Health products

Question 1

Health products governed by HBRA

Answer 1

All medical devices
Class 1 CTGTP

Question 2

Health products governed by health products (clinical trials) regulations

Answer 2

All therapeutic products
Class 2 CTGTP

Question 3

Clinical trial requirements for medicinal products

Answer 3

Clinical trial certificates

Question 4

Psychotropics that are not subjected to export rules

Answer 4

Zopiclone

Question 5

Codeine cough preparation limits

Answer 5

Liquid:
- 240 mL (2 bottles) within 7 days

Solid:
- 355 mg codeine base or 480 mg codeine phosphate within 7 days

Question 6

Dealer’s licensing requirement under the HPA

Answer 6

• Manufacturer’s license
• Importer’s license
• Wholesaler’s license

Required for all TP, MD and CTGTP
Except for class 1 and minimally manipulated CTGTP which requires prior notification individually to HSA

Question 7

Dealer’s licensing requirement under the medicines act

Answer 7

• Product license
• Manufacturer’s license
• Wholesale dealer’s license
• Import license

All medicinal products exempted except:
CPM which requires import/manufacturer/wholesale dealer’s license

Question 8

Registration requirement under the HPA

Answer 8

All TP, MD and CTGTP require product approval except:
- Class A MD
- Class 1 CTGTP (prior notice to HSA needed)

Question 9

Exemptions given in the health products (exemptions) orders

Answer 9

All:
- Used of product in clinical research
- Advertisement of product
- Reporting of non-serious adverse reactions

TP-specific:
- Presentation of product when dispensed by suppliers / meant for personal use / solely for export

MD-specific:
- Medical devices licensed under radiation protection act
- Dealing of class A MD
- Any wellness devices

CTGTP-specific:
- Dealing of OOS CTGTP