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Cosmetovigilance and post-marketing surveillance

The Regulation (EC) 1223/2009, as amended, defines a “serious undesirable effect” as any adverse reaction to human health arising from normal use or reasonably foreseeable use of a cosmetic product that causes temporary or permanent functional incapacity, disability, hospitalization, congenital anomalies, immediate mortal danger or death.

These serious undesirable effects should be promptly reported to the Competent Authority of the EU country where they have been detected. When the report is received, it is essential to recover as much useful information as possible to verify the existence of a causal link between the use of the product and the adverse reaction.

The Responsible Person is also bound to store all documentation relating undesirable effects and report all cases of known undesirable effects within the PIF (Product Information File). The continuous updating of such information will be necessary to re-evaluate the safety of the cosmetic product, when needed, considering a change in the formulation, if required.

Di Renzo Regulatory Affairs has a special unit dedicated to the vigilance of cosmetic products (cosmetovigilance), and can assist companies carrying out the following:

  • evaluation of the causal link
  • management of the reports to the Competent Authorities
  • management of post-marketing surveillance.

Thanks to its international cooperation with several consultants in the EU countries, Di Renzo Regulatory Affairs can perform this service not only in Italy, but also in the other Member States where the cosmetic products are marketed.