On October 2, 2025, Chemidex Pharma Ltd notified the Medicines and Healthcare products Regulatory Agency (MHRA) about incomplete safety information in the Patient Information Leaflets (PILs) for their topical steroid products. This affects specific batches currently on the market. Healthcare providers and regulatory professionals handling these medicines must assess the situation and implement appropriate risk mitigation measures.
To navigate key areas of concern, use the links below:
- What changed?
- Who is affected?
- Regulatory implications
- Frequently Asked Questions
- Conclusion and next steps
- Disclaimer
- Full announcement link
What changed?
Chemidex Pharma Ltd identified that the PILs accompanying several batches of their topical steroid products lack mandatory safety information. This omission contravenes established regulatory and safety standards, potentially leaving patients and healthcare providers unaware of critical usage information.
The missing information pertains to safety warnings required for proper use and management of risks associated with topical steroids. The company has engaged with the MHRA to ensure appropriate actions are taken to remedy this issue.
Who is affected?
This issue affects clinical teams, pharmacists, and patients using specific batches of Chemidex Pharma’s topical steroids. Regulatory and quality assurance professionals involved in distribution and oversight of these medicines also have a significant role in addressing the identified risk.
Patients who already have these products should be informed about the incomplete PILs and advised to contact healthcare providers for proper guidance.
Regulatory implications
Under regulatory frameworks such as MDR Annex XIV, it is mandatory for medicinal products to include comprehensive safety information with every distribution batch. Lapses such as this may result in regulatory reviews, product recalls, or additional obligations for the manufacturer to update materials promptly.
Regulatory affairs and compliance officers should verify that affected products are flagged in their systems. This is essential to prevent further distribution of batches with incomplete documentation. Organizations must also be prepared to assist in audits or provide traceability documentation to ensure compliance continuity.
Professionals are encouraged to monitor relevant updates and guidance from the MHRA to ensure their practices align with the latest safety and regulatory requirements.
Frequently Asked Questions
-
What batches are impacted?
The notification does not specify particular batch numbers. Stakeholders should refer to the MHRA link for detailed information. -
What actions should pharmacists take?
Pharmacists should inform patients about the missing safety information and provide counseling based on professional knowledge or alternative resources. -
What is the MHRA’s role in this case?
The MHRA is ensuring Chemidex Pharma addresses the issue in line with regulatory requirements and patient safety commitments.
Conclusion and next steps
Chemidex Pharma’s notification underscores the importance of accurate and complete patient information in medicinal products. Regulatory professionals and pharmacists must work together to mitigate risks from the affected batches and ensure patients are properly guided.
Ensure you review the details of this announcement and take necessary actions in line with your institutional policies to maintain high safety and compliance standards.
Disclaimer
This article provides information for clinical, quality, and regulatory professionals. It does not constitute legal or medical advice. For detailed regulatory guidance, refer to the MHRA or qualified professionals.
Full announcement link
For full information about the announcement, see the link below.