News Category: Regulatory news
As outlined on the HPRA website on 1 January 2021, the European Commission has published a Notice on ‘Application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period’.
This notice outlines that due to the historical dependence of Ireland, Malta, Cyprus and Northern Ireland on medicines supplied from Great Britain, in the exceptional cases where additional time is required to transfer certain functions to EU/EEA, and in the exceptional circumstance of a global pandemic, an additional period of up to one year (January 2021 to 31 December 2021) to comply with aspects of the Union’s acquis, has been agreed.
These exemptions, which are applicable for medicinal products and investigational medicinal products, are outlined here.
In order for the MAH (which must be established in the Union) or EU-based sponsor/legal representative for a clinical trial, to apply for this time-limited conditional exemption, a request form must be submitted to the HPRA for the evaluation of your request. Please note this should be no later than 30 January 2021 where it relates to quality control (QC) testing.
Please see further information here.