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EudraLex – amount 2 – Pharmaceutical legislation on notice to candidates and regulatory tips
Volume 2 for the magazines “The rules regulating products that are medicinal europe” contains a listing of regulatory directions associated with procedural and regulatory needs such as for instance renewal procedures, dossier requirements for Type IA/IB variation notifications, summary of item faculties (SmPC), package information and category for the supply, readability of this label and package leaflet demands.
The Notice to Applicants below was made by the Commission that is european assessment because of the competent authorities of this Member States as well as the European Medicines Agency (EMA). This Notice does not have any force that is legal will not fundamentally express the last views associated with Commission. In case there is question, consequently, guide must certanly be meant to the correct Union Directives and Regulations.
The Notice to Applicants was initially published in 1986 and it is frequently updated.
Amount 2A – Procedures for advertising authorisation
- Chapter 1 – Marketing Authorisation (updated variation – July 2019)
- Chapter 2 – shared Recognition (updated variation – February 2007)
- Chapter 3 – Union Referral treatments (updated version – 2018 november)
- Chapter 4 – Centralised Procedure (deleted – July 2015). The European Medicines Agency is in charge of the systematic evaluation of applications for European Union (EU) marketing authorisations for individual and veterinary medications within the procedure that is centralised. Continue reading “EudraLex – amount 2 – Pharmaceutical legislation on notice to candidates and regulatory tips”