Volume 9A brings together GENERAL guidance on the requirements, PROCEDURES, roles and activities in the field of pharmacovigilance, for both Marketing Authorisation Holders (MAH) 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
• Part IV provides Guidelines on pharmacovigilance COMMUNICATION

Volume 9A brings together general guidance on the requirements, procedures, roles and activities in the field of pharmacovigilance, for both Marketing Authorisation Holders (MAH) 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: