Article 104 of Directive 2001/83/EC sets out the obligations of marketing authorisation holders.
Marketing authorisation holders must maintain detailed records of all suspected adverse reactions occurring either in the Community or in a third country. All suspected serious adverse reactions brought to the attention of marketing authorisation holders by health care professionals must be recorded and reported to the competent authority of the Member State where the incident occurred within 15 days.
In addition, marketing authorisation holders are required to record and report suspected serious adverse reactions of which they can reasonably be expected to have knowledge which meet the reporting criteria set out in Volume 9. This addresses the fact that, in addition to adverse reactions reported by health care professionals, others will be identified in worldwide scientific literature or during post-authorisation studies.
Marketing authorisation holders must ensure that all suspected serious and unexpected adverse reactions that are brought to their attention by health care professionals and have occurred in a third country must be reported to the Agency and the competent authorities of the Member States where the product is authorised, within 15 days. The format for these reports is set out in Volume 9.
Where a medicinal product has been authorised through the mutual recognition procedure, the marketing authorisation holder must ensure that all suspected serious adverse reactions occurring in the Community are reported to the competent authority that first authorised the product (known as the Reference Member State) in a format and at a frequency to be agreed with that competent authority.
All suspected adverse reactions must be submitted to the competent authorities in the form of a periodic safety update report (accompanied by a risk/benefit scientific evaluation):
* immediately upon request; or
* at least every six months during the two years after a medicinal product has been granted a marketing authorisation; or
* once a year between the second and fifth years following the grant of the marketing authorisation.
At the end of the five-year period following authorisation, periodic safety update reports must be submitted every five years with each marketing authorisation renewal application.
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