| It's all going terribly well part 555744343423523523299797987 on 10:33 - Sep 3 with 3148 views | WeWereZombies |
And presumably as well as losing all those jobs and the guarantee of future economic growth we will suffer the double whammy of having to deal with every shyster in the world trying to ship inadequate or potentially harmful treatments to us. |  |
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| It's all going terribly well part 555744343423523523299797987 on 10:47 - Sep 3 with 3137 views | xrayspecs |
| It's all going terribly well part 555744343423523523299797987 on 10:33 - Sep 3 by WeWereZombies |
And presumably as well as losing all those jobs and the guarantee of future economic growth we will suffer the double whammy of having to deal with every shyster in the world trying to ship inadequate or potentially harmful treatments to us. |
Not true. Medicines entering the UK from outside the EU will be subject to inspection, as is the case today.
Medicines that have been inspected in Europe will enter the UK without additional checks under a recognition scheme. |  | | |
| It's all going terribly well part 555744343423523523299797987 on 11:12 - Sep 3 with 3109 views | WeWereZombies |
| It's all going terribly well part 555744343423523523299797987 on 10:47 - Sep 3 by xrayspecs |
Not true. Medicines entering the UK from outside the EU will be subject to inspection, as is the case today.
Medicines that have been inspected in Europe will enter the UK without additional checks under a recognition scheme. |
Truth is often malleable, dependent upon the receiving bodies senses and relative to it's surrounding entities.
We are seeing standards slip every day if we note what is going on around us and if you read my post more carefully you would have noted that I said the shysters would be trying. Even if they do not succeed we will still have additional inspection costs. But I suspect a lot more crud will get through than does at present, in the meantime would you mind checking out the definitions for 'de jure' and 'de facto'? | |
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| It's all going terribly well part 555744343423523523299797987 on 11:21 - Sep 3 with 3092 views | jaykay |
| It's all going terribly well part 555744343423523523299797987 on 11:12 - Sep 3 by WeWereZombies |
Truth is often malleable, dependent upon the receiving bodies senses and relative to it's surrounding entities.
We are seeing standards slip every day if we note what is going on around us and if you read my post more carefully you would have noted that I said the shysters would be trying. Even if they do not succeed we will still have additional inspection costs. But I suspect a lot more crud will get through than does at present, in the meantime would you mind checking out the definitions for 'de jure' and 'de facto'? |
i expect with x ray specs he thought he could see right through your post |  |
| forensic experts say footers and spruces fingerprints were not found at the scene after the weekends rows |
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| It's all going terribly well part 555744343423523523299797987 on 11:28 - Sep 3 with 3076 views | factual_blue |
balls.
Get behind your dodgy bloke in Clacton making snide vincristine and related drugs. |  |
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| It's all going terribly well part 555744343423523523299797987 on 11:50 - Sep 3 with 3051 views | xrayspecs |
| It's all going terribly well part 555744343423523523299797987 on 11:12 - Sep 3 by WeWereZombies |
Truth is often malleable, dependent upon the receiving bodies senses and relative to it's surrounding entities.
We are seeing standards slip every day if we note what is going on around us and if you read my post more carefully you would have noted that I said the shysters would be trying. Even if they do not succeed we will still have additional inspection costs. But I suspect a lot more crud will get through than does at present, in the meantime would you mind checking out the definitions for 'de jure' and 'de facto'? |
The MHRA is losing its evaluation arm of its business, the inspection arm will continue. There is no evidence that the UK would adopt a lower inspection standard compared to the EU.
By choosing to allow medicines that have already been inspected in the EU into the UK without further inspection, no additional costs will be incurred. | | | |
| It's all going terribly well part 555744343423523523299797987 on 11:58 - Sep 3 with 3032 views | No9 |
| It's all going terribly well part 555744343423523523299797987 on 10:47 - Sep 3 by xrayspecs |
Not true. Medicines entering the UK from outside the EU will be subject to inspection, as is the case today.
Medicines that have been inspected in Europe will enter the UK without additional checks under a recognition scheme. |
Your theory is OK but doesn't hold water relative to what the brexiteers are saying- that out of the EU regulations can be binned & the Americans have said catagorically IF the Uk wants a trade deal they will have to bin EU regulations and work with US reg's instead
That should worry you | | | |
| It's all going terribly well part 555744343423523523299797987 on 12:09 - Sep 3 with 3021 views | eireblue |
| It's all going terribly well part 555744343423523523299797987 on 11:50 - Sep 3 by xrayspecs |
The MHRA is losing its evaluation arm of its business, the inspection arm will continue. There is no evidence that the UK would adopt a lower inspection standard compared to the EU.
By choosing to allow medicines that have already been inspected in the EU into the UK without further inspection, no additional costs will be incurred. |
Hmmm, so EU civil servants, or eurocrats as I believe they are called, will be responsible for some of the medicines getting into the UK?
I thought this Brexit stuff was about bringing back control? |  | | |
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| It's all going terribly well part 555744343423523523299797987 on 12:30 - Sep 3 with 2995 views | No9 |
| It's all going terribly well part 555744343423523523299797987 on 12:09 - Sep 3 by eireblue |
Hmmm, so EU civil servants, or eurocrats as I believe they are called, will be responsible for some of the medicines getting into the UK?
I thought this Brexit stuff was about bringing back control? |
Taking back control is a joke when the gamblers are playing with sterling everyday & we rely on the EU for so much | | | |
| It's all going terribly well part 555744343423523523299797987 on 12:34 - Sep 3 with 2989 views | bluewein |
I can't wait for the day I have to regularly pay £100 a pop for my insulin to carry on living.
What a time to be alive... |  |
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| It's all going terribly well part 555744343423523523299797987 on 14:31 - Sep 3 with 2920 views | factual_blue |
| It's all going terribly well part 555744343423523523299797987 on 12:34 - Sep 3 by bluewein |
I can't wait for the day I have to regularly pay £100 a pop for my insulin to carry on living.
What a time to be alive... |
Just ask Mrs May how she'll be getting her insulin. | |
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| It's all going terribly well part 555744343423523523299797987 on 15:01 - Sep 3 with 2893 views | xrayspecs |
| It's all going terribly well part 555744343423523523299797987 on 11:58 - Sep 3 by No9 |
Your theory is OK but doesn't hold water relative to what the brexiteers are saying- that out of the EU regulations can be binned & the Americans have said catagorically IF the Uk wants a trade deal they will have to bin EU regulations and work with US reg's instead
That should worry you |
You will find that the FDA (the US medicines regulator) works to pretty much the same regs as the EMA. While there may well be regulatory divergence between the UK and EU post BREXIT, you are not going to see a race to the bottom in areas of public health and safety.
Why should I be worried? [Post edited 3 Sep 2018 15:11]
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| It's all going terribly well part 555744343423523523299797987 on 15:06 - Sep 3 with 2886 views | BryanPlug |
[content removed at owner's request] |  |
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| It's all going terribly well part 555744343423523523299797987 on 15:08 - Sep 3 with 2880 views | No9 |
| It's all going terribly well part 555744343423523523299797987 on 15:01 - Sep 3 by xrayspecs |
You will find that the FDA (the US medicines regulator) works to pretty much the same regs as the EMA. While there may well be regulatory divergence between the UK and EU post BREXIT, you are not going to see a race to the bottom in areas of public health and safety.
Why should I be worried? [Post edited 3 Sep 2018 15:11]
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Who outside of America would trust the FDA?
Just to remind you, the brexiteers want to bin the regulations | | | |
| It's all going terribly well part 555744343423523523299797987 on 15:10 - Sep 3 with 2874 views | xrayspecs |
| It's all going terribly well part 555744343423523523299797987 on 12:09 - Sep 3 by eireblue |
Hmmm, so EU civil servants, or eurocrats as I believe they are called, will be responsible for some of the medicines getting into the UK?
I thought this Brexit stuff was about bringing back control? |
The testing is conducted by commercial contract laboratories rather than civil servants.
The testing is undertaken within the country which imports the product, so any of the EU 28, rather than one central place.
All the UK is proposing is that it will accept, without further testings, any batch of medicine that has already been through a testing and certification process in the EU prior to arriving in the UK.
We could chose to retest products already certified in the EU. It would though lead to delays in supplying medicines to patients and increase costs to manufacturers and ultimately healthcare systems.
Seems sensible to me to not want to add bureaucracy and costs at the border in this instance. | | | |
| It's all going terribly well part 555744343423523523299797987 on 15:14 - Sep 3 with 2861 views | No9 |
| It's all going terribly well part 555744343423523523299797987 on 15:10 - Sep 3 by xrayspecs |
The testing is conducted by commercial contract laboratories rather than civil servants.
The testing is undertaken within the country which imports the product, so any of the EU 28, rather than one central place.
All the UK is proposing is that it will accept, without further testings, any batch of medicine that has already been through a testing and certification process in the EU prior to arriving in the UK.
We could chose to retest products already certified in the EU. It would though lead to delays in supplying medicines to patients and increase costs to manufacturers and ultimately healthcare systems.
Seems sensible to me to not want to add bureaucracy and costs at the border in this instance. |
The quality of products coming from the EU isn't the issue is it?
The real problem is with stuff that comes from Non Eu countries and does come in via the EU where it will have been tested.
The UK has a number of legal problems to resolve with =in EU courts over poor quality products and contraband carrying the EU mark tho' it has never been inspected to EU standards. | | | |
| It's all going terribly well part 555744343423523523299797987 on 15:17 - Sep 3 with 2857 views | xrayspecs |
| It's all going terribly well part 555744343423523523299797987 on 15:08 - Sep 3 by No9 |
Who outside of America would trust the FDA?
Just to remind you, the brexiteers want to bin the regulations |
The government position is for regulatory alignment with EMA when it comes to medicines.
I have yet to hear any Brexiteer call for regulatory divergence in quality testing of medicines. The likes of Liam Fox have been most supportive of the pharmaceutical industry argument for continued alignment in this area. | | | |
| It's all going terribly well part 555744343423523523299797987 on 15:22 - Sep 3 with 2842 views | xrayspecs |
| It's all going terribly well part 555744343423523523299797987 on 15:14 - Sep 3 by No9 |
The quality of products coming from the EU isn't the issue is it?
The real problem is with stuff that comes from Non Eu countries and does come in via the EU where it will have been tested.
The UK has a number of legal problems to resolve with =in EU courts over poor quality products and contraband carrying the EU mark tho' it has never been inspected to EU standards. |
I do not see why you view this as a problem.
Any product imported into the EU will need to satisfy stringent quality control checks before it is allowed to be released for use in the EU. If a product that enters the EU from a third country fails this test, it will not be released for use. It would also not be accepted in the UK.
We know that EU testing is stringent, so where does the risk lie to the UK in accepting EU approved batches without retesting?
In terms of court cases, any medicine examples you can cite? [Post edited 3 Sep 2018 15:23]
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| It's all going terribly well part 555744343423523523299797987 on 15:24 - Sep 3 with 2836 views | No9 |
| It's all going terribly well part 555744343423523523299797987 on 15:17 - Sep 3 by xrayspecs |
The government position is for regulatory alignment with EMA when it comes to medicines.
I have yet to hear any Brexiteer call for regulatory divergence in quality testing of medicines. The likes of Liam Fox have been most supportive of the pharmaceutical industry argument for continued alignment in this area. |
Wilbur Ross the American trade secretary has said if the Uk wants a trade deal with the US it will be on the US terms
The brexiteers have repeatedly said that EU regulatoins shall be droppped when we leave. That is at least part of what leaving the EU is about | | | |
| It's all going terribly well part 555744343423523523299797987 on 15:29 - Sep 3 with 2822 views | xrayspecs |
| It's all going terribly well part 555744343423523523299797987 on 15:24 - Sep 3 by No9 |
Wilbur Ross the American trade secretary has said if the Uk wants a trade deal with the US it will be on the US terms
The brexiteers have repeatedly said that EU regulatoins shall be droppped when we leave. That is at least part of what leaving the EU is about |
There will be some sectors where divergence is not in anyone's best interest and continued cooperation and alignment is the optimal approach.
Areas of public health safety, including medicines is one. Fight against terrorism etc. is another.
What has got lost in the debate on BREXIT is that any UK company that wants to export to the EU will be bound by its rules and quality standards. Leaving the EU does not give you free reign to do what you want if you still want to sell your product or services to them. [Post edited 3 Sep 2018 15:29]
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| It's all going terribly well part 555744343423523523299797987 on 15:30 - Sep 3 with 2818 views | WeWereZombies |
| It's all going terribly well part 555744343423523523299797987 on 15:01 - Sep 3 by xrayspecs |
You will find that the FDA (the US medicines regulator) works to pretty much the same regs as the EMA. While there may well be regulatory divergence between the UK and EU post BREXIT, you are not going to see a race to the bottom in areas of public health and safety.
Why should I be worried? [Post edited 3 Sep 2018 15:11]
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My apologies, I didn't realise your first reply was ironic. | |
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| It's all going terribly well part 555744343423523523299797987 on 15:32 - Sep 3 with 2814 views | eireblue |
| It's all going terribly well part 555744343423523523299797987 on 15:10 - Sep 3 by xrayspecs |
The testing is conducted by commercial contract laboratories rather than civil servants.
The testing is undertaken within the country which imports the product, so any of the EU 28, rather than one central place.
All the UK is proposing is that it will accept, without further testings, any batch of medicine that has already been through a testing and certification process in the EU prior to arriving in the UK.
We could chose to retest products already certified in the EU. It would though lead to delays in supplying medicines to patients and increase costs to manufacturers and ultimately healthcare systems.
Seems sensible to me to not want to add bureaucracy and costs at the border in this instance. |
You mean, a bunch of countries, on certain topics, kind-of all getting together, agree standards across all countries, and then allow things to move freely across the borders.
Hmmm, why has no one thought about this sort of thing before. | | | |
| It's all going terribly well part 555744343423523523299797987 on 15:34 - Sep 3 with 2807 views | No9 |
| It's all going terribly well part 555744343423523523299797987 on 15:29 - Sep 3 by xrayspecs |
There will be some sectors where divergence is not in anyone's best interest and continued cooperation and alignment is the optimal approach.
Areas of public health safety, including medicines is one. Fight against terrorism etc. is another.
What has got lost in the debate on BREXIT is that any UK company that wants to export to the EU will be bound by its rules and quality standards. Leaving the EU does not give you free reign to do what you want if you still want to sell your product or services to them. [Post edited 3 Sep 2018 15:29]
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The brexiteers have made numberous statements about leaving the EU which are bollox -including the point you make about Britsh companies needing to meet EU standards if they are to sell into the EU. However there are those who are now arguing this isn't important because UK exports to non EU countries is growing more rapidly that exports to the EU - no one mentiosn the fact that EU companies are sourcing their requirements from places other than the UK.
As far as regulations are concerned attached is what Me Gove said last year & I have not seen any brexiteer argue against that-
https://www.independent.co.uk/news/uk/politics/brexit-eu-regulations-michael-gov | | | |
| It's all going terribly well part 555744343423523523299797987 on 15:41 - Sep 3 with 2796 views | xrayspecs |
| It's all going terribly well part 555744343423523523299797987 on 15:32 - Sep 3 by eireblue |
You mean, a bunch of countries, on certain topics, kind-of all getting together, agree standards across all countries, and then allow things to move freely across the borders.
Hmmm, why has no one thought about this sort of thing before. |
It is a radical idea....
I think what has been coming to light, at least in political circles, over the last year or so is how much it will cost if the UK truly goes it alone. Activities that are currently done once at a EU wide level, will now need to be done in the UK as well as Europe. Batch testing and release of imported medicines being just one example.
Those costs will be borne by both UK and EU businesses/government, which will be bad news for us punters, as we will pick up the cost in some form. | | | |
| It's all going terribly well part 555744343423523523299797987 on 15:51 - Sep 3 with 2780 views | xrayspecs |
| It's all going terribly well part 555744343423523523299797987 on 15:34 - Sep 3 by No9 |
The brexiteers have made numberous statements about leaving the EU which are bollox -including the point you make about Britsh companies needing to meet EU standards if they are to sell into the EU. However there are those who are now arguing this isn't important because UK exports to non EU countries is growing more rapidly that exports to the EU - no one mentiosn the fact that EU companies are sourcing their requirements from places other than the UK.
As far as regulations are concerned attached is what Me Gove said last year & I have not seen any brexiteer argue against that-
https://www.independent.co.uk/news/uk/politics/brexit-eu-regulations-michael-gov |
Micheal Gove - enough said. Clinical trials are normally international and include patients recruited across multiple countries. The conduct of the study is governed by the study protocol and the standard expected by the regulatory bodies.
Liam Fox spoke at a reception in Westminster recently where he acknowledged the need for ongoing regulatory alignment for medicines.
I think that stat is a red herring. While exports to non-EU countries may be growing more quickly than for EU countries, they still account for a very significant percentage of UK business sales/revenues. Very few companies could afford to walk away from that business. [Post edited 3 Sep 2018 15:55]
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