Delayed implementation time limits for replacement changes
9 juin 2023 – Swissmedic now allows delayed implementation time limits for authorised variations to human and veterinary medicinal products in specially requested and duly justified exceptional cases. The guidance documents for human medicinal products (HMP) and veterinary medicinal products (VMP) have been revised accordingly. In addition, both guidance documents have been revised in terms of the GMP documentation required (full evidence of GMP compliance of foreign manufacturers) for applications for variation (HMP) and variations with assessment (VMP). The revised guidance documents are valid with effect from 1 June 2023.
For more information, see here.