Withdrawal of the United Kingdom and EU rules for batch testing of medicinal products: Communication from the European Commission (February 2019)

The European Commission has recently released a communication providing guidance on possible request for exemption regarding quality control testing performed in the United Kingdom.

Competent authorities may allow marketing authorization holders (MAH), for a limited period of time, as a justified case, to rely on quality control testing performed in the United Kingdom (hereafter “the exemption”) after the withdrawal from the European Union, under the following conditions:

  1. A batch release site in the EU27 is identified by the MAH by the withdrawal date (30 March 2019, 00:00h (CET)).
  2. The batch release site is supervised by a qualified person established in the EU27 by the withdrawal date.
  3. 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.
  4. All necessary steps have been taken to prepare the transfer of the quality control testing site from the United Kingdom to the EU27.

In order to make use of this exemption, affected MAHs must notify the relevant national competent authority that granted the marketing authorisation (or EMA in case of centrally authorised products) no later than 29 March 2019.

In the notification the MAH must confirm that the qualified person established in the EU27 is responsible for the quality control testing site in the United Kingdom.

If the national competent authority or EMA considers that the request is justified it should grant the exemption to rely on the quality control testing conducted in the United Kingdom for the time period strictly necessary and for the specific batches identified. Such request would fall outside the procedural requirements of Commission Regulation (EC) No 1234/2008 (variation regulation).

The qualified person would then be able to release the batches concerned for placing on the Union market.
Full details of this guidance is published at the following link: 
https://ec.europa.eu/health/sites/health/files/files/documents/brexit_batchtesting_medicinalproducts_en.pdf

This EC communication and other Brexit-related guidance can be found in:
https://www.ema.europa.eu/en/about-us/uks-withdrawal-eu/brexit-related-guidance-companies
http://www.hma.eu/535.html