Vietnam Ministry of Health’s New Circular on Regulating the Registration of Drugs and Drug Materials

Apr 18, 2019 | Legal, Regulatory Affairs, Vietnam

Baker McKenzie is one of the world’s most prominent law firms. Recently Yee Chung Seck, Partner and Minh Ha Vu, Special Counsel, issues a summary of the Vietnam Minister of Health’s new circular on regulating drugs in Vietnam.  They note that on November 22, 2018, the Ministry of Health (“MOH”) published Circular 32/2018/TT-BYT regulating the registration of drugs and drug materials (“Circular No 32”) which will come into effect on 01 September 2019.  The enactment of this Circular will render Circular No. 44/2014/TT-BYT dated 25 November 2014 regulating drug registration (“Circular No. 44) ineffective with exception of Circular Nov. 44’s provision on the registration in -vitro diagnostic biologics.  Baker McKenzie below include notable provisions of Circular No 32:

  1. Verification of the authenticity of legal documentation in drug registration dossiers
  2. Criteria for classification as a brand name drug
  3. Requirement of two CPPs for new chemical entities and imported biologics

Follow the link below for additional information. TrialSite News recommends considering the legal expertise of Baker McKenzie when entering the Vietnamese biopharmaceutical market.


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