✅ GVP Module X – Additional Monitoring

📘 Purpose

GVP Module X outlines the principles and procedures related to “Additional Monitoring” of certain medicines to enhance early identification of new safety information. It ensures transparency and helps promote reporting of adverse drug reactions (ADRs) by healthcare professionals and patients.

🔹 What is Additional Monitoring?

Certain medicines require closer observation after authorization to:

• Encourage more intensive ADR reporting

• Collect more information on risks

• Detect unknown or evolving safety issues

These medicines are said to be under “Additional Monitoring” and are identified with a black inverted triangle (▼) on their product information.

🔹 The Black Triangle (▼)

• A symbol printed on:

  • Summary of Product Characteristics (SmPC)

  • Package Leaflet (PIL)

• Accompanied by the statement:

  “This medicine is subject to additional monitoring.”

💡 Goal:

To encourage more ADR reporting for such medicines, improving the safety database.

🔹 Which Products Are Under Additional Monitoring?

1. New active substances authorized in the EU after Jan 1, 2011

2. Biological medicines (e.g., vaccines, biosimilars)

3. Medicines with:

   • Conditional marketing authorization

   • Authorization under exceptional circumstances

4. Products with a requirement to conduct PASS (Post-Authorization Safety Studies)

5. Other medicines, if PRAC considers it necessary

🔹 Duration of Additional Monitoring

• Typically for 5 years from initial authorization

• May be extended or shortened based on emerging safety data and PRAC recommendation

🔹 Responsibilities

🔸 Marketing Authorization Holders (MAHs):

• Ensure black triangle and associated text are included in SmPC and PIL

• Promote ADR reporting

• Monitor and submit safety data per GVP requirements

🔸 Regulatory Authorities (EMA, NCAs):

• Maintain and publish the EU list of products under additional monitoring

• Oversee compliance and assessment of safety data

🔹 Communication and Awareness

• Black triangle is not a warning—rather, it is an awareness tool

• Healthcare professionals are encouraged to:

  • Report any suspected ADRs

  • Educate patients about the meaning of the triangle

🔹 Transparency

• EMA publishes the list of products under additional monitoring on its website

• The list is updated monthly

📌 Conclusion

GVP Module X reinforces early and active safety surveillance for specific medicines. The black triangle helps stakeholders remain vigilant, promoting patient safety through timely ADR reporting and enhanced pharmacovigilance.

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