EMEA: Guideline on the Conduct of pharmacovigilance for vaccines for pre- and post-exposure prophylaxis against infectious diseases
This guidance is addressed to Marketing Authorisation Holders and Competent Authorities. It should be read in conjunction with other pharmacovigilance guidance in Volume 9A and is not intended to replace any other relevant guidance. This guidance mainly covers post-authorisation aspects specific for vaccines. Special attention is paid to the development of Risk Management Plans prior and after marketing authorisation.
Źródło wiadomośći: http://www.emea.europa.eu/pdfs/human/phvwp/50344907enfin.pdf