documentation and presentation Flashcards
valid prescription needed for
pom
ctgt
poisons
pom medicinal products under medicines act
locate prescription requirements
tp - r2(2)
can person dispensing pom product according to prescripiton
- dispense more than once or number of times specified for repeat prescription
- dont mark prescription with name address of dispenser and date of dispensing
- retain prescription after dispensing or after dispensing for the last time ( for repeat prescrption ) for less than 2 yrs
- must mark
- must retain for t least 2 yrs
what is a signed order
written order signed by purchaser or recipient
signed order required for
wholesale supply of
- poisons ( but only non products meaning raw materials after nov 2016 )
- TP , mainly pom or P
- CTGT
requirements for wholesaler of pom/p or ctgt products
- before supply must be satisfied recipeint carries on stated trade, business or profession
- at time of supply ,must ensure signed order stating
- recipeints name and address
recipients trade , business or profession
name and total qty of the therapeutic product supplied
( like counterpart to a prescription )
poisons act recording
r5
must record details of movement of stocks in form E record
- records must be retained for at least 2 yrs after the date of supply
presentation broadly includes what
labelling and marking of product
packaging and form of product
information leaflets and material accompanying product ( PIL _)
controls to regulate presentation specify what
what must be there - info on the nature and characteristics of product - special precautionary info what must not be there - claims not allowed to be made
presentation controls for poisons
found under r20+ of the poisons rules
presentation controls under medicines ( advert ) act
- section 7
- presentation of qty
presentation controls for CPM
under medicines act
found in subsidiary legislation - labelling for CPM
presentation controls for therapeutic products
found in subsidiary legislation dispensed - r17 not dispensed r20 cautionary labells - r20 for tartrazine, benzoic acid and sodium benzoate
( 4th schedule )
+ items in fifth schedule
r19 - for what shld not be included }
presentation controls for CTGT
subsidiary legislation r25 and 26
notet the diff between dispensed vs non dispensed
simialr to therapeutic products
presentation controls for MD
14 and 15 of subsidiary legislation
- cannot tamper then change the indication to smth different than manufacturer’s intention
b
