Key safety reporting requirements of EC No. 1223/2009. Is your organization in compliance?
Recent regulatory changes in the EU have created new safety reporting requirements for the distributors of cosmetics within that region. The requirements of EC Regulation 1223/2009, which took effect 11 July 2013, are quite substantial, with mandatory reporting of certain types of events to competent authorities as well as the establishment of a “responsible person” to oversee this reporting.
Although these regulations have helped streamline and harmonize reporting requirements across the EU, they have greatly increased reporting responsibilities for distributors of cosmetic products in the region.
With 14 years of experience and a unique focus on pharmacovigilance, Ashfield Pharmacovigilance has an established reputation and robust processes that allow us to help ensure your organization is in compliance with the new regulations. We can also guide you in understanding these requirements and taking the appropriate action to ensure your products stay on the market.
Download the full whitepaper: Cosmetics Safety in the EU.