Draft Pharmaceutical Law (to amend 44 out of 116 articles of the current Pharmaceutical Law 2016).
Following the sharings of the Deputy Director of Drug Administrative of Vietnam (DAV), Mr. Nguyen Thanh Lam (the link below), some new points of the draft Pharmaceutical Law (amendment) will be:
1. Implement reference, recognition, and mutual recognition mechanisms for new drugs (such as FDA, EMA, TGA, PMDA, etc.) to reduce the appraisal time for Marketing Authorization (MA). This involves using scientific evaluation results for new drugs, vaccines, and biological products.
2. Reform administrative procedures to reduce MA appraisal time from 12 months to 9 months. Establish regulations that align with international practices for the automatic renewal of MA.
3. Manage drug prices in accordance with the new Bidding Law and Price Law.
4. Provide special investment incentives for the production of innovative drugs, high-technology products, vaccines, and biological products in Vietnam.
5. Allow the sale of drugs on e-commerce platforms. This topic has sparked recent debate on social media and in newspapers, with discussions about whether it should be banned or allowed, and if both OTC and ETC drugs should be included or only OTC.
Link: HERE
Disclaimer: ThisLegal Update is intended to provide updates on the Laws for informationpurposes only, and should not be used or interpreted as our advice for businesspurposes. LNT & Partners shall not be liable for any use or application ofthe information for any business purpose. For further clarification or advicefrom the Legal Update, please consult our lawyers: Mr Ngo Thanh Hai at hai.ngo@lntpartners.com
External resources
PDF Document:
For further information, please contact:
Ngo Thanh Hai, LNT & Partners
hai.ngo@lntpartners.com
