bijsluiterteksten

15:58 Sep 2, 2013 

Bij deze vergunning voor parallelinvoer worden de bijsluiterteksten gevoegd, zoals die bij de vergunning werden aanvaard. De bijsluiterteksten, die in een andere taal dan de Nederlandse zijn opgesteld, moeten een juiste en volledige vertaling van de Nederlandse tekst omvatten.

applies to both human medicines and veterinary medicines.

The fact that writeaway mentions 'diergeneesmiddel' is just because of the document he clicked on.

You should have a look here as well: http://tinyurl.com/p2udxuk

14:33 Sep 2, 2013 

Are we perhaps talking about veterinary medicine here?

14:30 Sep 2, 2013 

I have changed my answer to 'package leaflet', as we are apparently dealing with veterinary medicine.

14:28 Sep 2, 2013 

Michael, I am not ignoring you. Just don't have time to investigate this now. To the best of my recollection, having worked both sides of the pond, it is called the same there too but I would need to check this and I simply don't have the time to do it right now. I am not saying that yours is wrong and it may very well be that this is EU/UK only. I cannot yet say.

14:15 Sep 2, 2013 

‘In addition to the obvious use of inclusion with medications, package inserts have been used or provided in other forms. In the United States, the package inserts for thousands of prescription medicines are compiled into a reference book called the Physicians' Desk Reference, better known as the PDR. South Africa has taken the initiative of making all package inserts available electronically via the internet, listed by trade name, generic name, and classification, and Canada is working on a similar capability. The UK-based electronic Medicines Compendium provides freely-available online access to both Patient Information Leaflets (intended for consumers) and Summary of Product Characteristics (aimed at healthcare professionals) for products available in the UK.’

Would these 'Patient Information Leaflets', aimed at consumers, then correspond to 'consumer information leaflet' (listed in my answer)?

14:09 Sep 2, 2013 

The Wikipedia article says:

PIL is the European version of the Package insert. The PIL is written by the manufacturing pharmaceutical company and is a patient friendly version of the Summary of Product Characteristics. All licenced medicines need to carry such a leaflet. There are guidelines that must be followed for producing this document, drawn up by the European Medicines Agency of the EU.

I have no medical training, so I wonder what a 'package insert' is then. Would this be a PIL, but then for countries outside of the EU? What about the UK? Is the UK covered by the EMA?

14:03 Sep 2, 2013 

So are you saying that:

package insert text,
information insert text,
text of the information insert, or
text of the package insert

are all wrong here, and that it should be: 'patient information leaflet texts'?

13:29 Sep 2, 2013 

I see in Michael's reference:

A package insert or prescribing information (in Europe, Patient information leaflet for human medicines or Package Leaflet for veterinary medicines) is a document provided along with a prescription medication to provide additional information about that drug.

http://en.wikipedia.org/wiki/Package_insert

13:19 Sep 2, 2013 

The whole field of pharmacology is about compliance with legal requirements. The two are inextricably related.

13:14 Sep 2, 2013 

Thank.
In fact I put my question as a law question, because the document is giving the rights and the rules for the said-medicines to be sold in such a country.

13:08 Sep 2, 2013 

In the industry which supplies medicines, a bijsluiter is called a patient information leaflet.

12:59 Sep 2, 2013 

I am looking for a law term and not a medical term
Thank

12:58 Sep 2, 2013 

My text is a law document and not a medical document
Thank