schedule-13 (Relating to Sub-rule (2) of Rule 8)
Government of Nepal
Ministry of Health
Department of Drugs Administration
License for clinical trial
This license is hereby issued, setting out the following matters, allowing the following
person to conduct clinical trial of the following new drug, subject to the Drugs Act,
2035(1978) and the Drugs Registration Rules, 2038(1981).
1. Of the new drug licensed for clinical trial:



2. Of the disease licensed for clinical trial:
(a) Name:
(b) Method of diagnosis:
3. Of the consumption of the new drug to be administered in the course of clinical trial:
(a) Method:
(b) Mode:
(c) Dosage (daily):
(d) Period:
4. Mode of clinical trial:
5. Place where clinical trial is to be conducted:
6. Of the person allowed to conduct clinical trial:
(a) Name, surname and address:
(b) Occupation:
(c) Qualifications:
7. Validity period of license:
License receiver’s:
License issuing officer’s: Signature: Name
and surname: Designation:
(The matters to be written on t he reverse side of this license.)