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United Kingdom’s withdrawal from the European Union

On 29 March 2017, the United Kingdom (UK) notified the European Council of its intention to withdraw from the European Union (EU). The implications of Brexit for the European Medicines Agency’s (EMA) location and operations depend on the future relationship between the UK and the EU, which is unknown at present.

No Member State has previously decided to leave the EU, so there is no precedent for this situation.

The Agency is in close contact with the EU institutions and national competent authorities in the EU Member States. EMA will share information on the latest developments with its stakeholders.

EMA’s ongoing mission

The Agency, its 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.

EMA’s procedures are not affected by Brexit. The Agency will continue its operations, in accordance with the timelines set by its rules and regulations.

The European medicines regulatory network as a whole is a very strong and flexible system that is able to adapt to changes without jeopardising the quality and effectiveness of its work.

Regulatory preparedness (new)

On 2 May 2017, EMA and the European Commission published a notice to marketing authorisation holders of centrally authorised medicines intended to remind them of their legal obligations in preparation for Brexit:

In April 2017, EMA initiated discussions with the national competent authorities on how work related to the evaluation and monitoring of medicines will be shared between Member States in view of the UK’s withdrawal from the EU.

This is currently based on a scenario that foresees that the UK will no longer participate in the work of EMA and the European medicines regulatory network as of 30 March 2019.

Decision on EMA’s location

The location of the Agency after Brexit will depend on the future relationship between the UK and the EU, which is unknown at present. Representatives of the Member States will determine the Agency’s location by common agreement.

EMA welcomes the interest expressed by some Member States in hosting the Agency in future.

EMA is confident that the Member States will make the most appropriate decision on the Agency’s location and arrangements, taking the complex political and legal environment into account.

For the source text on the Euopean Medicines Agency website click here.

New Real Decreto 1090/2015, de 4 de diciembre

Please find attached information on the conference which will be held the 27th of January in Madrid, concerning the upcoming changes in the Real Decreto (1090/2015, de 4 de diciembre) in Spain.

Please note that you can follow the conference on line via web page: http://www.aemps.gob.es/laAEMPS/eventos/medicamentos-uso-humano/2016/J-Real-Decreto-ensayos-clinicos-2016.htm

Here is a link to the content of the Real Decreto in the Boletin official del Estado of 24th of December: https://www.boe.es/boe/dias/2015/12/24/pdfs/BOE-A-2015-14082.pdf

It is essential that you update yourself as a Senior Consultant on these changes, as they have an effect on existing and upcoming studies. read more…

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