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 (8.5"x11") 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