Notification of Changes Form for an Authorisation in line with regulation 4(2) of the Medicines (Marketing Authorisation) Regulations, in accordance with article 126(a) of Directive 2001/83/EC.
Office use only
Notification Form received on:
Forms can be received either through the Common European Submission Portal (CESP).
This form is only required for changes to the authorisation document details, product information (Summary of product characteristics, package leaflet, and labelling) and information submitted for initial authorisation or for renewal of the authorisation (as detailed in this application form). No other changes need to be notified.
N.B. New applications for an authorisation in accordance with article 126(a) of Directive 2001/83/EC are required for changes in Member State (EEA) country of source.
LI034/03 Appendix 1 Version 1
Page 1 of 14