by Admin | Mar 22, 2026 | Inspections & Compliance
MHRA’s variations guidance says a reduced Type II procedure, shortened from 60 days to 30 days, is available for some safety-related variations when agreed between the agency and the marketing authorisation holder. The guidance says these are generally SmPC changes...
by Admin | Mar 22, 2026 | Regulatory Updates
MHRA’s Safety Roundup: February 2026 pulls together recent medicines and device safety information, including semaglutide-associated NAION and falsified Mounjaro pens, into a single regulator-issued summary. That makes it more than a newsletter-style update. It is...
by Admin | Mar 22, 2026 | Safety Signals
MHRA says non-arteritic anterior ischemic optic neuropathy (NAION) has been very rarely reported with semaglutide and has updated product information for Wegovy, Ozempic, and Rybelsus accordingly. The agency advises urgent ophthalmology referral for patients who...
by Admin | Mar 18, 2026 | Regulatory Updates
MHRA’s National assessment procedure for medicines guidance was updated on 24 February 2026. The page explains the agency’s national assessment procedure for marketing authorisation applications in the UK. Even though this is not a pharmacovigilance-specific page, it...
by Admin | Mar 18, 2026 | Inspections & Compliance
MHRA’s variations guidance says a reduced Type II procedure, shortened from 60 days to 30 days, is available for variations concerning safety issues when agreed between the MHRA and the marketing authorisation holder. The guidance says these are generally SmPC changes...
