On 21 February 2019, the European Commission wrote to the European Medicines Agency (“EMA”) and the Heads of Medicines Agencies of the EU-27 Member States concerning the acceptability of UK batch testing after Brexit (see the letter here). The letter seeks to address concerns that a number of pharmaceutical companies will not have been able to adjust their pharmaceutical supply chains to provide for quality control testing and batch release of product in the EU-27 and to reflect these changes in relevant marketing authorizations in time for a no-deal Brexit if that occurs on 29 March 2019. The Commission gives EU-27 (or EEA-30) regulators scope to accept the results of quality control and batch release testing in the UK, provided that marketing authorization holders (“MAHs”) submit valid requests for an exemption before 29 March 2019.
The UK will become a third country vis-à-vis the EU-27 at midnight CET on 29 March 2019, unless the parties agree an extension under Article 50 of the Treaty on European Union or a transitional period, e.g., by ratifying the Withdrawal Agreement.
This means that the rules for imports from third countries will apply to medicines entering the EU-27 from the UK. Specifically, Directives 2001/82/EC and 2001/83/EC require that: (a) medicinal products imported from third countries undergo quality control testing in the EU/EEA; and (b) the qualified person within an appropriately authorized batch release site within the EU/EEA batch releases the product onto the EEA market.
The Commission’s letter allows competent authorities to permit MAHs, manufacturers and importers of medicinal products coming from third countries “in justifiable cases” to have third parties carry out certain controls (Article 20(b) of Directive 2001/83/EC and Article 24(b) of Directive 2001/82/EC). With this in mind, competent authorities may grant MAHs an exemption allowing them to rely on UK quality control testing for a limited period after Brexit. The exemption is subject to the following conditions:
- A batch release site in the EU27 is identified by the marketing authorisation 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.
MAHs must notify their intention to rely on the exemption immediately and in any event before 29 March 2019 either to their national competent authority or to the EMA for centrally authorized products:
“In the notification the marketing authorisation holder must:
- 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.”
Under this special procedure, which falls outside the scope of the Variations Regulation (EC) No. 1234/2008, the EMA or national competent authority will assess the notification and if justified, grant the exemption “for the time period strictly necessary and for the specific batches identified.” The relevant authority will notify the MAH about the grant of the exemption in writing. The MAH shall provide a copy of the confirmation to the competent authority responsible for the batch release site. The effect of the exemption is that the qualified person may batch release UK-control tested products for the EU-27 (or EEA-30) market.
In the absence of an exemption, products entering the EEA-30 from the UK must undergo both control testing and batch release in the EU/EEA before they can be placed on the those markets. In this context, the Commission also reminds MAHs of their obligation to notify any anticipated disruption of supply two months in advance. This means, if companies anticipate Brexit-related supply issues, they should notify the relevant competent authorities now.
This exemption would not apply if the EU-27 and the UK are able to ratify the Withdrawal Agreement. The terms of that Agreement provide for a transitional period until the end of 2020, during which the medicines regime will continue to apply to and in the UK. Thus, MAHs could continue to rely on UK quality control testing during such a period.