Tuesday, 12 March 2024 14.00 - 16.00 h
On 8 July 2022 the EMA published the List of the Main Therapeutic Groups of Medicinal Products that are used for emergency care, surgeries and intensive care. This list was established by the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG). It will be used to help setting up the following further lists:
The list of the main therapeutic groups which is based on the WHO ATC classification, consisting of five levels, indicates the therapeutic subgroups (level 2) and the relevant pharmacological subgroups (level 2).
The legal basis for these lists as well as for the existence of the steering group is Regulation (EU) 2022/123 of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices.
Regulation (EU) 2022/123 assigns increased responsibility to the EMA in order to guarantee the smooth functioning of the internal market as regards medicinal products and medical devices in critical situations. EMA's extended mandate includes mainly the monitoring of the supply situation of medicinal products and medical devices in the case of public health emergencies. You can find further information on EMA's strengthened mandate under EU: Strengthening the EMA.
The methodology for the establishment of lists of the main therapeutic groups and of the lists of critical medicines is described in the EMA document Methodology for the establishment of lists of "main therapeutic groups" in crisis preparedness and of the lists of "critical medicines" in the context of a major event and/or public health emergency dated 11 May 2022.
The establishment and maintaining of the list of the main therapeutic groups is carried out in four steps:
A similar methodology is envisaged for the establishment and maintaining of the lists of critical medicines:
In order to facilitate the monitoring of shortages of medicinal products on the lists of critical medicines, the EMA may request the relevant marketing authorisation holders to submit all required information. Moreover, marketing authorisation holders were asked to designate their single points of contact by 2 September 2022. These and further obligations on marketing authorisation holders are regulated in Article 10 of Regulation (EU) 2022/123.