Introduction to the Mutual Recognition Facilitation Group
The Mutual Recognition Facilitation Group (MRFG) was established by the Member states in March 1995 and held its first meeting in June of that year. The Member states recognised that there needed to be a group that could coordinate and facilitate the operation of the decentralised mutual recognition procedure. The Group meets monthly at the same time as the CPMP and comprises senior representatives from each Member state. The Group is chaired by the country which holds the Presidency of the European Union.
The Group has no formal position in EC legislation, but has established itself as a major player in the new European system. The Group provides a forum where procedural issues can be discussed and problems resolved. It is able to undertake an overview of individual applications. However, scientific discussions related to individual applications are not discussed within the Group, but rather are handled through "breakout sessions" which are organised and chaired by the specific reference member states (the RMS). These meetings are usually held around the same time as the MRFG, but increasingly may be held separately and may use video conferencing. If the Group identifies that work is required on further scientific issues, then these will be referred to the CPMP for the consideration of the establishment of an expert group, or the development of a concept paper or guideline.
The European Commission attends the MRFG meetings and this permits many procedural matters to be resolved at the MRFG. For more complex issues are referred formally to the Commission for further work. The Group has elaborated an important best Practice Guide which is available on the website. A series of procedural documents have also been agreed and the Group has played a major role in the ongoing work on the revision of the Notice to the Applicants. The MRFG issues a press release after each meeting which gives the monthly performance and highlights issues which have been considered at the meeting. MRFG have initiated and developed the European tracking database (Eudratrack). This system allows the member states to follow the progress of individual applications and their subsequent variations. The database also generate statistical information for inclusion in the press releases. The MRFG has also developed the Mutual Recognition Index (Product Index) which contains of products approved via the MRP. The system is accessible on this website. The mutual recognition procedure has grown significantly over its first years, and this progress is shown in the reports and the statistics in this website.
As intended the mutual recognition procedure has become established as the major route for the licensing of medicinal products through the new European single system. Iceland and Norway attend the MRFG meetings as members pending their full incorporation into the mutual recognition procedure. The Group holds regular liaison meetings with the industry trade associations. The Group is unable to handle requests from individual companies about particular applications. Rather these should be referred to the potential RMS who may then bring matters to the attention of the Group after a prior consideration. There is a comparable group in the veterinary sector (VMRFG) and a close link has been established between the two groups.