.png)
The landscape of medicine packaging in Europe is evolving to address challenges related to medicine availability, particularly for low-volume, hospital-administered products. A significant stride in this direction is the recently launched Nordic Packaging Pilot by the medicine regulators in Denmark, Finland, Iceland, Norway, and Sweden. Running until 2030, this pilot aims to streamline packaging and labeling processes across borders, offering valuable insights for broader adoption in other regions, including Ireland.
What is the Nordic Packaging Pilot?
An initiative that focuses on introducing medicine packs with English-only labeling and package leaflets printed in English. The target is low-volume, hospital-administered products, where standardizing language and packaging can reduce production complexities and improve supply chain efficiency. This pilot not only benefits the Nordic countries but also sets a precedent for other regions looking to maximize medicine availability.
Conditions for Marketing Authorization Holders (MAHs)
MAHs can participate in this initiative under the following conditions:
Harmonized Product Information: The product information text must be fully harmonized, such as through the Mutual Recognition Procedure (MRP) or Decentralized Procedure (DCP)
Exclusion of Irish Blue Box Elements: The packs should not require additional Irish-specific blue box elements
If these criteria are met, MAHs can submit a national article 61.3 notification to add the necessary authorization details, such as the MAH and PA numbers, to the packs. This process ensures compliance while enabling the creation of joint packs that meet the needs of multiple regions.
Expanding the Scope to Centralized Products
The initiative is not limited to MRP/DCP products. Centralized products can also benefit from the approach, though their mock-up reviews fall under the remit of the European Medicines Agency (EMA). By aligning with EMA guidelines, joint packs can be extended to a wider range of products, further enhancing flexibility for companies and accessibility for patients.
Complementing Multilingual Packaging Initiatives
The joint pack concept complements existing multilingual packaging initiatives, as outlined in the CMDh Best Practice Guide on Multilingual Packaging. By simplifying labeling and packaging requirements, such initiatives aim to:
Improve medicine availability across regions
Reduce logistical and regulatory burdens for manufacturers
Ensure compliance with diverse regulatory frameworks while maintaining patient safety
Opportunities for Ireland
Adding Irish product details to such standardized packs presents a practical opportunity to enhance medicine availability in Ireland. This can be particularly impactful for low-demand products where multilingual packaging might otherwise limit supply. By leveraging the framework of the Nordic Packaging Pilot, Ireland can achieve greater flexibility and efficiency in its medicine supply chain.
Future Vision
The Nordic Packaging Pilot is a promising step toward more efficient and accessible medicine distribution across Europe. By adopting similar practices, Ireland can benefit from joint packs that reduce barriers to medicine availability. The collaboration between regulators and industry stakeholders is key to achieving this vision, ensuring that patients have timely access to essential medicines.
As we move toward 2030, such initiatives highlight the importance of harmonization and innovation in regulatory practices. Ireland’s engagement in these efforts will not only improve medicine availability but also position the country as a leader in adopting flexible, patient-centric solutions.
Commentaires