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.
Batch testing and release,Qualified Person Responsible for Pharmacovigilance (QPPV) etc.
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.
MAHs are expected to contact the Norwegian Medicines Agency in case any product is identified that could suffer from supply disruption as a consequence from Brexit or the implementation of FMD.
MAHs are asked to complete the linked survey in order to assess current Brexit and FMD status and preparedness. The intention is to remind MAHs of their 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 they 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?
Complete the survey before 11th of January 2019.