After March 29, 2019, the United Kingdom (UK) will no longer be a part of the EEA due to Brexit. Consequently, the EU rules in the field of medicinal products will no longer apply to UK, subject to any transitional agreement that may be contained in a possible withdrawal agreement. This means that the UK may have the same status as any other third country.
 
EU law requires that: Marketing authorisation holders (MAHs) are established in the EEA. Key activities and personnel are based or performed in the EEA. Activities include: Batch testing and release,Qualified Person Responsible for Pharmacovigilance (QPPV).
 
In addition, the Falsified Medicines Directive (FMD) requires certain categories of medicinal products to be equipped with safety features for batches to be released after February 9, 2019.

You are asked to complete the following questionnaire in order to assess your Brexit and FMD current status and preparedness. The intention is to remind you of your obligations in regard to these two events and the importance of taking proper measurements in order to secure a  continuous supply of all products for which you hold a marketing authorisation.The intention is also to identify any medicinal products that may be affected. 
 
Due to Brexit and the implementation of Safety Features  - have you done the necessary regulatory changes for medicinal products in Norway?
 
 


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