lecture 2: labelling of RMPs

Question 1

legislation underpinning labelling of medicines?

Answer 1

HMR 2012
Part13: packaging and leaflets
part 24: packaging information requirements
part 25: packaging for specific provisions

Question 2

CDs must also be labelled in accordance with?

Answer 2

misuse of drugs regulations 2001

Question 3

all labelling of containers and packaging of RMP shall be?

Answer 3

easily legible
comprehensible
indelible

Question 4

outer and immediate packaging information- legally required?

Answer 4

• 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

Question 5

if a p medicine?

Answer 5

P in a rectangle

Question 6

if a POM?

Answer 6

POM in a rectangle

Question 7

if a CD

Answer 7

downwards triangle

Question 8

If GSL

Answer 8

no requirement

Question 9

what does INN stand for?

Answer 9

international non-proprietary name

Question 10

what can outer packaging and leaflets NOT include?

Answer 10

any element of a promotional nature suggesting the product is better than another

Question 11

when is there an exemption to the labelling?

Answer 11

• box is too small to display all information

- blister pack and is placed in outer packaging which complies with above requirements

Question 12

what must blister pack be labelled with?

Answer 12

• 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

Question 13

labelling of small containers that aren’t blister packs?

Answer 13

all on previous slide and method of administration

Question 14

additional labels for products with paracetamol?

Answer 14

‘contains paracetamol’

‘do not take more than the label tells you to. if you do not get better, talk to your doctor’

Question 15

when does ‘contains paracetamol’ not need to be on the label?

Answer 15

when the word paracetamol appears on the outer and immediate packaging

Question 16

the requirements for advertising to the public and to health professionals is the same. True or False?

Answer 16

False, they’re different

Question 17

define ‘advertisements for medicinal products’

Answer 17

includes anything designed to promote the prescription, supple, sale or use of that product

Question 18

is door to door canvassing advertising?

Answer 18

yes

Question 19

is visits by medical sales reps to persons qualified to prescribe or supply medicinal products, advertising?

Answer 19

yes

Question 20

is supplying sampling advertising?

Answer 20

yes

Question 21

is sponsorship of promotional meetings attended by people qualified to prescribe or supply medicinal products, advertising?

Answer 21

yes

Question 22

what is vetting?

Answer 22

regulations allow the MHRA to require sight of advertising before its issued

Question 23

what medicines get vetted?

Answer 23

all MAs granted for new active substances have their promotional materials vetted

Question 24

what is vetting usually requested for?

Answer 24

a reclassified product

Products where previous advertising has breached the regulations

Question 25

who handles complaints about advertising?

Answer 25

MHRA

self regulatory bodies

Question 26

what happens to the outcome of complaints?

Answer 26

published

Question 27

what does PAGB deal with?

Answer 27

over the counter advertising

Question 28

what does PMCPA deal with?

Answer 28

POMS

Question 29

what does the ASA deal with?

Answer 29

general advertising matters