lecture 2: labelling of RMPs Flashcards
legislation underpinning labelling of medicines?
HMR 2012
Part13: packaging and leaflets
part 24: packaging information requirements
part 25: packaging for specific provisions
CDs must also be labelled in accordance with?
misuse of drugs regulations 2001
all labelling of containers and packaging of RMP shall be?
easily legible
comprehensible
indelible
outer and immediate packaging information- legally required?
- name, and braille
- strength and form
- who the product is intended for eg/ babies
- if up to 3 active substances, common name of each
- method of administration
- expiry date in month and year
- name and holder of MA
- batch number of manufacturer
if a p medicine?
P in a rectangle
if a POM?
POM in a rectangle
if a CD
downwards triangle
If GSL
no requirement
what does INN stand for?
international non-proprietary name
what can outer packaging and leaflets NOT include?
any element of a promotional nature suggesting the product is better than another
when is there an exemption to the labelling?
- box is too small to display all information
- blister pack and is placed in outer packaging which complies with above requirements
what must blister pack be labelled with?
- name
- strength and form
- who its intended for?
- if up to 3 substances, the name of all
- name of MA holder
- expiry date
- batch number
labelling of small containers that aren’t blister packs?
all on previous slide and method of administration
additional labels for products with paracetamol?
‘contains paracetamol’
‘do not take more than the label tells you to. if you do not get better, talk to your doctor’
when does ‘contains paracetamol’ not need to be on the label?
when the word paracetamol appears on the outer and immediate packaging
the requirements for advertising to the public and to health professionals is the same. True or False?
False, they’re different
define ‘advertisements for medicinal products’
includes anything designed to promote the prescription, supple, sale or use of that product
is door to door canvassing advertising?
yes
is visits by medical sales reps to persons qualified to prescribe or supply medicinal products, advertising?
yes
is supplying sampling advertising?
yes
is sponsorship of promotional meetings attended by people qualified to prescribe or supply medicinal products, advertising?
yes
what is vetting?
regulations allow the MHRA to require sight of advertising before its issued
what medicines get vetted?
all MAs granted for new active substances have their promotional materials vetted
what is vetting usually requested for?
a reclassified product
Products where previous advertising has breached the regulations
