New Procedure for Administrative Procedures in the Pharmaceutical Sector from the Ministry of Health

The Ministry of Health has enacted Decision No. 3166/QD-BYT to standardize the execution of administrative procedures related to the import of reference standards for research and testing purposes.

Scope and Purpose of the Decision

The Ministry of Health has shared Decision No. 3166/QD-BYT, which regulates the internal process for the execution of administrative procedures in the field of pharmaceutical business, with the public. Signed by Deputy Minister Do Xuan Tuyen, this new regulation aims to standardize the steps of application procedures within the management agency.

The relevant decision applies specifically to application procedures for import licenses of reference substances belonging to the list of narcotic substances, psychotropic substances, and precursor substances used for research and testing in pharmaceuticals.

Legal Basis and Process Details

This new procedure, coded QT.QLD.KD.18.01, was developed based on existing legal regulations such as Decree No. 163/2026/ND-CP. The processing time for applications is set at a total of 15 working days from the date of submission of complete and valid documents.

The authorized address where applications will be received and results officially notified is the One-Stop Service Center for Administrative Procedures operating under the Ministry of Health.

Working Steps and Required Documents

The working process consists of a total of 11 detailed steps, ranging from the receipt and review of documents by experts to coordination and approval from department heads and the Drug Administration Department.

During the application process, documents such as a written request, a copy of the legal entity's registration certificate, a detailed usage plan explaining the import purpose, and a certificate of eligibility for pharmaceutical trading are requested.