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.
Египет · 2009-01-01