SPC-PIL EU countries

(Abhishek Raval) #1

Can any one provide the current links for all EU members states’ SPC-PIL?

(Helen Crowley) #3

Please see attached link for QRD Templates for EU SPC,PIL, Packaging

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2009/10/WC500004368.pdf
and
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000134.jsp&mid=WC0b01ac0580022c59

Is this what you are looking for?

(Abhishek Raval) #4

Thanks but No this is just a template as per QRD.
What I need is the list of links to National Competent agency’s website where we can find the SPC-PIL of the Reference medicinal product for our proposed generic drugs and its PARs.

(Helen Crowley) #5

The following link appears to connect to all national databases:
https://pharm-infolinks.webnode.cz/drug-databases/national-drug-databases-eu/
For Ireland https://www.medicines.ie
For UK https://www.medicines.org.uk/emc

Hope this is what you are looking for.

(Abhishek Raval) #6

Many thanks Helen…
This is what needed exactly.
Much appreciated!