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blue-check Some issues relating to implementation of the Law on Pharmacy

Official letter No. 9296/QLD-DK dated August 9th, 2021 of the Drug Administration of Vietnam regarding issues relating to implementation of 2016 Law on Pharmacy
Posted: 18/8/2021 3:54:33 PM | Latest updated: 23/9/2021 8:58:25 AM (GMT+7) | LuatVietnam: 5290 | Vietlaw: 528
VietlawOnline

In principle dossiers of customs clearance of drugs imported/exported are not required to present the certificates of registration for free sale because they are searched on the Drug Administration of Vietnam's website (Clause 2 Article 29 of Decree No. 54/2017/ND-CPstatus2 ).

However, in case the declared information is insufficient or changed or different, Customs Authorities may request enterprises to provide the originals or valid photocopies of the certificates of registration for free sale for reviewing.

From January 1st, 2021, procedures for maintaining validity of certificates of registration for free sale of drugs are also settled online and updated on the Drug Administration of Vietnam's website. The way to search information about drugs of which the certificates of registration for free sale are maintained are instructed at Official letter No. 777/QLD-DK dated February 3rd, 2021.

However, it should note that drugs of which the certificates of registration for free sale were maintained before January 1st, 2021 by the direct method and information has not yet updated on the Drug Administration of Vietnam's website, enterprises have to provide the originals or valid photocopies of the documents maintaining validity of the certificates of registration for free sale for customs authorities for reviewing upon carrying out procedures for customs clearance.

For the case where there is incorrect information in certificates of registration for free sale due to mistakes in the course of preparing applications of enterprises or mistakes in the course of composing decisions on issuance of the certificates of registration for free sale, the Drug Administration of Vietnam shall offer documents to correct and the enterprises have to provide the originals or valid photocopies of documents on corrections for reviewing upon carrying out procedures for customs clearance.

This Official letter also attaches a List of documents guiding the extension, maintenance of validity of certificates of registration for free sale of drugs.

Ms Phuong Thao (VietlawOnline.com)
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Published Vietlaw's Newsletter No. 528
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