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Dear all,
Can anyone tell me the various Global Drug Regulatory Bodies web-links
from which, we can download the SmPC and PIL of medicinal products
approved through Centralized, Decentralized, Mutual Recognition and
National procedures.
Regards,
Dr.S.Gunasakaran,MBBS,MD,
Medical Affairs
[SmPC (Summary of Product characteristics)
PIL (Patient Information Leaflet/Package Leaflet)]
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Dear Dr Tushar Nahata,
Thanks for your valuable information. I will be great help, if you let
me know the link, where the drug products will be categorized based on
the Procedures (say DCP/MRP/CP) in the European Union.
Regards,
Dr.S.Gunasakaran,MBBS,MD.,
Medical Affairs
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The following message was posted to: PharmPK
You may check following:
http://medicines.org.uk/
http://www.hma.eu/mri.html
Kind Regards,
Neha
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Dear Dr Tushar Nahata,
Thanks for your valuable information. I will be great help, if you let
me know the link, where the drug products will be categorized based on
the Procedures (say DCP/MRP/CP) in the European Union.
Regards,
Dr.S.Gunasakaran,MBBS,MD.,
Medical Affairs
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Dear Dr Gunasakaran,
Regarding to SmpC and PIL, please refer to the below web sites:
electronic compendium:
http://www.medicines.org.uk/
EPARs:
http://www.emea.europa.eu/htms/human/epar/eparintro.htm
Any further questions, please don't hesitate to contact me.
Regards;
Hatice Atkaya, Pharm.
Regulatory Science Manager
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