Marketing Authorisation Holders should report literature cases to EMA through EudraVigilance and IMA can access them in the database. Generally, IMA does not require a copy of literature articles, however IMA may request these.
Marketing Authorisation Holders should report literature cases to EMA through EudraVigilance and IMA can access them in the database. Generally, IMA does not require a copy of literature articles, however IMA may request these.