A letter to the European Medicines Agency (EMA) and EU27 Heads of Medicines Agencies (HMA), written by the European Commission’s Directorate-General for Health and Food Safety (Sante), outlines an exemption to certain batch testing requirements for medicine manufacturers who currently perform batching test in the United Kingdom (UK).
According to article 51(1)(b) of Directive 2001/83/EC and article 55(1)(b) of Directive 2001/82/EC, medicines imported into the European Union (EU) must go through batch testing within the EU/European Economic Area (EEA). However, when the UK leaves the EU, medicine manufacturers who previously conducted batch testing in the UK are required to move their batch testing to the EU in order to import their products.
The Commission is aware that some companies may not be able to set up batch testing operations in the EU by 29th March 2019, therefore under certain circumstances, competent authorities may temporarily allow medicine manufacturers to continue to rely on batch testing performed in the UK. However, it is important to note that if the withdrawal agreement negotiated in November 2018 is accepted, the exemption would not be required as the agreement involves a 21-month transition period that would enable medicine manufacturers to continue batch testing in the UK.
In order to qualify for the exemption, the European Commission states that medicine manufacturers must have identified a new batch release site within the EU by the UK’s withdrawal from the EU, and that existing UK site should be supervised by an EU-based qualified person (QP). Furthermore, medicine manufacturers are required to demonstrate that they have taken all the necessary steps to prepare to move quality control testing operations to the EU.
Medicine manufacturers are also required to inform regulators of any issues that could potentially lead to a supply disruption of an authorised medicine two months in advance, thus companies expecting Brexit-related disruptions should notify the relevant authorities now.
To read the letter regarding withdrawal of the UK and EU rules for batch testing of medicinal products, please click here.