On 15 November 2016, the European Commission (“the Commission”) opened its second report on Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12...08 December 2016
THE EMA MEDICAL LITERATURE MONITORING SERVICE ENTERS INTO FULL EFFECT
In accordance with Module VI of the Good Pharmacovigilance Practices, marketing authorisation holders are required to submit individual case safety reports ("ICSR") in relation to suspected adverse reactions that occur in a single patient at a specific period.
As part of this requirement, marketing authorisation holders must monitor medical literature and report individual cases of suspected adverse reactions in relation to medicinal products for which they hold a marketing authorisation in the European Economic Area ("EEA"). A derogation to this monitoring requirement, however, applies in the case of listed active substances which are monitored by the EMA. The new medical literature monitoring service which has been implemented by the EMA reflects this derogation.
In accordance with Article 27 of Regulation (EU) 726/2004, the EMA is mandated to "monitor selected medical literature for reports of suspected adverse reactions to medicinal products containing certain active substances".
Paragraph 3 of Article 107(3) of the Community Code relating to medicinal products for human use provides that marketing authorisation holders are not required to report suspected adverse reactions through the Eudravigilance database where the substance is recorded in the list of substance and herbal substance groups published by the EMA. Marketing authorisation holders are not, however, exonerated from the obligation to monitor all other medical literature and report any suspected adverse reactions which are not included in the published EMA list. This requirement is provided in Article 107(3) of the Community Code relating to medicinal products for human use.
List of Substance and Herbal Substance Groups
Three hundred substances and one hundred herbal substances have been selected by the EMA for the purpose of this service.
The EMA has provided a search strategy for each of the four hundred named substances and herbal substances, which fall under the scope of Article 27 of the Regulation (EU) 726/2004. This guidance is intended to facilitate greater precision in terms of search results for marketing authorisation holders in relation to areas that must be monitored.
Training in relation to the medical literature monitoring service
Marketing authorisation holders are provided with information concerning the implementation of this new service on the dedicated medical literature monitoring webpage of the EMA. This includes the following resources:
• A Questions and Answers ("Q&A") document on medical literature monitoring;
• A series of short videos in relation to the service.
The list of substance groups and herbal substance groups which are made available on this dedicated webpage will be subject to review on an annual basis by the EMA.