A lot is going on at the moment concerning the Brexit. The UK is leaving the EU. This has quite some consequences for all types of industry. For the pharmaceutical industry this means that the EU rules and regulations no longer apply for the UK. Meaning the UK will become a so called third country.
The consequences of this are tremendous.
– if you currently have a market authorization for Europe. This no longer holds for the UK.
– if you are currently producing (part of) your product in the UK, your product needs to be imported into the EU. For commercial products this means that a full re-analysis needs to take place for each batch in the EU and the batch needs to be released again by a QP in de EU.
– if you currently import an (I)MP into the EU via the UK, you need to reimport it via an EU country, by a company having an EU manufacturing license and a QP.
The last weeks I have been asked a lot of times:” you are a QP, Can you import clinical trial material for a company and release it? Our current QP is in the UK and with the upcoming brexit we need to be prepared.” My answer then always is:”yes I am recognized by IGJ as a QP, but I can only act as a QP when I am on a manufacturing licence.”
So bottom line is. Brexit will have consequences for all industries and in this blog I have tried to summarize the main consequences for the pharmaceutical industry from my point of view.