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March 15, 2019 Compliance

Assumed Brexit & Batch Control Testing Site In UK

Vivian Jack Senior Consultant, Quality Assurance

The currently scheduled transition date in the Brexit process, 30 March 2019, is coming very close. In light of this, the European Commission (EC) published on 25 February 2019 a notice on the European rules for batch control testing of medicinal products in relation to the departure of the United Kingdom (UK) from the EU. Be aware that, if the transition date in the Brexit process will remain 30 March 2019, the notice mentioned above is fully applicable. On the other hand, any future developments in the Brexit-process may require an adjustment of the published notice.

Any medicines have to undergo quality control testing in the EU/EEA when being imported from a third country. When the UK will have become a ‘third country’, a batch control testing site within the EU remains a strict requirement in order to import medicines from the UK into the EU. There is a possibility for a temporary exemption. This exemption has to be officially requested at relevant authorities and may be granted for a limited period of time (until 31 December 2019 ultimately).

The potential risk of not complying to this requirement is very high; it may result in jeopardizing importation of involved medicines into the EU.

Exemption: Requirements

Marketing Authorization Holders (MAH) who are unable to transfer their Batch Control Testing site from the UK to the EU by 29 March 2019 may be permitted, for a limited period of time, to rely on quality control testing performed in the UK under certain conditions.
To apply for an exemption, the following conditions must be met:

  • A batch release site within the EU must be registered.
  • The Qualified Person at the EU-releasing site supervises the batch control site in the UK and ensures the batch control site is testing in accordance with EU GMP and the Marketing Authorization.
  • A batch control site within the EU is selected and necessary steps to prepare for a Transfer to this batch control testing site within EU have started. A planned completion date of the transfer should be defined and committed to. This date should be the earliest date possible, but in any case no later than 31 December 2019.

As part of the exemption request, the applicant should also declare the following items:

  • Upon request by authorities, batch testing results from the batch control site within the UK will be provided to the relevant health authorities.
  • Retention and reference samples for these batches will, in time, be transferred to an authorized site within the EU and will be made available for inspection.
  • Information on individual batches released under the exemption is recorded. Upon request, this information is provided to relevant health authorities.
  • Currently there is no batch control site in the EU authorized for batch control testing activities subject to the requested exemption.

Exemption Request: Process

The process for an exemption request is as follows:

  • Any exemption must be officially requested as soon as possible, but in any case no later than 29 March 2019.
  • The attached template may be used: template published by the CMDh and CMDv
  • The request for an exemption must be sent to the national competent authority (or EMA for centralized procedures).
    The relevant contact points are mentioned in the list of contact points.
    In case of MRP/DCP procedures, the exemption is submitted to the Reference Member State (RMS) on behalf of all MAHs in the CMS’s (also copying all CMSs).
  • If the request is justified, it should be granted by the relevant authority.
    The request for an exemption falls outside the procedural requirements of the Variation regulation (EC No. 1234/2008).
  • A copy of the letter granting the exemption, should be sent by the MAH to the supervising authority of the batch releasing site.
  • The EU QP is able to release batches for the EU-market based on the granted exemption.

In case of a Withdrawal Agreement (or a Mutual Recognition Agreement), the above exemption requirements are no longer applicable. If the Withdrawal Agreement, which provides a transition period, is ratified, the MAHs will be able to continue to rely on batch control testing conducted in the UK until the end of the transition period. The Withdrawal Agreement as a whole still has to be finalized and ratified.

In light of the very short remaining time period until the currently scheduled transition date in the Brexit process, it is crucial to prepare for the worst case scenario right now and to request time-limited exemptions to continue batch control testing in the UK for the very near future.

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