Packaging and label compliance in Europe: Successfully navigating regulations with Sciensus
Packaging and labeling compliance is crucial to successfully launching an orphan drug into the European market. With safety, efficacy, and accessibility at the forefront of any commercialization strategy, effective packaging and labeling are essential to ensuring patients receive the right medication and understand how to use it. However, with 24 languages spoken and a complex array of local specifications, getting to grips with European regulations can feel like an uphill battle.
With more than 30 years of experience helping biotech companies expand access to orphan and rare disease medications, Sciensus provides strategic solutions to ensure the success of your launch in the European market.
Understanding the European regulatory landscape
The regulatory environment for orphan drugs in Europe includes several specific provisions to address the unique challenges of rare disease medications. The European Medicines Agency (EMA) is a decentralized agency of the EU that is responsible for the evaluation, supervision, and safety monitoring of medicines in the region.
However, while the EMA approves medication for use, each country is free to develop its own guidelines and negotiate pricing and reimbursement. This means that Europe can’t be tackled as a single market but instead is made up of multiple individual markets, each with a unique regulatory and logistical landscape.
European labeling requirements for orphan drugs are stringent and information must include clear dosage and administration instructions, details of any potential side effects, and storage guidance. Packaging must also be secure and protect the product from contamination, tampering, and damage. The EMA and national health authorities oversee compliance with the regulations, ensuring that all orphan drugs meet the necessary standards before they reach the market. Non-compliance can lead to severe consequences, such as patient harm, and challenges in achieving further approvals and market access.
How Sciensus can help you overcome European labeling challenges
What makes this especially challenging in Europe is the fact that the exact details needed vary from country to country, meaning each nation will require bespoke labeling. At best, this means translating patient information into 24 different languages, but it can also include more precise requirements such as printing the price or a country-specific recycling symbol on the packaging.
While this presents a lot of information to gather and digest, it also has an impact on stock planning. With orphan drugs, we’re talking about low-volume, high-value products which makes the stock management process considerably more challenging. Preparing too much stock for one country risks wastage but holding everything back before printing packaging and shipping to Europe makes it incredibly difficult to fulfill orders efficiently.
To maintain compliance throughout the product lifecycle, biotechs must stay up to date with regulatory requirements and any upcoming changes and ensure that their regulatory, quality, and packaging teams work in close partnership. By working together from the early stages of product development, these teams can integrate compliance considerations into the product design, labeling, and packaging processes.
At Sciensus, we offer a fully managed service, designed to meet the specific challenges of launching and supplying orphan drugs in Europe. This includes support with regulatory compliance, import licenses, cash collection, customer service, order management, and the storage and delivery of your product.
From our central European hub, we offer clients the ability to store and finish off the packaging of their products as orders are received, known as late-stage customization. Late-stage customization enables you to prepare your product for the European market, without having to commit to precise volumes for specific countries. You can import your products to our medical warehouse in the Netherlands without the final packaging. With late-stage customization, all the local personalization and packaging design can be done by us based on your brand in small batches to meet country-specific needs.
Thanks to our centrally located hub, we can deliver to most European countries within 24-28 hours so we hold deliveries as late as possible and make small country-specific shipments to lower the stock risk for our clients. Where possible, we apply our extensive knowledge to group countries with similar requirements to simplify the customization process and can also help you apply to the EMA for any applicable exemptions.
Conclusion
Packaging and labeling compliance is critical to the success of new orphan drug launches. Effective compliance ensures patient safety, regulatory approval, and market access, enabling biotechs to bring life-saving treatments to patients in need.
With the support of Sciensus’ expert team, you can successfully navigate the complex European regulatory landscape, design compliant labels, and manage the entire packaging manufacturing process. Through a strategic partnership with Sciensus, you will be empowered to focus on developing innovative new treatments for rare diseases, safe in the knowledge that your products meet the regulatory standards and can reach the patients who need them quickly and safely.
