IPEC e-newsletter - Excipients Insight June/July 2017 - 10-07-17

 

Inside this issue

     

Regulatory guidance for industry as UK negotiates withdrawal from EU

The European Medicines Agency (EMA) and the European Commission have published guidance to help pharma companies prepare for the UK's withdrawal from the EU.

A new questions-and–answers (Q&A) document concerns information related to the location of establishment of a company in the context of centralised procedures and certain activities, including the location of orphan designation holders, qualified persons for pharmacovigilance (QPPVs) and companies' manufacturing and batch release sites.

EMA said it is also preparing a series of further guidance documents which will be published on its dedicated Brexit webpage in due course.

This Q&A document follows the publication of a Commission/EMA notice to marketing authorisation holders of centrally authorised medicines for human and veterinary use. That notice emphasises – among other things – that EU law requires that marketing authorisation holders are established in the EU (or EEA), and some activities - pharmacovigilance, batch release etc - must be performed in the EU/EEA.

 

 

 

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