Ongoing
Collection
Gathering reports of undesirable effects, wherever they occur.
Monitoring the undesirable effects of your products once they are on the market is an obligation under the European Regulation, and a real mark of trust for your customers. We help you set up this monitoring and protect your brand.
Even a perfectly formulated cosmetic can cause a reaction in a user. Cosmetovigilance organises the collection, analysis and reporting of these undesirable effects. Well managed, it protects your customers, your compliance and your reputation.
We structure your process for collecting and recording undesirable effects.
Assessment of cases to distinguish an undesirable effect from a serious effect.
Handling of mandatory reports and long-term follow-up.
Consistency with your Product Information File and your overall compliance.
We founded Costomise to be the laboratory we would have loved to find: human-scale, one that tells the truth about lead times and regulation, and that formulates natural products that really hold up.
Gathering reports of undesirable effects, wherever they occur.
Traceability of every case, properly documented.
Assessment of the causality and seriousness of the effect.
Reporting to the authorities when required, and follow-up of actions.
Costomise has developed dedicated expertise in cosmetovigilance. Let's talk about your current system.
It is the set of methods used to monitor and assess the undesirable effects of cosmetic products after they are placed on the market.
Yes. Regulation (EC) No 1223/2009 requires it of every Responsible Person who places a product on the European market.
An undesirable effect is a transient harmful reaction; a serious effect leads to hospitalisation, incapacity or a risk to life, and must be reported without delay.
To the ANSM, the French National Agency for the Safety of Medicines and Health Products, as soon as possible.
We structure your vigilance system, analyse the cases and handle the reports, consistently with your PIF.
