Packaging & Labelling Flashcards
Packaging & leaflets
It is an offence for anyone other than the MA holder to:
- Sell (or offer to sell)
- Supply (or offer to supply)
A medicine (human) which:
- does not comply with the packaging legislation
- without a leaflet
Offenders:
- fine
- conviction
- imprisonment
Public law
- Applies to everyone e.g criminal, constitutional, administrative law.
By law
- you have to supply a leaflet when dispensing meds
- manufacturer has to fulfil certain requirements for the manufacturing packaging
What does the HMR legislation say?
All labelling of containers & packages must be:
- Legible, comprehensible & indelible
- provided in English
Package:
- enclosure for one or more containers
Container:
- inner receptacle which actually contains the medicine
- Could be a bottle or pack
Labelling Requirements MA Holders (1-5)
For the outer packaging
- Name (& brand name) of medicinal product (must also be in Braille)
- Strength & pharmaceutical form
- Whether intended for babies, children or adults (where appropriate)- if it is just for adults you don’t need to write anything
- Active substance common name
(for up to 3 active substances) - Qualitative & quantitative expression of the
active substance (common name) per
dosage unit or for a given volume or weight
Labelling Requirements MA Holders (6-11)
For the outer packaging
- Pharmaceutical form & contents by weight, volume or number of doses
- The method of administration
- Where appropriate, space for the prescribed dose to be indicated (i.e., POMs require space for a dispensing label)
- A warning that the product must be stored out of the reach & sight of children
- Any applicable special warnings
- Any applicable storage precautions
Labelling Requirements MA Holders (12-17)
For the outer packaging
- Expiry date (month and year)
- Manufacturer’s batch number (lot no.)
- Name & address of MA holder
- Marketing Authorisation number (Product licence no.= PL number)
- Legal category if P or POM and if not a POM, instructions for use
- Any special disposal precautions
Labelling Requirements
MA Holders (18)
- A list of ( for certain products)
A) all excipients for injectable, topical or eye products
B) in any other case, excipients with a recognised
action or effect (i.e. anything active or colourings should be listed as s/ may be allergic to them, lactose allergy, peanut oil).
Excipient:
- A list of ( for certain products)
- “a constituent of a medicine other than the active
substance, added in the formulation for a specific
purpose… Most …are…inactive, some…have a
known action … must be declared…” EMA, 2021
Best Design Practice for Safety
MHRA Guidance for MA Holders
- Packaging & labelling must be approved by
MHRA (includes changes) before marketed (for patient safety) - Labelling can contribute to medication error
- Critical information together (same field of view)
- Full name on 3 non-opposing faces (at least)
- Generic cephalosporins Tallman lettering = Certain letters are highlighted or in bold to make it clear as to what exactly you are picking. Highlights differences in the name & helps things stand out.
Best Design Practice for Safety
MHRA Guidance for MA Holders
- manufacturers must express different strengths of the same drug in the same manner using the same units (e.g., 250mg, 500mg, 750mg, 1000mg and NOT 1g)
- No trailing zeros (e.g., 2.5mg and NOT 2.50mg) as they may be misread
- ‘micrograms’ is spelt out in full (not abbreviated) so that it isn’t misread
- Positive administration instructions only = For INTRATHECAL use ONLY = Clearer & more easily processed
- Consider colour to ensure accurate identification & selection
Con of similar designs
- s/ manufacturers use the same design across all their products & in busy settings one may not be able to easily distinct which is which
- errors can be made
Labelling Requirements
MA Holders
- Legislation allows symbols, diagrams, pictures or additional information:
- In line with summary of product characteristics (SmPC) = Has to be in w/ the licensed use of that drug)
- NOT promotional
- Fewer requirements for blister packs & small containers= Have to have expiry date & batch number
- Specific additional requirements for Traditional Herbal Remedies, homeopathic products & radiopharmaceuticals
- Different requirements for ‘special’ medicines, ingredients, contract manufacture, assembly & clinical trials (Special meds = Meds made specifically for a patient aren’t licensed)
- Additional requirements for paracetamol products
- Additional requirements for codeine & dihydrocodeine products
Labelling Requirements
Paracetamol Products
The following words MUST appear on the package
- ‘Contains paracetamol’ unless already stated in product name
- ‘Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor’ adjacent to dose directions
- If intended for over 12-year-olds ‘Do not take anything else containing paracetamol while taking this medicine. Talk to a doctor at once if you take too much of this medicine, even if you feel well’ (not e/o feels unwell)
- Either the leaflet or the packaging must include the explanation ‘This is because too much paracetamol can cause delayed, seriousliver damage’
Why does paracetamol have labelling requirements?
- Paracetamol untreated can result in irreversible
hepatotoxicity & death - Legislation change 1998
- Pack size sales restrictions
- From 100 tablets (pharmacy) & 24 tablets (non-
pharmacy) - To 32 tablets (pharmacy) & 16 tablets (non-
pharmacy)
Labelling Requirements
Paracetamol Products
The following words MUST appear on the package
- If intended for under 12-year-olds ‘Do not give anything
else containing paracetamol while giving this
medicine. Talk to a doctor at once if your child takes
too much of this medicine, even if they seem well’ = The same warning just rephrased for the caregiver
- Either the leaflet or the packaging must include the
explanation ‘This is because too much paracetamol can
cause delayed, serious liver damage’
