Development of a guideline on the safety of nanoparticles – in the context of the establishment of maximum residue limits and veterinary marketing authorisations

This concept paper addresses the need for a specific guideline on the establishment of maximum  residue limits (MRLs) for pharmacologically active nanoparticles, as well as on safety for veterinary medicinal products (VMPs) containing nanoparticles. 

Keywords: Novel therapies, nano, safety, veterinary regulation, persistent nanoparticles, nano-toxicology, nanoparticles, nanotechnology, veterinary medicinal products issued from nanotechnologies

Current version

Concept paper for the development of a guideline on the safety of nanoparticles – in the context of the establishment of maximum residue limits and veterinary marketing authorisations

Consultation dates: 26/04/2024 to 31/07/2024Draft: consultation openReference Number: EMA/CVMP/NTWP/143787/2023Summary:

This concept paper addresses the need for a specific guideline on the establishment of maximum  residue limits (MRLs) for pharmacologically active nanoparticles, as well as on safety for veterinary medicinal products (VMPs) containing nanoparticles.