Questo sito utilizza cookies tecnici per il corretto funzionamento. Leggi

Vigilance Biocides and Presidi Medico Chirurgici

This area has not yet been well regulated as regards vigilance. With regard to Presidi Medico Chirurgici, specific regulations have not been issued and companies are not required to have a responsible person or a specific sector to deal with safety issues related to their products. However, for biodical products there is an obligation for notification of unexpected or adverse effects.

The holder of a biocidal product authorisation shall notify to the Competent Authorities new data indicating that the biocidal product is not sufficiently effective, information on the adverse effects for humans, animals or the environment or any data indicating the potential of the active substance for the development of resistance.

Some companies are requesting us to provide them with information that may be useful for their activities and to provide consumers with safer products.

Within this sector Di Renzo Regulatory Affairs is able to offer its clients the following services:

  • Collection of information on adverse reactions
  • Collaboration with companies and communication with the competent Authorities
  • Regulatory updates and training for company personnel
  • Development of a quality system and the preparation of internal Standard Operating Procedures (SOPs)
  • Continuous availability