In a letter to the European Medicines Agency (EMA) and EU27 Heads of Medicines Agencies (HMA) last week, the European Commission’s Directorate-General for Health and Food Safety (Sante) detailed an exemption to certain batch testing requirements for drugmakers that currently perform batch testing in the UK.
The letter comes roughly one month ahead of the UK’s exit from the EU on 30 March 2019, with the prospect of a Brexit withdrawal deal looking dim.
Under article 51(1)(b) of Directive 2001/83/EC and article 55(1)(b) of Directive 2001/82/EC, drugs imported into the EU must undergo batch testing within the EU/European Economic Area (EEA). Once the UK leaves the EU, drugmakers who previously conducted batch testing in the UK will need to move their batch testing operations to the EU in order to import their products.
However, the Commission acknowledges that some companies, for reasons beyond their control, may not be able to set up batch testing operations in the EU by 30 March 2019.
“In these cases, Article 20(b) of Directive 2001/83/EC and 24(b) of Directive 2001/82/EC provide that competent authorities may allow importers of medicinal products coming from third countries to have in justifiable cases certain of the controls carried out by third parties,” the Commission writes.
Specifically, the Commission says that competent authorities throughout the EU may temporarily allow drugmakers to continue to rely on batch testing performed in the UK under certain circumstances. The Commission also notes that if the withdrawal agreement
negotiated by the EU and UK in November is ratified, the exemption would not be necessary as the agreement establishes a 21-month transition period that would allow for drugmakers to continue batch testing in the UK during the transition.
To qualify for the exemption, the Commission says that drugmakers must have identified a new batch release site within the EU by the UK’s withdrawal from the EU and that existing UK site be supervised by an EU-based qualified person (QP). Drugmakers will also need to show that they have taken “all necessary steps” to prepare to move quality control testing operations to the EU.
The Commission also says that batch testing sites may undergo verification and “on the spot checks” by EU competent authorities.
Drugmakers that wish to obtain an exemption for third party batch testing must notify EMA or the national competent authority that granted their marketing authorization by 29 March 2019 and include the following information:
- “Specify the batch release site in the EU27.
- Confirm that the qualified person established in the EU27 is responsible for the quality control testing site in the United Kingdom.
- Confirm and set out their precise timetable for transfer of the quality control testing site (which should allow the process to be completed quickly and in principle by the end of 2019 at the latest).
- Specify the period of time and batches (packs and quantities) that are requested to be exempted. This should be strictly restricted to what is necessary.
- Commit to providing batch testing results for those batches from the existing facilities within the United Kingdom.
- Transfer samples of those tested batches together with the testing results to the batch release site in the EU27 in due time to make them available for inspection.”
From there the Commission says that EMA or the national competent authority will review the request and determine if an exemption is justified.
The Commission also reminds drugmakers that they are required to notify regulators of any issue that could lead to a supply disruption of an authorized medicine two months in advance, meaning that companies anticipating Brexit-related disruptions should notify the relevant authorities now.