Medicinal products imported into the EU must undergo batch testing within the EU and the European Economic Area (EEA)*. Once the United Kingdom (UK) leaves the EU (Brexit), pharmaceutical manufacturers who have previously carried out batch testing in the UK must relocate their batch testing operations to the EU/EEA in order to import their products.
The European Commission's Directorate-General for Health and Food Safety (Sante) has now sent a letter to the Heads of Medicines Agencies of the remaining Member States (EU27) and to the Executive Director of the European Medicines Agency (EMA) explaining the possibility of an exemption for pharmaceutical companies currently carrying out batch testing in the UK.
In this letter, the Commission acknowledges that some companies may not be able to carry out batch testing in the EU by the time Brexit takes place. "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.
The competent authorities can therefore allow companies in the EU27 to refer to quality control tests carried out in the UK "for a limited period of time" and in justified cases under the conditions described below:
- 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.
In order to make use of this exemption, the companies concerned must inform the competent national authority immediately and before (!) the date of Brexit. In addition to the above information, the time period and batches (packs and quantities) to be exempted must also be reported.
If the competent authority or the EMA considers the application justified, the Qualified Person (QP) could then certify the batches concerned for placement on the EU/EEA market.
* See Article 51(1)(b) of Directive 2001/83/EC and Article 55(1)(b) of Directive 2001/82/EC.
Source: Letter entitled "Withdrawal of the United Kingdom and EU rules for batch testing of medicinal products".