Process Registration of Pharmaceuticals in Nepal Legal Provision Step 1: Registration of a Pharmaceutical Company at Office of Company Registrar Registration in Ward OfficeTax registration in a Tax office Company Act, 2063 (Sec 3) For Manufacturing For Sale Step 2: Recommendation letter to be obtained from;· Department of Drug Administration (DDA) to establish a drug industry.· Ward Office Recommendation letter to be obtained from;Department of Drug Administration (DDA) to establish a drug industryWard Office. Drug Act, 2035 (sec.7) Drug Registration Regulation, 2038 (Rule 3) Step 3: Registration of Pharmaceutical company in Department of Industry (DoI) Industrial Enterprises Act, 2076. (sec.4 and 5) Step 4: Initial Environmental Examination (IEE) or Environment Impact Assessment (EIA) to be done. Industrial Enterprises Act, 2076. (sec. 7) For Manufacturing For Sale Step 5: Obtain product license to manufacture drugs(Approval for manufacturing plant layout) Registration prior to importation of drugs/ Recommendation letter to be obtained for exportation or importation of drugs Drug Act, 2035 (sec.9) Drug Registration Regulation, 2038 (Rule 5) Step 4: Registration of drugs prior to its sale and distribution / Registration prior to importation of drugs Drug Act, 2035 (sec.8 ((2)) Drug Registration Regulation, 2038 (Rule 4B)] Step 5: Obtain certificate of registration of name, and shop or firm selling and distributing drug Drug Act, 2035 (sec.10) Drug Registration Regulation, 2038 (Rule 6)] Step 6: Obtain license to make publicity or advertisement of drug Drug Act, 2035 (sec.19) Drug Registration Regulation, 2038 (Rule 7)
In summary the whole process involves following steps:
- Registration of Pharmaceutical Company at Office of Company Registrar (OCR), following Ward and Tax Registration
- Recommendation letter to be obtained to establish drug industry (From Department of Drug Administration)
- Registration of industry (Through submission of application Department of Industry) Initial Environmental Examination (IEE) or Environment Impact Assessment (EIA) to be done after registration.
- Obtain product license to manufacture drugs
- Registration of drugs prior to its sale and distribution
- Registration prior to importation of drugs
- Recommendation letter to be obtained for exportation or importation of drugs
- Obtain certificate of registration of name, and shop or firm selling and distributing drugs
- Obtain license to make publicity or advertisement of drug