Vertaling van "authorisation for medicines for human use " (Nederlands → Frans) :

Simplified marketing authorisation (MA) for medicines for human use. Unique national registration number for medicines for human use.
Simplified marketing authorisation (MA) for medicines for human use. Unique national registration number for medicines for human use.

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.
Règlement (CE) n o 726/2004 du Parlement européen et du Conseil du 31 mars 2004 établissant des procédures communautaires pour l'autorisation et la surveillance en ce qui concerne les médicaments à usage humain et à usage vétérinaire, et instituant une Agence européenne des médicaments, JO L 136 du 30 avril 2004, pp.0001-0033 ( [http ...]

1974 on the opening, transfer and merger of retail pharmacies Royal decree of 9 July 1984 on the provision of information and advertising relating to medicines Royal decree of 11 January 1993 determining the conditions under which medicines for human use may be supplied in sample form Royal decree of 7 April 1995 on the provision of information and advertising relating to medicines for human use Royal decree of 15 July 1997 on active implantable medical devices, transposing Directive 90/385 EEC (AIMD) Royal decree of 19 December 1997 on the control and analysis of the raw materials used by dispensing chemists Royal decree of 18 March 1999 on medical devices, transposing Directive 93/42/EEC of 14 June 1993 (MDD) Royal decree of 11 July 2003 determining the conditions under which medicines for veterinary use may be supplied in sample form Law of 16 December 2004 modifying the regulations on combating abuses in the promotion of medicines Royal decree of 10 June 2006 establishing the report point referred to in Article 10, § 5, of the law of 25 March 1964 on medicines Royal decree of 23 November 2006 implementing Article 10, § 3, of the law of 25 March 1964 on medicines Royal decree of 25 February 2007 recognising the institutions referred to in Article 10 § 3 of the law of 25 March 1964 on medicines
1974 on the opening, transfer and merger of retail pharmacies Royal decree of 9 July 1984 on the provision of information and advertising relating to medicines Royal decree of 11 January 1993 determining the conditions under which medicines for human use may be supplied in sample form Royal decree of 7 April 1995 on the provision of information and advertising relating to medicines for human use Royal decree of 15 July 1997 on active implantable medical devices, transposing Directive 90/385 EEC (AIMD) Royal decree of 19 December 1997 on the control and analysis of the raw materials used by dispensing chemists Royal decree of 18 March 1999 on medical devices, transposing Directive 93/42/EEC of 14 June 1993 (MDD) Royal decree of 11 July 2003 determining the conditions under which medicines for veterinary use may be supplied in sample form Law of 16 December 2004 modifying the regulations on combating abuses in the promotion of medicines Royal decree of 10 June 2006 establishing the report point referred to in Article 10, § 5, of the law of 25 March 1964 on medicines Royal decree of 23 November 2006 implementing Article 10, § 3, of the law of 25 March 1964 on medicines Royal decree of 25 February 2007 recognising the institutions referred to in Article 10 § 3 of the law of 25 March 1964 on medicines

Advisory commission which is consulted e.g. in cases of non-availability of medicines Commission for the approval of institutions assigning preliminary approvals for scientific events Commission for the establishment of retail pharmacies and chambers of appeal (Frenchspeaking chamber and Dutch-speaking chamber) Commission for the recognition of pharmacists-clinical biologists Commission for the supervision of advertising for medicines for human use Evaluation commission for active implantable medical devices Evaluation commission for homeopathic medicines Evaluation commission for medical devices Evaluation commission for medicines for human use Evaluation commission for medicines for veterinary use Evaluation commission for traditional herbal medicines Pharmacopoeia commission
Advisory commission which is consulted e.g. in cases of non-availability of medicines Commission for the approval of institutions assigning preliminary approvals for scientific events Commission for the establishment of retail pharmacies and chambers of appeal (Frenchspeaking chamber and Dutch-speaking chamber) Commission for the recognition of pharmacists-clinical biologists Commission for the supervision of advertising for medicines for human use Evaluation commission for active implantable medical devices Evaluation commission for homeopathic medicines Evaluation commission for medical devices Evaluation commission for medicines for human use Evaluation commission for medicines for veterinary use Evaluation commission for traditional herbal medicines Pharmacopoeia commission

It is also essential for rational and safe use of medicines that the information in advertising agrees with the elements approved of when the marketing authorisation (MA) for the medicine was granted. Healthcare professionals when making a therapeutic choice should not be influenced by elements that are not associated with the characteristics of the medicine.
It is also essential for rational and safe use of medicines that the information in advertising agrees with the elements approved of when the marketing authorisation (MA) for the medicine was granted. Healthcare professionals when making a therapeutic choice should not be influenced by elements that are not associated with the characteristics of the medicine.

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.

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

Evaluation commission for active implantable medical devices Evaluation commission for homeopathic medicines Evaluation commission for medical devices Evaluation commission for medicines for human use Evaluation commission for medicines for veterinary use Evaluation commission for traditional herbal medicines Pharmacopoeia commission
Evaluation commission for active implantable medical devices Evaluation commission for homeopathic medicines Evaluation commission for medical devices Evaluation commission for medicines for human use Evaluation commission for medicines for veterinary use Evaluation commission for traditional herbal medicines Pharmacopoeia commission

Voor de producten die niet meer onder octrooi zijn, overweegt men in het EUvoorstel data protection voor nieuwe gegevens bij kinderen over veiligheid, kwaliteit en efficaciteit, te verbinden aan een nieuw type MA, PUMA (Pediatric Use Marketing Authorisation), tegelijk met een programma van financiering voor onderzoek hierin (Medicines Investigation for the Children of Europe, MICE).
Pour les produits qui ne sont plus sous patente, la Commission envisage dans sa proposition de subordonner une protection des nouvelles données pédiatriques en matière de sécurité, de qualité et d’efficacité à un nouveau type de M.A., la PUMA (Pediatric Use Marketing Autorisation), parallèlement à un programme de financement pour la recherche dans ce domaine (Medicines Investigation for the Children of Europe, MICE).

Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. [http ...]
Directive 2004/27/CE du Parlement européen et du Conseil du 31 mars 2004 modifiant la directive 2001/83/CE instituant un code communautaire relatif aux médicaments à usage humain, JO L 136 du 30 avril 2004, pp.0034-0057 ( [http ...]