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EDQM European Directorate for the Quality of Medicines

Vertaling van "directorate-general for medicinal " (Nederlands → Frans) :

The FAMHP has completely taken over the role and fields of competency of the Directorate-General for Medicinal Products (DG Medicinal Products) of the Federal Public Service (FPS) Public Health.

The FAMHP has completely taken over the role and fields of competency of the Directorate-General for Medicinal Products (DG Medicinal Products) of the Federal Public Service (FPS) Public Health.


The FAMHP was established by law on 20 July 2006 and as from 1 January 2007 completely took over the role and fields of competency of the Directorate-General for Medicinal Products (DG Medicinal Products) that was a part of the Federal Public Service (FPS) Public Health, Food Chain Security and Environment.

The FAMHP was established by law on 20 July 2006 and as from 1 January 2007 completely took over the role and fields of competency of the Directorate-General for Medicinal Products (DG Medicinal Products) that was a part of the Federal Public Service (FPS) Public Health, Food Chain Security and Environment.


The latter has been designated as having expertise as an “Official Medicines Control Laboratory”, recognised by the FAMHP and the European Directorate for the Quality of Medicines (EDQM), for the monitoring of immunological products for veterinary use prior to marketing authorisation for the Belgian market.

The latter has been designated as having expertise as an “Official Medicines Control Laboratory”, recognised by the FAMHP and the European Directorate for the Quality of Medicines (EDQM), for the monitoring of immunological products for veterinary use prior to marketing authorisation for the Belgian market.


De Europese Commissie heeft een voorstel tot “Directive of the European Parliament and of the Council amending, as regards information to the general public on medicinal products subject to medical prescription, Directive 2001l83/EC on the Community code relating to medicinal products for human use” goedgekeurd (bijlage).

La Commission européenne a déposé une proposition de “Directive of the European Parliament and of the Council amending, as regards information to the general public on medicinal products subject to medical prescription, Directive 2001/83/EC on the Community code relating to medicinal products for human use” (cf. annexe).


The BUM department is legally required to provide support with putting online the list of medicines authorised in Belgium for new medicine MA and of the official information (Summary of Product Characteristics for healthcare professionals and leaflet for the general public).

The BUM department is legally required to provide support with putting online the list of medicines authorised in Belgium for new medicine MA and of the official information (Summary of Product Characteristics for healthcare professionals and leaflet for the general public).


Praktijkrichtlijnen kunnen ook worden onderscheiden naar gelang hun plaats van herkomst: ze kunnen ontstaan op lokaal (vb. praktijkrichtlijn van Limburgse LOK – Methiciline Resistente Staphylococcus Aureus (MRSA) in rusthuizen), regionaal (vb. Recommendation sur lÊhypertension 13 van de Société scientifique de Médecine générale), nationaal (vb. KCE richtlijnen preoperatief onderzoek) en internationaal niveau (vb. richtlijn voor rugpijn van de European Commission research directorate general 14 ).

Les recommandations pour la pratique peuvent également être différenciées selon leur lieu dÊorigine : elles peuvent être créées au niveau local (par ex. recommandation pour la pratique du LOK limbourgeois – Methiciline Resistente Staphylococcus Aureus (MRSA) dans les maisons de repos), régional (par ex. Recommandation sur lÊhypertension 13 de la Société scientifique de Médecine générale), national (par ex. Recommandations KCE Evaluation des risques préopératoires) et international (par ex. directive concernant le mal de dos de la Direction générale de la recherche de la Commission européenne 14 ).


–– Het European Directorate for the Quality of Medicines (EDQM), groep Homeopathic Manufacturing Methods (HMM), voor de algemene monografie met betrekking tot de bereidingsmethodes van homeopathische stamproducten en de deconcentratie;

–– L’European Directorate for the Quality of Medicines (EDQM), groupe Homeopathic Manufacturing Methods (HMM), pour la monographie générale relative aux méthodes de préparation de souches homéopathiques et déconcentration ;


EDQM European Directorate for the Quality of Medicines

EDQM European Directorate for the Quality of Medicines


The implementation of the new organisation chart as envisaged for the start of 2009 requires the P&O Service to develop a definition of its future role in terms of the expectations from the 3 Directorates-General and other departments and services, to implement the 1 % reduction imposed for personnel expenditure and to further develop the strategic decision to convert the FAMHP into a “learning organisation”.

The implementation of the new organisation chart as envisaged for the start of 2009 requires the P&O Service to develop a definition of its future role in terms of the expectations from the 3 Directorates-General and other departments and services, to implement the 1 % reduction imposed for personnel expenditure and to further develop the strategic decision to convert the FAMHP into a “learning organisation”.


Externe validatoren: Luc Pineux (Société Scientifique de Médecine Générale), Stijn Van de Velde (CEBAM, voorzitter van de validatie) en Philip Van der Wees (Harvard Medical School) valideerden de richtlijn volgens de procedure van het Belgisch Centrum voor Evidence-Based Medicine (CEBAM)

Validateurs externes : Luc Pineux (Société Scientifique de Médecine Générale), Stijn Van de Velde (CEBAM, président de la validation) et Philip Van der Wees (Harvard Medical School) ont validé ce guide selon la procédure du Centre belge pour l'Evidence-Based Medicine (CEBAM)




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Date index: 2023-08-22
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