Traduction de «medicinal products used » (Néerlandais → Français) :

Herbal medicinal products In line with the provisions of the royal decree of 14 December 2006, three procedures are used for the issue of the MA or registration for herbal medicinal products: the full procedure, the “Well Established Use” procedure and a third specific procedure for traditional herbal medicines as stipulated in article 43 of the royal decree.
Herbal medicinal products In line with the provisions of the royal decree of 14 December 2006, three procedures are used for the issue of the MA or registration for herbal medicinal products: the full procedure, the “Well Established Use” procedure and a third specific procedure for traditional herbal medicines as stipulated in article 43 of the royal decree.

narcotics and concerning risk limitation and therapeutic advice and of 22 January 1998 governing certain psychotropic substances and concerning risk limitation and therapeutic advice and of 12 April 1974 containing certain provisions relating to substances with hormonal, antihormonal, anabolic, beta-adrenergic, anti-infectious, antiparasitic and anti-inflammatory action Law of 15 July 1985 on the use in animals of substances with hormonal, anti-hormonal, beta-adrenergic or production stimulating action Law of 13 June 1986 on the removal and transplanting of organs, with regard to cells and tissues Law of 28 August 1991 on the practice of veterinary medicine, regarding the provision of medicines to animal carers Law of 5 July 1994 on blood and blood derivatives of human origin Law of 7 May 2004 on experiments on the human person Royal decree of 31 May 1885 approving new instructions for physicians, pharmacists and druggists Royal decree of 22 September 1966 on the conditions and arrangements for the recognition of laboratories for the analysis and checking of medicines Royal decree of 6 June 1960 on the production, preparation and wholesale distribution and delivery of medicines Royal decree no. 78 of 10 November 1967 on the practice of the healthcare professions regarding the dispensing of medicines to the public and Royal decree of 25 September
narcotics and concerning risk limitation and therapeutic advice and of 22 January 1998 governing certain psychotropic substances and concerning risk limitation and therapeutic advice and of 12 April 1974 containing certain provisions relating to substances with hormonal, antihormonal, anabolic, beta-adrenergic, anti-infectious, antiparasitic and anti-inflammatory action Law of 15 July 1985 on the use in animals of substances with hormonal, anti-hormonal, beta-adrenergic or production stimulating action Law of 13 June 1986 on the removal and transplanting of organs, with regard to cells and tissues Law of 28 August 1991 on the practice of veterinary medicine, regarding the provision of medicines to animal carers Law of 5 July 1994 on blood and blood derivatives of human origin Law of 7 May 2004 on experiments on the human person Royal decree of 31 May 1885 approving new instructions for physicians, pharmacists and druggists Royal decree of 22 September 1966 on the conditions and arrangements for the recognition of laboratories for the analysis and checking of medicines Royal decree of 6 June 1960 on the production, preparation and wholesale distribution and delivery of medicines Royal decree no. 78 of 10 November 1967 on the practice of the healthcare professions regarding the dispensing of medicines to the public and Royal decree of 25 September

Advies van 21/09/2012 (PDF, 158.49 Kb) met betrekking tot " ethanol content in medicinal products used in children (including herbal medicinal products and homeopathic medicinal products)" (English version).
Avis du 21/09/2012 (PDF, 158.49 Kb) concernant l'" ethanol content in medicinal products used in children (including herbal medicinal products and homeopathic medicinal products )" (english version).

The prevention of adverse effects and adverse events attributable to the use of medicines and health products is closely linked with information for healthcare professionals and the public regarding the risks associated with the use of medicines and health products.
The prevention of adverse effects and adverse events attributable to the use of medicines and health products is closely linked with information for healthcare professionals and the public regarding the risks associated with the use of medicines and health products.

Healthcare professionals and consumers of medicines and health products need to be made aware of the utility and obligation (in the case of materiovigilance and haemovigilance) of reporting adverse effects and adverse events associated with the use of medicines and health products to the FAMHP. Furthermore, the report form should be made easy to complete
Healthcare professionals and consumers of medicines and health products need to be made aware of the utility and obligation (in the case of materiovigilance and haemovigilance) of reporting adverse effects and adverse events associated with the use of medicines and health products to the FAMHP. Furthermore, the report form should be made easy to complete

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).

De gegevens over de veiligheid van aliskiren werden recent herbekeken door het Committee for Medicinal Products for Human Use (CHMP) van het European Medicines Agency (EMA) [ www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2012/02/WC500122916.pdf ].
Les données concernant le profil d’innocuité de l’aliskirène ont été récemment revues par le Committee for Medicinal Products for Human Use (CHMP) de l’Agence européenne des médicaments (EMA) [ www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2012/02/ WC500122916.pdf ].

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.

Working through the backlog 54 –– Medicinal products for human use 54 –– Veterinary medicines Unit 55
Working through the backlog 54 –– Medicinal products for human use 54 –– Veterinary medicines Unit 55

De " hulpstoffen met erkende werking" (met de toedieningsweg en de drempelwaarde vanaf dewelke effecten mogelijk zijn, en met uitleg over de risicogroepen) zijn gedefinieerd in het richtsnoer van de Europese Commissie " Excipients in the label and package leaflet of medicinal product for human use" (juli 2003, te raadplegen via [http ...]
Les " excipients à effet notoire " (avec la voie d’administration et la valeur-seuil à partir de laquelle des effets sont possibles, ainsi que des explications sur les groupes à risque) sont définis dans une directive de la Commission européenne " Excipients in the label and package leaflet of medicinal product for human use" (juillet 2003, à consulter sur [http ...]