Product information – QRD ( Quality Review of Documents)


- SmPC in Bulgaria - HERE

 

- Наредба  № 38 за изисквания към данните за върху опаковките и листовките на лекарствените продукти - HERE

 

- Standard terms as of March 2015 on the BDA site - HERE

 

- Package leaflet: List of medical terms for Adverse drug reactions and their description - HERE

 

- Annex of exipients to be declared on the PIL and labeling - HERE