4. Pre-market controls on health products

Question 1

which laws don’t have pre-market registration

Answer 1

• sales of drug act
• poisons act
• Medicines (adv and sale) act

Question 2

what is the pre-market product registration requirement for medicinal products?

Answer 2

• product license (unique SIN number)

- assessed based on safety, efficacy, quality

Question 3

what are the exemptions for pre-market pdt registration under the Medicines act?

Answer 3

• herbal remedies
• pdts specified in Medicines (TM, HM, and other substances) (Exemption) order
• for CPM: no need product license BUT:
• • need to submit CPM pdt to assess for safety and quality
• • licensed CPM dealers can only deal with CPM pdts assessed and listed by the licensing authority
• • the local manufacturer or importer takes on roles of product license holder

Question 4

which products under HPA doesnt require pre-marker pdt registration?

Answer 4

• cosmetic pdts (only need to notify)
• class A medical device
• certain exemptions for
• -> therapeutic pdts
• ->class 1 CTGT pdt

Question 5

which therapeutic pdts are exempted from pre-market registration?

Answer 5

• compounded at hospitals/clinics/pharmacies
• compounded by the manufacturer, ordered from the hospitals/ clinics
• imported for specific named patients or personal use
• ships or aircraft
• manufactured solely for export OR imported solely for re-export
• non-clinical purposes

Question 6

exemptions from pre-market registration for medical devices

Answer 6

• manufactured by hospitals and clinics for own patient
• lab-developed test
• custom-made devices
• imported for the use of specific named patients
• manufactured for export or imported solely for re-export
• non-clinical purposes

Question 7

exemptions from pre-market registration for class 1 CTGT pdts

Answer 7

1. must give notice to HSA, receive HSA’s acceptance of notification
2. specific named patients; manufactured by or for private hospitals or medical clinics
3. not for supply to public, non-clinical purposes
4. manufactured solely for export or imported solely for re-export

Question 8

difference between cosmetic and CTGT pre-market registration requirements

Answer 8

cosmetic: need to notify before supplying the pdt
vs
CTGT: need to notify AND get HSA’s acceptance of notification