Notification for Changes in National Registrations and National Authorisations

Overview

A form that registration holders of products registered in accordance with Regulation 7 of Subsidiary Legislation 437.47 and Authorisation in accordance with Subsidiary Legislation 437.47 can use to notify the Animal Health and Welfare Department of changes in the product information.

What you'll get

Applicants are contacted if a clarification is required.

Eligibility

Registration holders of products authorised in accordance with Regulation 7 of SL 437.47.

How to apply

Fill in the online form and submit.

Required documents:
i) Copies of the updated Summary of Product Characteristics (SmPC) and Package Information Leaflet (PIL)
ii) The updated mock-ups of the outer and immediate labelling
iii) In the case of registration according to Regulation 7 of SL 437.47, a copy of the approval letter/s issued by the competent authority of the source country (if available)
apply