New Circular on Drug Registration

Circular 22/2009/TT-BYT issued by the Ministry of Health, effective May 24, 2010, has clarified certain issues related to intellectual property rights and drug marketing approval in Vietnam. The Circular emphasizes that the applicant for marketing approval for a drug shall be responsible for any infringement of IPRs used on or in relation to the drug. Consequently, proof of IP cleanness for a drug, such as search reports, registration certificates, or application acceptance decisions, is no longer required by the Drug Administration of Vietnam for obtaining drug marketing approvals.