Data submission of authorised medicines in the European Union: Outlines on Article 57(2) of Regulation (EC) No 726/2004

Data submission of authorised medicines in the European Union: Outlines on Article 57(2) of Regulation (EC) No 726/2004:

Article 57(2) of Regulation (EC) No 726/2004, as amended by later regulations, plays a crucial role in ensuring the European Medicines Agency (EMA) has a comprehensive overview of all authorized medicines within the European Union (EU) and the European Economic Area (EEA). This article mandates that marketing authorization holders (MAHs) electronically submit specific data on their products to the EMA.

Why is this data important?

The information submitted under Article 57(2) serves several key purposes:

• Creating a Complete Inventory: This data establishes a central repository of all authorized medicines for human use in the EEA. This includes medicines approved centrally by the EMA and those approved at the national level by individual countries’ competent authorities.
• Enhancing Pharmacovigilance: Pharmacovigilance refers to the monitoring of the safety of medicines after they are placed on the market. The Article 57 data allows the EMA to effectively code and analyze information from Individual Case Safety Reports (ICSRs) submitted within the EudraVigilance system. This system is vital for identifying and managing potential safety risks associated with medicines.
• Supporting Regulatory Activities: The EMA utilizes the data for various regulatory activities, including data analysis, trend identification, and communication with healthcare professionals and the public.

What data needs to be submitted?

MAHs are required to submit information following the Article 57 format or the eXtended EudraVigilance Product Report Message (XEVPRM) format. This data encompasses various aspects of the authorized medicine, including:

• Product name and marketing authorization number
• Active ingredients and their quantities
• Pharmaceutical form (e.g., tablet, capsule)
• Strength and dosage
• Marketing authorization holder details
• Therapeutic area
• Date of marketing authorization

Submission Process and Deadlines

MAHs must submit data on new marketing authorizations within 15 calendar days of receiving notification from the National Competent Authority (NCA) or the EMA. The EMA website provides resources and guidance to assist MAHs with the submission process. Additionally, they are responsible for keeping the submitted data up-to-date with any changes to the authorized product.

Benefits of Article 57(2):

This regulation offers significant benefits for public health and the pharmaceutical industry:

• Improved Patient Safety: By facilitating robust pharmacovigilance activities, Article 57(2) helps ensure the safety of medicines available to EU and EEA citizens.
• Enhanced Regulatory Decision-Making: Access to a comprehensive dataset empowers the EMA to make informed regulatory decisions regarding medicines.
• Streamlined Processes: The standardized electronic format simplifies data submission and management for MAHs and the EMA.

Conclusion

Article 57(2) of Regulation (EC) No 726/2004 is a cornerstone of the EU’s system for monitoring and ensuring the safety of authorized medicines. By mandating the submission of essential product data, this regulation contributes to improved pharmacovigilance, informed regulatory actions, and ultimately, better public health outcomes within the European Union.