The EMA have published a new question and answer guidance on the implementation of the Protocol on Ireland / Northern Ireland.
The document provides information to pharmaceutical companies and sponsors of clinical trials on changes required for medicinal products with national marketing authorisations in the UK submitted to the Article 57 database, as well as safety reporting to EudraVigilance, after 01 January 2021.
The EMA provided confirmation that marketing authorisation holders (MAHs) with medicinal product records currently referencing United Kingdom (GB) as the authorisation country code should review their product data in the Article 57 database and, for products that will continue to be authorised by UK with respect to Northern Ireland after 31 December 2020, change the country of authorisation to ‘United Kingdom (Northern Ireland)’ with the assigned country code ‘XI’.
The guidance also provides clarification of fees for UK nationally authorised products, as well as safety reporting into EudraVigilance and access to EudraVigilance data. It outlines processes surrounding EudraCT database and electronic application forms, PSUR repository, local representatives for NI, marketing status reporting, dossier submission, orphan designation, good manufacturing practice (GMP) and parallel distribution.
To view the document, click here.