Package Insert 42
Interesting facts and figures for customers and partners of mt-g.
Octobre 2017
In the spotlight
Brexit - How will the processes in the approval area be regulated in the future?
When the population of the United Kingdom voted in a referendum on whether their country would remain in the EU last June, there were probably very few observers who believed the country would exit the European Community. Around a year later, there is no doubt that Great Britain will leave the EU and that this separation will raise some questions.

For you as well as for us at mt-g, questions arise in particular in the sensitive fields of regulatory affairs for medicinal products and medical devices around how processes in this sector will be regulated going forwards. Will marketing authorisations or CE markings retain their validity once the exit is implemented? What will happen to regulatory affairs projects with important milestones that fall in the exact period in which Great Britain intends to break away from the EU?

It should be in the mutual interest of both sides to ensure that products that already have marketing authorisation can still be sold on both markets. Neither the UK nor the European market wants to suffer setbacks or resort to extensive repeat assessment and authorisation procedures.

The effects on companies can therefore not yet be gauged and, in addition, there is a lack of substantive information and planning from both sides. What is certain though is that the EMA will move from London to the European mainland, although its exact destination is not yet clear. In addition to various German cities, a total of 19 EU countries have shown interest in hosting the EMA.

It is also unclear what this separation will mean for the translation industry. One example is the European Data Protection Regulation, which prohibits the transmission of personal data to countries outside the EU if there is an inadequate level of data protection. The United Kingdom's proximity to the United States and its data exchange and data protection level could prompt the EU to prohibit the transmission of personal data to the United Kingdom. This could mean that translators based in the UK would no longer be able to work for language service providers based in the EU.

For Great Britain and the language service providers based there, the freedom of movement for workers will play an important role, as most language service providers in the country – and in London in particular – rely on multinational teams. It is not clear in this regard how the employees of these companies will be employed in Great Britain in the future or whether there might be a visa requirement for foreign employees.

At any rate, there will be some changes, although the time frame for their implementation and the effects of these changes cannot yet be foreseen. The process is sure to be gripping for all those involved, as rarely has there been such a Herculean administrative task in such a large and extensively regulated sector.

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