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Drug Seminar Registration under Decree 54

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DRUG SEMINAR REGISTRATION UNDER DECREE 54

16 May 2018

Under previous legislation, drug seminar and drug information registrations were treated differently and were given separate registration procedures.  Under Decree No. 54/2017/ND-CP (“Decree 54”), a drug seminar is treated as a form of drug information provision and the registration procedures are nearly identical.

Decree 54 sets out the procedural requirements for drug information registration for holding drug seminars as follows:

Applicant

The following entities may apply for certification of drug information:

  • Establishments applying for drug registration in Vietnam;
  • Representative offices in Vietnam authorized by the overseas establishments that apply for drug registration in Vietnam;
  • Vietnamese pharmacy business establishments authorized by the establishments mentioned in Section (a) herein; and,
  • Vietnamese drug importers, which may only provide information about the drugs they import by holding drug seminars.

Authority

The application dossier for the registration of seminar shall submitted to the provincial Departments of Health.

Required Documents for Registration

  • Application for drug information registration;
  • Drug information;
  • Specimens of the label and package insert approved by the Ministry of Health;
  • Reference documents relating to the drug information to be certified (if any);
  • The certificate of drug registration or the license for drug import;
  • The license for establishment of a representative office in Vietnam if the applicant is a foreign establishment; and,
  • The agenda of the drug seminar.

Issuing duration

15 days from the day on which the satisfactory application is received.

Effectiveness and Expiry Date

  • The certification of drug information is effective nationwide.
  • The certification of drug information does not have a specific expiration date and shall be invalidated in the following cases: (i) The certificate of drug registration or the license for drug import is revoked; or (ii) A change to drug information is made that requires issuance of another certification of drug information.

For more information, please contact Michael Lee at michael.lee@dilinh.com.