Batch Relief

If the UK leaves the EU without a deal on March 29, it will become a “third country,” which means quality control testing and Qualified Person (QP) batch release will have to be done in the EU/EEA for products exported to the EU.

In February 2018, we reported on concerns that the EU won’t be able to cope with the demand for testing facilities, post-Brexit (1). Virgina Acha, Executive Director of Global Regulatory Policy at MSD, said, “Today, 1,300 products produced by EFPIA members are batch released or tested in the UK. Forty percent of these EFPIA members anticipate challenges to ensure that there is sufficient capacity in the EU27 to replace this infrastructure.”

The EU has recognized that “there may be objective reasons beyond control of the marketing authorisation (MA) holders that may prevent timely transfer of such testing activities to the Union by the withdrawal date.” And so, “for a limited period of time, as a justified case,” the EU will allow MA holders to rely on quality control testing performed in the United Kingdom under four conditions (2):

• A batch release site in the EU27 is identified by the marketing authorization holder by
  the withdrawal date.

• The batch release site is supervised by a qualified person established in the EU27 by
  the withdrawal date.

• The establishment designated by the third party conducting the quality control testing
  may be verified by a competent authority of the EU27, including on the spot checks.

• All necessary steps have been taken to prepare the transfer of the quality control
  testing site from the United Kingdom to the EU27.

The guidance covers medicinal products authorized in the EU’s centralized procedure and therefore does not extend to the approval of clinical trials (which is done nationally). The EMA's press office also confirmed via email that this is limited to batch control testing and does not include batch release itself, “the batch release site and the QP would still need to be established in the EU27/EEA after the UK’s withdrawal from the EU in order to apply the exemption for the batch control testing in the UK,” the press office said.

In other Brexit (and batch) news, the UK and US governments agreed to maintain all relevant aspects of the current EU-US Mutual Recognition Agreement (MRA) after Brexit (3). What does that mean? When the UK leaves the EU, with or without a deal, the US FDA will continue to accept batch testing conducted in the UK, and vice versa – sparing companies the time and expense of testing in advance in their destination countries, or being intercepted and tested by customs at the border.

The UK government pointed out that total UK-US trade in sectors covered by the deal is worth up to £12.8 billion, based on recent average trade flows; and that pharmaceuticals account for around £7.7 billion of UK exports to the US – nearly 18 percent of total UK goods exports to the US.