - r3(1)
  • fitting/ adjusting device for end-user, or enabling continued use by end-user - r3(2)
  • solely for clinical lab’s own use -r3B
  • licensed importers and wholesalers, when manufacturing devices by way of ‘second assembly’ - r4
  • Class A (low risk) for charitable purposes -r3C
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11
Q

When are there exemptions of manufacturer’s license for CTGT?
HP (CTGT) Regulation

A
  • ‘known manufacturers’ of ‘minimally manipulated’ CTGT products -r41c
  • only for R&D, not for public, ‘non-clinical purpose’ -r5
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12
Q

Which controls have no specific controls on the control of importers?

A
  • Sales of Drugs Act

- Medicines (Advertisement and Sale) Act

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13
Q

Who must have an importer’s license under the Med Act?

A

CPM importers only - r3(2)

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14
Q

Who are exempted from controls on importation under Medicines Act?

A
  • manufactures of “herbal remedies” - s8
  • manufacturers from Medicines (Traditional Medicines, Homoeopathic Medicines and Other Substances) (Exemption) Order -p3
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15
Q

Who are CONDITIONALLY exempted from controls on importation under Medicines Act?

A
  • importers of products imported solely for re-export out of SG -p5
  • imported for use of specific ‘named pts’ -p4b and p4c
  • person importing limited qty solely for ‘personal use’ - p4a

under the Medicines (TM, HM) exemption order

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16
Q

Who are exempted from controls on importation under HP Act?

A

cosmetic products importers

17
Q

Who must have an importer’s license under the HP Act?

A
  • Medical devices
  • Therapeutic products
  • CTGT
18
Q

When is importer’s license issued for therapeutic products in HPA?

A
  • when applicant able to:
  • provide and maintain staff, premises, equipment and facilities for handling and storage of products
  • comply with GDP
19
Q

When is importer’s license issued for medical devices in HPA?

A
  • when applicant able to:
  • provide and maintain staff, premises, equipment and facilities for handling and storage of products
  • comply with GDP ISO 13485
20
Q

When is importer’s license issued for CTGT in HPA?

A
  • when applicant able to:
  • provide and maintain staff, premises, equipment and facilities for handling and storage of products
  • comply with GDP
21
Q

Who are conditionally exempted from requirement for importer’s license under HP (TP) Regulations?

A
  • private hospitals, medical clinics, pharmacies importing unregistered TP for use of specific ‘named pts’ -r51
  • person importing limited qty solely for ‘personal use’ -r52
22
Q

Who are exempted from requirement for importer’s license under HP (Medical Devices) Regulations?

A
  • importers of MD licensed under Radiation Protection Act, when importing those (irradiating) devices - r4B
  • person importing limited qty solely for ‘personal use’ - r4A
23
Q

Who are conditionally exempted from the requirement for an importer’s license under HP (CTGT) Regulations?

A
  • “known” importers” of “minimally manipulated” CTGT products - r71c
  • licensed or known manufacturers, when importing products required for manufacture of CTGT products - r8
24
Q

what are the requirements for the Poisons act on importers

A
  • importers of poisons must be licensed

- licensed importers subject to terms and conditions attached to license

25
Q
  1. Company ABC is a local company and manufactures medical device X and supply (transaction with) X to XYZ company. Which of the following license is required?
    a) Manufacturer’s license
    b) Importer’s license
    c) Wholesaler’s license
    d) Retailer’s license
A

a) Manufacturer’s license

26
Q
  1. Company AVC manufactures medical devices but does not need a manufacturer’s license. Why?
    a) Private hospitals and medical clinics when manufacturing custom-made medical devices
    b) For laboratory-developed tests
    c) Manufacturing by “secondary assembly”
    d) Manufacturing of Class A devices for charitable purposes
A

d) Manufacturing of Class A devices for charitable purposes

27
Q
  1. Person A brought 2 BP monitors from MY to SG. Why were the BP monitors not confiscated?
    a) Solely for re-export out of Singapore
    b) Use of specific ‘named patients’
    c) Importing limited quantities solely for personal use
    d) It is an irradiating device, thus licensed under Radiation Protection Act
A

c) Importing limited quantities solely for personal use

28
Q
  1. Manufacturers of medical devices must (choose more than 1):
    a) Provide and maintain staff, premises, equipment and facilities for manufacture, handling, storage of devices
    b) Ensure products are of correct identity, and conform with strength, quality and purity
    c) Ensure devices are not wrongly labelled
    d) Comply with requirements of ISO13485
    e) Comply with good manufacturing practices
A

a) Provide and maintain staff, premises, equipment and facilities for manufacture, handling, storage of devices
c) Ensure devices are not wrongly labelled
d) Comply with requirements of ISO13485

29
Q
  1. Which of the following are ‘subsets’ of health products? (more than 1)
    a) Medical devices
    b) Cosmetic products
    c) Therapeutic products
    d) Oral dental gum
    e) CTGT
A

a) Medical devices
b) Cosmetic products
c) Therapeutic products
d) Oral dental gum
e) CTGT

PL (12 decks)

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