In August 2016, the French Decree No.2016-1151 endorsed the creation of a web based portal for reporting adverse health related events; accessible to healthcare professionals, healthcare authorities as well as the general public. In March 2017, France’s Ministry of Affairs and Social Health officially opened the new online portal. The web based portal provides an easy to use platform for reporting and accessing information on various adverse health related events pertaining to products such as, medicines, medical devices, cosmetics, food supplements and other products used in daily life.
What is an adverse health related event?
An “adverse health related event” is an abnormal reaction (serious or not) that can affect a person’s health leading to allergies, poisoning, inflammation or death due to the use of a given product. The ineffectiveness of a product does not fall within the scope of reporting adverse health related events.
What does this mean for cosmetic companies?
Cosmetic manufacturers as well as distributors are obliged to immediately report any adverse effects that occur or are likely to occur during or after the use of their cosmetic products; including the effects that may arise from the misuse of these products. This also implies that cosmetic manufacturers and distributors need to be proactive in their cosmetovigilance practices by ensuring they have the right teams (including a designated European Responsible Person), systems and processes put in place to respond effectively to any adverse health related events.
Although the portal is a French initiative, other countries within the European Union will be looking closely to assess the effectiveness and impact of this new approach to cosmetovigilance and may possibly adopt a similar strategy in the future.
If you wish to know more about the new portal for reporting adverse health related events, please do not hesitate to contact us. Obelis Expert Consultants, having nearly 30 years of experience with EU Regulations, will gladly answer any questions you may have and assist you in safeguarding your products’ compliance.