6_documentation and recording

Question 1

for the older laws, which products needed a prescription?

Answer 1

Poisons act: Schedule 3 posions (r15 of poisons rules)

Medicines (Prescription Only) (not found in the book): POM medicinal pdts under Medicines act

(less relevant after 1 Nov 2016)

Question 2

the requirements of the prescription to be valid for therapeutic and CTGT pdts

Answer 2

r2(2) of the HP (TP) regulation and HP (CTGT) regulation

Question 3

the required things to do by the person dispensing POM pdt (therapeutic and CTGT) - record what

Answer 3

r17(2) of TP regulation
r26(2) of CTGT regulation

• mark prescription with name and address of dispenser and date of dispensing
• retain prescription for at least 2 years

Question 4

requirements in a signed/written order that allows for wholesale supply

Answer 4

• r11(2) Poison rules: for non-products
• HP (TP) regulation: r10; ingredients specified in the second schedule
• CTGT reg: r20

Question 5

signed order must state:

for TP and CTGT

Answer 5

• 10(2)(b)

Question 6

for wholesalers under the Poison rule, what needs to be recorded

Answer 6

• Form E record
• -> date of transaction
• -> delivery order/ sales note no
• -> name and address of purchaser or supplier
• -> opening stock, qty transacted and closing stock

–> retain transaction records for at least 2 years

Question 7

for licensees under the Medicines act, what needs to be recorded

Answer 7

• whatever required under the standard provision of license
• record form similar to form E records
• must retain for at least 2 yrs

(licensees - import, manufacturer, wholesale licenses)

Question 8

what records are required to be made by manufacturers and receipt/supply for TP?

Answer 8

• manufacturers need to record the therapeutic pdts they manufacture (r31)
• registrants and licensees (and certain other suppliers) to record the therapeutic pdt they receive and supply (r32(3)(a))

Question 9

what records are required to be made by retail suppliers of PRESCRIBED TP?

Answer 9

r16 of HP (TP) reg

Question 10

what records are required to be made by retail suppliers of pharmacy-only medicines?

Answer 10

r13(2) of HP(TP) reg

Question 11

what records are required to be made by manufacturers and receipt/supply for CTGT?

Answer 11

• manufacturers need to record the therapeutic pdts they manufacture (r32)
• registrants and licensees (and certain other suppliers) to record the therapeutic pdt they receive and supply (r33 (2)(a))

Question 12

what records are required to be made by retail suppliers of PRESCRIBED CTGT?

Answer 12

r23 of HP (CTGT)

Question 13

what records are required to be made by manufacturers and receipt/supply for medical devices?

Answer 13

• manufacturers need to record the therapeutic pdts they manufacture (r38)
• registrants and licensees (and certain other suppliers) to record the therapeutic pdt they SUPPLY (r39 - 2(a)details of the supply)

Question 14

qualified practitioners must keep records of what type of medical devices?

Answer 14

• implantable medical devices listed in the fifth scheldule of the regulation

Question 15

who keeps the record of the cosmetic product

Answer 15

the person responsible for placing a cosmetic pdt

• r10
• keep records for at least 2 years
• records must have the details stated in 10(2)(a)