#Idocument 2 review update

The shortened period of the 'droit de regard' does, however, not apply in the following cases:

This applies also in the recess periods of European Parliament. 'Droit de regard' : Important notice to stakeholders - follow-up to the notice of 29/07/09įollowing an agreement with the responsible Committee in the European Parliament and in accordance with the interinstitutional agreement of 3 June 2008, the period of the 'droit de regard' for the Commission Decisions taken as part of the 'Decision making process' is shortened on a permanent basis to 7 days. 1–2).Ĭhapter 6 - Community Marketing Authorisation (updated version - November 2005)

Chapter 5 - Guidelines of on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures - C (2013) 2804 (OJ C 223,, p.

#Idocument 2 review update

Regular update of this guidance will be available directly on the relevant website. To be noted that this guidance is not a NTA document anymore. As the Agency provides relevant information and guidance for companies and individuals involved in developing and marketing medicines for human use in the Union no dedicated chapter on the centralised procedure has been included in the NTA. The European Medicines Agency is responsible for the scientific evaluation of applications for European Union (EU) marketing authorisations for human and veterinary medicines in the centralised procedure. Chapter 4 - Centralised Procedure (deleted - July 2015).Chapter 3 - Union Referral Procedures (updated version - November 2018).Chapter 2 - Mutual Recognition (updated version - February 2007).Chapter 1 - Marketing Authorisation (updated version - July 2019).Volume 2A - Procedures for marketing authorisation The Notice to Applicants was first published in 1986 and is regularly updated. In case of doubt, therefore, reference should be made to the appropriate Union Directives and Regulations. This Notice has no legal force and does not necessarily represent the final views of the Commission. The Notice to Applicants below has been prepared by the European Commission, in consultation with the competent authorities of the Member States and the European Medicines Agency (EMA). Volume 2 of the publications 'The rules governing medicinal products in the European Union' contains a list of regulatory guidelines related to procedural and regulatory requirements such as renewal procedures, dossier requirements for Type IA/IB variation notifications, summary of product characteristics (SmPC), package information and classification for the supply, readability of the label and package leaflet requirements.