Resolution No. 297 of 2009 on the registration rules and procedures of biological medicines, serums, vaccines and blood derivatives. Pays/Territoire Égypte Type du document Règlement Date 2009 Source FAO, FAOLEX Source d'origine Official Gazette No. 158 (Supplement), 8 July 2009, 26 pp Sujet Bétail Mot clé Médicaments Enregistrement Vaccination Certification Santé des animaux Aire géographique Afrique, Méditerranée, Moyen-Orient, Afrique du Nord et Proche-Orient, Afrique du Nord, Mer Rouge et le Golfe d'Aden Entry into force notes This Resolution enters into force on the day after its publication in the Official Gazette. Résumé These Rules and Procedures are composed of 14 articles and 9 Annexes. Article 1 gives terms and definitions. Articles 2 to 14 deal with the following procedures and steps for the registration of biological medicines, serums, vaccines and blood derivatives: the Technical Committee for Control of Medicines is charged to recommend a number of medicines to be registered for each drug group; applicants shall submit a request to the Central Administration of Pharmaceutical Affairs for information about active substances, concentration, use, pharmaceutical form, pricing documents and industry of drugs; registration procedures after pricing; requirements for the registration of imported drugs; re-registration of biological medicines, serums and vaccines every 5 years; obligations of applicants; and, cases of the revocation of the registration. Annexes I to IX contain the following matters: documents necessary for pricing local and imported drugs; necessary documents for the registration and re-registration of local and imported biological medicines, serums, vaccines and blood derivatives; and, wording of the pledge of applicants. Texte intégral Arabe