Resolution No. 275/1 of 1997 establishing a committee for study and registration of vaccines and veterinary medicines.

This Resolution is composed of 7 articles: establishment of a Committee composed of 10 members from the public and private sectors to regulate the importation of vaccines and veterinary medicines, to control their registration, to study the relevant international legislation, to control high quality and price (art. 1); establishment of a sub-committee to study the applications presented by importers which must contain the following documents: factory information form, factory licence from country of origin, medicine registration form, licence for manufacturing and vending of the medicine, the technical file of the medicine which must include (pharmacology, toxicology, bioavailability, inhibition test for antibiotics, teratogenecity, stability data, physico-chemical properties of preparation and clinical studies) and two samples of each medicine with the instructions for use (art. 3); registered medicines require authorization and must include proforma, analysis certificate and certificate of origin (art. 5).