Type II Variations vs Extension applications: Regulatory and procedural guidance
HumanRegulatory and procedural guidance
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- 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