HMA/EMA Task Force on Availability of authorised medicines for human and veterinary use (TF AAM)
Introduction/Overview/Mandate
The HMA/EMA Task Force will provide strategic support, advice for coordination and concerted approach to the Network on the availability of the medicinal products authorised in the EU.
The scope includes medicinal products for human and veterinary use.
The HMA/EMA Task Force will focus on the availability of authorised medicines and deal directly with a number of actions proposed in the MAWP.
The TF provides the strategic steer and management oversight to the overall project ensuring that thematic work plans are consistent with the overall task force work plan and strategic objectives.
The TF will function as a "supply and availability Hub" and will track progress on supply and availability activities ongoing under the Joint Action on Shortages and the European Commission Pharmaceutical Strategy for Europe, in order to streamline processes, ensure synergies and avoid duplication of work within the network.
The HMA/EMA Task Force activities focus primarily on structural and strategic solutions hence on "peace time" while the structures foreseen under Regulation (EU) 2022/123 such as the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) will focus on activities related to the preparedness for and during crisis situations.
The task force is also in charge of ensuring that any thematic work streams have specific objectives identified and progress measured while ensuring that resources are made available to support.
The Task Force will have at its core the following key objectives taking into account the goals and timelines in the HMA and EMA multi-annual work plan and will monitor the progress of the initiatives and projects and advise the HMA and EMA within the scope of two main areas:
- Medicinal products are authorised but are not marketed or no longer marketed
- Supply chain disruptions directly prevent the availability of authorised and marketed products.
The Task Force establishes two thematic working groups to deal with topics and objectives involving availability and supply disruptions and communication.
The TF will make use of existing working groups as far as possible and will ensure that specific activities related to availability of authorised medicinal products are included in work programmes of identified Committees and working groups (e.g. GMDP IWG, CMDh, CMDv) who will be asked to report back to the Task Force on progress.
Members and Representatives
The Task Force is chaired by 2 co-chairs for a term of three years by a NCA senior official nominated by the HMA and an EMA’s senior staff member.
HMA: Hugues Malonne, The Federal Agency for Medicines and Health Products (BE)
EMA: Monica Dias
The Task force is composed of a Steering Committee and 2 thematic working groups.
- Steering Committee composed of HMA representatives from the Multi Annual Work Plan lead and supportive NCAs (DE-PEI, ES, FR-V, IE, IT, PT, SI), chair of the CMDh and CMDv, representatives from the GMDP IWG, HMA ESS WG, HMA WGCP and co-chairs of the thematic working groups.
- Thematic working groups are composed of representatives nominated by the interested NCAs and EMA:
- Thematic working group 1 – availability and supply disruptions: AT, CZ, DE-BfARM, DE-V, DK, ES, FI, FR-V, IE (co-chair), IT, LV, NL, NO, SE & SI
- Thematic working group 2 – communication: CZ, DE-V, DK, ES, FI, NL, NO (co-chair).
- Representatives nominated by EMA are members of either the Steering Committee or 2 Thematic Working groups.
- Representative nominated by EC (DHoU B4) is a member of Steering Committee.
The participation of additional members of other HMA Task Forces/groups can be also considered by the Task Force.
Contact
Activities and achievements
Work programme
- Work programme of the HMA/EMA task force on availability of authorised medicines for human and veterinary use 2021 - 2025 | pdf
Updated May 2023 - Work programme of the HMA/EMA task force on availability of authorised medicines for human and veterinary use 2018 - 2020 | pdf
July 2019 - Work programme of the HMA/EMA task force on availability of authorised medicines for human and veterinary use | pdf
August 2018
Guidance
- EU regulatory network reflection paper on the availability of authorised medicinal products for human and veterinary use | pdf
- Guidance for patients’ and healthcare professionals’ organisations | link
- Guidance for marketing authorisation holders on reporting of shortages in the EU | pdf
- Good practice guidance for communication to the public on medicines’ availability issues | pdf
- Good practice guide for industry for the prevention and management of shortages (May 2023) | pdf
News and events
- HMA/EMA multi-stakeholder workshop on shortages on 1 and 2 March 2023 | pdf
- HMA/EMA workshop on availability of authorised medicines report
9 November 2018 multi-stakeholder meeting | pdf - Working with stakeholders to improve availability of medicines in the EU
Press release | pdf - EU-wide Task Force publishes work programme 2019/20 and prepares multi-stakeholder workshop
Press release | pdf