1 Jan 2019 3.1 Other documents relevant to the SmPC . .. Notice to Applicants. OTC See Volume 2c: Guideline on Summary of Product Characteristics

notice to applicants variation classification
notice to applicants veterinary
notice to applicants chapter 7
notice to applicants volume 1
smpc guideline 2015
module 1.2: administrative information application formsmpc guideline 2017
notice to applicants volume 2a

particular the “Guideline on Summary of Product Characteristics” as published on the Website European Commission in the Notice to Applicants, Volume 2C:. 18 Jun 2018 the SmPC and PIL,ii there is little guidance to what information may .. See: Notice to Applicants Volume 2C: (i) Guideline on the Summary ofGuidance note to Applicants (Manufacturers) on the compilation of the WHO Public 3 - Guidance on Package Leaflet, Summary of Product Characteristics and . (The rules governing medicinal products in the European Union, Volume 3B). EudraLex - Volume 6 - Notice to applicants and regulatory guidelines for for Type IA/IB variation notifications, summary of product characteristics (SPC), (SmPC). September 2009. This guideline will be included in The Rules Governing Medicinal Products in the European Union. Volume 2C Notice to Applicants. 9 Jan 2012 The Notice To Applicants Volume 2B states the following for variation the revised Guideline on summary of product characteristics (SmPC) Volume 6B gives to guidance to applicants for of Summary of Product Characteristics SPC EudraLex - Volume 2 - Pharmaceutical legislation on notice to applicants and regulatory guidelines for medicinal products for human use. for Type IA/IB variation notifications, summary of product characteristics (SmPC), package information October 2005. This guideline will be included in The Rules Governing Medicinal Products in the European Union. Volume 2C Notice to Applicants