Notification for Changes in National Registrations and National Authorisations

Overview

A form that registration holders of products registered in accordance with regulation 8 of  S.L 437.115 in line with Article 116 of Regulation (EU) 2019/6 and Authorisation in accordance with regulation 5 of S.L 437.115 in line with Article 5(6) of Regulation (EU) 2019/6 use to notify changes in the Product Information.

What you'll get

Applicants are contacted if a clarification is required.

Eligibility

Registration holders of products registered in accordance with regulation 8 of  S.L 437.115 in line with Article 116 of Regulation (EU) 2019/6 and Authorisation holders of products authorised  in accordance with regulation 5 of S.L 437.115 in line with Article 5(6) of Regulation (EU) 2019/6.

How to apply

Fill in the online form and submit.

 

Required documents:

 

  1. Copies of the updated Summary of Product Characteristics (SmPC) and Package Information Leaflet (PIL), where applicable.
  2. The updated mock-ups of the outer and immediate labelling.
  3. In the case of registration according to regulation 8 of  S.L 437.115 in line with Article 116 of Regulation (EU) 2019/6 a copy of the approval letter/s for the variation  issued by the competent authority of the source country (if available).
apply