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EudraLex – amount 2 – Pharmaceutical legislation on notice to applicants and regulatory tips

Amount 2 of this magazines “the guidelines regulating medicinal items in europe” contains a summary of regulatory tips pertaining to procedural and regulatory demands such as for instance renewal procedures, dossier requirements for Type IA/IB variation notifications, summary of product faculties (SmPC), package information and category for the supply, readability regarding the label and package leaflet demands.

The Notice to Applicants below happens to be made by the European Commission, in assessment because of the competent authorities associated with Member States and also the European Medicines Agency (EMA). This Notice doesn’t have force that is legal doesn’t always express the ultimate views for the Commission. In case there is question, consequently, guide ought to be built to the correct Union Directives and Regulations.

The Notice to Applicants was initially posted in 1986 and it is frequently updated.

Volume 2A – Procedures for advertising authorisation

  • Chapter 1 – Marketing Authorisation (updated variation – 2019 july)
  • Chapter 2 – Mutual Recognition (updated variation – February 2007)
  • Chapter 3 – Union Referral Procedures (updated variation – 2018 november)
  • Chapter 4 – Centralised Procedure (deleted – July 2015). Continue reading