In the UK, there are a number of different rules and regulations in place relating to pharmaceutical packaging. On this page, we will take a look at these laws and guidelines on pharmaceutical products in further detail, as well as touching on how Brexit will impact pharma packaging.
General rules, regulations, and standards
There are 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.
The MHRA guidelines represent one of the primary resources to refer to when it comes to pharma packaging regulations in the UK. The MHRA approves all labelling and packaging information of medicines sold in the United Kingdom. Medicines must have a patient information leaflet (PIL) included if the necessary information is not displayed on the label. Patient information leaflet guidelines are as follows:
These leaflets must not feature any personal information that could make a person easy to identify, for example, digital signatures or names of staff members
These leaflets must be easy to understand
The UK Government has issued a best practice guidance for all products, so it is worth referring to these.
Safety feature legislation
There are two mandatory safety features that were implemented as part of the EU2016/161 legislation. These are as follows:
What are the tamper evidence features on the pack?
A unique identifier that is placed on products, enabling them to be scanned at points in the supply chain
What about Brexit?
If there is one thing that everyone is talking about at the moment, it is Brexit. The pending exit from the European Union is going to have repercussions across all industries, and the pharma packaging sector is no different. At the moment, there are two separate pieces of legislation in place regarding UK labelling for medicines and EU labelling. In the UK, the regulations are outlined in The Human Medicines Regulation 2012. For Europe, there is the Title V of Council Directive 2001/83/EC, which has since been updated twice. Therefore, there are distinct pieces of legislation that companies are already following depending on the market they are distributing in. Nonetheless, the biggest consequence is likely to be seen in terms of the European Medicines Agency (EMA), which governs marketing authorisation for pharma products, moving from London to the Netherlands. This will add complexities when it comes to responsibilities and remits, as well as key members of staff being lost.
Hopefully, you now have a better understanding of the different rules and regulations that are in place concerning pharmaceutical packaging. As you can see, there are lots of stringent requirements, and corners certainly cannot be cut. Plus, with the uncertainty surrounding Brexit, it is important for companies to keep an eye on the latest updates regarding legislation, as there are likely to be some changes on the horizon. Please do not hesitate to get in touch for more information.
Legislations/ Case Studies:
MHRA Medical device regulations and how they enforce them: Medical Device Regulations
MHRA Guidance on Marketing Drugs or Medicines: License Guidance
Safety Feature Legislation, EU Directive: Safety Feature Legislations