EMA Continues Operations As Usual Despite Brexit

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 07-08-2016 11:10


The European Medicines Agency (EMA) has assured that its procedures and work stream are not affected by the United Kingdom’s exit from the European Union (EU). The EMA will continue operations as usual in accordance with the timelines set by its rules and regulations. On June 23, 2016 the UK voted in a public referendum to end its membership in the EU in a move widely known as Brexit.

“The [EMA] acknowledges the outcome of the referendum of 23 June 2016. A majority voted against [the UK’s] continued membership of [EU] and it is now up to the UK government to decide how to act upon the outcome of the referendum,” the agency said in a statement.

The UK's decision to exit the EU marks the first member state to ever leave the EU of its own volition, and the EMA recognizes that there is no precedent for this situation. The implications for the seat and operations of the EMA depend on the future relationship between the UK and the EU, which remains unknown at present.

The EMA, the EU’s pharmaceutical regulatory authority, is housed in London. It employs 890 employees and “all the European experts contributing to EMA’s work will continue to focus on EMA’s mission to protect human and animal health and ensure access to medicines that are safe, effective and of good quality,” the agency said.

Although the EMA acknowledged that some member states are interested in hosting its seat, the agency has not made a decision about a move from London to another EU member state location.

“EMA welcomes the interest expressed by some member states to host the agency in future. The decision on the seat of the agency will however not be taken by EMA, but will be decided by common agreement among the representatives of the Member States. We are confident that the Member States will take the most appropriate decision on EMA's location and arrangements in due course, taking also into account the complex political and legal environment generated by the outcome of the UK referendum,” the EMA said in its statement.

The agency continued to say: “The European Regulatory Network as a whole is a very strong and flexible system that is able to adapt to changes without jeopardizing the quality and effectiveness of its work. The Agency is in close contact with the EU institutions. As soon as concrete information will become available, EMA will share it with its stakeholders”, the agency added.

See the related article: Brexit: What Does It Mean For Pharma? 

Source: European Medicines Agency


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