EU consultation on changes to pharmacovigilance

Source: DG Enterprise

The DG Enterprise wishes to consult stakeholders on changes to Eudralex Volume 9A "Pharmacovigilance for Medicinal Products for Human Use".

The Volume 9A Revision 2008 concerns additional guidance in Chapter I.7 on post-authorisation safety studies and clarifications in response to frequently asked questions, mainly regarding electronic reporting, in Chapters I.2, I.4, I.5 and Part III.

The changes to the text are in track changes in the document here

All comments should be sent to Ulla Närhi (ulla.narhi@ec.europa.eu ) by 2 January 2009 and the bellow emplate (word document) should be used for comments.

Template answer consultation EC

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European Association of Hospital Pharmacists (EAHP) | rue Abbé Cuypers, 3| B- 1040 Brussels, Belgium | Tel: +32 (0)2 741 68 22 | Fax: +32 (0)2 734 79 10

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EU consultation on changes to pharmacovigilance

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