Reports from the literature
A detailed guidance on the monitoring of the scientific and medical literature has been developed in accordance with Article 27(3) of Regulation (EC) No 726/2004; it is included in GVP module VI, Appendix 2. As a marketing authorisation holder, you must have a strategy for actively monitoring reported adverse reactions in the medical literature. The MEB and the Health and Youth Care Inspectorate (IGJ) do not have a list available with (local) literature for a search. What you need to monitor differs by type of product, indication(s) for use, and geographical area.
Monitoring by marketing authorisation holder
For active monitoring of reported adverse reactions in the medical literature you can use:
- Standard international literature search databases, such as Medline and Embase
- 'Standard' local medical publications. For the Netherlands, these include Pharmaceutisch Weekblad, Nederlands Tijdschrift voor Geneeskunde, Geneesmiddelenbulletin and Medisch Contact. In any case, the local publications must be part of your strategy and should always be included in your strategy for a literature search.
- Depending on the product (e.g. herbal medicinal product) and/or indication (e.g. cardiovascular), other local publications may also be relevant.
The MEB advises you to record the rationale of your strategy so that it is clear how it was established.
For literature reports you submit to EudraVigilance, you do not have to send the published article as an attachment by default.
Monitoring by the EMA
The EMA is responsible for monitoring a number of substances and selected medical literature to identify potential adverse reactions for medicinal products registered in the EU and for entering the relevant information in the EudraVigilance database. Therefore, as a marketing authorisation holder, you do not have to report suspected adverse reactions to EudraVigilance as they appear in the said medical literature that is monitored by the EMA.
A detailed guideline has been developed to monitor scientific and medical literature. It can be found in GVP module VI, appendix 2.