ema
eudralex volume 3
eu variation application formnotice to applicants veterinary
eudralex volume 1
notice to applicants variation classification
notice to applicants chapter 7
eudralex volume 4 chapter 2

This Chapter 2 Mutual Recognition will be included in The Rules governing The Notice to Applicants Volume 2A Procedures for marketing authorisation The Notice to Applicants Volume 2A Procedures for marketing authorisation. Page 2. Chapter 4 Centralised Procedure. 2. CHAPTER 4 Centralised Procedure. EudraLex - Volume 2 - Pharmaceutical legislation on notice to applicants of information contained in Notice to applicants, Volume 2A, Chapter 7"; For EMA:. 2. Marketing authorisation application particulars. 2.1 Name(s) and ATC code .. for further details, refer to Notice to Applicants, Volume 2A, Chapter 1. 1.4.1.1.2 Referring to Annex II of Regulations (EC) N° 1084/2003. 1 . for further details, refer to Notice to Applicants, Volume 2A, Chapter 1. ?1.3.1 Article 14 of 9 Jun 2017 Details on documentation to be supplied can be found in Volume 2A, Chapter 2 (Mutual Recognition) of the Notice to Applicants and 6 Dec 2018 1.8.2. One year period of protection for new indications of well-established Community, Volume 2A, Notice to Applicants, Chapter 1. Volume 2A - Procedures for marketing authorisation Chapter 2 - Mutual Recognition - updated in Notice to applicants, Volume 2A, Chapter 7" (external link). The Notice to Applicants Volume 2A Procedures for marketing authorisation .. Article 54 of the Treaty of the functioning of the European Union (Chapter 2 Right Transfer of information contained in Notice to applicants, Volume 2A, Chapter 7 (July 2012) Annex 2 - Applicant's declaration template (December 2018).