Drugs Registration Rules, 2038 (1981) 

Section 5. Recommendation letter to be obtained for exportation or importation of drug: (1) For purposes of Section 9 of the Act, a person who intends to import or export a drug shall make an application to the Department in the format as referred to in Schedule-6. (2) If, on making necessary inquiry into the application received pursuant to Sub-rule (1), the Department deems proper to import or export the drug mentioned in the application, it shall issue the recommendation letter in the format as referred to in Schedule-7 by collecting the drug import and export fees as prescribed in Schedule-14

(3) Each drug manufacturer who has obtained the product license pursuant to Section 8 of the Act prior to the commencement of these Rules shall register each drug manufactured by it pursuant to these Rule within one year after the date of commencement of these Rules and obtain the drug sale and distribution registration certificate.