Legal Documents

Legal Documents

Title Drugs Act 2035 (1978)
Legal Type Act
Issue Agency Ministry of Health
Responsible Agency Ministry of Health
Issuing Date 2017-02-07
Download English Drugs Act 2035 (1978)
Download Nepali Drugs Act 2035 (1978)

List Measures/Standards

Name Description Comment Status Measures/Standards Measure Class
Recommendation letter to be obtained to establish drug industry Section 7. Recommendation letter to be obtained to establish drug industry: Any person who intends to establish an industry to manufacture any drugs shall obtain a recommendation letter from the Department as prescribed, prior to the obtaining of approval of the Government of Nepal pursuant to the prevailing law. Comments Active measures Goods
Drug production license to be obtained Section 8. Drug production license to be obtained: (1) After the establishment of a drug industry by obtaining recommendation of the Department pursuant to section 7 and before the manufacturing of that drug, the drug manufacturer shall obtain the product license from the Department as prescribed, by paying the prescribed fees. (2) Any drug industry which has already been established prior to the commencement of this Act shall also obtain the product license pursuant to Subsection (1), -------- by paying the prescribed fees.. Comments Active measures Goods
Registration of drug Section 8A. Registration of drug Comments Active measures Goods
Recommendation letter to be obtained for exportation or importation of drug Section 9. Recommendation letter to be obtained for exportation or importation of drug Comment Active measures Goods
Registration of name for sale and distribution of drug: Section 10. Registration of name for sale and distribution of drug: Any person who sells and distributes a drug shall get his/her name and shop or firm registered with the Department, as prescribed, and obtain a certificate, on payment of the prescribed fees. Comments Active measures Goods
Prohibition on manufacture, sale, distribution, export, import, storage or consumption of drug not conforming to prescribed standard Section 13. Prohibition on manufacture, sale, distribution, export, import, storageor consumption of drug not conforming to prescribed standard: Noperson shall manufacture, sell, distribute, export, import, store, or cause to dosame or cause the consumption of, a drug which is not safe for publicconsumption, efficacious and of quality standard. Comments Active measures Goods