Legal Documents

Legal Documents


Title	Drugs Registration Rules, 2038 (1981)
Legal Type	Regulation
Issue Agency	Ministry of Health
Responsible Agency	Ministry of Health
Issuing Date	2017-02-07
Download English	Drugs Registration Rules, 2038 (1981)
Download Nepali	Drugs Registration Rules, 2038 (1981)

List Measures/Standards

Name	Description	Comment	Status	Measures/Standards	Measure Class
Recommendation letter to be obtained for exportation or importation of drug	To prevent the misuse or abuse of drugs and allied pharmaceutical substances and false or misleading information relating to the efficacy and use of drugs and to control the production, sale, distribution, export, import, storage and consumption of those drugs which are not safe for public consumption, efficacious and of standard quality	Rupees 10 postage stamp in the application. Drug import and export fees as prescribed in Schedule-14.	Active	measures	Goods
Registration prior to importation of drug	Prevent the misuse or abuse of drugs and alliedpharmaceutical substances and false or misleading information relating to the efficacy and use ofdrugs and to control the production, sale, distribution, export, import, storage and consumption ofthose drugs which are not safe for public consumption, efficacious and of standard quality.	Rupees 10 Postage Stamp on the application formImport fees as per the Schedule 14	Active	measures	Goods
Recommendation letter to establish drug industry	Section 3 - Recommendation letter to establish drug industry	Comments	Active	measures	Goods
Product license to be obtained to manufacture drug	Section 4- Product license to be obtained to manufacture drug	Comments	Active	measures	Goods
Registration of drug prior to its sale and distribution	Section 4A. Registration of drug prior to its sale and distribution	Comments	Active	measures	Goods
Recommendation letter for exportation or importation of drug	Recommendation letter to be obtained for exportation or importation of drug	Comments	Active	measures	Goods

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