Titre :	Contract Manufacturing of Medicines
Type de document :	texte imprimé
Auteurs :	Magdalena KREKORA, Auteur
Mention d'édition :	3ème édition
Editeur :	KLUWER LAW INTERNATIONAL
Année de publication :	2008
Importance :	460 pages
Format :	Relié
ISBN/ISSN/EAN :	978-90-411-2642-9
Langues :	Anglais (eng)
Catégories :	Droit comparé et droits étrangers Droit de la santé, droit pharmaceutique, droit de la personne et du corps humain Droit des contrats spéciaux Droit économique, droit du marché
Mots-clés :	industrie pharmaceutique  médecine  médicaments  droit de la santé  fabrication  importation  bonnes pratiques de fabrication  contrat de fabrication  autorisation de mise sur le marché
Index. décimale :	344.042 33 : Contrôle des médicaments
Résumé :	Taking advantage of liberal regulations under the current world trade regime that permit the separation of manufacturing from marketing, many pharmaceutical companies (like other companies) outsource the actual manufacture of their products. However, because the quality of medicines is crucial to public health, the pharmaceutical industry is perhaps the most regulated of all industries. In most countries medicines are controlled prior to their marketing, and their manufacture is carried out under strict supervision. Necessarily, numerous international initiatives have led to elaboration of standards relating to the manufacture and marketing of medicines. These standards impose stringent rules on all parties to pharmaceutical manufacturing contracts. This very useful book provides a comprehensive global guide to the legal issues and procedures involved in outsourcing the manufacture of medicines. It describes the legal requirements relating to the manufacture and distribution of medicines, emphasising the impact of regulatory supervision on the rights and obligations of persons who outsource manufacturing of medicines and on those who provide the manufacturing services. Indispensable to counsel for pharmaceutical companies of any size, Contract Manufacturing of Medicines will also be of great value to practitioners and academics concerned with international trade for its precise, in-depth delineation of the inner workings of a complex and highly significant trade regime.

Contract Manufacturing of Medicines [texte imprimé] / Magdalena KREKORA, Auteur  . -  3ème édition . - KLUWER LAW INTERNATIONAL, 2008 . - 460 pages ; Relié.
ISBN : 978-90-411-2642-9
Langues : Anglais (eng)

Catégories :	Droit comparé et droits étrangers Droit de la santé, droit pharmaceutique, droit de la personne et du corps humain Droit des contrats spéciaux Droit économique, droit du marché
Mots-clés :	industrie pharmaceutique  médecine  médicaments  droit de la santé  fabrication  importation  bonnes pratiques de fabrication  contrat de fabrication  autorisation de mise sur le marché
Index. décimale :	344.042 33 : Contrôle des médicaments
Résumé :	Taking advantage of liberal regulations under the current world trade regime that permit the separation of manufacturing from marketing, many pharmaceutical companies (like other companies) outsource the actual manufacture of their products. However, because the quality of medicines is crucial to public health, the pharmaceutical industry is perhaps the most regulated of all industries. In most countries medicines are controlled prior to their marketing, and their manufacture is carried out under strict supervision. Necessarily, numerous international initiatives have led to elaboration of standards relating to the manufacture and marketing of medicines. These standards impose stringent rules on all parties to pharmaceutical manufacturing contracts. This very useful book provides a comprehensive global guide to the legal issues and procedures involved in outsourcing the manufacture of medicines. It describes the legal requirements relating to the manufacture and distribution of medicines, emphasising the impact of regulatory supervision on the rights and obligations of persons who outsource manufacturing of medicines and on those who provide the manufacturing services. Indispensable to counsel for pharmaceutical companies of any size, Contract Manufacturing of Medicines will also be of great value to practitioners and academics concerned with international trade for its precise, in-depth delineation of the inner workings of a complex and highly significant trade regime.