Other government information and services

Management Support

Meetings

0 x
Direction Committee
0 x
Expanded Direction Committee
0 x
Transparency Committee
0 x
Consultative Committee
0 x
Transversal Support Staff Meeting
0 x
Management Support Network

Questions

0
parliamentary questions of which

35

written questions

48

verbal questions

0
questions from citizens

Trend

40% decrease.

Due to the dissolution of the parliament after the elections and a caretaker government, we saw a noticeable decrease in parliamentary questions.

39% increase.

Questions from citizens

New

The Expanded Direction Committee was reformed in early 2019 with a focus on efficiency and transversality between the various entities within the FAMHP. The Committee evolved from a more formal body, where the Direction Committee passed on information to those responsible from the various services at the FAMHP (MidMas), into a more informal platform. The agenda items are now primarily determined by the MidMas.

DATA PROTECTION OFFICER​

The Data Protection Officer (DPO) advises the management and the staff at the FAMHP on matters of privacy and data protection. The DPO ensures that the FAMHP correctly applies its legal obligations and that the rights of data subjects whose data is being processed are respected.

Requests for advice

0
requests for advice on the privacy of internal and external collaborators

Requests GDPR rights

0
request to apply GDPR rights

Reports of data breaches

0
reports of data breaches

1 of these required a notification to the Data Protection Authority

GDPR information campaigns and training

0
internal GDPR newsletters
0
transversal training course on the GDPR

Prevention Adviser

Accidents

0
accidents on the way to and from work
0
work accidents

Interventions

0
interventions with a confidential counsellor

Coordination of projects and portfolio management

all projects are planned over a period of several years

0
projects were closed

ICT Division

The primary responsibility of the ICT Division is to provide the internal and external clients of the FAMHP with the necessary equipment and human resources, as well as software for transferring and communicating information. The necessary tools are implemented for creating, collecting, storing, processing and revising information in various formats.

Projects and Development Entity

The Projects and Development Entity ensures the development of new projects, the maintenance of existing applications and supporting  or advising users in choosing and implementing a solution that meets their needs.

Activity
In hours
In %
Projects and transversal activities
39 024 hours
77,50 %
Maintenance/support
7 588 hours
15 %
Administration
3 767 hours
7,50 %

Operations Entity

The Operations Entity ensures that FAMHP‘s information management systems stay operational at all times.

Service Desk Team

Infrastructure Team

System
Availability in %
MeSeA (Hum)
100 %
MeSeA (Vet)
100 %
MeSeA (Homeo)
100 %
MeSeA (Phyto)
100 %
DMS Quality
100 %
Package leaflets database
100 %
Internal systems
100 %
Phone
99,73 %
Network
99,87 %
FedMAN
99,88 %

Budget and management control Division

Budget and Management Control

In 2019, the Budget and Management Control (B&MC) Division realised two major achievements.

For the first time, the income and expenses per stakeholder were mapped out in a full and detailed manner. Thanks to this analysis of the cross-financing, the FAMHP can check for each stakeholder whether the cost of the service provision they receive from us and the price they are paying for it, in the form of fees and taxes, is balanced. Our analytical accounting meets the demand for transparency from our stakeholders, and enables the FAMHP to adjust the rates to obtain fair financing.

Furthermore, in 2019 there was a strong focus on collecting fees and taxes more efficiently. From now on, most of the contributions will be collected after payment by invoice and no longer by pre-payment or payment through allowance accounts. The structured notification on the invoice enables the FAMHP to link payment obligations and effective payments. Small, frequent amounts have been grouped into monthly invoices since 2019, including an easy overview of the partial amounts. This reduces the workload for the FAMHP and for the clients.

Detailed figures can be found in the Budget section.

COMMUNICATIONS DIVISION​

Internal communication

0
160 newsletters for employees

New

The FAMHP informs citizens, healthcare professionals, the academic world, industry and other national and international government institutions on a daily basis on all topics regarding medicines and health products. The Communications Division is also responsible for all internal communication, this means writing and rewriting texts – many texts.

Filling a piece of paper is not difficult. Turning those words into an easily legible and understandable text, takes a lot more work.

This is why, in September 2019, the Communications Division launched “The five principles of writing”

The FAMHP staff also receives a practical writing tip every month via a newsletter called.

Schriftips_texte_DEF_Def

Press

0
press questions recorded
0
audiovisual reports
0
press releases

External communication

0
questions from citizens and other external partners recorded
0
news items on the FAMHP’s website
0
impressions on social media
0
information campaign

In 2019, the FAMHP launched an information campaign to inform healthcare professionals and their patients about medical devices. The aim of this campaign was raising awareness among healthcare professionals on the importance of reporting incidents with medical devices and further improve the monitoring of medical devices used by and for patients.

New

A picture tells a thousand words, and moving pictures are definitely helpful when conveying complex messages. Therefore, the Communications Division invested in equipment, software and training in 2018 to be able to produce its own videos. One of its first achievements was the video launch for PharmaStatus, the online application for unavailable medicines. Discover all our videos on the FAMHP YouTube channel.

Legislation and Litigation Division

0
law
0
Royal Decrees
0
Ministerial Decree
0
requests relating to the public nature of administration

Personnel and Organisation Division

Detailed figures are included in the Personnel section.

Quality Division

Quality documents

Progress of SOP's and WIT's

Documents available in Quality DMS

0 %
FAMHP SOP's and WIT's
0 %
DG PRE authorisation SOP's and WIT's
0 %
DG PRE authorisation SOP's and WIT's 64% DG POST authorisation SOPs and WITs
0 %
DG Inspection SOP's and WIT's
0 %
Transversal Support SOP's and WIT's

Processes

process sheets available for

0 %
of business processes
0 %
of support processes
0 %
of management processes

Audits

0
internal audits
0 hour
average duration per auditor per audit
0
non-conformities identified, of which

1

critical

36

serious

39

minor

0
non-conformities closed, of which

34

serious 

35

minor

External complaints

Complaints received

Complaints received per type of channel

Processing complaints

0
legitimate complaints received
0
complaints still unresolved

(received in 2019, but still being processed in 2020)

the average lead time was

0 calendar days

50%

of the complaints processed were dealt with within a lead time of 40 calendar days

Complaints about the FAMHP

Facility Unit

0
incoming postal items
0
outgoing postal items
0
tickets for logistical requests

Satisfaction survey on Logistics service provision

0
satisfaction surveys sent
0 %
= average satisfaction

Translation Team

0
translations

(651,284 words), of which 219 outsourced to an external agency (255,455 words)

New

In the context of unifying the translation services for the FPS Public Health, the NIHDI and the FAMHP within the Redesign project for the healthcare administrations, the Translation Team switched to new, collective translation software, Babelfed.

In addition to their translation activities, the translators are also active participants in the working group seeking to ensure the merger is well-managed.

The Translation Team became a member of the Be.Translators community, which accommodates various translation services for the federal government and for regional services. This community aims to strengthen the bonds between the various translators, exchange information and good practices and explore possible collaboration.

International Relations Unit

Preparation and feedback of international meetings

0 x
HMA
0 x
Management Board of the EMA

international meetings organised by the FAMHP

For HMA:

0
European Surveillance Strategy

active participation in the TFCIVR (HMA-v Task Force on Co-ordination of the Implementation of the Veterinary Regulation)

0
study visit to the FAMHP:

Cuban delegation – May 2019

0
public consultations/questionnaires for the competent national authorities
  • questionnaire – October 2019 – Fee review – DG SANTÉ exercise on NCAs’ additional activities: input from Belgium
  • revision of the EMA Fee System – October 2019 – Comments on the Commission proposal
  • public consultation – November 2019 – Evaluation of the European Drugs Strategy 2013-2020 and the European Action Plan on Drugs 2017-2020
  • questionnaire – March 2019 – Medicinal cannabis
  • French Audit Office questionnaire – June 2019 – Comparison of ANSMFAMHP

A culture of consultation

The FAMHP attaches great importance to dialogue with all external partners. The FAMHP has therefore established various committees, commissions and consultation platforms to provide a structure for and organise its consultation efforts.

You can find additional information on the FAMHP’s website, such as their role, composition, rules of procedure, agendas and reports.

The main activities of the Advisory Committee and the Transparency Committee are explained below.

Consultative Committee

The Consultative Committee advises the FAMHP on its current and future policy. This committee is made up of representatives of patients and consumers from all sectors that fall within the competence of the agency and of representatives of the federal public services concerned. The Committee is chaired by the Chief Executive Officer of the FAMHP.

In 2019, a number of themes were systematically presented on the agenda, such as the implementation of the European Regulation on Medical Devices (Recast) and Chenodeoxycholic Acid (CDCA). This enabled external members to closely monitor the developments in these matters in and gave them the opportunity to express their views.

In addition, ad hoc issues that the members were being confronted with in their daily practice were also discussed, with the aim of developing a clear solution in cooperation with the agency.

Transparency Committee

The Transparency Committee is and will remain a body where collaboration with and transparency towards the stakeholders who contribute to the funding of the agency are key.

In 2019, the Transparency Committee elected a new chairman among its members. Marnix Denys, representing BeMedTech, took over from Ann Adriaensen for the following four years.

As usual, the Transparency Committee advised on the FAMHP’s Operational Plan for 2019. The 2018 results were presented to the Committee. Special this year was the evaluation of the FAMHP’s Strategic Plan for 2014-2018 and the proposal of the FAMHP’s new Strategic Plan for 2019-2021.

In 2019, the Transparency Committee issued formal advice on the FAMHP’s budget for 2020 to the Minister responsible for Public Health.

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