Reply to: EU publish thoughts for their negotiations. UK Govt still clueless/directionless

[BR14]

When you say “you lot” are you referring to Brexit Party members on here?

nope, all gumbeaters included.

hth

[WTFH]

do you lot think you're going to change/affect anything with this unending drivel??

ffs, you're like JtB on steroids

When you say “you lot” are you referring to Brexit Party members on here?

I’m trying to point out the realities of a situation to those who like their heads buried in the sand, or up Farage/Trump’s backside.

[BR14]

do you lot think you're going to change/affect anything with this unending drivel??

ffs, you're like JtB on steroids

[darmstadt]

At this point I expect the standard Brexiter response of: But we didn't vote for that, it wasn't a referendum option. No, you're right. You didn't specifically vote for it, but it's a direct consequence of the vote.

I bet you can find at least one Brexiter who will say that they voted for that even if they don't know what 'that' is....

[WTFH]

Government guidelines 09/18-02/19:
[Withdrawn] Quality and safety of organs, tissues and cells if there’s no Brexit deal - GOV.UK

Since 02/19:
Quality and safety of human organs, tissues and cells if there's a no-deal Brexit - GOV.UK

Note that one of the lines says "You will be able to use the traceability systems you had in place before the introduction of the SEC."
The SEC was introduced in 2006.
The Tory Brexit solution is to tell businesses to rip out the systems they have been running for the last 13+ years and replace them with the ones they were using in 2005.

One of the reasons the SEC was introduced was to give proper traceability and control on blood, tissues and organs. Getting rid of it is a major step back in the medical industry, but hey, blue passports go well with blue bodies.
https://ec.europa.eu/health/sites/he...cas_tes_en.pdf

At this point, I'd like to put a plug in for organ donors. If you're not already signed up, please do:
Home - NHS Organ Donation
Blood donors too.
Home - NHS Blood Donation


At this point I expect the standard Brexiter response of: But we didn't vote for that, it wasn't a referendum option. No, you're right. You didn't specifically vote for it, but it's a direct consequence of the vote.

[Whorty]

Javid actually said some things will change - some for the better and some for the worse, but also everyone has had 3+ years to prepare so...

This has to be trolling .... surely you can't be that dumb?!?

Also again you are quoting man made rules at me - which can be changed.

These are Boris/Tory man-made rules we are being made to follow. They could have been changed if idiots didn't vote them in to power with a majority. Suck it up fella .... you voted for this

[Cirrus]

Have I seen you on the Harry Enfield Show??

Javid actually said some things will change - some for the better and some for the worse

I recall you once saying, despite your moniker, that you weren't a PM. You didn't say what you actually were but I'm still betting you're not unknown on the stand-up circuit.

Your impersonation of a village idiot is something I think you do very well (although some woke people might not approve). Quoting Javid is clever humour.

Javid: "Hello Mum! Guess what??? "
Mrs Javid: "Oh Sajid, you can tie your own shoe laces?"
Javid: "No, Mum"
Mrs Javid: "You're potty trained, at last ??"
Javid: "No Mum - I'm the first Asian to be in 11 Downing Street!!!!"
Mrs Javid: "Oh I'm so proud. Not only the first Asian but also the first person with special needs!!!"

[WTFH]

...everyone has had 3+ years to prepare so...

But to prepare for what?
In the early days we were told it was the easiest deal in history, that everything would continue with minimal change, that the EU needs us more than we need them.
We've waited almost 4 years to find out what we need to prepare for, to find out where all the benefits are coming from, to learn how the UK is going to be better.

And Javid said that there would be "No alignment" on regulations.
Can you explain how that is better for any business that needs to ensure safe supply of pharma/medical products?

Based on your comments, either you've not worked in business in the last 15+ years or you're Donald Trump.

[NotAllThere]

It's not like we are trying to change the rules of physics eh!

No. That's child's play in comparison!

[original PM]

Javid actually said some things will change - some for the better and some for the worse, but also everyone has had 3+ years to prepare so...

Also again you are quoting man made rules at me - which can be changed.

It's not like we are trying to change the rules of physics eh!

[WTFH]

But if we are currently happy with what goes into the EU - why can we (as the Uk) not agree that we will still accept that as acceptable in the Uk - until such time as we get another licence of that is what is needed?

Also if we had stayed in the EU who is it who would have certified those products and what control do we have over the certification process?

There is not always a need to re-invent the wheel.

Javid says we have to re-invent the wheel. He has said that the UK will not enter into alignment on regulations.

As for how it currently works, the business registers an importer into the customs region as the point of import. If there is a recall, or emergency relating to the product, that importer is responsible. The issue for businesses is not just about getting the licences, it's also about duplicating manufacturing effort and duplicating distribution processes and warehousing.
That all costs a lot of money, if you consider a medical company that maybe makes 10,000 products that are all regulated globally.

These two are a good place to start:

https://publications.parliament.uk/p...ch/163/163.pdf

https://eur-lex.europa.eu/legal-cont...898055&from=EN

[original PM]

Here’s an example - not of manufacturing, but of importing.
Currently if a business imports medical devices into the EU, they have to get a certificate of compliance as the importer. (Can’t remember the exact term for it, I apologise). This code is printed on the packaging at the time of manufacture. There can only be one code on the packaging.
If the product is coded as valid for import into the EU, then currently it can be used anywhere in the EU under that certificate. If we break all ties with the EU, then any medical device or implant imported into the EU will not be legal to import into the UK, and any product where the cert is for import into the UK will not be legal to import into the EU.

The solution is that the manufacturer now has to get two import certificates, arrange for a second import company, split their manufacturing so that the products packages are legal, and update their supply chain process.

Nothing major, time consuming or expensive about that. It normally takes 2 years to get an import licence.

But if we are currently happy with what goes into the EU - why can we (as the Uk) not agree that we will still accept that as acceptable in the Uk - until such time as we get another licence of that is what is needed?

Also if we had stayed in the EU who is it who would have certified those products and what control do we have over the certification process?

There is not always a need to re-invent the wheel.

[WTFH]

If UK regs are a down grade they will ignore them and stick to the EU versions so they can continue to sell into the EU. If they are harsher, i.e. more expensive to comply with, they will up sticks and move.

Here’s an example - not of manufacturing, but of importing.
Currently if a business imports medical devices into the EU, they have to get a certificate of compliance as the importer. (Can’t remember the exact term for it, I apologise). This code is printed on the packaging at the time of manufacture. There can only be one code on the packaging.
If the product is coded as valid for import into the EU, then currently it can be used anywhere in the EU under that certificate. If we break all ties with the EU, then any medical device or implant imported into the EU will not be legal to import into the UK, and any product where the cert is for import into the UK will not be legal to import into the EU.

The solution is that the manufacturer now has to get two import certificates, arrange for a second import company, split their manufacturing so that the products packages are legal, and update their supply chain process.

Nothing major, time consuming or expensive about that. It normally takes 2 years to get an import licence.

[darmstadt]

Oh, UK starting to show it’s hand:
Brexit: 'No alignment' with EU on regulation, Javid tells business - BBC News

That’s going to go down well with regulated businesses, such as med/pharma.

What it does show is that you cannot trust this government, they speak with forked tongues:

Javid once said the UK’s best economic place was to remain in the EU and the single market. In May 2016, a month before the referendum he said the only thing guaranteed about leaving the bloc was a decade of “stagnation and doubt”.

“Just like the Bank of England governor, Mark Carney, and IMF head Christine Lagarde, I still believe that Britain is better off in. And that’s all because of the single market.


“It’s a great invention, one that even Lady Thatcher campaigned enthusiastically to create. The world’s largest economic bloc, it gives every business in Britain access to 500 million customers with no barriers, no tariffs and no local legislation to worry about,” he said in an article in the Daily Telegraph.

[DaveB]

Oh, UK starting to show it’s hand:
Brexit: 'No alignment' with EU on regulation, Javid tells business - BBC News

That’s going to go down well with regulated businesses, such as med/pharma.

If UK regs are a down grade they will ignore them and stick to the EU versions so they can continue to sell into the EU. If they are harsher, i.e. more expensive to comply with, they will up sticks and move.