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Chapter- 4

Chapter- 4
Manufacture, Sale, Distribution, Export and Import of Drugs

7. Recommendation letter to be obtained to establish drug industry:

Any person who intends to establish an industry to manufacture any drugs shall obtain  recommendation letter from the Department as prescribed, prior to the obtaining of approval of the Government of Nepal pursuant to the prevailing law.

8. Product 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 Sub- section (1), ——– ? by paying the prescribed fees.

♦ 8A. Registration of drug:

(1) Any drug manufacturing industry shall, prior to the

♦ Inserted by the Second Amendment.
? Amended by the Second Amendment.
? Deleted by the Second Amendment.
♦ Inserted by the Second Amendment.

sale and distribution of each drug manufactured by it, register the drug with the
Department, as prescribed, and obtain the drug registration certificate, by paying
the prescribed fees.
(2) Any person who intends to import a drug shall, prior to its importation, get each drug of a licensed company which it intends to import registered with the Department, as prescribed, and obtain the registration license, by paying the prescribed fees ? .

9. Recommendation letter to be obtained for exportation or importation of drug: Any person who intends to export or import a drug shall, prior to obtaining the export or import license pursuant to the prevailing law, obtain a recommendation letter from the Department, as prescribed, on payment of the prescribed fees.

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 ? .

♦ 10A. Sale and distribution of registered drugs only : Any person who has obtained the certificate pursuant to Section 10 shall sell and distribute only the drugs registered pursuant to Section 8A.

♣ 11. Validity period and renewal of product license, recommendation letter and certificate :

(1) The license as referred to in Section 8, the certificate as referred to in section 8A ♦ , the recommendation letter as referred to in Section 9 and the certificate as referred to in section 10 shall remain valid for two years from the date of its issue.
(2) Each license, recommendation letter and certificate shall be got

Inserted by the First Amendmend .
Inserted by the First Amendmend .
♦ Inserted by the Second Amendment.
♣ Amended by the First Amendment.

renewed for each year within thirty five days of the expiry of its validity period ? .
♦ (3) If the renewal is not made within the specified time limit pursuant to Sub-section (1), and an application is made, setting out the reasons for the failure to have renewal, within thee months after the date of expiry of the time limit, the Department shall make renewal by charging an additional fee of twenty five percent of the renewal fee. The license, recommendation letter or certificate not renewed even within that time limit shall ipso facto be invalid.


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