These Rules are framed in exercise of the powers conferred by section 40 of the Drugs Act, 2035 (1978). They contain provisions and procedure relating to obtaining: recommendation letter to establish drug industry (Rule 3); product licence for manufacturing the drug (Rule 4); registration of drug prior to its sale and distribution (Rule 4A); registration prior to importation (Rule 4B); recommendation letter for exportation or importation of drug (Rule 5); certificate of registration for sale and distribution of drug (Rule 6); licence for publicity or advertisement of drug (Rule 7); and licence for clinical trial of new drugs (Rule 8). The Schedules contain the format for the various applications mentioned in the Rules.
尼泊尔 · 1981-08-03