To optimally perform the tasks of FAMHP, the agency calls on different institutions: FAMHP commissions, the national consultation platforms with other public services, institutions and partners and the FAMHP representatives in national and international commissions, committees and working groups.
DG PRE authorisation
The DG PRE authorisation plays an important role in stimulating innovation, giving scientific advice, evaluating CTA and processing applications for granting a MA for medicines for human and veterinary use. For medicines for human and veterinary use that are authorised through the CP for obtaining a MA, the DG PRE authorisation is also responsible for the follow-up of the changes to the MA or variations. The scientific assessment of the data that support the different types of applications is generally performed within the DG PRE authorisation, also if the application was filed in another entity of FAMHP. With this assessment, European guidelines and directives are used, independent from the fact of whether it is about a national or European procedure.
It is extremely important that the DG PRE authorisation closely follows the scientific evolutions and evolutions in the legislation and provides, on the European level, relevant active input in the discussions in that area. The DG PRE authorisation is therefore permanently represented in most European scientific committees and associated working groups. European evaluation tasks, for example as rapporteur of the central procedure or as coordinator in the European procedure for scientific advice, can only be acquired and efficiently performed if the DG PRE authorisation is present in the relevant committees and working groups.
DG POST authorisation
The DG POST authorisation is for its part represented in different European committees or working groups that work in the area of vigilance and proper use of medicines and health products. Through this participation, FAMHP always remains informed about the developments regarding medicines, medical devices and human tissue material: blood, cells and tissues. The Belgian knowhow is shared with our European colleagues and the consultation ensures a better harmonisation.
In the framework of the harmonisation of inspection and control activities and the battle against pharmaceutical criminality, the employees of the DG INSPECTION are represented in international fora with other international authorised institutions in the field of medicines and health products.
The Support Services of FAMHP are chiefly involved in EMA working groups that develop the approach to the automation of certain tasks for the European network. This consultation, which is often by teleconference, is generally geared towards “business” aspects, so that it is not always necessary to engage the ICT experts. When there is a meeting on a specific ICT tool, the ICT Division will primarily be involved.
Chief Executive Officer’s Services
The Chief Executive Officer is a member of the EMA Management Board and attends the meetings held within the framework of the HMA. This should allow the national strategy to be optimally coordinated with the strategy applied at the European level. In this regard, the representatives for the Communication, the Quality and the Legal Affairs Divisions, the International Relations Unit, and the Human Tissue Material Coordination also regularly attend European meetings that are relevant for efficient functioning within the European framework in terms of their areas of competency.
A current overview of FAMHP committees, consultation platforms organised by the FAMHP and the consultation platforms with public services and institutions based on a protocol.