There are a number of rules and regulations in place regarding pharmaceutical packaging across Europe. Here, Origin takes a look at some of the most important laws*.
European guidelines on pharmaceutical packaging
According to the ‘Europe Pharmaceutical Packaging Market,’ Europe is currently the second-largest market for pharmaceutical packaging, accounting for roughly 33 per cent of the worldwide market – which is expected to be worth around $128 billion by 2025.
In order to regulate this market – and ensure the safe delivery of vital medication – the European Medicines Agency has put together scientific guidelines designed to assist medicine developers in preparing marketing authorisation applications for human medicines.
EU pharma packaging regulations
The procedures and requirements for marketing authorisation – as well as the laws for monitoring authorised products – are primarily laid down in Regulation (EC) No. 726/2004 and Directive 2001/83/EC. This regulation features harmonised provisions regarding the marketing, wholesaling, and manufacturing of medicinal products for human use.
There are also specific rules in places that govern certain areas of medicine, including:
- Advanced therapy medicinal products – Regulation EC No 1394/2007
- Medicinal products for children – Regulation EC No 1901/2006
- Medicinal products for rare disease – Regulation EC No 141/2000
One of the more recent pieces of legislation that came into place in 2015 is the EU Directive of Falsified Medicines. This is officially labelled as Directive 2011/62/EU and came into place to recognise the increasingly complicated medicinal products distribution network, with an increasing number of players.
The legislation states a number of different safety features that stakeholders must have implemented in all products, including a unique identifier and tamper-evident features. These features are designed to stem the tide of the growing fraudulent pharma product market and keep patients safe from the impact of counterfeit products.
The Brexit fall-out
In addition to the existing challenges facing UK pharma packaging manufacturers – in meeting EU regulations – Brexit has delivered its own tests. The impact of the UK leaving the EU is being felt by all those who distribute medicines across these territories.
Pre-Brexit, products authorised and regulated by the European Medicines Agency (EMA) were licensed for distribution across all EU nations – with EU medicines moving to the UK and vice versa. However, post-Brexit, UK medicines are now regulated by the Medicines and Healthcare Products Regulatory Agency (MHRA).
And while the UK has enacted EU-equivalent laws to allow European medicines to be distributed legally in the country, it will also have to continue developing new laws for patient information, labelling, and packaging – so, we are likely to see some important changes in the near future.
Compliant packaging from Origin
We hope that this has helped you to get a better understanding of the laws that are in place for pharma packaging Europe-wide.
For more information on medical device regulation in the UK and EU, or the ongoing impact of Brexit on your business – as well as how all our products meet the latest industry standards to ensure patient safety – contact Origin 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 with official sources.
