In the UK, there are various rules and regulations* in place relating to pharmaceutical packaging.
Here, Origin looks at these laws and guidelines in further detail – as well as touching on how Brexit has impacted pharma packaging.
General pharma packaging rules, regulations, and standards
The UK government offers guidance on the manufacturing and sale of pharma packaging – designed to keep patients safe through accurate administering information and the avoidance of accidental ingestion, for example, by children.
There are also strict laws in place ensuring packaging is manufactured in an environment deemed suitable, with the correct processes followed so that the pharmaceutical product does not get contaminated.
There are numerous pharmacopoeia standards that must be adhered to. For example, if water is utilised in the process, it needs to be EP grade, which ensures worldwide specifications are met and impurities are low.
MHRA guidelines
MHRA guidelines represent one of the primary resources to refer to when it comes to pharma packaging regulations in the UK – approving all labelling and packaging information of medicines sold.
For example, medicines must have a patient information leaflet (PIL) included if the necessary information is not displayed on the label, with PIL guidelines as follows:
- Leaflets must not feature any personal information that could make a person easy to identify, for example, digital signatures or names of staff members
- Leaflets must be easy to understand
The UK Government has also issued best practice guidance for all products, so it is worth referring to these.
Safety feature legislation
The UK also requires all pharma packaging to include two mandatory safety features (originally as part of the EU2016/161 legislation, pre-Brexit).
These are as follows:
- A unique identifier – enabling products to be scanned at points in the supply chain to combat counterfeit products.
- An anti-tampering device – to avoid product contamination or patient consumption of potentially harmful products.
The impact of Brexit
Brexit caused major disruption to the regulation of pharma packaging in the UK.
Pre-Brexit, the UK adhered to European Medicines Agency (EMA) regulations, with compliant products licensed for distribution across all EU nations. EU medicines were able to move into the UK and vice versa. However, post-Brexit, UK medicines are now regulated by the Medicines and Healthcare Products Regulatory Agency (MHRA).
The UK has acted to combat some of this disruption by enacting EU-equivalent laws to allow European medicines to be distributed legally in the country. However, it will have to continue developing new laws for patient information, labelling, and packaging.
Compliant UK pharma packaging from Origin
Origin is an industry leader in the design and delivery of compliant pharma packaging – meeting all UK regulations and ensuring patient safety.
For more information on medical device regulation in the UK – as well as the ongoing impact of Brexit on the industry – contact Origin’s expert team today.
*Please note legislation is changing all of the time, and therefore, Origin cannot be held responsible for any of the legal information that is supplied. It is vital that you confirm the comprehensive legal literature with official sources.
