INFARMED holds meeting on Mutual Recognition and Decentralised Procedures

INFARMED holds meeting  on Mutual Recognition and Decentralised Procedures
April 13, 2021

INFARMED hosted, this tuesday, the tenth meeting under the scope of the Portuguese Presidency of the Council of the European Union. The event gathered over 60 participants of the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh).

During the meeting, various topics of strategic, operational and scientific were addressed, as well the possible implications of future legislative actions in the medicines area.

The participants discussed its Multiannual Workplan, to be implemented until 2025, and were informed on the set of projects that will resort to new technological tools in order to streamline the work in the regulatory area.

It was also presented the pilot projet regarding Multilingual Labelling and a new-members mentoring project. Finnaly, possible cooperative actions between the Group and the European Directorate for the Quality of Medicines and HealthCare (EDQM).

The CMDh started its activities in November 2005 in order to coordinate and facilitate the operation of the mutual recognition procedure. The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh), was set up in Directive 2004/27/EC for the examination of any question relating to marketing authorisations of a medicinal product in two or more Member States in accordance with the mutual recognition procedure or the decentralised procedure. The task of the CMDh was substantially extended in 2012 by Directive 2010/84/EU, amending Directive 2001/83/EC as regards pharmacovigilance.

The meeting was part of a set of 20 meetings of the several Committees and Working Groups that INFARMED will be holding during the six months of the Portuguese Presidency.


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