We would love to hear your thoughts about our site and services, please take our survey here.
London South East prides itself on its community spirit, and in order to keep the chat section problem free, we ask all members to follow these simple rules. In these rules, we refer to ourselves as "we", "us", "our". The user of the website is referred to as "you" and "your".
By posting on our share chat boards you are agreeing to the following:
The IP address of all posts is recorded to aid in enforcing these conditions. As a user you agree to any information you have entered being stored in a database. You agree that we have the right to remove, edit, move or close any topic or board at any time should we see fit. You agree that we have the right to remove any post without notice. You agree that we have the right to suspend your account without notice.
Please note some users may not behave properly and may post content that is misleading, untrue or offensive.
It is not possible for us to fully monitor all content all of the time but where we have actually received notice of any content that is potentially misleading, untrue, offensive, unlawful, infringes third party rights or is potentially in breach of these terms and conditions, then we will review such content, decide whether to remove it from this website and act accordingly.
Premium Members are members that have a premium subscription with London South East. You can subscribe here.
London South East does not endorse such members, and posts should not be construed as advice and represent the opinions of the authors, not those of London South East Ltd, or its affiliates.
Thanks Joey...but in order to implement deals struck they will have to agree or disagree by 15 October - well that's the deadline given by Boris. So 15 October is really so much more significant!!!!!
Bella6532 I too worried about Brexit and the implications. The German BfArM website helpfully has a dedicated Brexit part of their site I read.
https://www.bfarm.de/EN/Drugs/licensing/ZulRelThemen/Brexit/_node.html
Following the signature and ratification by both the UK Parliament and the European Parliament of the agreement regulating the UK's withdrawal from the European Union on 31 January 2020, the European Council adopted the decision to conclude the withdrawal agreement on 30 January 2020. As of 1 February 2020, the United Kingdom is therefore considered a third country. However, a transitional period until 31 December 2020 was agreed, during which the conditions and obligations of the acquis communautaire continue to apply to the United Kingdom.
So 31st Dec until Britain truly shoots their own foot :)
Unless the UK get their finger out, there will be no supply left for British patients.
6 to 8 to 10...perfect...
Not wanting to split hairs...but we're not officially still in the EU or EEA...perhaps this might be why discussions have been going on a bit!!!
I'm sure now France have approved and are adding SNG001 to their ATU List the rest will follow as this is too important to split hairs over...
Hopefully it's going to snowball, and then create such volume pressures that authorities will have no choice but to fully endorse then facilitate a tri-party agreement to deliver at scale with a partner/acquisition.
The first approval is so crucial, looking like it will come from the French. I am confident other European countries will soon follow, especially once they see the positive outcomes from France and with them all being in the EMA. And we have no shortage of cases there.
SirSwish1982 - Ye essentially we get to step 10. )
I have taken a look at The Spanish approval system but their site not as helpful as Germany as no English translation :)
The Spanish Medicines and Healthcare Products Agency (AEMPS) may authorize the use of medicines under investigation before being marketed in Spain
https://www.aemps.gob.es/medicamentos-de-uso-humano/acceso-a-medicamentos-en-situaciones-especiales/?lang=en
I believe the best info to be had is in this pdf
http://www.boe.es/boe/dias/2009/07/20/pdfs/BOE-A-2009-12002.pdf
It does suggest approvals can be based on EMA/Partners directives so it seems there is a good chance that once France and Germany approve they would quickly follow suit IMO. If anyone is fluent Spanish have a read :)
Hi Joey,
I assume you mean that when we get to step six, that we have an ongoing trial in UK which points to step 8, where the answer is no and therefore gets AMHV use approval.
Thanks Joey......We are starting to see how this can go from here.......
We may look back and say RM played a binder............!
VGLA!
OK did some research into Germany and what their process for granting a drug is.
The main body is called The Federal Institute for Drugs and Medical Devices (BfArM) and they have a program called AMHV which is their equivalent ATU.
https://www.bfarm.de/EN/Drugs/licensing/clinicalTrials/compUse/_node.html
Now lots of great information in English on this website but something particularly cool lies in this pdf flowchart
https://www.bfarm.de/SharedDocs/Downloads/EN/Drugs/licensing/clinicalTrials/compUse/AMHV-Flow-chart.pdf?__blob=publicationFile&v=3
I wont ruin the surprise but follow the flowchart to the end and look at the implication of the French news. :)