EudraLex - amount 2 - Pharmaceutical legislation on notice to candidates and guidelines that are regulatory

EudraLex – amount 2 – Pharmaceutical legislation on notice to candidates and guidelines that are regulatory

Amount 2 of this magazines “the guidelines regulating medicinal services and products in europe” contains a summary of regulatory recommendations linked to procedural and regulatory demands 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 associated with label and package leaflet demands.

The Notice to Applicants below is made by the Commission that is european assessment using the competent authorities for the Member States and also the European Medicines Agency (EMA). This Notice doesn’t have force that is legal doesn’t fundamentally express the last views for the Commission. In case there is question, consequently, guide must certanly be built to the correct Union Directives and Regulations.

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

Amount 2A – Procedures for advertising authorisation

  • Chapter 1 – Marketing Authorisation (updated version – July 2019)
  • Chapter 2 – shared Recognition (updated variation – February 2007)
  • Chapter 3 – Union Referral Procedures (updated variation – November 2018)
  • Chapter 4 – Centralised Procedure (deleted – July 2015).Read more