Unilateral declarations on the withdrawal agreement joint committee on human and veterinary medicines released by the EU and UK
The European Union and the United Kingdom have both released unilateral statements on the joint committee on human and veterinary medicines. Both are summarised below.
The EU statement:
“The full and proper implementation of the Protocol on Ireland and Northern Ireland is an essential element in the Union’s relationship with the United Kingdom. As regards the supply of medicines, this Protocol provides for the application of the Union’s pharmaceutical acquis in respect of Northern Ireland after the transition period. We also note that Northern Ireland faces particular challenges in this regard, due to the withdrawal of the United Kingdom from the Union…
“The Union suggests a practice in the application of the Union’s pharmaceutical acquis in respect of Northern Ireland which includes the following three elements:
- A temporary removal of the obligation to decommission safety features applied to medicinal products supplied to the United Kingdom by a manufacturer, importer or wholesaler in the Union
- A consideration of small markets historically dependent on medicines supply from or through Great Britain as “justifiable cases” allowing for quality control testing in Great Britain during a limited time
- An abstention from sanctioning certain breaches of Union law arising due to the absence of manufacturing authorisation holders in Northern Ireland.
“By applying this approach for a period of up to twelve months after the end of the transition period, the Union aims to give all relevant stakeholders sufficient time to adapt to the United Kingdom’s withdrawal and to establish new supply routes where necessary, while providing for undisrupted supply of medicines and a high level of public health protection.”
The UK statement:
“The United Kingdom takes note of the European Union’s declaration setting out its approach to the application of Union law on pharmaceuticals in respect of Northern Ireland for a period of up to twelve months after the end of the transition period.”
MAP will continue to monitor the situation in regard to the supply and provision of human and veterinary medicines post-Brexit.