HMA / EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use

The HMA / EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use (TF-AAM) provides strategic and structural solutions to tackle disruptions in the supply of medicines and ensure their continued availability in the EU. It focuses on the availability of authorised human and veterinary medicines, irrespective of the authorisation route. It does not cover unauthorised medicines.

This content applies to human and veterinary medicines.

The Task Force is designed to function as a 'supply and availability hub', tracking progress on the medicine availability and shortage-related activities that the European medicines regulatory network is undertaking in the context of the:

• European medicines agencies network strategy to 2025
• European Commission's Pharmaceutical Strategy for Europe
• HMA/EMA multi-stakeholder workshop on shortages
• joint action on shortages, the Coordination and Harmonisation of the Existing Systems against Shortages of Medicines (CHESSMEN), a three-year plan starting in January 2023 to enhance national systems in tackling medicines shortages in a harmonised way and to promote the use of best preventive practices to reduce shortages of medicines

This aims to streamline processes, ensure synergies and avoid duplication of work within the regulatory network.

In contrast, the structures and processes that EMA set up for dealing with medicine shortages in accordance with the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123) primarily focus on crises and preparedness. More information:

• Crisis preparedness and management

The Task Force's priorities include:

• developing strategies to improve prevention and management of shortages caused by disruptions in the supply chain (for example developing guidance for companies on reporting shortages);
• encouraging best practices to prevent shortages;
• improving the sharing of information and best practices among EU regulatory authorities to coordinate actions across the EU better;
• fostering collaboration with stakeholders and enhancing communication of supply problems to EU citizens.

Structure, work programme and terms of reference

EMA and HMA agreed an updated structure for the Task Force in June 2022 and to extend its mandate for three years.

They first set up the Task Force in December 2016, building on the network’s efforts since 2012 to improve processes for handling shortages caused by good manufacturing practice (GMP) non-compliance.

Its work was temporarily suspended between March 2020 and December 2021 due to the COVID-19 pandemic.

Work programme until 2025 of the HMA/EMA task force on availability of authorised medicines for human and veterinary use

Reference Number: EMA/724592/2022 Rev.2

Terms of reference of the HMA/EMA task force on availability of authorised medicines for human and veterinary use

Reference Number: EMA/857232/2016 Rev. 2

For more information, see:

• Heads of Medicines Agencies
• HMA/EMA Task Force on Availability of Authorised Medicines for Human and Veterinary Use
• HMA/EMA multi-stakeholder workshop on shortages (01-02/03/2023)

Composition

The Task Force is composed of a steering committee and two thematic working groups.

Thematic working group 1 focuses on medicine availability and supply disruptions and thematic working group 2 focuses on communication.

The steering committee is co-chaired by a senior representative appointed by HMA and a senior EMA staff member, as follows:

• Monica Dias - EMA's co-chair
• Hugues Malonne (Belgium's AFMPS) - HMA's co-chair

Its full list of members is available in the document below.

Composition of the HMA/EMA task force on availability of authorised medicines for human and veterinary use