Thread by @GeorgePeretzQC

I think an explanation is needed. Here goes.

https://twitter.com/theousherwood/status/1334090216446046208

The UK is still entirely within the EU medicines regime. Under that regime, licensing of the Covid-19 vaccines is reserved to the EMA (technically the Commission advised by the EMA, but let’s simplify): only the EMA can license biotechnological products for medical use.

However, the Medicines Directive (2001/83) allows national medicines regulators (the MHRA) to approve unlicensed products for use in response to the spread of pathogens (Article 5(2)). That is what the MHRA has done here.

It is therefore incorrect to say that what has happened is something that could not have happened while we were in the EU (which we essentially still are, for these purposes). Raine is right.

What will happen after 31/12/2021 is that the MHRA will be the body that decides whether to grant a full licence to the vaccines (though any full licence granted by the EMA before then will continue to apply in the UK as a matter of UK law).

It would take a while to explain the differences that flow from the fact that the Pfizer vaccine is now “approved” but not yet licensed: there are a number of regulatory consequences important to those involved but not so much to the public.

This rings true. The MHRA is impressive. (Disclosure: I have often acted for it.)

https://twitter.com/PippaCrerar/status/1334091477761335296

This, unfortunately, does not ring true and should be corrected. The UK regulations dealt with some of the regulatory consequences of approval under Article 5(2) of the Directive. They did not add to the power to approve, which was already there in EU law, as explained above.

https://twitter.com/jacob_rees_mogg/status/1334068994345754625

For anyone interested in the challenges here post-transition, here is a thread from March.

https://twitter.com/georgeperetzqc/status/1239254500629712897