Type II Variations vs Extension applications: Regulatory and procedural guidance

• Guideline on the categorisation of Extension Applications (EA) versus Variations Applications (V)
• Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products
• Notice to Applicants - Volume 2B - Presentation and content of the dossier - Application form (Word
• Notice to Applicants - Volume 2B - Electronic application form (zip file)
• Notice to Applicants - Volume 2B - Presentation and content of the dossier - User guide to the application form
• Q&A: Type II Variations vs Extension applications