Supplementing Various Cases of Drug Recall and Destruction from March 16, 2020

Illustrative image (source: internet)

Clause 12, Article 1 of Circular 03/2020/TT-BYT supplements cases of medicine subject to recall and destruction as stipulated in Clause 2, Article 15 of Circular 11/2018/TT-BYT:

“d) Counterfeit medicine, smuggled medicine, medicine of unknown origin or source, expired medicine, medicine containing prohibited substances, medicine made from substandard materials, medicine subject to destruction as prescribed by the Decree on administrative penalties in the healthcare sector, and stored medicine samples that have exceeded the retention period as per regulations.

Thus, from March 16, 2020, in addition to the cases specified in Points a, b, c, Clause 2, Article 15 of Circular 11, counterfeit, smuggled, or medicine of unknown origin subject to recall will all be destroyed.

Additionally, Circular 03/2020/TT-BYT also amends and supplements Clause 6, Article 15 of Circular 11 concerning the destruction of recalled medicines as follows:

- The head of the facility with medicine subject to destruction shall make a decision to establish a Medicine Destruction Council to organize, decide the method of destruction, and supervise the destruction process.

- The destruction of medicine must ensure the safety of people and animals and prevent environmental pollution according to the legal regulations on environmental protection. The facility with medicine subject to destruction shall bear all responsibility related to the destruction and must report along with the destruction minutes to the local Department of Health as stipulated in Form No. 06, Appendix III issued with this Circular.

- Regulations on vaccine destruction:

+ At least 07 days prior to the vaccine destruction, the destroying facility must provide a written notice of the destruction plan to the local Department of Health, including information on the name, quantity, concentration, or dosage of each vaccine to be destroyed, reasons for destruction, time, place, and method of destruction. The local Department of Health shall supervise the vaccine destruction.

+ The process and act of vaccine destruction must comply with the current regulations in Joint Circular 58/2015/TTLT-BYT-BTNMT and Circular 36/2015/TT-BTNMT.

+ Within 07 days from the completion date of vaccine destruction, the facility must submit a destruction report, along with the destruction minutes, to the local Department of Health and the Drug Administration of Vietnam. The destruction minutes as stipulated in Form No. 06, Appendix III issued with this Circular.

- The destruction of specially controlled drugs must follow the regulations in Article 48 of Decree 54/2017/ND-CP.

Please refer to other regulations in Circular 03/2020/TT-BYT, effective from March 16, 2020.

Tue Ba

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