Traduction de «registration of new veterinary medicinal » (Néerlandais → Français) :

-- Further guidance on interpretation of the data from guideline CVMP-VICH GL27 guidance on pre-approval information for registration of new veterinary medicinal products for food producing animals with respect to antimicrobial resistance (CVMP/VICH/644/01)
-- Further guidance on interpretation of the data from guideline CVMP-VICH GL27, guidance on pre-approval information for registration of new veterinary medicinal products for food producing animals with respect to antimicrobial resistance (CVMP/VICH/644/01)

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

Veterinary medicines Unit For the fifth year in a row the number of applications closed for obtaining marketing authorisation (MA) within the Veterinary medicines Unit has exceeded the number of new applications submitted.
Veterinary medicines Unit For the fifth year in a row the number of applications closed for obtaining marketing authorisation (MA) within the Veterinary medicines Unit has exceeded the number of new applications submitted.

The Registration (marketing authorisation) department of the FAMHP is responsible for evaluating new applications and applications for changes to existing marketing authorisations (variations), with a view to grant the authorisation for marketing a medicine or health product.
The Registration (marketing authorisation) department of the FAMHP is responsible for evaluating new applications and applications for changes to existing marketing authorisations (variations), with a view to grant the authorisation for marketing a medicine or health product.

Other concrete initiatives were also taken to increase the effectiveness of the FAMHP, such as the stabilisation and improvement of the MeSeA system, as well as the commencement of a new project to clear the backlogs within the Registration department within the entity for medicines for human use.
Other concrete initiatives were also taken to increase the effectiveness of the FAMHP, such as the stabilisation and improvement of the MeSeA system, as well as the commencement of a new project to clear the backlogs within the Registration department within the entity for medicines for human use.

Processing of registrations, five-yearly renewals (RQ), variations for veterinary medicines via NP, DCP, MRP
Processing of registrations, five-yearly renewals (RQ), variations for veterinary medicines via NP, DCP, MRP

Some achievements and figures for the Veterinary Medicines unit in 2007 KPIs and measurement results The most important KPI for this unit is the proportion of the number of finalised applications to the number of new, submitted applications, as a measure of the evolution of the unit’s backlog.
Some achievements and figures for the Veterinary Medicines unit in 2007 KPIs and measurement results The most important KPI for this unit is the proportion of the number of finalised applications to the number of new, submitted applications, as a measure of the evolution of the unit’s backlog.

Various roadshows were organised in order to inform the FAMHP stakeholders about this new activity within the FAMHP and to provide a coherent explanation of recent regulations regarding medicines for veterinary use and the distribution of these products in particular; the roadshows were organised for and in collaboration with the veterinarian professional organisations.
Various roadshows were organised in order to inform the FAMHP stakeholders about this new activity within the FAMHP and to provide a coherent explanation of recent regulations regarding medicines for veterinary use and the distribution of these products in particular; the roadshows were organised for and in collaboration with the veterinarian professional organisations.