The European Medicines Agency (EMA) has introduced detailed guidelines for marketing authorization holders (MAHs) regarding Article 61(3) notifications. These guidelines streamline the process for making minor changes to drug labelling and package leaflets without altering the Summary of Product Characteristics (SmPC). Starting January 2025, MAHs must utilize the new IRIS platform for managing these updates, ensuring a more efficient and standardized approach across the European Union.
Clear Submission Requirements
Under Directive 2001/83/EC, Article 61(3) notifications pertain to modifications in Annexes IIIA (labelling) and IIIB (package leaflet) that do not impact the SmPC or Annex II. Examples include changes to local representatives, minor textual adjustments, and harmonization of wording across different language versions. The EMA emphasizes that these changes must be consistent across all EU languages, ensuring uniformity and clarity for consumers and healthcare professionals alike.
Streamlined Review Process
The EMA has outlined a comprehensive review process for these notifications. Upon submission through the IRIS platform, a dedicated Procedure Manager (PM) will evaluate the documentation within 90 days. If the submission is incomplete, the MAH will be prompted to provide additional information within five days. Approved changes will be reflected in the next regulatory procedure or implemented immediately if the EMA does not respond within the stipulated timeframe.
- Ensures consistency across all EU languages for labelling changes.
- Reduces administrative burden by allowing submission at any time.
- Introduces the IRIS platform for better management and monitoring.
- Provides clear guidelines on when mock-ups and specimens are required.
- Eliminates fees for submitting Article 61(3) notifications.
EMA’s initiative aims to foster a more efficient regulatory environment, enabling pharmaceutical companies to make necessary labelling updates swiftly and accurately. By clarifying the requirements and simplifying the submission process, the agency supports MAHs in maintaining compliance while minimizing disruptions to their operations.
The new guidelines not only enhance the regulatory framework but also ensure that critical information regarding medicinal products remains accurate and accessible to all stakeholders. This development underscores the EMA’s commitment to improving public health outcomes through streamlined processes and enhanced communication between regulatory bodies and industry players.
Pharmaceutical companies should familiarize themselves with the IRIS platform and the updated Article 61(3) procedures to ensure seamless compliance. Staying informed about these changes will facilitate timely updates to product information, ultimately contributing to better patient safety and informed healthcare decisions across the European Union.
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