South Africa SAHPRA: eCTD Validation and Technical Screening for Renewals - Template
Saudi's SFDA: Guidance on Regulatory Framework for Drugs Approval
Swissmedic Guidance: Renewal and Discontinuation of Authorization or Change of Status (Main Authorization/Export License)
Ireland HPRA: Guide to Renewal of Marketing Authorisations –Human Medicines
UK MHRA: Guidance on Renewing Marketing Authorisations & Implementation of Med Dev. Future Regime
South Africa's (SAPHRA): Renewal Of Human Medicines Requirements and Process
SFDA's Guidance on Data Requirements for the Renewal of Marketing Authorizations Drug Products
Guidance on Renewal & Discontinuation of Authorisation on change of Status -Swiss Medic
Swissmedic Guidance on Renewals, Variations & Extensions
Saudi Arabia’s (SFDA) Guide on Regulatory Framework for Drug Registration, Variation or Renewals