Businesses making use of pharmaceutical packaging companies must make sure they’re operating in line with guidelines set out by the Medicines and Healthcare Products Regulatory Agency, which approves all packaging and labelling information for medication in the UK.
Safe use of medication is dependent upon people being able to read the labels and packets carefully and accurately so they’re able to act on the information they’re given. The main purpose for labelling and packaging is to provide users with unambiguous identification of what’s inside.
Labels must contain all the elements set out in article 54 of Council Directive 2001/83/EEC: the name of the medicine, the expression of strength where relevant, the route of administration, posology and warnings.
It’s also necessary for the name of the medication to be shown on the packaging in Braille, with the name chosen carefully so both blind, partially sighted and sighted patients are able to find out what it is with ease.
And the full name of the medication in question should be found on at least three non-opposing faces of the packet to assist with accurate identification.
If your product is a controlled drug, you should make sure the letters CD are included in an inverted triangle. This isn’t mandatory, but it is encouraged. For licensed medicines, all information on packaging has to be printed directly onto the packet, with no over-labelling ever used.
Unless all information can be found on the packaging, medication has to include a patient information leaflet, which must be easy to understand and not contain any personal information that could identify someone, such as digital signatures or names of staff members.
Labels must also come with warnings for safe use of medication and anything with paracetamol in it must come with a statutory warning.
You must also make sure that the packaging you’re using is child-resistant if the medication contains aspirin, paracetamol and more than 24mg of elemental iron. However, if the product is effervescent or in single dose units, this isn’t necessary.
In the future, we’re likely to start seeing increased interest in the likes of smart packaging, which makes use of technology to track and monitor dosage information and even give people reminders of when to take their medicine.
This kind of innovation can also help to prevent unauthorised access to drugs, as well as supporting child-resistance. For example, it’s likely that pre-filled syringes and tamper-evident packaging will start to become more commonplace.
With the UK leaving the EU at some point in the future, products that are being approved by the European Medicines Agency at the moment will be covered by the MRHA if we leave in a no-deal scenario.
In this event, new laws and systems for pharmaceutical packaging will have to be brought in, which is something for companies to bear in mind.