Pharmaceutical industry urges MHRA to publish Windsor Framework packaging and labeling guidelines

13 Sep 2023 --- The pharmaceutical packaging industry faces a complex landscape of regulations and standards, especially with the UK’s withdrawal from the EU. One of the key developments in this context is the Windsor Framework, set to take effect on January 1, 2025. We speak to industry experts at the Association of the British Pharmaceutical Industry (ABPI) to gain insights into how this framework and other regulations impact pharmaceutical packaging.

Richard Greville, director of ABPI Wales Cymru and distribution supply chain, and Ross Maclagan, distribution and supply chain policy manager at the association, shed light on the challenges and opportunities the pharmaceutical industry is facing.

Greville details that the beginning of 2025 signifies the beginning of significant changes in pharmaceutical packaging regulations. While the framework introduces complexity, it also aims to streamline distribution and labeling practices across Northern Ireland and Great Britain.

“The industry view for medicines is that the Windsor framework introduces an overall efficiency in terms of distribution and logistics arrangements, including labeling of medicines,” Greville states while highlighting the industry’s overall positive perspective. Despite initial complexities, the framework is expected to improve the pharmaceutical supply chain in the long run.

During the interview, concerns regarding the timeline and clarity of regulations emerged. Maclagan emphasized the importance of having ample time to plan and implement changes, stating, “The longer you have to plan, the more likely that you’re going to be ready on January 1, 2025.” 

The pharmaceutical industry eagerly awaits guidance from the Medicines and Healthcare Products Regulatory Agency (MHRA), emphasizing the need for clear and timely information to ensure a smooth transition to the Windsor Framework despite the challenges posed by compressed timelines and additional regulations.

The conversation with ABPI revealed industry frustrations regarding the short notice periods and the need for clear guidelines. 

“There are associated guidance documents related to labeling, specifically concerning the licensing or marketing authorization of medicines to be released by the MHRA. We’re still waiting for this guideline to be issued, so until that time, we don’t have a complete picture of the regulators expectations for labeling medicines under the Windsor Framework,” states Greville.

The Windsor Framework removes complexity because the UK can be considered a single market for medicines.Beyond Windsor Framework
The discussion with ABPI experts also touched upon other regulations that the pharmaceutical packaging industry must contend with, such as the Plastic Packaging Tax (PPT) and Extended Producer Responsibility (EPR). 

Maclagan clarified that these regulations are separate from the Windsor Framework but add complexity to the packaging process. It was noted that these additional requirements present challenges in terms of compliance and coordination.

The regulatory landscape for pharmaceutical labeling differs between Northern Ireland and Great Britain (Scotland, England and Wales). Northern Ireland follows European regulations, while Great Britain adheres to UK regulations. A significant distinction lies in the application of the falsified medicines directive, which still applies in Northern Ireland but not in Great Britain.

Under this directive, medicines supplied to Northern Ireland are required to have serialization features as a mandated requirement. These features include batch numbers, product identifiers, Global Trade Item Number, expiry dates and a unique serialization number. These details must be incorporated into a two-dimensional matrix on each medicine pack.

Additionally, a system for verifying medicines upon supply to patients is in place in Northern Ireland. Pharmacists or dispensers in Northern Ireland scan medicines, decommission them from a central repository and then provide them to patients. This system ensures the authenticity and safety of medicines.

However, these serialization features are not mandated in Great Britain but can be added voluntarily. This distinction arises from the impact of Brexit, which eliminated the requirement for these features in medicines supplied to Great Britain.

“There have been quite a few changes [since Brexit] – there has been the need to manage labeling options for medicines for the whole of the UK, which has caused complexity to the system. But added complexity to the system will be removed when the Windsor framework comes into play,” says Greville. 

“It’s a reversion to a UK-wide approach to the packaging of medicines, which will make things a bit easier.”

“Swings and roundabouts”
Maclagan explains the situation before Brexit: “Pre-Brexit, the UK was part of the European Union, and EU-compliant packaging, as described in the Falsified Medicines Directive, applied across the entire UK.” This allowed shared packaging with other European markets.

However, after Brexit, the dynamics changed significantly. “From a manufacturing and packaging perspective, supplying Northern Ireland became more complicated,” Maclagan continues. “Historically, the majority of supplies for Northern Ireland came from Great Britain, but post-Brexit, there was a need to potentially provide European-compliant packaging to Northern Ireland, separate from what was supplied to Great Britain.”The pharmaceutical industry is awaiting associated guidance to be issued by MHRA.

Greville adds that the Windsor Framework is a balance, “it’s swings and roundabouts.” 

“The Windsor Framework introduces some complexity by introducing a new ‘UK only’ label. However, it also removes complexity because the UK can be considered a single market for medicines, whereas, for the last two or three years, it’s been a separate relatively small market.” 

“Supply to Northern Ireland over the last few years has been a bit of a headache despite remaining under EU regulations. But headache will be removed by the Windsor Framework,” clarifies Greville.

The ABPI experts reiterate that the industry’s view is that while the Windsor Framework introduces overall efficiency in distribution and logistics, it comes with challenges and trade-offs, emphasizing the importance of balance.

In discussing the Windsor Framework and its challenges, Greville highlights the need for guidance from the MHRA, stating, “We are waiting for the MHRA to issue guidance on the licensing arrangements under the Windsor Framework that should be published soon.” This guidance is crucial for companies to make preparations for the changes set to take place.

Greville also stresses that time is running out, and the industry is frustrated due to the delay in publishing necessary guidance. He notes, “inevitably, change is a challenge to implement.”

“In our engagements with the EC and the UK government, while they were negotiating the Windsor Framework, we made the point that our industry, in general, requires 18 months’ notice of change. We will not have 18 months’ notice between the time the guidance is published and the date of implementation of the Windsor Framework, which is disappointing.”

The ABPI experts stress that the pharmaceutical industry seeks clarity and sufficient notice regarding regulatory changes. While there are concerns about the compressed timeline, there is no desire to delay the implementation of the Windsor Framework.

In the context of additional regulations like the PPT and EPR, Greville acknowledges that the pharmaceutical industry is accustomed to dealing with rules and regulations. However, clarity and notice remain essential for businesses to adapt effectively to these changes.

By Radhika Sikaria