Controls on Manufacturers & Importers Flashcards
Which acts do not have specific controls on manufacturing?
Sale of Drugs Act
Poisons Act
Medicines (Advertisement and Sale) Act
Which act separately defined “manufacture” & “assembly”?
Medicine Act
- Health Products Act combined both the manufacturing & assembly (i.e. secondary manufacturing) into one definition under “manufacture”
Which legislation defines “compound”?
Health Products (Therapeutic Products) Regulations
Describe the general controls on manufacturing under the Medicines Act.
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).
Which type of products are exempted from the requirement of having a manufacturer’s license before manufacturing under the Medicines Act?
- 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
Which type of products does the controls on manufacturers under the Medicine Act apply to?
Generally only CPM
- since HPA regulates “Western” pharmaceutical medicines under “therapeutic products” as of 1 Nov 2016.
Describe the general controls on manufacturing under the Health Products Act.
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.
Which type of products are exempted from the requirement of having a manufacturer’s license before manufacturing under HPA?
Cosmetic products (under First Schedule of HPA)
Which type of products does the controls on manufacturers under the Health Products Act apply to?
All health products except cosmetic products.
- Therapeutic products
- Medical devices
- Cell, tissue and gene therapy (CTGT) products
- Oral dental gums
What are the required conditions to achieve before issuing a manufacturer’s license for therapeutic products?
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
What are the required conditions to achieve before issuing a manufacturer’s license for medical devices?
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
What are the required conditions to achieve before issuing a manufacturer’s license for CTGT products?
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
Under what conditions do the exemption from the requirement of having a manufacturer’s license apply for therapeutic products?
Compounded therapeutic products from private hospitals, medical clinics & licensed retail pharmacies.
Under what conditions do the exemption from the requirement of having a manufacturer’s license apply for medical devices?
- 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
Under what conditions do the exemption from the requirement of having a manufacturer’s license apply for CTGT products?
- “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
Which acts do not have specific controls on importation?
Sale of Drugs Act
Medicine (Advertisement and Sale) Act
Describe the general controls on importation under the Poisons Act.
Importers of poisons must be licensed & are subjected to terms & conditions attached to license.
Describe the general controls on importation under the Medicines Act.
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).
Which type of products are exempted from the requirement of having an importer’s license before importation under the Medicines Act?
- 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’
Which type of products do the controls on importation under the Medicine Act apply to?
Generally only CPM
- since HPA regulates “Western” pharmaceutical medicines under “therapeutic products” as of 1 Nov 2016.
Describe the general controls on importation under the Health Products Act.
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.
Which type of products are exempted from the requirement of having an importer’s license before manufacturing under HPA?
Cosmetic products (under First Schedule of HPA)
Which type of products does the controls on importation under the Health Products Act apply to?
All health products except cosmetic products.
- Therapeutic products
- Medical devices
- Cell, tissue and gene therapy (CTGT) products
- Oral dental gums
What are the required conditions to achieve before issuing an importer’s license for therapeutic products?
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
