CTGT products

Question 1

keep rx for how long?

Answer 1

2 years

Question 2

keep dispensing rec for how long (traceable)

Answer 2

30 years

Question 3

disp record keep how long non traceable

Answer 3

1 y after ctgt expires or
5 y after manufacture

Question 4

AE of ctgt keep how long

Answer 4

2 years

Question 5

report AE LT within?

Answer 5

48h

Question 6

report AE non LT within ?

Answer 6

15d

Question 7

recall tell HSA in?

Answer 7

24h

Question 8

what is iso13485 for

Answer 8

medical device’s industry standard

Question 9

do licensed manufacturers of any ctgt product need to report to hsa its manufacturing activities for MINIMALLY manipulated ctgt pdts?

Answer 9

no

Question 10

if exempted from licences, need to do duties and obligations?

Answer 10

yes. record keeping, reporting defect and AE, product recall

Question 11

what is considered minimally manipulated ctgt?

Answer 11

only cell expansion

Question 12

can a manufacture license holder of any ctgt product import minimally manipulated ctgt products? what if it is a import license holder? what if it is a wholesale license holder

Answer 12

yes

Question 13

licensed manufacturer comply with

Answer 13

GMP standard

Question 14

known manufacturer comply with the

Answer 14

good tissue practice standard

Question 15

manu record keep how long for non traceable

Answer 15

1y after exp or 5y after manu whichever longer

Question 16

if traceable manu record

Answer 16

at least 30y or shorter expiry date allowed by hsa

Question 17

class 1 ctgt need to register? class 2?

Answer 17

1: no. notif only
2: yes

r15,r29