Resolution No. 297 of 2009 on the registration rules and procedures of biological medicines, serums, vaccines and blood derivatives. Country/Territory Egypt Document type Regulation Date 2009 Source FAO, FAOLEX Original source Official Gazette No. 158 (Supplement), 8 July 2009, 26 pp Subject Livestock Keyword Drugs Registration Vaccination Certification Animal health Geographical area Africa, Mediterranean, Middle East, Near East and North Africa, Northern Africa, Red Sea & Gulf of Aden Entry into force notes This Resolution enters into force on the day after its publication in the Official Gazette. Abstract 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. Full text Arabic