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Helen Kerr

07 September 2015
On 1 September 2015, the European Medicines Agency ("EMA") announced that its medical literature monitoring service, which is intended to identify suspected adverse reactions with medicinal products authorised in the European Union ("EU") had entered 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.

Legal basis

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 user manual and training slides in relation to the new Eudravigilance functionalities in support of the medical literature monitoring service;

• 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.

Helen Kerr

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