Reading...
Play button
Play button
Use LEFT and RIGHT arrow keys to navigate between flashcards;
Use UP and DOWN arrow keys to flip the card;
H to show hint;
A reads text to speech;
14 Cards in this Set
- Front
- Back
|
What does TGA stand for?
|
Therapeutic goods Act or
Therpeutic goods administration |
|
|
What does SUSDP stand for?
|
Standard for Uniform Scheduling of Drugs and Poisons
|
|
|
What does GMP stand for?
|
Good Manufacturing Practice
|
|
|
What does ARTG stand for?
|
Australian Register of Therapeutic Goods
|
|
|
What does CMEC stand for?
|
Complimentary Medicine Evaluation Committee
|
|
|
What does NDPSC stand for?
|
National Drugs and Poisons Scheduling Committee
|
|
|
What certification are herbalists required to have to be exempt from TGA requirements in Australia?
|
TGA Certficate of exemption
|
|
|
What jurisdiction does the Therapeutic Goods Act 1989 cover?
|
Manufacturing processes and any products crossing state borders
Each state has sightly different legislation |
|
|
What is teh Act of Parliament that governs the manufacture, sale and supply of medicinal products?
|
Therapeutic Goods Act 1989
|
|
|
Who admisisters the Therapeutic Goods act of Australia?
|
Therapeutic Goods administration
|
|
|
If a herbalist wants to manufacture, what are teh rules?
|
Can produce and provide products from own premises for own clients. Cannot lease or sell generic products to individuals without consultation
|
|
|
Why do herbalsists not need to gain an approval for each medicine that they dispense?
|
They have an extemporaneous exemption.
|
|
|
What is the difference between an registration and a listing on the ARTG?
|
Registered products are higher risk and need to be evaluated, from ingredients through to manufacture.
Listing equals evaluated for safety and quality- not efficacy |
|
|
What is teh difference between AUST R and AUST L?
|
Registered and listed on the ARTG
|
