How do serious undesirable effects (SUE) reporting work with an EU Cosmetics Responsible Person?

## How Do Serious Undesirable Effects (SUE) Reporting Work with an EU Cosmetics Responsible Person? The EU requires reporting of **serious undesirable effects (SUE)** to competent authorities. Understanding the RP's role in this process is essential for maintaining compliance and consumer safety. ### EU SUE Reporting Requirements Under Regulation (EC) No 1223/2009, manufacturers and Responsible Persons must report: 1. **Serious undesirable effects** - Adverse effects that meet the definition of "serious" under the regulation 2. **Non-serious undesirable effects** - May also need to be reported in certain circumstances 3. **Trend reporting** - Patterns of effects that may indicate systemic issues ### The RP's Key Role Article 23 of Regulation (EC) No 1223/2009 puts the RP in a **key role** for SUE reporting: The RP is responsible for **ensuring** that serious undesirable effects are reported to competent authorities. The RP serves as the contact point for authorities and must coordinate SUE reporting. ### For Foreign Manufacturers Regulation 1223/2009 indicates that the **Responsible Person should be included in SUE communications**. This means: - The RP should be notified of SUEs - The RP should be involved in the reporting process - The RP should be kept informed of corrective actions ### Practical Workflow A well-functioning SUE reporting workflow should include: #### 1. **Complaint/Effect Intake** - Receive and log complaints or adverse effect reports - Triage against "serious undesirable effect" criteria - Determine if the effect occurred in the EU #### 2. **Triage Against Criteria** - Assess whether the effect meets the definition of "serious undesirable effect" - Determine reporting requirements and timelines - Identify if corrective action is needed #### 3. **Draft Authority Report** - Prepare the SUE report in the required format - Include all required information - Coordinate with RP for review and submission #### 4. **Submit + Track Corrective Actions** - Submit report to competent authority through appropriate channels - Track submission and any follow-up requests - Implement corrective and preventive actions (CAPA) - Submit market withdrawal notifications if required #### 5. **Closeout Evidence** - Document that reporting is complete - Maintain records of submissions and responses - Update PIF and safety assessment files ### Reporting Timelines While specific timelines may vary, you should: - **Report serious undesirable effects promptly** - Typically within days, not weeks - **Notify RP immediately** - Don't wait to involve them - **Coordinate with RP** - They need to ensure submission happens - **Track and follow up** - Ensure competent authority receives and processes the report ### RP Responsibilities Your RP should: - ✅ Have a clear process for receiving SUE notifications - ✅ Review reports before submission - ✅ Submit reports to competent authorities in required format - ✅ Track submissions and follow up as needed - ✅ Coordinate with you on any authority requests - ✅ Maintain records of all SUE reporting activities ### What to Ask Your RP 1. **"What is your process for handling serious undesirable effect reports?"** - How quickly can they review and submit? - What format do they require from you? 2. **"Do you actively manage reporting, or do you rely on us to draft everything?"** - Some RPs draft reports, others review manufacturer drafts - Understand the division of labor 3. **"How do you track submissions and ensure competent authorities receive them?"** - You need confirmation that reports were submitted - Track record of successful submissions 4. **"What happens if competent authorities ask follow-up questions?"** - Who responds? - How quickly? - What information do they need from you? ### Best Practices 1. **Establish Clear Processes** - Document your SUE reporting workflow 2. **Communicate Early** - Notify RP as soon as you identify a reportable SUE 3. **Maintain Records** - Keep detailed records of all SUEs and reports 4. **Regular Review** - Review your SUE reporting process with RP periodically 5. **Train Your Team** - Ensure your team knows when and how to report ### Common Mistakes - ❌ Waiting too long to notify RP - ❌ Not including RP in SUE communications - ❌ Assuming RP will handle everything without your input - ❌ Not maintaining proper records - ❌ Not following up on submissions ### Next Steps 1. Establish clear SUE reporting workflows with your RP 2. **[Compare EU Cosmetics Responsible Person providers & request quotes](https://cruxi.ai/regulatory-directories/cosmetics_rp)** - Find providers with strong SUE reporting capabilities --- *Written by **Lo H. Khamis**, Regulatory Experts. [Connect on LinkedIn](https://www.linkedin.com/in/lo-h-khamis) for regulatory guidance.* ### Official Sources: - [Regulation (EC) No 1223/2009 - Article 23](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009R1223)