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Cosmetovigilance
biologit
Meeting the Challenges in Safety Regulations for Cosmetics
The cosmetics industry is becoming increasingly regulated. This is underpinned by EU Regulation that came into play in July 2013: Regulation (EC) No. 344/2013, thus amending the previous, less stringent Regulation (EC) No.2013/2009. Under this amendment, manufacturers, distributors, and retailers are required to report serious undesirable effects (SUE) on cosmetic products to the appropriate authorities globally.
In the USA, MoCRA FDA Cosmetics Registration, implemented in December 2023, will aim to ensure the safety of cosmetic products consumed by customers daily. A key part of ensuring cosmetic safety is conducting cosmetovigilance. Cosmetovigilance can be defined as the collection, evaluation, and monitoring of spontaneous reports of undesirable events observed during or after the use of a cosmetic product.
Your Partner in Cosmetovigilance
As your global partner, our cosmetovigilance experts can help solving your safety surveillance and regulatory submissions needs:
Cosmetovigilance systems setup
Medical literature monitoring of suspected undesirable effects (SUE)
Cosmetic Product Safety Report (CPSR)
Responsible person (RP) services
Training and Support
Literature Monitoring for Cosmetovigilance
Monitoring the scientific literature for adverse events is a critical component for cosmetovigilance and regulatory submissions of cosmetics.
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The biologit's MLM-AI platform is a validated and compliant SaaS solution for cosmetics companies of all size, with a flexible workflow, unified scientific literature database and unique AI productivity to help ensure your products are compliant and audit ready.