Brexit: quality control and batch releases - exemption

date: 25/04/2019

The FAMHP would like to inform pharmaceutical companies that Belgium is following the European Commission’s decision with regards to the exemption procedure in application post-Brexit for UK-based quality control sites for batches of medicinal products.

European legislation requires that medicinal products imported into the European Union undergo quality control testing (“batch testing”) carried out at a batch release site located within the EU. With regards to batch release sites currently located in the United Kingdom (UK), and in the event of a no-deal Brexit, marketing authorisation (MA) holders must comply with this requirement at the latest by the United Kingdom’s effective withdrawal date from the European Union.

However, in legitimate cases where the prompt transfer of batch testing to an EU facility is not possible, European legislation (Article 20b) of Directive 2001/83/EC and 24 b) of Directive 2001/82/EC) provides for certain measures that may be applied by the competent authorities to grant an exemption and authorise MA holders to rely, for a time-limited period and on a case-by-case basis, on batch testing carried out in the UK.

  1. An EU27 batch release site must be identified by the MA holder at the latest by the date of the UK’s withdrawal from the EU.
  2. The batch release site is supervised by a qualified person established within the EU27 at the latest on the UK’s withdrawal date from the EU.
  3. The establishment designated by the third country performing the batch testing may be verified by a competent authority from the EU27, including by means of on-site inspections.
  4. All necessary measures have been taken to prepare for the transfer of batch testing from the UK site to a location within the EU27.

In order to benefit from this exemption, the MA holder concerned must submit their request either to the national competent authority that granted the MA in the case of nationally authorised products, or to the Reference Member State (RMS), with a copy sent to the Concerned Member States (CMS), for products authorised through the Decentralised Procedure (DCP) or through the Mutual Recognition Procedure (MRP), or to the EMA in the case of products authorised through the centralised procedure. The application must be submitted immediately and, in any case, not after the 12 April 2019. In the notification, the MA holder must:

  • specify the batch release site established within the EU27,
  • confirm that the qualified person established in the EU27 is responsible for batch testing carried out in the UK,
  • confirm and indicate the exact timeline for the transfer of the batch control test site (which should allow for the rapid completion of the process, by the end of 2019 at the latest),
  • specify the period and the batches (packaging and quantities) for which the MA holder would like an exemption (this must be strictly limited to what is necessary),
  • agree to provide test results for batches cleared by existing UK facilities,
  • transfer samples of these tested batches along with the test results to the batch release site within the EU27 in due time, for inspection.

The MA holder must send a copy of the letter granting the exemption to the competent authority that issued the manufacturing authorisation for the batch release site, in accordance with Article 40 of Directive 2001/83/EC and Article 44 of Directive 2001/82/EC.

Based on the above, the qualified person will then be able to release the batches concerned for placement on the EU market.

In the absence of any such exemption on the UK’s effective withdrawal date, if the batch has not been inspected within the EU27:

  • the MA shall become non-compliant and the competent authorities may take measures in view of suspending or revoking this authorisation;
  • it shall no longer be possible to import medicinal products originating from the UK into the EU27.

Please note that in the event that the withdrawal agreement, which allows for a transition period, is approved, marketing authorisation holders will be able to continue to rely on batch testing carried out within the UK until the end of said transition period. In this case, no exemption shall be required.

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Last updated on 27/11/2020