Home Public Health Drug and Medicine Related Act, Rules, Regulations, Policies, Guidelines & Directives in Nepal

Drug and Medicine Related Act, Rules, Regulations, Policies, Guidelines & Directives in Nepal

by Public Health Update

Overview

Government of Nepal has established Department of Drug Administration (DDA) in 1979 to implement and fulfill the aim of Drug Act 1978 and various regulations under it. The National Drug Policy 1995 focuses on establishing co-ordination among government, non-government and private organizations involved in the activities related to medicine production, import, export, storage, supply, sales, distribution, quality assessment, regulatory control, rational use and information flow. Here are the list of major Drug and Medicine Related Plan, Policies & Directives endirsed by Government of Nepal.

List of Drug and Medicine Related Plan, Policies & Directives in Nepal

S.NoDocuments
1Codes on Sales and Distribution of Drugs, 2071 (English)
2Codes on Sales and Distribution of Drugs, 2071 (Nepali)
3Drug Act 2035 (English)
4Drug Act 2035 (Nepali)
5Drug Consultative Council and Drug Advisory Committee Regulation 2037
6Drug Investigation and Inspection Rules 2040
7Drug Registration Guidance 2073 (Medicine registration guidance)
8Drug Registration Regulation 2038
9Drug Registration Regulation Revision
10Drug Standard Regulation 2043
11Drugs Registration Rules, 2038 (1981)
12Emergency Use of Medicines or Vaccines Code, 2078
13Essential Medicine List
14Emergency Use of Medicines or Vaccines Code, 2078 Revision
15Guidelines for Drug Donation to Nepal
16Health Technology Product a Medical Device Directive 2074
17Health Technology Product a Medical Device Regulation
18Hospital Pharmacy Guideline 2072 (English)
19Hospital Pharmacy Guideline 2072 (Nepali)
20Hospital Pharmacy Guideline 2078 (New)
21Narcotic Drugs Control Act 2033
22National Drug Policy 1995
23National GMP Code 2072
24National GMP Code 2072 (Updated National GMP Codes)
25Nepalese National Formulary (NNF)- 3rd edition
26Nepalese National Formulary NNF 2nd Edition
27Special Permission Guidance (1st revision) 2021
28Special Permission Guidance 2074
29Special Permission Guidance 2074 (2017)_Translated Final
30SOP for Product Recalls
Drug and Medicine Related Act, Rules, Regulations, Policies, Guidelines & Directives in Nepal


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