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Volume 9A has been prepared by the European
Commission in close consultation with the
Agency, Member States and interested parties
and is specifically related to human
pharmacovigilance.
This 229 page technical manual brings
together general guidance on the
requirements, procedures, roles and
activities in this field, for both Marketing
Authorisation Holders and Competent
Authorities of medicinal products for human
use; it incorporates international
agreements reached within the framework of
the International Conference on
Harmonisation (ICH).
Volume 9A is presented in four parts:
-Part I deals with Guidelines for Marketing
Authorisation Holders;
-Part II deals with Guidelines for Competent
Authorities and the Agency;
-Part III provides the Guidelines for the
electronic exchange of pharmacovigilance in
the EU; and
-Part IV provides Guidelines on
pharmacovigilance communication.1
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