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European drug formulary / pharmacopeia
Thread poster: Vito Smolej

Vito Smolej
Germany
Local time: 17:18
Member (2004)
English to Slovenian
+ ...
Mar 24, 2007

You know all those little scraps of paper in the medication boxes nobody ever reads? - that's what I meant.

I would appreciate any hints / URLs for the subject. Of course the best would be euroterm / polylingual sources.

TiA

Vito


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Jim Tucker  Identity Verified
United States
Hungarian to English
+ ...
those are "PIL"s Mar 24, 2007

no, not pills -

PILs. Patient Information Leaflets. Here are a few to browse:

http://xpil.medicines.org.uk/BrowsePils.aspx

But you can do a search on most any pharma site and you'll find others.

No I haven't found a multilingual compendium yet. Hope someone in this thread does.


There's also a more technical version for medical professionals to read called the SPC (summary of product characteristics)

Jim


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Sonja Tomaskovic  Identity Verified
Germany
Local time: 17:18
English to German
+ ...
... Mar 24, 2007

http://www.edqm.org

http://www.emea.eu.int/

The latter one contains so called templates, available in all official EU languages, including Slovenian (I suppose that's what you were looking for).

Unfortunately I don't have a link for all the docs right away. You will have to search for yourself (a bit tedious).

Sonja


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xxxLia Fail  Identity Verified
Spain
Local time: 17:18
Spanish to English
+ ...
EMEA Mar 24, 2007

Vito Smolej wrote:

You know all those little scraps of paper in the medication boxes nobody ever reads? - that's what I meant.

I would appreciate any hints / URLs for the subject. Of course the best would be euroterm / polylingual sources.

TiA

Vito


Standard formats:

See http://www.emea.eu.int/htms/human/qrd/qrdtemplate.htm


You can align them and adapt them to your product.

[Edited at 2007-03-24 10:01]


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Maria Diaconu  Identity Verified
Romania
Local time: 18:18
English to Romanian
If you are looking for the QRD template... Mar 24, 2007

The package leaflet is Annex III, letter B, of the pdf document which can be found (in English) at the following address:
http://www.emea.eu.int/htms/human/qrd/qrdplt/QRD%20template.pdf

You also have the annotated version at the following address:
http://www.emea.eu.int/htms/human/qrd/qrdplt/Annotated%20QRD%20template%20with%20QRD%20notes.pdf

And for various languages:
http://emea.europa.eu/htms/human/qrd/qrdtemplate.htm

HTH


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Vito Smolej
Germany
Local time: 17:18
Member (2004)
English to Slovenian
+ ...
TOPIC STARTER
EMEA, PIL, QRD .... it's all coming back Mar 24, 2007

The package leaflet is Annex III, letter B, of the pdf document which can be found (in English) at the following ... etc


The URLs (at emea for instance) are EXactly what I was looking for (what I actually lost some time ago). I really appreciate, thanks. My (limited) experience in the field can be summarized as follows:

i) rigid rules (i.e. repeating segments at probably 75%) ...
ii) ... intermixed with meta fields

iow a lot of repeats and some real stuff...

I have a TM with app 2000 segments, with half of them probably useless (my learning curve in pharmaceuticals, Id say) , but even thousand is probably more than strictly necessary - of course they have to be the right segments, and that's my problem right now. But with URLs I have a way to check them out.

Now ... if there's anybody doing it on a substantial / industrial scale, I would appreciate any practical information I should factor in before jumping into this pool.

TiA for (more) help

Vito

[Edited at 2007-03-24 14:17]


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Maria Diaconu  Identity Verified
Romania
Local time: 18:18
English to Romanian
Help Mar 24, 2007

Vito Smolej wrote:

Now ... if there's anybody doing it on a substantial / industrial scale, I would appreciate any practical information I should factor in before jumping into this pool.


I would gladly help you, but what exactly are you looking for?


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VIVA VOCE Ltd.  Identity Verified
Croatia
Local time: 17:18
English to Croatian
+ ...
veterinary drug links Mar 25, 2007

please excuse me if my question will seem off-topic, but I would really appreciate some similar useful links, but regarding veterinary drugs.

TiA...


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Vito Smolej
Germany
Local time: 17:18
Member (2004)
English to Slovenian
+ ...
TOPIC STARTER
should be right next door to medicinal stuff... Mar 25, 2007

some similar useful links, but regarding veterinary drugs.


Bog, Ljerka:

you can start digging here:

http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev4.htm

One more address would be eurolex, and then follow the trail of directives, pertaining to the subject - I dont know them, but you need just the year and the seq. number to find them (like 2005/78/EC)

http://eur-lex.europa.eu/sl/index.htm


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VIVA VOCE Ltd.  Identity Verified
Croatia
Local time: 17:18
English to Croatian
+ ...
great! Mar 25, 2007

Živio, Vito!

great! Many thanks


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VIVA VOCE Ltd.  Identity Verified
Croatia
Local time: 17:18
English to Croatian
+ ...
on second thought... Mar 25, 2007

Now that I think about it, we've actually gone through general EUP and Emea documentation quite thoroughly. What I'd really like though is some links to PIL veterinary drug references. Now because "patients" are animals, I guess it will be Veterinarian Information Leaflets

Appreciate it...


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DBG  Identity Verified
United States
Local time: 11:18
Member (2002)
French to English
another link re vet drugs Mar 26, 2007

Hello Ljerka,

I have this link in my bookmarks and hope you'll find it helpful. It concerns:
"The Community Code Relating to Veterinary Medicinal Products".
There is a section about requirements for "Labelling and Package Leaflets (PL)".
Best Regards,
Diantha


Ljerka Polegubić wrote:

please excuse me if my question will seem off-topic, but I would really appreciate some similar useful links, but regarding veterinary drugs.

TiA...


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DBG  Identity Verified
United States
Local time: 11:18
Member (2002)
French to English
my reply above: here is the url Mar 26, 2007

Sorry, I forgot to paste the url.
http://europa.eu/scadplus/leg/en/lvb/l21231.htm

Diantha

[Edited at 2007-03-26 18:11]


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VIVA VOCE Ltd.  Identity Verified
Croatia
Local time: 17:18
English to Croatian
+ ...
thanks :) Mar 27, 2007

Many thanks. This is exactly what I was looking for.

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