Orphan Drug Designation (ODD) and establishment of the Holder in EEA: are you ready for Brexit?

- 11 September 2018

Orphan Drug Designation (ODD) and establishment of the Holder in EEA: are you ready for Brexit?

Following the vote in favour of the United Kingdom (UK)’s withdrawal from the European Union (EU) taken on 23 June 2016, the decision for the UK to leave the EU will become effective as of 31 March 2019.

As a consequence, from this date onwards, Orphan Drug Designation (ODD) holders based in UK will have to relocate and be established in the European Economic Area (EEA) (please refer to European Medicines Agency UK withdrawal guideline, see below).  

 

Such a change of sponsor will result in a transfer of the orphan medicinal product designation if it involves a change in legal entity.

 

BlueReg is an international regulatory consultancy company based in the UK and also in the European Union (France) with a solid expertise in ODD. Should you try to find a sponsor based in EEA, your ODD designation can be transferred to BlueReg who will act on your behalf.

 

If you wish one of our experts to contact you, please enter your contact details below, we will be pleased to get back to you very soon.

 

Our website: https://www.bluereg-group.com//

EMA Guidance: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2017/11/WC500239369.pdf

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