English title translated by Policy Nepal for navigation. The Nepali legal text is authoritative.
- Type
- Ordinance
- Year
- २०७९ BS
- Status
- Status not yet confirmed
- Official text
- Official page
Analysis drawn from official reports, court rulings and published research, each cited. Figures are being double-checked against the source documents; corrections are welcome.
What does it do?
- This version of the Medicine (Third Amendment) Ordinance again amends the Drugs Act, 2035 with the same provisions as earlier versions, and treats everything done under the Medicine (Third Amendment) Ordinance issued on 2078 Baishakh 21 as done under this one.औषधि (तेस्रो संशोधन) अध्यादेशको यो संस्करणले पहिलेकै व्यवस्थाअनुसार औषधि ऐन, २०३५ संशोधन गर्छ, र २०७८ वैशाख २१ मा जारी भएको औषधि (तेस्रो संशोधन) अध्यादेशबमोजिम भए-गरेका काम यसै अध्यादेशबमोजिम भएको मानिन्छ। Federal Parliament Secretariat (na.parliament.gov.np) — ordinance text as tabled in the National Assembly Sections 1 and 4, PDF pp. 1–2
- It adds section 9A to the Drugs Act, 2035 on emergency use of medicines and vaccines: to prevent, control or eradicate an infectious disease that has spread as an epidemic, the Department registers for emergency use in Nepal, on the Drug Advisory Committee's recommendation, any medicine or vaccine listed by the World Health Organization, registered by the drug regulator of the country concerned, or given emergency-use authorisation by such a regulator. The Department recommends the import licence, may fix quantities and conditions of use, sale or distribution, and may cancel the registration if use needs to be stopped.यसले औषधि ऐन, २०३५ मा दफा ९क. थपी औषधि वा खोपको आपत्कालीन प्रयोगको व्यवस्था गर्छ: महामारीका रूपमा फैलिएको सङ्क्रामक रोगको रोकथाम, नियन्त्रण वा निर्मूलन गर्न विश्व स्वास्थ्य सङ्गठनमा सूचीकृत, सम्बन्धित मुलुकको औषधि नियामक निकायमा दर्ता भएका वा त्यस्तो निकायले आपत्कालीन प्रयोगको अनुमति दिएका औषधि वा खोपलाई औषधि सल्लाहकार समितिको सिफारिसमा विभागले नेपालमा आपत्कालीन प्रयोगका लागि दर्ता गर्छ। विभागले पैठारी अनुज्ञापत्रका लागि सिफारिस दिन्छ, पैठारी परिमाण र प्रयोग, बिक्री वा वितरणका शर्त तोक्न सक्छ र प्रयोग रोक्नुपर्ने देखिएमा दर्ता खारेज गर्न सक्छ। Federal Parliament Secretariat (na.parliament.gov.np) — ordinance text as tabled in the National Assembly Section 2 (new s. 9A), PDF p. 1
- It replaces section 31 on clinical trials: anyone wishing to run a clinical trial of a new medicine or vaccine needs a permit from the Department, and the Government of Nepal may allow a company developing a vaccine that is in clinical trials under the permission of a foreign government or regulator to run trials of that vaccine in Nepal.यसले क्लिनिकल ट्रायलसम्बन्धी दफा ३१ प्रतिस्थापन गर्छ: नयाँ औषधि वा खोपको क्लिनिकल ट्रायल गर्न चाहनेले विभागबाट अनुमतिपत्र लिनुपर्छ, र विदेशी सरकार वा नियामक निकायको अनुमतिमा क्लिनिकल ट्रायलमा रहेको खोप विकास गर्ने संस्था वा कम्पनीलाई नेपालमा त्यस्तो खोपको ट्रायल गर्न नेपाल सरकारले अनुमति दिन सक्छ। Federal Parliament Secretariat (na.parliament.gov.np) — ordinance text as tabled in the National Assembly Section 3 (new s. 31), PDF p. 2
- Under Article 114 of the Constitution, an ordinance has the same force as an Act, but it must be tabled at the next session of both Houses; it ceases to have effect if both Houses do not adopt it, if the President repeals it, or sixty days after both Houses meet. The National Assembly's ordinance-status list records it as 'स्वीकार' (accepted).संविधानको धारा ११४ अनुसार अध्यादेश ऐनसरह मान्य हुन्छ, तर यसलाई संसद्का दुवै सदनको पछिल्लो अधिवेशनमा पेश गर्नुपर्छ; दुवै सदनले स्वीकार नगरेमा, राष्ट्रपतिले खारेज गरेमा वा दुवै सदनको बैठक बसेको साठी दिनपछि यो स्वतः निष्क्रिय हुन्छ। राष्ट्रिय सभाको अध्यादेश-अवस्था सूचीमा यसलाई 'स्वीकार' भनी उल्लेख गरिएको छ। Nepal Law Commission · Federal Parliament of Nepal Article 114(1)–(2), PDF p. 62; NA ordinance-status entry
Gaps, loopholes and improvement ideas
None documented in the official reports we have reviewed so far.
Where does it conflict with other laws?
No conflict with another law is documented in the sources we have reviewed so far.