Swissmedic now allows delayed implementation time limits for authorised variations to human and veterinary medicinal products in specially requested and duly justified exceptional cases.
This concerns technical changes (primarily quality variations) that must be implemented simultaneously worldwide (replacement changes).
The marketing authorisation holder requests the desired delay and justifies this in full in the application for variation.
Section 6.7 Implementation of variations and extensions in the guidance document (WL) for human medicinal products (HMP) and section 6.2.6 Implementation of variations in the WL for 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.