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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.

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