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PR3146 Pharm Law > Controls on Manufacturers & Importers > Flashcards

Controls on Manufacturers & Importers Flashcards

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1
Q

Which acts do not have specific controls on manufacturing?

A

Sale of Drugs Act
Poisons Act
Medicines (Advertisement and Sale) Act

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2
Q

Which act separately defined “manufacture” & “assembly”?

A

Medicine Act
- Health Products Act combined both the manufacturing & assembly (i.e. secondary manufacturing) into one definition under “manufacture”

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3
Q

Which legislation defines “compound”?

A

Health Products (Therapeutic Products) Regulations

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4
Q

Describe the general controls on manufacturing under the Medicines Act.

A

1) Manufacturers (including assemblers) of medicinal products must be licensed. (i.e holders of manufacturer’s license).
2) Licensed manufacturers must comply with “standard provisions” attached to license
- Additional controls are enforced for Chinese Proprietary Medicines (CPM).

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5
Q

Which type of products are exempted from the requirement of having a manufacturer’s license before manufacturing under the Medicines Act?

A
  • Herbal remedies
  • Traditional medicines
  • Homoeopathic medicines
  • Quasi-medicinal products
  • Raw materials used as ingredients in preparation or manufacture of any medicinal product
  • Medicated oil & balm
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6
Q

Which type of products does the controls on manufacturers under the Medicine Act apply to?

A

Generally only CPM

- since HPA regulates “Western” pharmaceutical medicines under “therapeutic products” as of 1 Nov 2016.

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7
Q

Describe the general controls on manufacturing under the Health Products Act.

A

1) Manufacturers of “health products” must be licensed.
2) Manufacturers must be carried out according to license conditions.
3) Manufacturing must be at authorised premises or facility.

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8
Q

Which type of products are exempted from the requirement of having a manufacturer’s license before manufacturing under HPA?

A

Cosmetic products (under First Schedule of HPA)

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9
Q

Which type of products does the controls on manufacturers under the Health Products Act apply to?

A

All health products except cosmetic products.

  • Therapeutic products
  • Medical devices
  • Cell, tissue and gene therapy (CTGT) products
  • Oral dental gums
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10
Q

What are the required conditions to achieve before issuing a manufacturer’s license for therapeutic products?

A

1) Provide & maintain staff, premises, equipment & facilities for manufacture, handling & storage of products
2) Ensure products are of correct identity and conform with strength, quality & purity
3) Comply with Good Manufacturing Practice

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11
Q

What are the required conditions to achieve before issuing a manufacturer’s license for medical devices?

A

1) Provide & maintain staff, premises, equipment & facilities for manufacture, handling & storage of devices
2) Ensure devices are not wrongly labelled
3) Comply with requirements of ISO 13485

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12
Q

What are the required conditions to achieve before issuing a manufacturer’s license for CTGT products?

A

1) Provide & maintain staff, premises, equipment & facilities for manufacture, handling & storage of products
2) Ensure products are of correct identity and conform with applicable standard of quality
3) Comply with Good Manufacturing Practice

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13
Q

Under what conditions do the exemption from the requirement of having a manufacturer’s license apply for therapeutic products?

A

Compounded therapeutic products from private hospitals, medical clinics & licensed retail pharmacies.

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14
Q

Under what conditions do the exemption from the requirement of having a manufacturer’s license apply for medical devices?

A
  • Private hospitals & medical clinics, when manufacturing “custom-made medical devices” for own patients
  • Fitting or adjusting device for end-user or enabling continued use by end-user
  • Clinical laboratory manufacturing laboratory-developed tests solely for laboratory’s own use
  • Licensed importers & wholesalers, private hospitals, medical clinics & retail pharmacies when manufacturing medical devices by way of “secondary assembly”
  • Manufacturers of Class A (i.e. low-risk) devices for charitable purposes after obtaining approval from HSA
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15
Q

Under what conditions do the exemption from the requirement of having a manufacturer’s license apply for CTGT products?

A
  • “Known manufacturers” of “minimally manipulated” CTGT products by HSA
  • Manufacturers of CTGT products not for supply to public, but solely for R&D, scientific education or non-clinical purposes
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16
Q

Which acts do not have specific controls on importation?

A

Sale of Drugs Act

Medicine (Advertisement and Sale) Act

17
Q

Describe the general controls on importation under the Poisons Act.

A

Importers of poisons must be licensed & are subjected to terms & conditions attached to license.

18
Q

Describe the general controls on importation under the Medicines Act.

A

1) Importers of medicinal products must be licensed. (i.e holders of importer’s license).
2) Licensed importers must comply with “standard provisions” attached to license
- Additional controls are enforced for Chinese Proprietary Medicines (CPM).

19
Q

Which type of products are exempted from the requirement of having an importer’s license before importation under the Medicines Act?

A
  • Herbal remedies
  • Traditional medicines
  • Homoeopathic medicines
  • Quasi-medicinal products
  • Raw materials used as ingredients in preparation or manufacture of any medicinal product
  • Medicated oil & balm

Conditional exemptions include:

  • Import of products solely for re-export out of Singapore
  • Imported for the use of specific “named patients”
  • Imported limited quantities solely for ‘personal use’
20
Q

Which type of products do the controls on importation under the Medicine Act apply to?

A

Generally only CPM

- since HPA regulates “Western” pharmaceutical medicines under “therapeutic products” as of 1 Nov 2016.

21
Q

Describe the general controls on importation under the Health Products Act.

A

1) Importers of “health products” must be licensed.
2) Importation must be carried out according to license conditions.
3) Imported goods must be at stored authorised premises or facility.

22
Q

Which type of products are exempted from the requirement of having an importer’s license before manufacturing under HPA?

A

Cosmetic products (under First Schedule of HPA)

23
Q

Which type of products does the controls on importation under the Health Products Act apply to?

A

All health products except cosmetic products.

  • Therapeutic products
  • Medical devices
  • Cell, tissue and gene therapy (CTGT) products
  • Oral dental gums
24
Q

What are the required conditions to achieve before issuing an importer’s license for therapeutic products?

A

1) Provide & maintain staff, premises, equipment & facilities for manufacture, handling & storage of devices
2) Comply with Good Distribution Practice for Medical Devices or ISO 13485

25
Q

What are the required conditions to achieve before issuing an importer’s license for therapeutic products?

A

1) Comply with proper storage & handling requirements

2) Comply with Good Distribution Practice

26
Q

Under what conditions do the exemption from the requirement of having an importer’s license apply for therapeutic products?

A
  • Private hospitals, medical clinics & retail pharmacies importing unregistered therapeutic products for specific “named patients”
  • Persons importing limited quantities of therapeutic products for “personal use”
27
Q

Under what conditions do the exemption from the requirement of having an importer’s license apply for medical devices?

A
  • Importers of (irradiating) medical devices licensed under the Radiation Protection Act
  • Persons importing limited quantities of medical devices for “personal use”
28
Q

Under what conditions do the exemption from the requirement of having an importer’s license apply for CTGT products?

A
  • “Known importers” of “minimally manipulated” CTGT products by HSA
  • Licensed or known manufacturers of CTGT products when importing products required for further manufacture of CTGT products

PR3146 Pharm Law (2 decks)

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