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Lately I have been absolutely amazed by the number of changes that have been made to EU legislation/directives that have coincided with the progression of Avanir and our drug Nuedexta. I’m not saying that any of these new path ways will be taken advantage of however the fact is they now exist.
Excuse me while I have a little fun, not fiction not reality but pure fun on what may be under the latest EC Directive. I’m going to send Nuedexta direct from the USA to Spain’s hospitals as a starter. How can this be possible with all the barriers in place, well those barriers as of yesterday have been lifted. (Sarge if you are reading this, you know you were dispatched to Spain to carry Rzr’s bag how did you get on)
The United States of America requested, by letter dated 17 January 2013, to be listed in accordance with Article 111b(1) of Directive 2001/83/EC. The equivalence assessment by the Commission confirmed that the requirements of that Article were fulfilled.
Good afternoon Placesontherun
Thank you for your kind words, it certainly works both ways I get a great deal of useful information from the likes of your good self and others from your side of the pond, do I call it head office ;-)
Have a very pleasant weekend.
Falconi, thanks for this most excellent news....speaking of the importation determination rather than Sarge carrying my bags in Spain. I'm afraid that I must report that based on his performance in servitude he should be reduced in rank to Private, not even first class. Such a whiner he is and like he said his Spanish is certainly not up to the task. When I approached the ordering agent in the first hospital to get Neudexta on formulary, instead of saying Buenos dias, Senior, he said something to the effect of Go........yourself. Well, you can only imagine the scene that this triggered. We were ushered out of the hospital straight away and told to never come back. Based on this very brief experience, I would suggest that Avanir management might think about partnering with those that know the persuasive arts far better than our dear Sarge! Now, about that flask - was this Spain thing just a diversion to keep us from asking very tough questions regarding its whereabouts? You, of course, wouldn't know anything about that would you? Just ask'n!
I believe, Sir, that it is quite clear who has control of the flask right now.
It's all becoming clear now. While sending me to all corners of the country looking for obscure vintages of port, you have, in very short order, become known to all of Barcelona as "El Gringo Loco". Where would you be if my Persuasive arts" had not prevailed upon that gendarme when he was heck bent on arresting you?
I'm applying for a field promotion. Major Pepper has a nice ring, wouldn't you say?
Dispatched is an accurate word. I'll tell you, giving the Razor man his own personal valet may have been a miscalculation. It went straight to his head. Instead of focusing on the task at hand, he's had me scurrying all over the Iberian peninsula looking for what he calls his "perks". You may need to send a supervisor down here to get him under control.
Personally, my Spanish is a little rusty and a few things might be getting lost in translation. The first medical rep we saw thought we were selling hats....
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On the 21/06/2013
The Unites States have been added to the "list of third countries" as regards standards of manufacture and supervision of active pharmaceutical ingredients equivalent to those of the EU.
What does this mean.
On 1 July 2011, Directive 2011/62/EU of the European Parliament and of the
Council of 8 June 2011 amending Directive 2001/83/EC on the Community code
relating to medicinal products for human use, as regards the prevention of the entry
into the legal supply chain of falsified medicinal products was published. This
Directive amends Directive 2001/83/EC on the Community Code relating to
medicinal products for human use.
Directive 2011/62/EU introduces EU-wide rules for the importation of active
substances:3 According to Article 46b(2) of Directive 2001/83/EC, active
substances shall only be imported if, inter alia, the active substances are
accompanied by a written confirmation from the competent authority of the
exporting third country which, as regards the plant manufacturing the exported
active substance, confirms that the standards of good manufacturing practice and
control of the plant are equivalent to those in the Union.
The requirement of a written confirmation is waived for third countries listed by the
Commission in accordance with Article 111b of Directive 2001/83/EC.
Good afternoon Harry
I noticed you raised this today You may have missed this while you was away.
There may be a few more details for you in the thread that you have not seen.
Have a great weekend.
I don't see where you guys think this is some kind of significant change.
To me this is only about ensuring medicines imported into Europe are not counterfeit and they have been certified as being produced under, "good manufacturing practice".
This "news" seems to just be that the U.S. is considered by the Europeans to be a reliable source of medications and so written confirmation from the U.S. FDA is no longer required to certify drugs exported from the U.S. have been reliably manufactured.
On the other hand, a drug manufactured in Nigeria, for example, would probably still need the Nigerian FDA to sign a letter saying the drug is authentic and has been made with good manufacturing practice.
This "news" seems to change nothing about needing a third party to do a drug launch in Europe.