Autorisation de mise sur le marché des médicaments à usage ...

Références et autres sources documentairesVariations[73] Guidance on variations to a prequalified product dossier. In: WHO Expert Committeeon Specifications for Pharmaceutical Preparations. Forty-first report. Genève,Organisation mondiale de la Santé, 2007, Annex 6 (OMS, Série de Rapports techniques,N° 943).[74] Guideline on dossier requirements for Type IA and IB notifications. EuropeanCommission/Enterprise and Industry Directorate-General/Pharmaceuticals[75] Guideline on the categorisation of extension applications (EA) versus variationsapplications (VA). Notice to applicants. Brussels, European Commission Enterprise andIndustry Directorate-General, Pharmaceuticals, (October 2003).Impuretés[76] Impurities in new drug substances Q3A(R1). (February 2002). - International Conferenceon Harmonisation of Technical Requirements for Registration of Pharmaceuticals forHuman Use. ICH Harmonised Tripartite Guideline.[77] Impurities in New Drug Products Q3B(R1). (February 2003) - International Conferenceon Harmonisation of Technical Requirements for Registration of Pharmaceuticals ForHuman Use - ICH Harmonised Tripartite Guideline[78] Impurities: Guideline for Residual Solvents Q3C(R3) (November 2005) - InternationalConference on Harmonisation of Technical Requirements for Registration ofPharmaceuticals For Human Use - ICH Harmonised Tripartite Guideline.ATC Classification[79] Guidelines for ATC classification and DDD assignment. Oslo, Centre collaborateurOMS pour la méthodologie des statistiques pharmaceutiques (révisé annuellement).(Disponible à l'adresse suivante: http://www.whocc.no/atcddd/).[80] The Anatomical, Therapeutic Chemical (ATC) classification system. In: The Selectionand Use of Essential Medicines. Report of the WHO Expert Committee. Genève,Organisation mondiale de le Santé, 2007, Annex 3 (OMS, Série de Rapports techniques,N° 946).Validation des procédés[81] Bonnes pratiques de fabrication des produits pharmaceutiques: lignes directricesconcernant la validation des procédés de fabrication. Dans : Comité OMS d’experts desspécifications relatives aux préparations pharmaceutiques. Trente-quatrième rapport.Genève, Organisation mondiale de la Santé, 1996, Annexe 6 (OMS, Série de Rapportstechniques, N° 863).[82] Supplementary guidelines on good manufacturing practices: validation. In: WHOExpert Committee on Specifications for Pharmaceutical Preparations. Fortieth report.Genève, Organisation mondiale de la Santé, 2006, Annex 4 (OMS, Série de Rapportstechniques, N° 937).[83] Note for guidance on process validation. Committee for Proprietary MedicinalProducts. London, European Agency for the Evaluation of Medicinal Products, 2001.(EMEA/CPMP/QWP/848/96/2001).131