What happens if a serious adverse reaction is reported for my cosmetic product?

## What Happens If a Serious Adverse Reaction Is Reported for My Cosmetic Product? The regulation requires communication of serious undesirable effects to the competent authority by the responsible person (and distributors) without delay, with product identification and any corrective measures taken. ### Legal Requirement According to Article 23 of Regulation (EC) No 1223/2009, the regulation requires communication of serious undesirable effects to the competent authority by the responsible person (and distributors) **without delay**^{<a href="#cite-16">[1]</a>}, with product identification and any corrective measures taken. ### What Is a Serious Undesirable Effect (SUE)? A serious undesirable effect is an undesirable effect which: - Results in temporary or permanent functional incapacity - Results in disability - Results in hospitalization - Results in congenital anomalies - Results in immediate vital risk - Results in death - Results in other serious effects as defined in the regulation ### Reporting Requirements **Who Must Report:** - ✅ Responsible Person (must report) - ✅ Distributors (must report) - ✅ Manufacturers (should notify RP) **What Must Be Reported:** - Product identification - Description of the serious undesirable effect - Any corrective measures taken - Other information as required **Timeline:** Reports must be submitted **without delay**^{<a href="#cite-16">[1]</a>} ### SUE Reporting Process Checklist When a serious undesirable effect is reported: - [ ] Receive and log the SUE report - [ ] Triage against "serious undesirable effect" criteria - [ ] Determine if effect occurred in EU - [ ] Identify product involved - [ ] Gather all relevant information - [ ] Prepare SUE report in required format - [ ] Submit report to competent authority without delay - [ ] Document submission - [ ] Implement corrective measures if needed - [ ] Track follow-up requests - [ ] Update PIF and safety assessment ### Corrective Measures If corrective measures are taken, they must be reported and may include: - [ ] Product withdrawal from market - [ ] Product recall - [ ] Labeling changes - [ ] Formula modifications - [ ] Warnings added - [ ] Instructions for use updated - [ ] Other corrective actions ### 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 - [ ] Update PIF and safety assessment when needed ### SUE Reporting Workflow **Step 1: Intake** - Receive SUE report - Log and document - Triage against criteria **Step 2: Assessment** - Determine if reportable - Gather product information - Identify corrective measures needed **Step 3: Reporting** - Prepare report in required format - Submit to competent authority - Document submission **Step 4: Follow-Up** - Track authority requests - Implement corrective measures - Update documentation ### Common SUE Reporting Mistakes - ❌ Delaying reports instead of submitting "without delay" - ❌ Not reporting because effect seems minor - ❌ Incomplete reports (missing required information) - ❌ Not coordinating with RP - ❌ Not implementing corrective measures - ❌ Not updating PIF and safety assessment - ❌ Not maintaining records ### 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 ### Questions 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?"** - Understand the division of labor 3. **"How do you track submissions and ensure competent authorities receive them?"** - You need confirmation that reports were submitted 4. **"What happens if competent authorities ask follow-up questions?"** - Who responds and how quickly? ### Next Steps 1. Establish clear SUE reporting workflows with your RP 2. Train your team on SUE identification and reporting 3. **[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: <a id="cite-16"></a>[1] [Regulation (EC) No 1223/2009 - Article 23](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009R1223)