Health Products Act (registration, license, good distribution practice) Flashcards
1
Q
What are the criteria for product registration?
A
- safety of product
- efficacy of product
- quality of product
2
Q
What are the three forensic classification for TPs?
A
- prescription only meds (POM)
- pharmacy only meds (P)
- general sale list meds (GSL/OTC)
3
Q
What are the registration and licenses under HPA
A
- product registration
- TPIL (importer)
- TPML (manufacturer)
- TPWL (wholesaler)
4
Q
When is the retention fee due date for TPs?
A
anniversary of the date of registration of the TP.
5
Q
What is the role of the Product Registrant?
A
- ensure that all information contained in the application is truthful and not misleading
- inform HSA of any emerging information that may affect the benefit-versus-risk assessment of the TP as soon as the applicant becomes aware of such information
- submit the application and all the accompanying supporting documents
- required to hold a TPIL/TPWL if they intend to import and or wholesale their own registered TP
6
Q
What is the validity of the licenses and where can they renew their licenses?
A
One year, renew on HSA website
7
Q
What is the importance of good distribution practice?
A
- ensure the quality and integrity of products
- safeguard and protect public health
8
Q
Who can be the Responsible Person?
A
- qualified to handle import and or supply by wholesale of registered tp
- adequate knowledge of the activities
- relevant work experience
- receive training in GDP
