There are a number of rules and regulations that are in place regarding pharmaceutical packaging across Europe. On this page, we will take a look at some of the laws that are in place. However, it is imperative to note that 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 double check with official sources.
According to ‘Europe Pharmaceutical Packaging Market,’ Europe is currently the second-largest marketing for pharmaceutical packaging, accounting for roughly 33 per cent of the worldwide market. It is believed that the global market will be worth around $128 billion by the time we reach 2025. This is clearly an industry that is growing at a rapid pace.
European guidelines on pharmaceutical packaging
The European Medicines Agency has put together scientific guidelines that are designed to assist medicine developers in preparing marketing authorisation applications for human medicines. Plus, you will find that the procedures and requirements for marketin authorisation, and also the laws for moinotiring authorised products, are primarily laid down in Regulation (EC) No. 726/2004 and Directive 2001/83/EC. They also feature harmonised provision 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. Some examples are as follows:
- 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 came into place in 2015. This is the Eu Directive of Falsified Medicines, which was published in July 2011. This is offically labelled as Directive 2011/62/EU. This 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 by the close of 2015.
The Brexit fall-out
One thing that all European and UK businesses are concerned with, as well as those who distribute medicines across these territories, is the fall-out of Brexit. No matter what the final terms of the agreement turn out to be, UK pharmaceutical companies will not be able to act as ‘co-rapporteurs’ when it comes to the marketing authoritsation process for UK products. Plus, if there is a no-deal agreement, this means that products that are advertised in the UK, which are currently approved by the EMA, will actually become the responsibility of the MRHA. This means that new laws for patient information, labelling, and packaging will need to be made, and so we are likely to see some important changes in the near future.
We hope that this has helped you to get a better understanding of the laws that are in place for pharma packaging Europe wide. However, if you need further assistance about medical device regulation EU, the Brexit impact on your business, or anything else, please do not hesitate to give us a call.