HMA/EMA Task Force on Availability of authorised medicines for human and veterinary use (TF AAM)
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 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:
1. Medicinal products are authorised but are not marketed or no longer marketed.
2. Supply chain disruptions directly prevent the availability of authorised and marketed products.
The Task Force establishes three thematic areas to deal with topics and objectives involving marketing, supply chain 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: Kristin Raudsepp, Director General, Estonian State Agency of Medicines
EMA: Noel Wathion, Deputy Executive Director, the European Medicines Agency
The Task force is composed of a Steering Committee and 3 thematic working groups.
- Representatives nominated by the interested NCAs (BE, HR, DK, FI, IS, IT VET, LV, NO, RO, SI, UK HUM) are members of one of the 3 Thematic working Groups of the Task force. HMA representatives from the MAWP lead and support NCAs (PT, ES, SE, NL and FR VET) are members of Steering Committee.
- Representatives of working groups (CMDh, CMDv, IWG, WGCP, ESS WG) are members of both the Steering Committee and one of the 3 Thematic working groups.
- Representatives nominated by EMA are members of either the Steering Committee or 3 Thematic Working groups.
- Representative nominated by EC (DHoU B4) is a member of Steering Committee.
NCAs and EMA will each appoint a single point of contact for exchange of information on availability matters. These single points of contact will act within Thematic Working Group 2 and support Thematic Working group 3.
The participation of additional members of recently proposed/created HMA Task Forces/groups can be also considered by the Task Force.
Activities and achievements
- 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
- Work programme of the HMA/EMA task force on availability of authorised medicines for human and veterinary use 2018-2020 | 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
- Work programme of the HMA/EMA task force on availability of authorised medicines for human and veterinary use | pdf
- EU regulatory network reflection paper on the availability of authorised medicinal products for human and veterinary use | pdf