Introduction to borderline products

This Practice Note provides an introduction to the concept of data-ln-csis="393990" data-ln-lnis="5PV7-GPD1-F18F-K3TB-00000-00">borderline products, how the regulatory status of such products is determined in the EU and UK and explores some of the key borderline issues.

The UK regulatory framework for these products has originated from EU law. As a consequence of Brexit, the body of EU-derived laws has been preserved and converted into UK domestic law with effect on IP completion day (11 pm on 31 December 2020). Many principles and requirements derived from EU law have been maintained in UK domestic law, unless specific provisions stipulate otherwise. In addition, under the Ireland/Northern Ireland Protocol, the EU law requirements apply in Northern Ireland. As a consequence, guidance issued by the European Commission may still be relevant to interpret and implement them in the UK where equivalent guidance has not been provided by the Medicines and Healthcare Products Regulatory Agency (MHRA).

For further information on retained EU law, see Practice Note: Introduction to retained EU law while for a discussion on retained EU case law, see Q&A: Are UK courts and tribunals bound by decisions of the Court of Justice of the European Union post-Brexit?