Labelling Of Relevant Medicinal Products Flashcards
What is a relevant medidcnal product
A product that holds a marketing authorisation and are produced by manufacturers in the pharmaceutical industry
Which legislation underpins labelling of medicines
Human medicines regulations 2012:
Part 13 Packaging and leaflets
Schedule 24 packaging information requirements
Schedule 25 packaging requirements: specific provisions
No CDs must also be labelled in accordance with the misuse of drugs regulations 2001
What must be included to make the label easy to read
Easily legible, indelible, comprehensible
Either in English only or in English and other languages provided some things are expressed in all languages
The name of the product must also be in braille on the outer packaging
What info needs to be present on a relevant medicinal product (or authorised medicinal product)
The name of the medicinal product
Strength and form
If its for babies, children or adults
The common name of each active substance
A statement of the active substances
The contents by weight, volume or number of doses
A list of all excipients if the product is injectable, topical or for the eye
A list of some notable excipients if its any other med
Method and route of administration
Space for the prescribed dose to be included
Keep out of reach and sight of children
Special warnings for the product
The products expiry date
Any storage precautions
Any precautions relating to disposal of the product
Name and address of the holder of its MA
number of the marketing authorisation
Manufacturers batch number
Gsl and p, instructions for use
What are the rules around active substance labelling
- where the product contains up to 3 active substances, the common name of each substance must be used
- a statement of active substances in the product explained quantitatively and qualitatively per dosage unit or according to form of administration for given volume or weight using their common names
What are the 3 types of name a drug can have
Its INN - International non propriatory name (its generic name)
Common name
Brand name
Eg. INN - acetylsalicylic acid, common - aspirin, brand aspirin (registered name)
What shapes are the legal classification letters contained in
P in a rectangle
POM in a rectangle
CD (sch 2 and 3) in a triangle is a reccomendation
GLS there is no requirement
Can manufacturers include appropriate symbols, diagrams or pictures alongside the product packaging
Yes, but there cane be no element of a promotional nature
What info needs to be contained on a blister pack
Name of medicine Strength and form Whether its for babies, children or adults The common name of the active substance The name of the holder of the MA Expiry date Batch number
What info needs to be on very small medicine packages
Name of medicine Strength and form Whether its for babies, children or adults The common name of the active substance Method of the administration of the product and route if administration if necessary Expiry date Batch number The contents by weight, volume or unit
What are the additional requirements for products containing paracetamol
Detailed in the HMR (unusually). Packaging must state ‘contains paracetamol’ (unless the outer packaging contains the word paracetamol) and ‘do not take more medicine than the label tells you to. If you do not get better, talk to your doctor’
If there is no package leaflet the phrase talk to your doctor if you take too much of this medicine, even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage’
Where can the legislation surrounding advertising be found
Was an EU directive, then part of HMR2012. Also in the blue guide
What constitutes advertising by sales representatives
Door to door canvassing, visits by medical sales reps, supply of samples, gifting or incentives, sponsorship to induce supply of certain medicines
What role does the MHRA play in the vetting of advertising materials
They can see all medicine advertising before it is issued - this is particularly thorough for new medicines, a medicine thats becoming reclassified or medicines which have previously breached the rules
Who handles complaints about advertising
MHRA and self regulatory bodies
