Asset Publisher

null In what situations can the MAH ask to see the narrative/open fields of the reports (others than reports it has reported itself)?

In what situations can the MAH ask to see the narrative/open fields of the reports (others than reports it has reported itself)?

The access rights of the MAH are described in the European Medicines Agency policy on access to EudraVigilance data for medicinal products for human use (EudraVigilance Access Policy) document.

The answer to this question can be found in Annex C of the document: Access to the ICSR data set Level 2B under the policy.

24 Jan 2018