Other official information and services: www.belgium.be   

CHIEF EXECUTIVE OFFICER’S

SERVICES

 

MANAGEMENT SUPPORT

MEETINGS

0 x

Direction Committee

0 x

Expanded Direction Committee

0 x

Transparency Committee (+ 4 dedicated budget workgroups)

0 x

Consultative Committee

0 x

Staff Chief Executive Officer’s services

0 x

Management Support Network

QUESTIONS

parliamentary questions

questions from citizens

COMMUNICATION DIVISION

INTERNAL COMMUNICATION

newsletters for the employees

PRESS

press questions

audio visual interviews

press releases

EXTERNAL COMMUNICATION

questions from citizens and external partners

news items on the FAMHPFederal Agency for Medicines and Health Products‘s website

niew-icon-glitteNew

In November 2017 the FAMHPFederal Agency for Medicines and Health Products also started using Facebook and Twitter. By the end of the year there was already an average reach of almost 15,000 views per week.

INFORMATION CAMPAIGNS

Taking medicines at the desire of children, pregnancy or breastfeeding?

The aim of the campaign is to guide and inform women by repeating the recommendations for a correct and careful use of medicines, to remind them of the need to plan a pregnancy when they take medicines for a long time, and to promote the dialogue with the doctor, the pharmacist and the midwife.

More information on www.geneesmiddelenenzwangerschap.bewww.medicamentsetgrossesse.be

2031 needs you!

This campaign is aimed at potential participants in clinical trials and at doctors who are important players in informing and recruiting participants.

More information on www.klinischeproeven.bewww.essaiscliniques.be

BROCHURES

0

More than 3,500 brochures of the various information campaigns were ordered by health care professionals, schools, citizens …

THE FAMHPFederal Agency for Medicines and Health Products PUBLISHES THE JUBILEE MAGAZINE 2007-2017

1 January 2007, creation of the Federal Agency for Medicines and Health Products.

The past ten years have been an example of collaboration and, above all, of hard work to become the respectable, professional agency of today, both on a national and international level.

The jubilee magazine (NL – FR), we not only look back on a few achievements of the first ten years, but we also take a look at the future. We let a few partners speak and you can read several interviews with both FAMHPFederal Agency for Medicines and Health Products staff and people who left the FAMHPFederal Agency for Medicines and Health Products to use their talents elsewhere.

QUALITY DIVISION

IMPROVING POINTS

Follow-up of improving points

QUALITY DOCUMENTS

Number of quality documents approved and implemented

SOPsStandard Operating Procedure - a serie of written working instructions, WITsWork instruction

PROCESSES

Process sheets available for

0 %

of the business processes

0 %

of the support processes

0 %

of the management processes

AUDITS

0

internal auditors

0

internal audits

0

processes audited

19,0 hours

= average duration per auditor per audit

0

shortcomings
of which

0 %

critical

63.0 %

serious

34.0 %

minor

EXTERNAL COMPLAINTS

Number of complaints received

0

complaints against the FAMHPFederal Agency for Medicines and Health Products

0

complaints against FAMHPFederal Agency for Medicines and Health Products partners

Complaints against the FAMHPFederal Agency for Medicines and Health Products

0

days average time to deal with a complaint

0 %

dealt within the set complaints handling time

Complaints against FAMHPFederal Agency for Medicines and Health Products partners

0

days average time to deal with a complaint

0 %

dealt within the set complaints handling time

P&OPersonnel and organisation DIVISION

Our organisation as a whole benefits from the tasks of the P&OPersonnel and organisation division, which deal with human resources management. The related figures are included under the Personnel heading.

laws

royal decrees

ministerial decrees

circular letters

requests relating to the public nature of administration

proposals for amicable settlements of which

were sent for prosecution (no payment received)

The list of new FAMHPFederal Agency for Medicines and Health Products regulations adopted in 2017 can be found on the FAMHPFederal Agency for Medicines and Health Products website.

HUMAN TISSUE MATERIAL COORDINATION

Human tissue material-related figures can be found in the results section for DG Inspection.

PROJECT & PORTFOLIO MANAGEMENT OFFICE CO-ORDINATION

Projects filed

Duration of the project

projects were closed

INTERNATIONAL RELATIONS UNIT

Preparation and feedback of international meetings

0 x

HMAHeads of Medicines Agencies - network of the European competent authorities

0 x

Management Board of the EMAEuropean Medicines Agency

0

international meetings organised by the FAMHPFederal Agency for Medicines and Health Products

for the EDQMEuropean Directorate for the Quality of Medicines (within the Council of Europe)

0 x

SPOCSingle Point of Contact KnowX workshop – Committee of Experts on Minimising Public Health Risks Posed by Falsification of Medical Products and Related Crimes (CD-P-PH/CMED)

for the HMAHeads of Medicines Agencies - network of the European competent authorities

0 x

European Surveillance Strategy

0

study visit to the FAMHPFederal Agency for Medicines and Health Products: Chinese delegation

0

public consultations/ questionnaires for competent national authorities:

  • HMAHeads of Medicines Agencies - network of the European competent authorities/EMAEuropean Medicines Agency Joint Task Force on big data – Survey for National Competent Authorities
  • European Commission’s stakeholder consultation for the evaluation of EUEuropean Union legislation on blood, tissues and cells
  • European Commission’s Public Consultation on Transformation Health and Care in the Digital Single Market
  • European Commission’s survey regarding Shortage of medicines: Questionnaire on measures implemented in the Member States territories in the context of Article 81 of Directive 2001/83/EC
  • HMAHeads of Medicines Agencies - network of the European competent authorities’s Questionnaire on Compassionate Use Programmes and other possibilities to tackle unmet medical needs
  • HMAHeads of Medicines Agencies - network of the European competent authorities’s Survey related to the regulatory implementation of safety features Falsified Medicines Directive – Commission Delegated Regulation (EUEuropean Union) 2016/161

niew-icon-glitteNew

5 work meetings with Belgium and the Grand Duchy of Luxembourg resulted in a cooperation agreement on medicines and health products.

A CULTURE OF CONSULTATION

The FAMHPFederal Agency for Medicines and Health Products attaches great importance to dialogue with all its external partners. The FAMHPFederal Agency for Medicines and Health Products 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 FAMHPFederal Agency for Medicines and Health Products‘s website, such as the role, composition, rules of procedure, agendas, and reports of these committees, commissions and consultation platforms.

Here, we explain the main activities of the Advisory Committee and the Transparency Committee.

 

 

CONSULTATIVE COMMITTEE

The Consultative Committee advises the FAMHPFederal Agency for Medicines and Health Products on the current and future policy. This committee is made up of representatives of patients and consumers from all sectors involved in the matters for which the agency is responsible and of representatives of the federal public services concerned. It is chaired by the Chief Executive Officer of the FAMHPFederal Agency for Medicines and Health Products.

Two meetings were held at which current themes were addressed:

  • Adaptive Pathways
  • Impact of the Medical Technologies Pact on the FAMHPFederal Agency for Medicines and Health Products
  • Reporting of adverse effects by patients at the pharmacist
  • Analysis of the Statement on homeopathic products of the European Academies Sciences Advisory Counsel
  • New packaging of medicines
  • Autocontrol in the medical devices sector
  • PRIMEPRIority MEdecines - program of the EMA to support the development of medicines aimed at an unmet medical need
  • New European Regulation No 536/2014 on clinical trials on medicinal products for human use

 

 

TRANSPARENCY COMMITTEE

Within the Transparency Committee, co-operation and transparency with the stakeholders remain the keywords. The Transparency Committee is chaired by Ann Adriaensen (pharma.be), with Marc-Henry Cornély (Ophaco) as vice-chairman.

The Transparency Committee gathered seven times and organised four dedicated budget workgroups.

The main items of the plenary meeting were:

  • Budget 2018
  • Feedback of the Audit committee
  • Financing Act for the FAMHPFederal Agency for Medicines and Health Products
  • New reporting tool for performance monitoring
  • Degree of achievement of the 2017 operational plan
  • Drafting of the 2018 operational plan

The committee issued four official opinions:

 

  • 2 on the preliminary draft of the new financing law for the FAMHPFederal Agency for Medicines and Health Products
  • 1 on the draft Royal Decree Orphan Drug
  • 1 on the 2018 budget

© 2018 - FAMHP | Privacy | Disclaimer | Complaints | Contact | Colophon 

Follow us

FAMHP Annual report 2017 - powered by THE CREW COMMUNICATION

Share This

Share this post with your friends!