The European Commission (EC) published a notice to stakeholders on April 27, 2018 regarding the impacts of Brexit on supplementary protection certificates (SPCs) for medicinal products and plant protection products.

In view of the considerable uncertainties, in particular concerning the content of a possible withdrawal agreement, stakeholders are reminded of legal repercussions, which need to be considered when the UK becomes a third country from the withdrawal date of March 30, 2019.

Subject to any transitional arrangement that may be contained in a possible withdrawal agreement, the Brexit has in particular the following consequences.

1. CALCULATION OF DURATION OF SPCs

An authorisation to place the product on the market granted by a UK competent authority as of the withdrawal date will not be considered as the first authorisation to place the product on the market in the EU for the purposes of Article 13 of Regulation (EC) No 469/2009 and Article 13 of Regulation (EC) No 1610/96.

However, an authorisation to place the product on the market granted by a UK competent authority before the withdrawal date is to be considered as the first authorisation to place the product on the market in the EU for the purposes of Article 13 of Regulation (EC) No 469/2009 and Article 13 of Regulation (EC) No 1610/96.

2. APPLICATIONS FOR SPCs AS OF THE WITHDRAWAL DATE IN THE UK

As of the withdrawal date, Regulation (EC) No 469/2009 and Regulation (EC) No 1610/96 no longer apply to the UK.

Read the document here.