EMA publishes "Toolkit" for Shortages of Medicinal Products

The European Medicines Agency EMA has published a so called "MSSG Toolkit on recommendations on tackling shortages of medicinal products", a guidance document for use by the MSSG to facilitate identification of recommendations on critical shortages of medicinal products.

The MSSG is the Executive Steering Group on Shortages and Safety of Medicinal Products, established by Regulation (EU) 2022/1231. It is responsible for providing advice and recommendations on how to deal with critical shortages of medicinal products in the EU, especially during major events or public health emergencies. The MSSG can propose actions at the Union level or for the Member States, marketing authorisation holders and other stakeholders. The MSSG is supported by a working party of national competent authorities, the Medicine Shortages SPOC Working Party (SPOC WP), which monitors and reports events that could lead to shortages of medicines. You can find more details here: MSSG Solidarity Mechanism.

The document describes the process and criteria for the MSSG to identify and provide recommendations on critical shortages of medicinal products, which are defined as shortages that have a serious impact on public health, patient care or animal health, or that could lead to a major event or public health emergency. The recommendations can be addressed to the European Commission, Member States, marketing authorisation holders and other stakeholders, and can include measures to prevent, mitigate or manage the shortages.

The document also outlines the methodology for the MSSG to establish and update lists of main therapeutic groups (MTGs) and critical medicines in the context of a major event or public health emergency. The MTGs are categories of medicines that are necessary for emergency care, surgeries and intensive care, and serve as a basis for the preparation of the critical medicines lists. The critical medicines lists include authorised medicines that are considered essential to address the specific needs and challenges posed by a major event or public health emergency.

The document is based on the experience gained by the European Medicines Regulatory Network during the COVID-19 pandemic and other critical shortages escalated by the SPOC WP since the MSSG was set up. It aims to facilitate a coordinated and harmonised approach to tackle shortages of medicinal products in the EU and to ensure a high level of human health protection.

Source: EMA (2023): MSSG Toolkit on recommendations on tackling shortages of medicinal products.