Swissmedic has released key insights on parenteral products in the cosmetic sector. This update, published on October 13, 2025, emphasizes specific regulatory criteria for these unique formulations. Targeted at clinical, quality, and regulatory professionals, the announcement serves as guidance to navigate specialized requirements.
What changed?
Swissmedic’s latest communication outlines distinct features of parenteral products used in cosmetics. These products, often administered through injection, require close attention to safety, sterility, and efficacy due to their invasive nature. The focus is on ensuring their compliance with appropriate standards.
In the shorter version of its position paper, Swissmedic provides practical, targeted details for manufacturers, distributors, and regulatory teams. This documentation promotes aligned interpretation of existing regulatory frameworks for parenterals.
Why parenterals matter
Parenteral products differ significantly from topical or oral applications. They bypass digestive processes and interact directly with internal tissues, necessitating stringent control measures. In cosmetics, such products are gaining traction for their advanced benefits, including enhanced delivery of active ingredients.
Swissmedic emphasizes the critical need for sterility and precise dosing. Additionally, due consideration must be given to the products’ intended medical or aesthetic purpose, in alignment with European MDR Annex XIV standards. These factors dictate their risk classification and associated compliance activities.
Who is affected?
This update is particularly relevant for clinical researchers, quality assurance teams, and regulatory affairs professionals in companies that manufacture, distribute, or oversee parenteral cosmetic products.
Medical device companies engaged in developing injectable cosmetic formulations will benefit from understanding these guidelines. Similarly, laboratories responsible for biocompatibility testing and sterility assurance must align their methodologies with regulatory expectations.
Swissmedic’s recommendations also shed light on the cosmetic-medical crossover, underscoring precise labeling and delimitation practices for products intended for aesthetic use versus therapeutic indications.
FAQ
Q1: What types of parenteral products are covered?
A: Parenteral solutions, injectables for aesthetic purposes, and devices used for cosmetic procedures.
Q2: Are these new regulations?
A: No, Swissmedic is clarifying existing guidelines to improve compliance and understanding.
Q3: How detailed is Swissmedic’s position paper?
A: Swissmedic provides practical advice focusing on sterility, risk assessments, and product categorization.
Conclusion
Swissmedic’s latest update aims to refine the understanding of parenteral cosmetic products. Stakeholders should review the position paper closely to ensure compliance with the outlined criteria. Regular updates like these are essential for maintaining both product safety and competitive market positioning.
Disclaimer
This information is provided for educational purposes. It does not constitute legal advice. Always consult regulatory experts for specific compliance requirements.
Swissmedic announcement
For full information about the Swissmedic announcement, see the link below.