South Africa's SAHPRA: Communication to Industry on Quality Variations
EMA Guidance: Application of the Amended Variations Regulation from 1 January 2025
Saudi's SFDA: Guidance on Regulatory Framework for Drugs Approval
EMA Guidance: Proposed Amendments - Variations Categories and Procedures
Swiss Medic: Guidances on Varaiations, Temporary Authorisation, Meetings for Applicants and Time Limits for Authorisation
UK MHRA Guidance: Applying for a Variation to a Marketing Authorisation
Swissmedic Guidance: Navigating Variations, Product Information, and Electronic ICSRs through PV Gateway
Pakistan's DRAP: Guidelines for Post-Registration Variation of Drugs
SwissMedic Guidance on Fast-Track Authorisation, Temporary Authorisation and Variations & Extensions
South Africa: Information Guideline and Quality and Bioequivalence guidelines Aligning with EMA/ICH
EMA Procedural Advice: Recommendations on Unforeseen Variations
EMA Checklist: Updated Validation checklist for Type II quality variations
EMA Guidance: How to Fill the Application Form for Centralised Type IA and IB Variations
MALAYSIAN (NPRA): VARIATION GUIDELINE FOR PHARMACEUTICAL PRODUCTS
SFDA - Guidelines for Variation Requirements
South Africa (SAHPRA) Guidance on How to Submit Variation Applications
Swissmedic Guidance on Renewals, Variations & Extensions
Ireland's guidance on New Application & Variations, Registartion Requirements,
Guidance on Variations, Extensions, Doc Protections, Form & Criteria Annex – Swissmedic -HMV4